common services agency · mr gerry marr, chief executive, nhs tayside (chair) ... nursing &...

National Services Division Gyle Square, 1 South Gyle Crescent, Edinburgh EH12 9EB Director Deirdre Evans

07\Policy Grps\NSSC\Agendas\2013\2013-11-26 NSSC Ag

National Specialist Services Committee

NSSC

Gyle Square

1 South Gyle Crescent

Edinburgh EH12 9EB

Telephone 0131 275 6575

Fax 0131 275 7614

www.nsd.scot.nhs.uk

NSSC 2013/37

Date: Tuesday, 26 November 2013

Location: Meeting Room 19, Gyle Square, Edinburgh

Time: 1.30pm-4.30pm

1. 2.

Welcome and Apologies Minutes of 27 August 2013

NSSC 2013/36

3. 4.

Matters Arising New Proposals Submitted:

Facial Transplant Unusual and Complex Sleep Disorders Epilepsy Next Generation Sequencing Genetic Service Scottish Paediatric & Adult Haemoglobinopathy (SPAH)

National Managed Clinical Network (NMCN)

NSSC 2013/38 NSSC 2013/39 NSSC 2013/40 NSSC 2013/41 NSSC 2013/42

5. Service Reviews / developments: Adult Neuro-Oncology Network Hyperbaric Medicine Proposed extended role for NSSC in light of changes to NPF

NSSC 2013/43 NSSC 2013/44 NSSC 2013/45

6. 7. 8. 9.

Work commissioned by SGHSC / NHS Board Chief Executives’ Group Review of risk share Adult renal transplantation Stereotactic radiotherapy for benign conditions - PID Co-location of congenital cardiac services

Horizon Scanning

Planning Transplantation to 2020 Any Other Business Dates of Future Meetings: All 1.30pm – 4.30pm Wednesday, 5 March 2014, Board Rooms Gyle Square, Edinburgh Wednesday, 14 May 2014, Meeting Room 7, Waverley Gate, Edinburgh Wednesday, 20 August 2014, Board Rooms Gyle Square, Edinburgh Wednesday, 19 November 2014, Board Rooms Gyle Square, Edinburgh

NSSC 2013/46 NSSC 2013/47 NSSC 2013/48 NSSC 2013/49 NSSC 2013/50 NSSC 2013/51

NSSC 2013/36

07 HSS/Cttees & Grps/Policy Grps/NSSC/Mins/ 2013-08-27 NSSC Mins Page 1

MINUTES OF 27 AUGUST 2013 MEETING

Subject: NATIONAL SPECIALIST SERVICE COMMITTEE (NSSC)

Date: 27 August 2013 File ref: 07 HSS/Cttees & Grps/Policy Grps/NSSC/Mins/2013/2013-08-27 NSSC Mins

Author: Mrs Deirdre Evans

Present: Mr Gerry Marr, Chief Executive, NHS Tayside (Chair)

Dr Ian Bashford, Medical Director, NHS Highland Mr Neil Fraser, Strategy & Performance Manager, NHS Tayside (deputising for Caroline Selkirk) (via video conference)

Dr Allan Gunning, Executive Director, Policy, Planning & Performance, NHS A&A Mr Colin Lauder, Head of Planning & Development, NHS Lanarkshire Mr Craig Marriott, Finance Director, NHS Dumfries & Galloway

Professor Alex McMahon, Director of Planning, NHS Lothian (Deputy Chair) Mr Craig Pratt, Assistant Director of Finance, NHS Fife Ms Catriona Renfrew, Director of Planning, NHS Greater Glasgow & Clyde

Dr Jeremy Thomas, Consultant Pathologist, NHS Lothian Chair of Professional Public & Patient Reference Group (NPPPRG) Dr Anne Maree Wallace, Director of Public Health, NHS Forth Valley

Dr Louise Wilson, Director of Public Health, NHS Orkney (via video conference) Observers: Scottish Government Health & Social Care Directorates (SGHSC)

Mr Craig Bell, National Planning Manager Mrs Elizabeth Porterfield, Head, Strategy and Planning Team

Secretariat: National Services Division (NSD) Mrs Deirdre Evans, Secretary Mr Peter Croan, Financial Adviser

Mrs Ruth Meechan, Assistant Secretary Miss Pauline Tollins, Assistant Secretary NPPPRG Dr Mike Winter, Medical Secretary

Apologies: Ms Kathy Collins, Nursing & Quality Adviser, National Services Division

Mr Mark O’Donnell, Scottish Government Health & Social Care Directorates (SGHSC) Ms Caroline Selkirk, Deputy Chief Executive, NHS Tayside Mrs June Smyth, Director of Work force, NHS Borders

Dr Pauline Strachan, Chief Operating Officer, NHS Grampian Dr Sarah Taylor, Director Public Health & Planning, NHS Shetland

1. Welcome and Apologies

Mr Marr welcomed those attending and listed the apologies. He introduced Mr Neil Fraser, Strategy and Performance Manager, NHS Tayside, who was deputising for Ms Caroline Selkirk. Mr Marr reported that it was the last meeting for Dr Anne Maree Wallace who was retiring from the NHS and who would be replaced in future meetings by Dr Graham Foster, Interim Director of Public Health & Planning, NHS Forth Valley. Mr Marr also informed the Group that it would be his last meeting because he too

NSSC 2013/36


was retiring and would be moving to Australia in the Winter. The Board Chief Executives’ Group would consider their nomination for his successor as chair of NSSC. All members thanked Dr Wallace and Mr Marr for their contributions to the work of NSSC and wished them well.

2. Minutes of 15 May 2013 – NSSC 2013/24

The Minutes were approved as a correct record. 3. Matters Arising – NSSC 2013/26

A written update had been circulated reporting on progress which was noted by the Committee. 3.1 Interventional Fetal Therapy – Fetoscopic Laser Ablation (for Twin to Twin Transfusion Service) – NSSC 2013/27 Dr Winter presented an update to the proposal that had been considered in February 2013 by NPPPRG which involved extending the current designated interventional fetal therapy service to provide twin to twin fetoscopic laser ablation. NPPPRG had recommended that a meeting of referring clinicians was held to ascertain clinical support. The paper reported on the meeting and set out potential options for the provision of a fetoscopic laser ablation service for residents of Scotland. In presenting the paper Dr Winter outlined that an initial aim of the interventional fetal therapy service was to provide twin to twin laser ablation along with other interventions, but when the service was first designated it was not in a position to provide this option. Subsequently, considerable work had been done to train appropriate staff, and NHS Greater Glasgow and Clyde was now in a position to offer the service. At the meeting in May between referring clinicians and those who deliver the service, concerns were expressed about some elements of providing the service in Scotland - largely relating to the single handled practitioner, and the need to ensure adequate numbers to maintain expertise. There was now a formal commitment from Birmingham to offer proctoring or, when required, for women from Scotland to travel to Birmingham as quaternary referrals from the Glasgow service. Publication of quality standards in England was imminent and these might involve minimum numbers of interventions per centre, although it was difficult to demonstrate a clear cut volume and outcome relationship. The service in Glasgow was likely to meet the volume standard in the quality standards for England. In any case there was a commitment for the service in Scotland to gather data so that the next 5 years could be evaluated to ascertain clinical outcomes in this new procedure. In response to a question from Dr Thomas, Dr Winter confirmed that the service had the broad support of obstetricians within Scotland, although there were some concerns. Obstetricians had provided reassurances that, if NSSC recommended the provision of this service in Scotland, they would refer to the service to ensure an appropriate patient pathway even if subsequent referral was to England. Dr Wallace indicated that there were risks for a single operator, including:

- sustainability, but this was covered by Birmingham providing cover; - isolation, again addressed by the link with Birmingham; and - the risk of potential poor outcome, and data would be collected to monitor this

prospectively.

NSSC 2013/36


In conclusion, NSSC supported the recommendation for a service in Scotland (Option 1) subject to the development of the relationship with Birmingham and a formal contract with Birmingham to back up the service in Glasgow. This should cover aspects such as training and mentorship, and access to treatment when required. It was agreed that the service should be kept under review. If operator numbers increased in England, NSSC should be alerted and withdrawal should be considered. The next steps would be for submission of the proposed extension to the NHS Board Chief Executives’ Group and subsequently to SGHSCD.

Action: Dr Winter 4. Performance Report – NSSC 2013/28

NSSC considered that the report provided useful information and suggested several improvements which would make it more meaningful and dynamic so that it would support NHS Boards better in the governance of national specialist services. It was noted that the report covered similar areas to the previous 6 month report, and the Group suggested that it would be better to move the spotlight more frequently to new areas to give a different picture across the whole spectrum every six months. While the report showed variation, it would be an advantage to have some explanation of the causes for variation; and also more benchmarking information to set the report in context. In order to support NSSC perform its governance role, the report needed to cover bad news as well as good. The suggestion was made that the Autumn report could be financially based and the Spring report more outcome or quality based. It could also be abbreviated and backed up by an online version which was kept more alive on the NSD website using supporting graphics in the report to illustrate specific area requiring attention. Specifically on the table on page 6, it would be helpful to have the percentage, not just figures. Another specific improvement would be for the report to focus on performance improvement, such as HEAT targets or access targets, and it needed to “close the loop” to draw out areas on which the Committee needed to focus in order to achieve improvements in performance. This would provide a much better basis for action, and for decision, than the “one dimensional” presentation of information. It would be important in future reports to conclude what members of the Committee should be taking back to their NHS Boards for local action, and what the Committee should do collectively as a result of receiving the report. For example, the report should make clear where benchmarking highlighted opportunities to drive costs down; and where costs were avoided by investing in one area rather than another. In order to obtain better information for the report, the Committee recognised that NSD would require improved information from providers of designated services, particularly when it comes to quality indicators, continuous quality improvement, patient safety initiatives, and clinical outcomes. In summary, the Group welcomed the report and the level of detail included, but wanted it to provide clear indications where performance could be improved including a summary at the end such as “from the above NSD draws the following conclusions and commends the following action to NHS Boards”. Such a report could be taken

NSSC 2013/36


up by NHS Boards and shared with local Governance Committees and used as a basis for investigating and further work around the variances identified.

Action: NSD 5. New Proposals Submitted

5.1 Children’s and Young People’s Allergy Network Scotland (CYANS) – NSSC 2013/29

Mrs Catriona Johnson, Senior Programme Manager, NSD, presented the proposal form the CYANS network for designation as a formal National Managed Clinical Network. The network had been established through National Delivery Plan funding as a project network for information gathering for 2 years, recognising that afterwards there would be an implementation stage. There had been good stakeholder engagement with patients and family; and work with primary, secondary and tertiary professionals to identify education needs and pilot training and education. There had been direct involvement with young people in establishing a website and an exemplary approach to data collection. The network had developed quality indicators and understood what was needed in relation to monitoring outcome. The network had support from the National Delivery Plan Monitoring Group to formalise its status as a National Managed Clinical Network. NPPPRG supported the establishment of CYANS as a formal designated network, although the SGPC representative expressed concern about the potential impact on primary care that the development of the network might have. After discussion, NSSC supported the recommendation for designation but considered that: - there should be a time limit to designation - which should be set in discussion

with the network; - there needed to be a quantification of the impact on Primary Care; - the aim should be for the network to put in place links with regional and

NHS Board services so that it “worked itself out of a job” over a fixed period. This was because allergy was a very common condition, and the continuation of a national network posed a risk to inhibiting regional and local work;

- the network should therefore develop a planned move to regional provision within the timeframe to be agreed.

The next step was for NSD to submit the NSSC recommendations to the NHS Board Chief Executives’ Group and subsequently to SGHSCD for approval.

Action: Mrs Evans

5.2 Selective Internal Radiation Therapy (SIRT) – NSSC 2013/30

Mrs Janice Birrell, Senior Programme Manager, NSD, presented the paper and reported on discussions that had been ongoing following the NPPPRG discussion in June 2013. At the NPPPRG meeting, NHS England colleagues had reported that consideration was being given to a new approach to introducing technologies for which there was limited evidence, through “Commissioning for Evaluation”. Ms Ann Jarvis, Acute Portfolio Director - Specialised Commissioning, NHS England, extended an invitation for NHS Scotland to take part in English work around Commissioning for Evaluation on SIRT. Mrs Birrell reported that there had been

NSSC 2013/36


2 weekly meetings since then, and very rapid progress in setting up the basis for the Commissioning for Evaluation of SIRT. Provider and patient selection criteria had been defined, and in England it was likely that there would be 10 participating SIRT centres for patients who did not fit the criteria for the Foxfire trial (patients who had not had chemotherapy could still continue to be recruited to the Foxfire trial). Edinburgh was the only centre in the UK that met the current English provider criteria in full, and it was proposed that the same patient selection protocol would be used as in the English evaluation. Dr Thomas indicated that NPPPRG had recommended that the Edinburgh centre should be part of the UK Commissioning for Evaluation study. Mrs Birrell invited NSSC to decide whether: - NHS Scotland should take part in this evaluation; and, if so, whether - funding should be centrally allocated or patient access funded by NHS Boards on

a cost per case basis. NSSC supported the recommendation that the Edinburgh centre should be part of the Commissioning for Evaluation study and that central funding should be allocated along the same lines as in NHS England. The next step was for NSD to submit the NSSC recommendations to the NHS Board Chief Executives’ Group and subsequently to SGHSCD for approval.

Action: Mrs Birrell / Mrs Evans

5.3 Specialist Prosthetics – NSSC 2013/31 Dr Winter presented this proposal which was yet to have formal approval from NHS Greater Glasgow and Clyde - the lead Board within Scotland. The paper was being brought to NSSC in advance of consideration by NHS Greater Glasgow and Clyde in the light of the considerable background and Ministerial announcements on the matter, and the work previously undertaken by a Working Group chaired by Dr Allan Gunning, NHS Ayrshire and Arran. Dr Winter indicated that the people who benefited from specialist prosthetics were not only the young, fit, traumatically injured, but there were potential benefits for people in older age for improved balance. It would therefore be important for there to be a tight definition of the patient selection criteria for the service. There were significant additional costs compared to a standard prosthetic service and Scottish Government Health and Social Care Directorates had sought funding through the spending review for the costs of the initial years of this service. In relation to numbers, around 4,000 amputees were present in the civilian population and of these some 500 would merit assessment for state of the art prosthetics; of these, a smaller number would require a specialist limb. Ms Renfrew confirmed that NHS Greater Glasgow and Clyde supported the proposal. NSSC concluded that this service met the criteria for designation and that national designation was the logical conclusion of earlier work undertaken by Dr Gunning and the Working Group. There was clear Ministerial commitment to the establishment of the service in Scotland. NSSC considered that it was essential that clear patient selection criteria were developed prior to the establishment of the service. It was recognised that the

NSSC 2013/36


service needed to develop for both upper and lower limbs and that there was an obligation to seek to reduce waste by recycling kit where possible. NSSC recommended designation of the service as specified. The next step was for NSD to convey NSSC’s recommendations to the NHS Board Chief Executives’ Group, and subsequently to SGHSCD.

Action: Mrs Evans

6. Service Reviews/Developments 6.1 Ophthalmic Oncology – NSSC 2013/32 Mrs Janice Birrell, Senior Programme Manager, NSD, presented this review report which had been considered and commended by NPPPRG. The service had initially been designated to treat intra ocular tumours but was seeing and treating both intra and extra ocular tumours. The review recommended greater shared care both prior to, and post, treatment using the ability to share images taken close to the patient’s home and read in the specialist centre. The review had recommended more formalised MDT meetings and this had now been taken forward by the service. Further work would be needed at a UK level on the treatment of metastatic disease and this needed to be kept under review. The review report concluded that the service should continue to be designated; with a wider definition to include extra ocular tumours; and should be provided within the same budget. Dr Thomas confirmed that NPPPRG supported the recommendations of the review, and considered that there should be better monitoring of outcomes. Dr Wallace had concerns about the quality of outcome data included in the review report. She strongly supported the last recommendation for better quality of outcome data and also considered it was important to get information on 5 year survival. NSSC accepted the recommendations in the review report and commended these to NHS Board Chief Executives and SGHSC.

Action: Mrs Birrell / Mrs Evans

6.2 Prostate Cryotherapy – NSSC 2013/33 NSD had conducted a minor review and had picked up inequitable geographical referral rates and a different pattern of care within the East and West of Scotland. The West of Scotland tended to use open surgery and radiotherapy leading towards cryotherapy in some cases. The East of Scotland tended to use radical prostatectomy and laparoscopic interventions and rarely used cryotherapy. These trends suggested that a full review was required and NSSC agreed that a major review should be undertaken.

Action: Mrs Birrell

7. Business Case for National Funding 2014/15 – NSSC 2013/34

Mrs Evans explained that this was NSD’s first attempt at producing the kind of business case that the National Planning Forum had suggested for NSSC. She invited feedback on whether it met the requirement and provided the information which NSSC needed to decide on recommendations to NHS Board Chief Executives and SGHSC on the amounts to be top sliced. The aim was to ensure that there was good consideration and scrutiny of the proposed budget for national services prior to

NSSC 2013/36


submission to NHS Board Chief Executives and the next step would be submission of a revised and updated paper to NHS Board Directors of Finance prior to submission to NHS Board Chief Executives. NSSC made the following suggestions for improvement to the Report: - It would help to include a section on horizon scanning identifying any other issues

that might have an impact on funding in future years. - The report should capture more about the impact of decisions and investment in

specialist services on potential savings elsewhere. - On efficiency savings there needed to be greater clarity on where efficiencies had

been achieved. The presentation of netting off efficiency savings against costs was not sufficiently clear.

- The report should indicate what NHS Boards could do in order to improve cost

effectiveness, or improve efficiency in these services, and should tie in with the performance report in order to clarify what had already been done to manage costs and to improve efficiency.

- Ms Christine McLaughlin, Scottish Government, needed to be involved in

considering the paper prior to it going to NHS Board Chief Executives. In particular, Scottish Government should make clear what funding would be allocated by SGHSC to clarify on what areas Boards needed to take decisions.

- On recombinant coagulation concentrates for haemophilia, a further revision of

the likely costs would be circulated to Directors of Finance once the contracts were awarded for the recombinant products. Over the last 2 contract rounds the costs of recombinant had halved.

- There was increasing expenditure on orphan drugs as a result of greater genetic

diagnosis, and the potential for high cost medicines to treat people with rare conditions.

In summary, NSSC recommended that the paper should be adapted to make it clear what decisions NHS Board Finance Directors needed to make; and to identify specific issues to spotlight for potential “best value” reviews. The next step was submission to the NHS Board Directors of Finance Group and subsequently to NHS BCEs.

Action: Mr Croan

8. Horizon Scanning – NSSC 2013/35

The paper was noted along with an update from Dr Winter who clarified that he expected a proposal for surgery for Selective Dorsal Rhizotomy to be submitted through the Neurosurgery Managed Service Network to NSSC in due course. 9. Any Other Business

Mrs Evans explained that contracts had now been awarded for Specialist Gender Reassignment Surgery, and these would be available from 1 October 2013.

NSSC 2013/36


10. Dates of Future Meetings

Tuesday, 26 November 2013 – Meeting Room 19, Gyle Square, Edinburgh Wednesday, 5 March 2014 - Boardrooms, Gyle Square, Edinburgh Wednesday, 14 May 2014 – Meeting Room 7, Waverley Gate, Edinburgh Wednesday, 19 November 2014 - Boardrooms, Gyle Square, Edinburgh All meetings commence at 1.30pm (sandwich lunch available from 1pm) Gyle Square meetings – block car parking has been booked

07 HSS\Cttees &Grps\Policy Grps\NSSC\Papers\2013\2013-11-26\NSSC 2013-38 Matters Arising

1


NSSC

Matters Arising

NSSC PAPER 2013/38

1. Progress on proposals:

1.1 Selective Internal Radiation Therapy (SIRT)

The SIRT application was received positively at the NHS Board Chief Executive meeting on 9 October and the recommendation has now been formally approved by Scottish Government Health and Social Care. An announcement is expected shortly on NHS Scotland’s participation in the NHS England Commissioning for Evaluation project. 1.2 Interventional Fetal Therapy - Fetoscopic Laser Ablation (for Twin to Twin Transfusion) Service NHS Board CEs supported the NSSC recommendation to extend the current Interventional fetal therapy service to include twin to twin transfusion at their meeting on 9 October and the proposal has been formally approved by SGHSC with the clear qualification that an agreement with Birmingham is formalised to provide training and backup support to provide a service all year round, and to meet the expected recommendations that such a service requires at least 2 trained operators with a caseload of at least 15 patients per year. 1.3 Children’s and Young People’s Allergy Network Scotland (CYANS) NSSC’s recommendations to extend the funding for this network were endorsed by NHS Board Chief Executives’ Group on 9 October and have been approved by SGHSCD. 1.4 Ophthalmic Oncology NSSC’s recommendations to extend the designated service to include extra ocular tumours were endorsed by NHS Board Chief Executives’ Group on 9 October and have been approved by SGHSCD. 1.5 Specialist prosthetics NSSC’s recommendations to designate this service were endorsed by NHS Board Chief Executives’ Group on 9 October and have been approved by SGHSCD. 2. Progress on service reviews:

Current service reviews on cochlear implantation and paediatric intensive care are progressing as planned. 3. NSSC Subgroups

There are currently 5 subgroups:

Intensive Pain Management Services – Subgroup is to have one final meeting in January once

consultation is complete to consider implementation of the option preferred by SGHSCD.

07 HSS\Cttees &Grps\Policy Grps\NSSC\Papers\2013\2013-11-26\NSSC 2013-38 Matters Arising

2

Specialist Prosthetics – Subgroup now planning implementation because application has now

been formally approved by SGHSCD, and central funding has been allocated.

Orphan drugs risk share – Reporting deadline extended to March 2014 by NHS Board Chief

Executives on 9 October following announcement by SGHSCD on 8 October on New Medicines review and replacement of Individual Patient Treatment Reviews. See paper NSSC 2013/46.

Adult renal transplantation – Final meeting held and report now being agreed in

correspondence. See paper NSSC 2013/47.

NSSC Secretariat November 2013

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-39 Cover Paper – Facial Transplant 1


NSSC

NSSC PAPER 2013/39

Facial Transplantation Service (National Facial Transplant Service)

1. Provider and location

Maxillofacial Services. Southern General Hospital, NHS Greater Glasgow and Clyde.

2. Description of service Facial transplant is a new branch of Vascularised Composite Allotransplantation that offers a reconstructive option for those patients in whom conventional reconstruction has been unable to provide a satisfactory result. Since the first partial face transplant in 2005, 28 facial transplants have been carried out worldwide (the majority in Paris). There have not been any cases carried out in the UK to date. The service will provide facial transplants for individuals within Scotland who have experienced significant facially disfiguring injuries as a result of traumatic events or congenital conditions. Examples of such event are facial burns, animal attacks, ballistic injuries, industrial injuries, vascular lesions and type I neurofibromatosis. A transplant will help to restore functions such as swallowing, breathing without a tube, talking and communicating as well as improving appearance.

3. Assessed Needs

1-2 Scottish residents per annum.

4. Costs

The service’s annual transplantation costs are £260,511 per annum based on providing 2 facial transplants per year for Scottish residents. Due to the requirement for long-term follow-up and medication, there will be a cumulative annual cost increase of £16,808 from year 2 onwards (£8,404 per patient).

Year 1 2 3 4 5 Service cost £260,511 £277,319 £294,126 £310,934 £327,742

5. Quality, Clinical and Cost Effectiveness

Severe facial disfigurements are not merely “cosmetic defects,” but conditions that render the patient unable to properly eat, breathe, or speak. Furthermore, the face is essential for communication and relating to others, which is the foundation for how we understand ourselves as human. Restoring the face with composite tissue allotransplantation can provide results that are unattainable with current reconstructive techniques. Major improvements in facial aesthetic and function allowed patients to recover social relations and improved their quality of life. Face transplant is a credible therapeutic alternative to conventional reconstructive procedures. This technique can be used to help patients with severe disfigurement when the other alternative of conventional surgery has not been able to achieve optimal outcome provided that strong technical, immunological and ethical guidelines are respected.

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-39 Cover Paper – Facial Transplant 2

6. Professional, Patient and Public Views

This proposal is supported by:

NHS Blood and Transplant The Scottish Transplant Group (comprising representation from Scottish transplant

teams and the Scottish Government)

The French Facial Transplant Team

The Human Tissue Authority have been supportive of the proposed service, and have confirmed that there would be no need for a separate licence for composite tissue transplant as this activity can be included under the existing NHS Greater Glasgow and Clyde HTA licence.

7. Progress on application

NSD have been in initial discussions with NHS England about whether a potential Scottish national service could provide a facial transplantation service for the patients from England.

It has been highlighted that the Royal Free Hospital in London are in the initial stages of considering whether they should develop a face transplant service, but have undertaken no in-depth work in this area. It would take a number of years to develop a new programme in the Royal Free Hospital.

In the absence of another UK service, NPPPRG considered whether there was scope for the Scottish service to provide a service for the UK, increasing activity levels to 20-25 cases per annum.

NPPPRG considered whether to invite the applicants to submit a full stage 3 proposal.

8. Conclusions and NPPPRG Recommendation

NPPPRG recommends to NSSC that:

Further dialogue is undertaken with the Royal Free Hospital, and specialised Commissioners from NHS England, NHS Wales and Health and Social Care in Northern Ireland, to clarify whether NHS Scotland could provide a service for other parts of the UK

NHS Greater Glasgow and Clyde are invited to submit a full stage 3 proposal, which takes into account the outcome of discussions on service provision across the UK


Appendix C(i)

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-39A – Facial Transplant

1


NSSC

STAGE 2 NSSC 2013/39A

New Proposals for National Specialist Services Committee Criteria - Outline Proposal Evaluation Template

Applicants should provide a description of the application under the following headings. Full details and supporting evidence are not required at the outline stage. The total outline application should be no more than 3-4 pages. Section A: Introductory information 1. Full name of proposed service

National Facial Transplant Service 2. Short title for proposed service

Applicants should provide a title that can be used for meeting papers, etc, which should be no more than 30 characters. National Facial Transplant Service 3. Brief description of proposed service

Applicants should provide a ‘lay’ description of no more than 50 words. The service will provide facial transplants for individuals within Scotland who have experienced significant facially disfiguring injuries as a result of traumatic events or congenital conditions. Examples of such event are facial burns, animal attacks, ballistic injuries, industrial injuries, vascular lesions and type I neurofibromatosis. A transplant will help to restore functions such as swallowing, breathing without a tube, talking and communicating as well as improving appearance. 4. Name, title, and contact details of lead applicant

Colin MacIver, Consultant Maxillofacial Surgeon, Maxillofacial Services, Institute of Neurological Sciences, Southern General Hospital, Glasgow. Email : [email protected] Telephone Number : 0141 232 7509

Section B: Evidence of the benefits 5. Summary of patient need

Facial transplant is a new branch of Vascularised Composite Allotransplantation (VCA) that offers a reconstructive option for those patients in whom conventional reconstruction has been unable to provide a satisfactory result. Since the first partial face transplant in 2005, 28 facial transplants have been carried out worldwide. There have not been any cases carried out in the UK so far. Transplant offers the possibility

mailto:[email protected]

Appendix C(i)


2

of restoring function (breathing without a tracheostomy, swallowing, talking and communicating) as well as restoring facial form.

Based on the experience of the French program and their calculation of treatment need, we estimate that there will be 1-2 patients per year that would be suitable for facial transplant within a Scottish population. French group estimate a need of around 20-25 patients per year in a French population of 62.8 million (Index mundii 2013). This is a similar size to the UK -around 63.7 million (office for national statistics 2012) and therefore a similarestimate, the population Scotland is 5.2 million (national records of Scotland 2011) thereby the possible need would be 1-2 /year. See Annex A 6. Description of the current provision

No current service provision within Scotland or elsewhere within the United Kingdom 7. Description of the proposed service

Proposed Centre and Clinical leads

Southern General Hospital - currently provides regional Head and Neck Surgery service for West of Scotland. Clinical Leads

Surgery Mr Colin MacIver Transplant Medicine Dr Neal Padmanabhan Psychiatry Dr Adam Burnel Psychology Dr Rebecca Crawford H&I Dr Anne Margaret Little

Components Parts of the Patient Pathway

Patient selection - Medical, Surgical, Psychiatric and Psychological assessment Histocompatability and Immunogenicity (H&I) testing Radiological and EMG assessment Retrieval - Surgical and Nursing team H&I Laboratory testing Maxillofacial Technologist for donor reconstruction Implant - Surgical and Nursing Team Transplant Medicine - induction immunosuppression Perioperative - ITU, HDU, Ward Care Follow up - Surgical Clinic Follow up Transplant clinic outpatient H&I testing Treatment of rejection episodes Dermatology assessment

Appendix C(i)


3

Details of Clinical pathway

A detailed pathway including referral criteria and exclusions is attached in the protocol with all relevant literature in Annex D. Data Storage Patient data will be stored on the current renal services IT system for which a specific section on facial transplant will be created. Patient information is also stored on GGC IT systems which are available at all GGC locations. Proposed activity

1-2 cases per year for 5 years - maximum expected number 10 patients in first 5 years. Currently the service at The southern General treat approximately 120 major head and neck reconstruction cases per year. Increase in demand for the service is unlikely as world wide experience has shown a constant low number would be expected. Accessibility and Equity

The Southern General hospital currently provides regional and national services. Within the maxillofacial unit there is currently a national vascular anomaly service, a craniofacial service and a skull base surgical oncology service. The service would be offered to the entire population of Scotland. As numbers will be small the provision of a national service at a single centre is the only way a sustainable service could be developed to ensure experience is concentrated at a single site. Skills and Support

The Scottish Facial Transplant Group (SFTG) is a multidisciplinary group combining the resources of head and neck reconstruction, solid organ transplant, psychiatric and psychological services and all allied healthcare connected with them. It has been developed with the support of NHSBT, Scottish Transplant Group and the Scottish Organ Retrieval Team (SORT). Protocols have been discussed in detail with each group to ensure that it is complimentary to the already successful solid organ transplant programs. The skill set required for facial transplant already exists within the surgical team which currently provides an extremely effective head and neck microvascular and craniofacial service. A member of the team has trained in France and participated in facial transplant, within the unit that has the greatest experience of the procedure. This link has led to the French team mentoring the development of this service. The immunological members of the group are from the renal transplant program for the West of Scotland and the immunosuppression is similar to that used for renal transplant patients. The renal team have liaised with the French team in setting up the immunosupression protocol. The liaison psychiatric and psychology service will provide assessment of and support for potential recipients. The team have also worked closely with the London group who previously had an active face transplant program. The group will provide training for all nursing staff and allied healthcare professionals. They would also train Specialist nurses in Organ Donation (SN-OD’s) in issues

Appendix C(i)


4

related to facial transplant. The Assessment Process

The assessment of potential patients will take place over several months and include a full surgical, medical and psychological assessment and of equal importance a full patient education process, related to the impact of lifelong immunosuppression. Final selection will involve a multidisciplinary team clinic and meeting. Once a suitable recipient is identified histocompatability and immunogenicity testing will be required on a 3 monthly basis and this will allow a virtual cross match to be performed at the time of transplant (as with current renal transplants). The Surgical Procedure and Medical Management

The SFTG will provide 2 teams of surgeons for a procedure - a retrieval team and a recipient team. The service will be a consultant delivered service but trainees and clinical fellows will assist in order to gain experience for succession planning. The retrieval team will work together with the Scottish Organ Retrieval Team and provide all equipment and staff necessary for the retrieval of facial tissue. The team will consist of 2 consultant surgeons, 2 experienced scrub nurses and a maxillofacial technologist that will be required to reconstruct the donor. The recipient team will be situated at the Institute for Neurological Sciences at the Southern General Hospital where surgery and perioperative care of the recipient will take place. When the retrieval team return with the organ, the retrieval surgeons will join the recipient team to perform the implant. The transplant medicine team members will advise on selection of suitable recipients and will manage induction and maintenance immunosuppresion therapy as well as monitoring and dealing with rejection and side effects of immunosuppression. During the in patient stay this will be done on daily ward rounds and on discharge will be done at the transplant clinic where a member of the surgical team will attend. Anticipated hospital stay would be 3-4 weeks with a 4-5 day critical care period. Psychological follow up is an integral part of the protocol with daily review by the surgical and medical team during the inpatient stay using the psychological assessment tools in the protocol and regular follow up by the team psychiatrist/psychologist at predetermined times during the recovery period and as an outpatient. Outpatient Follow up

Outpatient follow up care will be provided at the surgical clinic for a defined time period and then at the medical transplant clinic at the health board of residence. Psychological follow up for the recipient is an integral part of the protocol, as is support for the donor family that will be provided by NHSBT and recipient family as required. Clinical Governance SFTG will hold a database of patients which will include potential recipients, donor information, immunosuppression data, functional improvement information and complications. Results and progress would be reported at regional audit meetings and at STG. A member of the facial transplant group will be a member of the STG

Appendix C(i)


5

and the NHSBT special interest group and update both of these bodies on the progress of patients. Cases will be added to the NHSBT database and world database of VCA held by the American Society of Reconstructive Transplant Surgeons (ASRT) and presented biennially at their meeting. Licensing

An extension to the existing license held by Greater Glasgow and Clyde for solid organ transplant will be made to the human tissue authority (HTA). A meeting with the HTA has already taken place and existing protocols will be implemented or adapted in conjunction with the HTA in order that licensing regulations are complied with at every stage. A presentation has already been given to the HTA regarding the proposed service. Progression of service development Once funding is secured a patient screening program can begin, retrieval equipment can be purchased and transport contracts established. A recipient co ordinator can be identified and trained and begin staff training of all ancillary staff that will be involved in facial transplant. When potential recipients are identified the patients can be added to the NHSBT register of potential recipients. Staff training and succession planning All consultant surgeons involved in facial transplant must regularly undertake head and neck reconstruction or craniofacial surgery. They will be able to demonstrate their competence by recording logbook activity that supports their role within the team and undertake regular appraisal. Trainees will be given opportunity to assist with retrieval and implant procedures as part of the National Training Programme and will assist in managing the patients during the perioperative period. The SFTG will undertake review of practice at peer review meetings and present outcomes nationally and internationally. Research and audit will be conducted by the group and results of research and outcomes will be published to progress this new area of transplant medicine.

Appendix C(i)


6

8. Clinical benefit over current NHS alternatives

Severe facial disfigurements are not merely “cosmetic defects,” but conditions that render the patient unable to properly eat, breathe, or speak. Furthermore, the face is essential for communication and relating to others, which is the foundation for how we understand ourselves as human. Restoring the face with composite tissue allotransplantation can provide results that are unattainable with current reconstructive techniques. Major improvements in facial aesthetic and function allowed patients to recover social relations and improved their quality of life. Face transplant is a credible therapeutic alternative to conventional reconstructive procedures. This technique can be used to help patients with severe disfigurement when the other alternative of conventional surgery has not been able to achieve optimal outcome provided that strong technical, immunological and ethical guidelines are respected.

9. Financial impact: estimated costs

COSTS CALCULATED ON 2 CASES PA.xls

Section C: Support for the proposal

12. Support for the proposal

This proposal is supported by :

NHS Blood and Transplant (attached 2 parts) The Scottish Transplant Group (attached) The French Facial Transplant Team (attached) Human Tissue Authority (attached)

HTA.htm France.pdf

NHSBT LETTER OF SUPPORT.pdf

STG LETTER OF SUPPORT.pdf

Scan 20 Sep 2013 14_44.pdf

13. Potential opposition to the proposal

It is unlikely that there would be opposition to establishing such a service. A former program at the Royal Free in London was suspended. We have worked closely with them to ensure the problems they encountered were not repeated. We are represented on the NHSBT specialist composite transplant group and are the only team in a position to offer this service at present. 14. Any other relevant information See Annex D - attached Literature Signature of Lead Consultant: Printed Name of Lead Consultant: COLIN MACIVER Date: 20th September

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NSSC

NSSC PAPER 2013/40

National Specialist Service for Unusual and Complex Sleep Disorders


Department of Sleep Medicine, Royal Infirmary Edinburgh, 51 Little France Crescent; EH16 4SA

2. Description of service

The proposed service will improve patients with unusual and complex sleep disorders require a multi-disciplinary approach to their management, involving experts from several specialties, state of the art diagnostic facilities and sleep trained technicians -this is only available in NHS Lothian at present. The new service would provide equitable access to these facilities for the Scottish population.

3. Assessed Needs

For possible narcolepsy: 30 referrals a year fulfilling the above criteria which would, after expert history and investigation, result in the diagnosis of approximately 3 – 5 new patients per year with narcolepsy. For possible violent and complex parasomnias: 30-50 referrals per year resulting in the diagnosis of approximately 20 new patients per year with significant parasomnias.

4. Costs

Total annual cost: £ 92, 245


Patients with unusual and complex sleep disorders require a combination of sleep trained doctors from a range of specialties, high-tech diagnostic facilities and sleep trained technicians. At present, patients with these disorders receive no service or suboptimal care, unless they live in Lothian.


As recognition of the medical problems related to sleep have increased, patients with a range of rare, complex and treatable sleep disorders are being referred to the these respiratory physicians and neurologists who have neither the facilities nor the training to investigate or manage these patients appropriately. The proposal is supported by all sleep specialists, respiratory physicians and neurologists in Scotland, including public health officials at Greater Glasgow Board.

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7. Issues for discussion

A previous wider application was not recommended for designation and further work was commissioned by NSSC. This application is narrower in scope and targeted at a particular subset of patients which place a high level of demand on other parts of the NHS and wider care system. This proposal requires modest funding and would appear to provide value for money for a challenging but small group of patients. The applicants believe that national designation will assist their ability to maintain this specialist service within the sleep centre in Lothian.

8. Conclusions and Recommendation

NPPPRG reviewed the application and recommended that a Stage 3 application should be developed for consideration.


Appendix C(i)

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NSSC

STAGE 2

NSSC 2013/40A

New Proposals for National Specialist Services Committee Criteria - Outline Proposal Evaluation Template

Applicants should provide a description of the application under the following headings. Full details and supporting evidence are not required at the outline stage. The total outline application should be no more than 3-4 pages. Section A: Introductory information 1. Full name of proposed service

National specialist service for unusual and complex sleep disorders 2. Short title for proposed service

Applicants should provide a title that can be used for meeting papers, etc, which should be no more than 30 characters. Complex sleep disorder service 3. Brief description of proposed service

Applicants should provide a ‘lay’ description of no more than 50 words. Patients with unusual and complex sleep disorders require a multi-disciplinary approach to their management, involving experts from several specialties, state of the art diagnostic facilities and sleep trained technicians. This is only available in Lothian currently. The new service would provide equitable access to these facilities for the Scottish population. 4. Name, title, and contact details of lead applicant Dr Renata L Riha; Department of Sleep Medicine, Royal Infirmary Edinburgh, 51 Little France Crescent; EH16 4SA Tel: 07880821423 Email: [email protected] Section B: Evidence of the benefits

5. Summary of patient need 1. Narcolepsy. Narcolepsy is estimated to have a prevalence of around 0.01% in the Scottish population. We currently look after 120 narcoleptic patients (defined as sleepiness + cataplexy plus classical multiple sleep latency tests), accrued over 20 years, one of the largest cohorts in the UK. Narcolepsy is a rare disorder caused by failure of the hypocretin neurotransmitter system and is characterised by disabling, severe daytime sleepiness and is typically associated with cataplexy (loss of muscle tone + collapse on strong emotion, without loss of consciousness). The key aspect of the management of narcolepsy is initial definitive diagnosis. This requires both an accurate history and appropriate investigation with overnight polysomnography followed by a multiple sleep latency test (MSLT) requiring neurophysiological sleep recording in a sound proofed environment – ours is the only such clinical facility in Scotland. History alone does not suffice! Accurate diagnosis is critical for the following reasons:

The condition usually starts in adolescence and impacts in a major way on the patients’ quality of life, their ability to drive and work for the rest of their

Appendix C(i)


2

life, life insurance as well as future pregnancies in women with this condition. Treatment involves the use of controlled (amphetamines) and sodium oxybate, also known as GHB, (£1000/month) drugs which should not be given to patients in error. Sodium oxybate will be coming off license in the next year, the danger of incorrect prescribing will increase.

Munchausen syndrome. We have published 5 cases of Munchausen syndrome presenting with classical histories of narcolepsy but clearly identified by sleep study and MSLT;these had been misdiagnosed as narcolepsy elsewhere. We identified a further 10 patients, in the last 2 years alone, through our clinics.

Misdiagnosis. Over the last 5 years, we have identified 41 patients who had been misdiagnosed with narcolepsy by other consultant physicians and commenced on amphetamines.

The referral criteria for possible narcolepsy would be: 1. Excessive daytime sleepiness not otherwise explained by sleep deprivation, ,

shift work, medication abuse, circadian rhythm disorder, psychiatric illness, OSAHS or medical illness

2. Unexplained recurrent muscular weakness in association with emotional stimuli

2. Violent/Complex parasomnias.

Parasomnias are disorders of unknown aetiology characterised by movement, either purposive or non-purposive, during sleep. The main parasomnias of concern are REM behaviour disorder (RBD) which can lead to extreme violence and harm to bed partners. Such parasomnias can be precursors of and associated with neuro-degenerative disorders like Parkinson’s disease. Violent parasomnias can also arise from slow-wave sleep. Many parasomnias are exacerbated by psychological problems as well as psychiatric problems, particularly posttraumatic stress disorder (PTSD). Frequent nocturnal interruptions can result in excessive daytime sleepiness. Treatment is generally by lifelong clonazepam (a benzodiazepine), which must be taken consistently to work and often psychiatric or psychological support. Many patients have medico-legal issues which require calling on the expertise of a number of specialists including sleep physicians, psychiatrists and psychologists. The referral criteria for parasomnias would be abnormal behaviour during sleep resulting in actual or potential harm to the patient or bed-partner. The intention is to provide a diagnostic service with initial and where necessary, subsequent, advice on management of these disorders. This will be implemented in the spirit of shared care and managed clinical networks. We are not applying for reimbursement for cost of drugs. Incidence/prevalence of unusual sleep disorders

Narcolepsy is thought to have a prevalence of 0.01% in the Scottish population. REM behaviour disorder is a rare disorder of unknown prevalence. Confusional Arousals and violent sleepwalking/sexsomnia likewise have an unknown prevalence Estimate of likely need for service

: For possible narcolepsy: 30 referrals a year fulfilling the above criteria which would, after expert history and investigation, result in the diagnosis of approximately 3 – 5 new patients per year with narcolepsy. For possible parasomnias: 30-50 referrals per year resulting in the diagnosis of approximately 20 new patients per year with significant parasomnias.

6. Description of the current provision

Until 1995, The Department of Sleep Medicine in the Royal Infirmary of Edinburgh

Appendix C(i)


3

delivered a national service for the diagnosis and treatment of the obstructive sleep apnoea/hypopnoea syndrome (OSAHS). As awareness of this condition rose, we facilitated the development of local services run by respiratory physicians around Scotland who now diagnose and manage most of the patients with OSAHS in their areas. As recognition of the medical problems related to sleep have increased, patients with a range of rare, complex and treatable sleep disorders are being referred to the these respiratory physicians and neurologists who have neither the facilities nor the training to investigate or manage these patients appropriately. They are seeking our help. These patients with unusual and complex sleep disorders require a

combination of sleep trained doctors from a range of specialties, high-tech diagnostic facilities and sleep trained technicians. At present, patients with these disorders receive no service or suboptimal care, unless they live in Lothian.

The Department of Sleep Medicine, Edinburgh Royal Infirmary has all the facilities required to run a specialised service for these patients, including staff with the necessary expertise needed including :-

5 experienced sleep consultants, one of whom is the UK’s only fully trained Physician in Sleep Medicine (Dr R L Riha FRACP Level II accredited in sleep medicine in Australia)

6 USA board-certified sleep technicians

14 sleep-trained nurses 7 sound proofed, electrically screened bedrooms fitted with video

polysomnography for high-tech sleep recording This proposal seeks to build on our current expertise and these expensive facilities already in place, to benefit such patients throughout Scotland. 7. Clinical benefit over current NHS alternatives

Currently there are limited sources of sleep services within Scotland. All the other sleep units throughout Scotland, including Glasgow, Inverness, Aberdeen, Dundee and Dumfries, focus on the treatment of OSAHS and have asked us to provide a national service for these other sleep disorders. Some neurological services will see people with parasomnias and narcolepsy but none have expertise in these areas and none have the necessary sound proofed sleep rooms with video-polysomnography equipment. The majority of neurologists throughout Scotland as well as the respiratory sleep services throughout Scotland wish to refer directly to the Department of Sleep Medicine in Edinburgh patients who may have difficult parasomnias or suspected narcolepsy. 9. Financial impact: estimated costs The staffing costs sought are

Psychiatry Consultant 0.2 WTE £22,575 Sleep Technician – 1 WTE (Band 7) £36,966 Secretarial/Admin 0.2WTE (Band 5) £ 4,904 TOTAL STAFFING COSTS: £ 64, 445 The running cost per annum, proposed are

Proportion of sleep lab capital costs including maintenance and depreciation of building, computing facilities and major equipment

60 Nights for polysomnographies (30 for narcolepsy and 30 for parasomnia)

30 Day long tests (MSLTs) for narcolepsy TOTAL: £10, 000

Revenue costs Consumables and night nurse time for 30 ? narcoleptics @ £90 = £2,700

Appendix C(i)


4

30 ? parasomnias @£90 = £2,700 30 LPs and Orexin levels for ?narcolepsy @ £80 = £2,400

TOTAL ANNUAL RUNNING COSTS: £ 17, 800 TOTAL ANNUAL COST FOR SERVICE: £ 92, 245

Total proposed capital costs The vast majority of the facilities required are in place. The only additional capital costs required would be Sleep-specific database which integrates with NHS IT systems - £30,000 Section C: Support for the proposal


The proposal is supported by all respiratory physicians and neurologists in Scotland, including public health officials at Greater Glasgow Board. Ms Lyn McDonald – Head of Operations, RIE, NHS Lothian Professor Alex McMahon, NHS Lothian 13. Potential opposition to the proposal

Dr Eric Livingstone and Dr Chris Carlin have some doubts (respiratory physicians in Glasgow). Neither is fully sleep trained and we have explained that this is not an exercise in ‘taking patients away’ but a vital service for the vast majority of Scottish Specialists and a highly qualified centre with an international reputation for expertise in the management of sleep disorders. 14. Any other relevant information

There is a possibility for significant income generation by taking referrals from N.I. and also Northern England. This already happens to some degree but is not appropriately recognised or costed. Signature of Lead Consultant: ……………………………………………………. Printed Name of Lead Consultant: …Renata L Riha………………………. Date: ……09.10.2013……………………………………………………

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NSSC

NSSC PAPER 2013/41

Epilepsy Next Generation Sequencing Genetics Service


Yorkhill Hospital and West of Scotland Genetic Service, NHS Greater Glasgow & Clyde, Laboratory Medicine, South General Hospital, Govan Road, Glasgow, G51 4TF.


The proposed service will provide integrated advanced genetic testing and specialist multi disciplinary clinical case management providing earlier diagnosis and individualised management of children with genetic epilepsies in Scotland. Specific diagnosis leads to targeted treatment which can improve cognition and prevent neurodiasability which otherwise may have a lifelong impact on the individual The West of Scotland Genetic Service currently provides screens for genetic abnormalities in 12 genes. Utilising Next Generation Sequencing (NGS) techniques will allow the expansion of screening for 87 genes in a single panel. 3. Assessed Needs

It will be expected that there will be 300 Scottish patients per year who will be eligible for this specialist service: 140 new cases being identified per year (children less than 3 years with new onset suspected genetic epilepsies in Scotland) and the secondary group comprising undiagnosed older cases whose epilepsy started less than 3 years of age or with strong clinical suspension of a genetic epilepsy presenting at an older age. 4. Costs

£555,406 per annum, this is based on 300 Scottish cases per year.

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Many epilepsies have complex presentations and can take years to diagnose. The Next Generation Sequencing (NGS) panel of genetic tests will focus on epilepsy genes where there is no other clue to diagnosis. Research and audit carried out in Glasgow has shown that genetic testing and expert clinical case management leads to early diagnosis and prevents children having invasive investigations. It has been demonstrated that that a specific genetic diagnosis can result targeted treatment, better seizure control and improved psychological adjustment for the family. (Brunklaus et al 2012). The analysis of the NGS data filters out non-significant variants with the results linked to the phenotyping data collected from each patient. The data generated inform reviews at Multi Disciplinary Team meetings which will include genetic scientist, consultant paediatric neurologist and consultant clinical geneticist, allowing specialist joint genetic and clinical reports for each patient. A gene dossier form will be submitted UK Genetic Testing Network (UKGTN). The UKGTN evaluate all tests for scientific validity and clinical utility to ensure that all tests undertaken by member laboratories are evidence based. Offering genetic testing to this group of patients will allow a definitive diagnosis earlier in life which in turn can help direct appropriate targeted drug treatment and eliminates the need for unnecessary investigations. It is difficult to calculate the costs saving to other services but the correct diagnosis and treatment can prevent seizures allowing a child to progress to normal schooling. 6. Professional, Patient and Public Views The proposal is supported by the Scottish Paediatric Epilepsy Managed Clinical Network and the Scottish Paediatric Neurology Group. Epilepsy Scotland is strongly supportive of provision to ensure availability of genetic diagnosis. 7. Issues for discussion NPPPRG was invited to consider this “Stage 2” application for a full clinical service against the agreed criteria for designation (attached) and decide whether to:

reject the proposal on the grounds that it does not meet criteria;

recommend to NSSC that the applicants should be invited to work up a full Stage 3 proposal without further work;

commission further work to ascertain views on the proposal through the professional, public, patient and regional networks brought together by NPPPRG to inform a decision at the 23 April meeting on progression to Stage 3.


NPPPRG recommends that NSSC should invite a stage 3 application, and that NSD should seek feedback from the wider Scottish Genetics Consortium and UKGTN on this application. NSSC Secretariat November 2013

Appendix C(i)

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NSSC

STAGE 2 NSSC 2013/41A

New Proposals for National Specialist Services Committee Criteria - Outline Proposal Evaluation Template Applicants should provide a description of the application under the following headings. Full details and supporting evidence are not required at the outline stage. The total outline application should be no more than 3-4 pages. Section A: Introductory information 1. Full name of proposed service

Glasgow Epilepsy Next Generation Sequencing Genetics Service

2. Short title for proposed service

Glasgow Epilepsy Genetics Service 3. Brief description of proposed service

Using a multidisciplinary team approach with genetic scientists, epilepsy specialist doctors, clinical geneticists and a genetic counsellor we plan to establish a service using the latest Next Generation Sequencing (NGS) genetic testing technology available in order to allow earlier diagnosis and provide better more individualised management of children with genetic epilepsies in Scotland. 4. Name, title, and contact details of lead applicant

Nicola Williams, Consultant Clinical Scientist and Head of Laboratory (Molecular Diagnostics), West of Scotland Genetic Services, Laboratory Medicine (Level 2B), Southern General Hospital, Govan Road, Glasgow, G51 4TF. Tel: 0141 354 9313. [email protected]

Section B: Evidence of the benefits 5. Summary of patient need

The epilepsies are the commonest group of serious neurological disorders affecting 1 in 200 children (4500 in Scotland). Approximately 60% of the epilepsies are genetic in nature, many beginning in early childhood and associated with poorly controlled seizures and subsequent learning disability. Many epilepsies have complex presentations and can take years to diagnose. Different genetic epilepsies are associated with different outcomes and they can respond to different specific therapies. The 2011 Epilepsy12 audit identified 400 new-onset childhood epilepsy cases per year in Scotland, about 250 will be primarily genetic with 140 onset less than 3 years of age. Research and audit carried out in Glasgow has shown that genetic testing leads to early diagnosis and prevents children having invasive investigations. We have demonstrated that a specific genetic diagnosis leads to targeted treatment and reduction in epileptic seizures. Through prospective questionnaires to referrers and families we have shown the importance of a specific diagnosis to families; allowing them to set appropriate goals, move on emotionally, not feel guilt and make informed reproductive choices. Specific treatment in certain epilepsies can improve cognition and prevent neurodisability which otherwise may have a lifelong impact on the individual and society [Brunklaus et al. – additional documents].

Appendix C(i)


2

Our current genetic technology described below allows us to make genetic diagnoses in about 26% of referrals to our service when we target specific clinical subtypes of epilepsy. When we look at a wider group of genetic epilepsies with our limited number of genes this falls to less than 5%. A recent paper suggests that targeted sequencing of 65 genes allows a genetic diagnosis to be made in 10% of cases [Carvill et al. – additional documents]. Our panel will focus on epilepsy genes where there is no other clue to the diagnosis, for example from brain imaging and we anticipate a 10-20% diagnostic yield. Utilising Next Generation Sequencing (NGS) techniques will allow us to dramatically expand the number of genes we test (87) in a single panel, increasing diagnostic yield, with the benefits described above, to a greater number of individuals and families. The number of potential diagnoses and the complexity and volume of data generated will require bioinformatics and database expertise. Detailed (deep) phenotyping with expertise in genotype-phenotype relationships will be critical to delivering meaningful and clinically relevant results to referrers. The genetic diagnosis of epilepsy patients will require even greater integration of laboratory and clinical epilepsy services. In addition to Scottish patients (300 per year), we estimate 300-500 patients will access this service form the rest of the UK. 6. Description of the current provision

The Glasgow Epilepsy Genetics Service is delivered by a multidisciplinary team comprising clinical and laboratory genetics and paediatric neurology. Genetic testing is performed by the Molecular Diagnostics laboratory at the Southern General Hospital with clinicians and scientists advising referrers on which genes to test and the clinical relevance of genetic changes detected in individual patients DNA. The service also comprises a specialist genetic epilepsy clinic at the Fraser of Allander Neurosciences Unit at Yorkhill where children and adults referred from Scotland and throughout the UK are seen. The current provision by the Molecular Diagnostics laboratory (CPA accredited) uses Sanger sequencing and where available, copy number analysis using multiplex ligation-dependent probe amplification (MLPA) to look for genetic abnormalities in 8 genes (SCN1A, SLC2A1, CDKL5, MECP2, PCDH19, ARX, STXBP1 and UBE3A). Furthermore, genetic testing using Sanger sequencing will soon be available for 6 additional genes (CACNA1A, SLC25A22, POLG, GABRG2, PRRT2, and KCNQ2). We have UKGTN approval or have submitted gene dossiers or additional provider forms where appropriate, for all of these genes. The laboratory screens for gene mutations in ~350 probands per year and performs ~96 specific gene tests per year in the relatives of affected patients. Specimens are received from across Scotland and the rest of the UK, and also overseas. Our current referral data shows that ~105 cases per annum are referred from Scotland for genetic testing. The current test provision is funded through National Service Division (NSD) as part of the Scottish Genetics Laboratories Consortium. Referrals from out with Scotland are charged a standard predefined price based on the workload cost per test. These external referrals are income generating for NHS Scotland. 7. Description of the proposed service

Centres & clinicians involved in the Glasgow Epilepsy Genetics Service:

A. West of Scotland Genetic Services, Southern General Hospital, Glasgow Head of Molecular Diagnostic Laboratory – Nicola Williams supported by Clinical Genetic Scientists Rachael Ellis & Eleanor Reavey. Consultant Clinical Geneticists – Dr John Tolmie & Dr Shelagh Joss

B. Royal Hospital for Sick Children, Glasgow Clinical Lead for Epilepsy Genetics – Dr Sameer Zuberi (Honorary Clinical Associate Professor) supported by Dr Stewart Macleod (Consultants in Paediatric Neurology)

C. Glasgow Polyomics, College of Medical, Veterinary and Life Sciences, University of Glasgow NGS Bioinformatics – Dr Pawel Herzyk Referral pathways & proposed activity numbers

The primary target group comprises children less than 3 years with new onset suspected genetic epilepsies in Scotland i.e. those without a known structural or metabolic cause of their epilepsy (140 cases). The secondary group comprises undiagnosed older cases whose epilepsy started less than

Appendix C(i)


3

3years of age or with strong clinical suspicion of a genetic epilepsy presenting at an older age (160 cases). We therefore expect 300 Scottish cases to access this service per annum (we currently only test 105 cases from Scotland per annum). Furthermore as the UK specialist centre for genetic testing in childhood epilepsy, we predict that 300 – 500 cases per annum will also be referred for testing from the rest of the UK and overseas. These external referrals from out with Scotland would be income generating and do not form part of the costing as outlined in this proposal. Every District General & Teaching Hospital in Scotland in which children with epilepsy are seen is a part of the Scottish Paediatric Epilepsy Network (SPEN) with a link clinician who will refer cases. Pathways for pre-referral discussion with epilepsy specialists are established. Referral for specialist genetic testing of patients affected by childhood onset epilepsies is often limited by the referring consultants understanding of genetics in epilepsy and phenotypes. This service would not require detailed knowledge about genetic testing as it would be delivered as a front line test in all patients that meet the referral criteria. A three page detailed, yet rapidly completed and primarily tick box based pre-referral form has been devised to aid the collection of phenotypic data (see appendix 1). Patients will provide blood specimens that will be sent to the Molecular Diagnostics laboratory for NGS genetic analysis. Molecular Genetic Testing & Data Analysis

Traditional genetic testing involving Sanger sequencing is limited by the amount of data that can be generated and by the relative cost (up to 6Mb per day at a cost of ~£500 per Mb), consequently genetic testing is only made available for a limited number of genes. We plan to deliver genetic testing of ~87genes using an Ion Torrent™ Personal Genome Machine (PGM) NGS platform, which can generate up to 1600Mb of data per day at a relative cost of ~£10 per Mb. A data analysis pipeline will be established using the bioinformatics expertise based at Glasgow Polyomics (University of Glasgow). The analysis of NGS data will be required to filter out non-significant variants and the output results will be linked to the phenotype data collected from each patient, using database expertise. Clinical Interpretation & Reporting

The data generated will be reviewed at MDT meetings that will include genetic scientist/s, consultant paediatric neurologist/s and consultant clinical geneticist/s. The meetings will allow the genetic data to be interpreted in the context of the phenotype recorded, allowing us to generate specialist joint genetic and clinical reports for each patient. Patients in whom a genetic diagnosis is made will be referred to the specialist joint epilepsy genetics clinic in Glasgow. Reporting will conform to national best practice guidelines. 8. Clinical benefit over current NHS alternatives

Many more genes will be tested resulting in greater diagnostic yield [Carvill et al – additional documents]. Next generation sequencing is just entering clinical practice and is not offered for epilepsy in the Scottish NHS. Smaller epilepsy panels may be available elsewhere in the UK NHS for example targeting specific causes such as malformations of cortical development where the primary diagnosis could be made on a brain scan (<10 genes). The Glasgow panel will be the most comprehensive for epilepsies with no other clue to diagnosis. Making a genetic diagnosis can result in medication change, better seizure control, improved access to therapies and better psychological adjustment or the family [Brunklaus et al. – additional documents]. 9. Financial impact: estimated costs

The cost to deliver a NGS epilepsy service for 87 genes and 300 Scottish cases is estimated at £555,406 per annum (£2,777,030 over 5 years). Approximately £282,838 (£1,414,190 over 5 years) will be allocated to staffing resources, £180,000 (£900,000 over 5 years) will be allocated to laboratory reagents and consumables and a further £92,568 per annum (£462,840 over 5 years) will cover overheads. We will employ scientific laboratory staff, bioinformatics support and a database manager to perform the NGS testing, data analysis and results/ phenotypic information processing. Staffing costs also includes consultant clinician time and the employment of a genetic counsellor. Laboratory reagents and consumable costs include all genetic testing and variant confirmation, and subsequent family studies. No additional capital equipment will be required to deliver this service. Costs quoted are for Scottish patients only, referrals from the rest of the UK will be income generating (~300-500 per annum) and would require additional resourcing. Cost avoidance for NHS Scotland following the implementation of this service are estimated to be £2000 per year per patient (£600,000 per 300

Appendix C(i)


4

patients), see appendix C(iv). Section C: Support for the proposal


The proposal for Next Generation Sequencing for Epilepsy based in Glasgow is supported by the Scottish Paediatric Epilepsy Managed Clinical Network which will ensure that children throughout Scotland gain equitable access to the service. Genetic testing for Epilepsy was established in Glasgow with support from paediatric neurology in Edinburgh, Dundee and Glasgow. The proposal is supported by the Scottish Paediatric Neurology group representing child neurologists in Scotland. Epilepsy Scotland, the principal advocate for people with epilepsy is strongly supportive of increased availability of genetic testing and better diagnosis. 11. Potential opposition to the proposal

None anticipated.

12. Any other relevant information We have completed a UK Genetic Testing Network (UKGTN) gene dossier for the 87 genes which will be tested by NGS and are working with the UKGTN regarding the submission of this form. The consultant clinicians and laboratory scientists detailed in section 7 above have cross referenced the scientific literature for all 87 genes outlined in this proposal, to determine their suitability for inclusions in our epilepsy panel (see appendix 2). We have undertaken prospective audit and research on epilepsy genetic testing in Scotland since our service was established, which in turn has resulted in the publication of 8 high impact scientific papers. We have Research Ethics Committee (REC) approval for an anonymised genotype-phenotype research database and plan to continue our clinical research as we collate genetic results from NGS with phenotypic data. In addition, our research funded externally and administered through NHS R&D was awarded the Mac Keith Prize 2013 by the British Paediatric Neurology Association. In November 2012 our service won the Scottish Health Award for Services to Women & Children in recognition of the collaborative nature of our work, the patient benefit and active audit and research directly translating back to clinical patient care. Signature of Lead Consultant: ……………………………………………………. Printed Name of Lead Consultant: …………………………………………………. Date: …………………………………………………………………………

Nicola Williams

30/08/2013

Appendix C(i)


5

Appendix C(iv) Finance & Activity Information for Outline Application for National Commissioning

Please refer to Guidance Notes on completion

Patient need (question 5)

Existing identified patients

a Total current patient numbers at centres 105 per annum

Predicted future need

b Incidence of condition (per million) 3030 per million (1 in 330)

c Total anticipated long term patient numbers at centres ( at year 5) 1500

Brief explanation of c (if different from a x eligible population) Our service will capture new diagnoses in young children and older undiagnosed cases (combined total = 300/year). The incidence quoted in b is the number of affected patients in Scotland, and encompasses all age groups.

d Anticipated long term annual activity (e.g. number outpatient attendances, number procedures per annum) 300

Appendix C(i)


6

Financial impact (question 9)

£m

Existing identified expenditure

e

Current spend at centres (to nearest £m if over £2m total, otherwise to nearest £0.1m) per annum

£62,625 Cost for genetic testing component only for our current cohort of 105 patients. If we tested all 300 children as outlined in our proposal, this would = £178,929 per annum.

Breakdown of funding sources for this:

f NHS £62,625 All current funding from NSD.

g Non-NHS

f+g=e Total income (should be equal to e above) £62,625

Details of non-NHS funding sources for this

h

Estimated current spend on this patient group/service elsewhere in the NHS/health system (to nearest £m if over £2m total, otherwise to nearest £0.1m)

£1,206,300 Costs based on our future service of 300 patients (£4,021 x 300 patients).

Explanation of spend incurred in h above (e.g. outpatient attendances at local services, emergency admissions & hospital stays)

Biochemical tests (£401), MRI under general anaesthetic (£940), inpatient overnight stay (£781), outpatient with EEG consultations (£1,899) = £4,021. This is a conservative estimate for an average referral. Many children will require speciailised tests and investigations which will in turn incur additional costs.

Appendix C(i)


7

Predicted future expenditure

i Anticipated long term spend at centres (at year 5) per annum (to the nearest £m if over £2m total, otherwise to nearest £0.1m) £555,406 Cost per 300 patients.

Financial impact of proposal

i-(h+f) Estimated overall change in costs for NHS Scotland -£713,519

Estimated savings to the NHS by national commissioning per annum £226,673 ((£1,206,300 x 50%) + £178,929) - £555,406

Explanation (see guidance notes) We estimate that offering genetic testing to this group of children will reduce other NHS investigation costs by more than 50%, to approximately £2,000 for an average referral. True cost saving is difficult to calculate for some of these children since they present with complex phenotypes and require multiple specialised investigations due to the nature of their disorder. Therefore the estimated spend (h) for additional tests following the implementation of a national service would = £603,150 per annum (£1,206,300 ÷ 2). When added to the cost of testing all 300 children using the current service (eD), the total cost per annum would = £782,079 (£603,150 + £178,929). If we subtract this figure from the anticipated long term spend at centre £555,406 (i), the estimated cost avoidance for NHS Scotland would = £226,673 per annum. Offering genetic testing will result in a significant cost avoidance for NHS Scotland of ~ £1,133,365 over 5 years. In addition, more children would have a definitive genetic diagnosis earlier in life, which in turn will help direct appropriate targetted drug treatment and therefore save more money. Appropriate targetted treatment eliminates the need for other unecessary investigations.

Appendix C(i)


8

Costs of proposed expansion of Glasgow Epilepsy Genetics Service

Scale

no of patients WTE £

Clinical scientist band 7

2.00 89,120

Genetic Technologist band 5

1.00 29,858

Consultant Paediatric Neurologist

0.20 24,754

Genetic Councillor band 7

1.00 44,560

Bioinformatician band 7

1.00 44,560

Database Manager band 6

1.00 37,247

Admin and clerical band 4

0.50 12,739

Consumables

300 £600 180,000

Total exc Overheads £462,838

Overheads 92,568

Total inc Overheads

£555,406

costed at midpoint +1

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-42 Cover Paper - SPAH

1


NSSC

NSSC PAPER 2013/42

SPAH- Scottish Paediatric and Adult Haemoglobinopathy National Managed Clinical Network 1. Provider and location

The case for a managed clinical network for haemoglobinopathies was first made in 2010 further to SGHSCD CEL 31 (2008) that directed a range of developments to pregnancy and newborn screening in Scotland, including a national, linked sickle cell and thalassaemia programme. Central funding was for 1 year in the first instance and has been renewed on a year to year basis in 2012 and 2013 following resubmission of the business case to SGHSCD. SPAH now seeks formalisation of its status and funding through the national designation process for a period of three years. Within that period, under the auspices of the planned National Network Management Service, consideration will be given to embedding the work of SPAH, and all NMCNs, within business as usual. If approved, network support for SPAH will be through the national network support structure.


Planning for the developments in pregnancy and newborn screening had highlighted

Increasing patient numbers due to changing population demographics

Inequity in standards of clinical care for children and adults with haemoglobinopathies

Variable access to haemoglobinopathy screening in pregnancy.

SPAH was established on 1 April 2011 as a vehicle to ensure adequate clinical support for cases identified via the programme and provide robust links with both laboratory and clinical staff to facilitate monitoring of the screening process and outcomes.

Ongoing evaluation of Sickle Cell screening in Scotland, undertaken by the Scottish National Screening laboratory (SNSL), has shown that sickle cell prevalence in Scotland is higher than anticipated. Greater Glasgow and Grampian health boards fulfil the definition of “high prevalence” areas for sickle cell disease, as defined by a birth rate of 1.5 per 10,000 pregnancies or greater. The evaluation also highlighted a number of areas for improvement including the management of sickle cell carriers and pre transfusion samples.

The pattern of service for patients with major haemoglobinopathies varies depending on the underlying diagnosis. Patients with sickle cell disorders are likely to have a greater requirement for unpredictable acute care services, whereas patients with thalassaemia are more likely to require regular outpatient/day care based services. Both groups will require access to specific specialist investigations and at least annual review at a tertiary care centre.


2

National guidelines suggest that the optimal model for care of these patients is a comprehensive care network consisting of a specialist haemoglobinopathy centre with links to local acute care services and primary care. All patients should have access to a consultant haematologist or (paediatric haematologist) with experience of haemoglobinopathy management. This person may not be responsible for the delivery of all acute care but would be responsible for liaising with the local service providers. SPAH has established a pivotal role in facilitating effective delivery of the desired service model.

3. Assessed Needs

The SPAH network is structured and organised to meet the core principles within SGHSC guidance for MCNs. It’s multi-disciplinary/multi-professional Steering Group and working groups reflect the diverse healthcare requirements of this group of patients as well as the various professional groups involved with the Pregnancy and Newborn Screening Programme and the TCD Screening Service. It successfully supports collaborative working across organisational and geographical boundaries and professional groups and has led the way in some aspects of the development and use of the national clinical audit system for MCNs. Monitoring of SCD screening referrals has shown that in each case clinical management has met UK standards for initiation of specialist care and ongoing management.

Highly successful national education events have been held in both years, bringing together service users with multi disciplinary health professionals and experts from screening and clinical services

The Network has engaged with patients and families as a matter of priority and has hosted 2 successful patient and family events. The network has facilitated the establishment of a support group for patients and families - The “Scottish Society for Sickle Cell and Thalassaemia” - and has continued to work closely with the group which has gone from strength to strength and has branches in Glasgow, Edinburgh and Aberdeen.

4. Costs

Costs will be subsumed within the national network management service. Specific costs associated with this network are:

NMCN SPAH Lead Clinician Backfill 1 session £10,500 NMCN SPAH Network manager £22,500 NMCN SPAH Administrator £13,000 Other costs supplies, training, travel, conferences £ 5,000 Total £ 51,000


Since its establishment the network has been subject to performance management by NSD and has provided satisfactory evidence of its effectiveness and progress against its objectives within the six dimensions of quality as detailed below.

To provide links to the pregnancy and newborn screening programme in terms of referral

pathways, education and monitoring against defined quality standards

To ensure prompt diagnosis and access to treatment for all new cases according to defined patient pathways

To ensure that care is provided according to agreed evidence based clinical protocols which are regularly reviewed and updated

To facilitate the planning and resourcing of service developments required to fulfil national standards of care

To ensure access to a multi-disciplinary health care professional team supported by a strong education programme


3

To ensure access to appropriate and prompt acute care when required in a location that as close to home as possible

To facilitate provision of specialist investigations and tertiary service review including MDT reviews as defined in national care guidelines

To facilitate access to genetic counselling services

To facilitate access to a support network / charitable network who will be able to offer support and guidance on day to day living

A comprehensive programme of audit, led by the Network has highlighted a number of areas for improvement in access to and standards of haemoglobinopathy care, particularly in relation to adult provision and the network has a pivotal role in work that is being done to address these issues.


Provided in Appendix 1 of the full application are testimonies from a representative range of stakeholders as an indication of its relevance and impact on patients, families and services;

Consultant Haematologists

Associate Specialist in Public Health

UK Thalassaemia Society

Child Health Commissioner

Senior Healthcare Scientist The “Scottish Society for Sickle Cell and Thalassaemia”


SPAH was established in April 2011 through temporary, short term funding from SGHSC to ensure adequate clinical support for haemoglobinopathy cases identified via pregnancy and newborn screening and provide robust links with both laboratory and clinical staff to facilitate monitoring of the screening process and outcomes. NPPPRG considered that the network is at a critical stage of development; not only has it been effective in delivering its initial objectives but also, through audit and service mapping undertaken under its auspices, additional issues that impact on the delivery of safe, effective, person centred care have been identified. SPAH, with its proven organisational effectiveness and healthy working relationships across geographical and professional boundaries is pivotal in coordinating an effective response to these issues.

NPPPRG recommends that the MCN is best placed to facilitate and co-ordinate monitoring of outcomes both in relation to the relevant screening programmes and patient care and therefore recommends continuing designation for a further 3 years. NPPPRG also recommended that there should be a planned exit strategy for the end of the 3 year period.


07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-42A SPAH – Final

NSSC 2013/42A

Application to NSSC for the ongoing approval of a Scottish Managed Clinical Network for Paediatric and Adult Haemoglobinopathy (SPAH MCN) 2013

1.0 Executive Summary The case for a managed clinical network for haemoglobinopathies was first made in 2010 further to SGHSCD CEL 31 (2008) that directed a range of developments to pregnancy and newborn screening in Scotland, including a national, linked sickle cell and thalassaemia programme. Planning for these developments had highlighted

Increasing patient numbers due to changing population demographics

Inequity in standards of clinical care for children and adults with haemoglobinopathies

Variable access to haemoglobinopathy screening in pregnancy. Ongoing evaluation of Sickle Cell screening in Scotland, undertaken by the Scottish National Screening laboratory (SNSL), has shown that sickle cell prevalence in Scotland is higher than anticipated. Greater Glasgow and Grampian health boards fulfil the definition of “high prevalence” areas for sickle cell disease, as defined by a birth rate of 1.5 per 10,000 pregnancies or greater. Scottish Government policy recognises NMCNs as a successful model for service development and improvement. The Scottish Paediatric and Adult Haemoglobinopathy (SPAH) National Managed Clinical Network (MCN) was established on 1st April 2011 as a vehicle to ensure adequate clinical support for cases identified via the programme and provide robust links with both laboratory and clinical staff to facilitate monitoring of the screening process and outcomes. Central funding was for 1 year in the first instance and has been renewed on a year to year basis in 2012 and 2013 following resubmission of the business case to SGHSCD. The Network’s activities have made a positive impact on the quality of care provided for this group of patients and families who are often considered hard to reach.

The network has undertaken a range of audits and data collection highlighting

the ongoing need for service improvement in the care of haemoglobinopathy patients. It aims to ensure equity of access and standards of care for all patients, regardless of their age or geographical location in Scotland.

The network has established and populated a Clinical Audit System (CAS) database of patients with haemoglobinopathies. This database has been used to audit aspects of patient care and will be used to inform targeted service developments

The network was instrumental in establishing a National service for Transcranial Doppler (TCD) screening for assessment of stroke risk in children with sickle cell disease and a National “Ferriscan®” service for assessment of iron stores in transfused children with haemoglobinopathies. Improvements in the provision of these services to all patients are being considered by the network.

The network has identified a need for ongoing education of healthcare professionals in all aspects of the diagnosis and clinical management of


haemoglobinopathies. It has actively pursued its educational aims and has organised successful teaching events for nursing, medical, genetics and laboratory professionals. Plans include an event for haematology registrars and development of the online managed knowledge network (MKN).

The network has established, and continues to develop a nationally accessible website with links to clinical management guidelines for adults and children with haemoglobinopathies. Links to information for patients and carers and to support groups are included.

The network has published and facilitated access to printed information leaflets on haemoglobinopathies for patients, carers and healthcare professionals.

The network co-ordinates quarterly, Scotland-wide, multidisciplinary team (MDT) meetings for discussion of new and established haemoglobinopathy cases. These meetings bring together medical and nursing professionals and trainees to allow discussion of clinical and diagnostic problems. An update of new cases detected by the newborn screening programme is presented at each meeting. These meetings are the only official forum for peer review of haemoglobinopathy cases and provide the opportunity for education of professionals who may see only small numbers of cases because of their geographical location.

The network has carried out audits of the antenatal screening programme and has established that further work is needed to achieve UK standards in screening and clinical care for women and their partners and to link the pregnancy and newborn aspects of screening

The network has facilitated and supported the development of a support group “Scottish Society for Sickle Cell and Thalassaemia” and has organised two successful patient and family events. Ongoing communication between the network and support group is considered key to the success of both organisations.

The Network is central to the achievement of the highlighted improvements and is seeking formalisation of its status and funding through the national designation process for a period of three years in order to continue its work in supporting SG policy aims outlined in the NHS Healthcare Quality Strategy of providing safe, effective, and person centred healthcare in relation to this group of conditions.. Within that period, under the auspices of the planned National Network Management Service, consideration will be given to embedding the work of SPAH, and all NMCNs, within business as usual. i


2.0 Network Description

The SPAH network is structured and organised to meet the core principles within SGHSC guidance for MCNs. It’s multi-disciplinary/multi-professional Steering Group and working groups reflect the diverse healthcare requirements of this group of patients as well as the various professional groups involved with the Pregnancy and Newborn Screening Programme and the TCD Screening Service. It successfully supports collaborative working across organisational and geographical boundaries and professional groups and has led the way in some aspects of the development and use of the national clinical audit system for MCNs. Highly successful national education events have been held in both years, bringing together service users with multi disciplinary health professionals and experts from screening and clinical services The Network has engaged with patients and families as a matter of priority and has hosted 2 successful patient and family events. The network facilitated the establishment of a support group for patients and families - The “Scottish Society for Sickle Cell and Thalassaemia” - and has continued to work closely with the group which has gone from strength to strength and has branches in Glasgow, Edinburgh and Aberdeen. Since its establishment the network has been subject to performance management by NSD and has provided satisfactory evidence of its effectiveness and progress against its objectives within the six dimensions of quality as detailed below. Also provided are testimonies from a representative range of stakeholders as an indication of its relevance and impact on patients, families and services. Appendix 1 3.0 Network aims:

To provide links to the pregnancy and newborn screening programme in terms of referral pathways, education and monitoring against defined quality standards

To ensure prompt diagnosis and access to treatment for all new cases according to defined patient pathways

To ensure that care is provided according to agreed evidence based clinical protocols which are regularly reviewed and updated

To facilitate the planning and resourcing of service developments required to fulfil national standards of care

To ensure access to a multi-disciplinary health care professional team supported by a strong education programme

To ensure access to appropriate and prompt acute care when required in a location that as close to home as possible

To facilitate provision of specialist investigations and tertiary service review including MDT reviews as defined in national care guidelines

To facilitate access to genetic counselling services

To facilitate access to a support network / charitable network who will be able to offer support and guidance on day to day living


4.0 Network Activities

A brief summary of the network’s activities is provided below. Further details are provided in Appendix 2 4.1 Patient Centred

Patient/ Parent/ Carer involvement is core to the work of the network. The network recognises that the views of patients, including children and their families, are central to any service developments that are proposed. The MCN has had active patient involvement from its inception.

The network facilitated the formation of the “Scottish Society for Sickle Cell & Thalassaemia” which provides an important mechanism for dialogue between the MCN and families.

A successful Patient/Family Event was held at the Kelvingrove Museum, Glasgow in October 2011. This was an extremely positive day and included presentations from the UK Sickle Cell Society, the UK Thalassaemia Society and the Genetics Alliance. It was the first time UK Haemoglobinopathy charities had been involved with an event in Scotland.

A follow up Patient/Family event was held at Robert Gordon University Sports Facility in Aberdeen on Saturday 23rd March 2013. Children were entertained by play co-ordinators and had access to facilities including the climbing wall. Local speakers were joined by representatives from both the Sickle cell and Thalassaemia Societies. The meeting was well attended and patients travelled from across Scotland for the event.

Education for patients, parents and carers is vital for the management of these conditions. There is an ongoing programme to develop educational materials/leaflets for families and Network links have facilitated the use of screening information literature from other relevant bodies involved with haemoglobinopathy screening and patient care.

Locally completed materials include information on the Network (how to get involved), the Clinical Audit System (CAS) database, TCD screening, Hydroxycarbamide use and information on each of the conditions for newly diagnosed families. We have produced leaflets and care plans for schools with patient/carer input.

Following an assessment by the Network of foreign language requirements these materials are provided in different languages so as to be accessible to all patients and their families. NHS Health Scotland approached the Network as they were keen to work collaboratively with us to provide patient/family information leaflets in different languages to help address inequalities of access.

The MCN will continue to support patients and families via educational initiatives and materials. 4.2 Safe

A wide range of healthcare professionals are involved in the provision of care for this patient group. Increasing patient numbers due to changing population demographics and the introduction of screening mean that many healthcare professionals, across


primary, secondary and tertiary care, are now coming into contact with these disorders but are poorly equipped to deal with the often complex needs of these patients. Failure to recognise clinical problems in a timely manner is recognised as a significant risk to this patient group. This lack of expertise has been compounded by previously limited educational opportunities and the clear need to address gaps in education was highlighted in a Learning Needs Analysis (LNA) carried out by the MCN. The MCN is well placed to co-ordinate educational initiatives and events relating to both screening and patient care and has endeavoured to address this from the outset. Initiatives include:

Successful and well supported Annual Education Event, held in Edinburgh Training & Conference venue in June 2012

Laboratory Education event held in Forth Valley Royal Hospital on 30th April, 2013 with invited keynote speaker, Chris Lambert from Kings College, London

National Multidisciplinary team meetings (MDT) began in December 2012 with subsequent meetings quarterly. These meetings bring together medical and nursing professionals and trainees from across Scotland and allow discussion of clinical and diagnostic problems. An update of new cases detected by the newborn screening programme is presented at each meeting. These meetings are the only official forum for peer review of haemoglobinopathy cases and provide the opportunity for education of professionals who may see only small numbers of cases because of their geographical location.

SPAH website continues to be updated regularly, providing links, information and updates on all UK events for both patients and professionals

The SPAH website has links for professionals to guidelines for the management of haemoglobinopathies in both the adult and paediatric populations

The Managed Knowledge Network (MKN) continues to be developed

Educational booklet for teachers on Sickle Cell Disease has been developed for Schools

The Network has, and will continue to provide relevant educational opportunities to a range of Health Care Professionals according to a formal education strategy. 4.3 Effective

Quality indicators exist for the Pregnancy and Newborn Screening Programme, the TCD Service and for the Clinical Care of Patients with Sickle Cell Disease and Thalassaemia. The key performance indicators (KPI’s), listed below, are being measured and reported against, either via a paper audit or through the Clinical Audit System.

% of screen positive babies seen by a paediatric haematologist or paediatrician within 8weeks of referral from Newborn Screening Laboratory

% of screen positive babies in whom results of confirmatory testing are returned to the Newborn Screening Laboratory

% of infants with Sickle Cell disease offered and prescribed penicillin V (or alternative) by 3months of age

% of children receiving pneumovax by 2 years of age (24-27months) and 5 early thereafter.

% of children aged 2-16 years offered an annual TCD scan


% of patients on regular transfusion undergoing appropriate monitoring of iron overload (regular ferritins, MRI as per guidelines)

% of adults with Sickle Cell disease offered pneoumovax, HIB and meningovax vaccinations

Audits carried out to date are:

Haematology Laboratory audit of antenatal haemoglobinopathy screening procedures (May 2012 and March 2013)

Management of painful crises in children with Sickle Cell Disease carried out by N. Boyd (medical student SSC). Presented at the RCPCH/Europaediatrics meeting in May 2013.

Availability of MRI scanning for the assessment of iron overload in adult patients with transfusion dependent Sickle Cell or Thalassaemia.

Newborn Screening programme outcomes – reported quarterly at MDT.

Audit of the Transcranial Doppler Service.

Vaccination with Pneumovax at 24-27months of age in children with Sickle Cell disease – rolling audit

Scotland wide evidence based Protocols/Guidelines based on National Standards of Care are being developed for both children and adults with Sickle Cell Disease and Thalassaemia by the network. Several guidelines dealing with acute care issues have already been completed and distributed. 4.5 Efficient

Prior to the Network there was no system within Scotland for data collection in relation to these conditions. The Network has subsequently agreed to use the CAS for data collection and audit purposes. This initially involved the design of a specific dataset for this network and training of network users. Inputting of basic demographic and condition data has been, and will continue to be completed providing the Network with a patient registry. Progress is now ongoing with other data collection and the system will be used to carry out audits against national standards and Key Performance Indicators (KPI) as per the current work plan. This includes monitoring outcomes from the newborn screening programme for which a specific core data set has been developed. In collaboration with the Newborn Screening Programme initial problems with the screening pathway in relation to pre-transfusion sampling have already been identified and amended. 4.6 Equitable

Service mapping has been carried out to assess current healthcare provision across Scotland. The network was pivotal in securing a National Service for Transcranial Doppler (TCD) Screening to assess the risk of stroke in children with sickle cell disease. A National Paediatric “Ferriscan®” service for assessment of iron status was established concurrently. Both are based at Yorkhill Hospital in Glasgow. A number of gaps in service provision have been identified and strategies to address these issues are currently being examined. Service gaps/areas of potential inequality in the provision of care include:

Poor uptake of TCD screening services in Glasgow from Grampian families. Consideration of the provision of a “portable” TCD Screening Service in Grampian


The absence of Ferriscan MRI scanning for adults on long term transfusion.

Inconsistent provision of automated exchange transfusion.

The absence of a hub and spoke model of care for adult patients particularly in the West of Scotland.

The MCN is taking these issues forward to improve services for patients. 4.7 Timely

Patient pathways have been developed to facilitate rapid referral of new cases and appropriate time scales for investigations.

Many of the quality standards relate to the timeliness of interventions and as discussed above are being actively monitored through the use of the CAS system.

4.8 Future plans

The SPAH network has made a very positive start and has several working groups now established.

A new nursing subgroup has been formed who are due to meet in November.

We have established and will continue to update the Clinical Audit System (CAS) which is vital for the planning of services and audit of care for this patient group.

The network is working to secure equity of access and universal uptake of TCD screening for children and Ferriscan® services for adults with haemoglobinopathies.

The network has already proved invaluable in bringing together and educating healthcare professionals working in different areas in relation to both the screening programme and patient care. It has the potential to significantly influence clinical practice and will continue with regular education events and the development of management protocols.

National guidance recommends that SCD carriers identified through newborn screening should be referred to their GP for onward referral to local genetic counselling services, if requested by the family. The network is establishing what level of support and education materials GP pratices require for the effective management of these patients and aims to engage a GP representative for its Steering Group.

The network has helped to bring together sickle cell and thalassaemia patients who have often felt isolated and alone with these conditions. We will continue to host and support patient and family events across Scotland.

In England, a National Peer review process of Haemoglobinopathy services has been established by the UK Forum on Haemoglobin disorders. Separate Paediatric and Adult Peer Reviews were completed in 2010/11 and 2012/13 respectively and a second round of visits by Peer Review assessors has been proposed for 2014-2017. This second round will combine review of adult, transition and paediatric services. The network plan to approach the Peer review steering group and request inclusion of Scottish centres in the review process.

The aim of the network over the next 5 years would be to consolidate what has been achieved to date and to strive to achieve equity and high standards of care for patients and their families across Scotland. 5.0 Background


5.1 Conditions

The term ‘haemoglobinopathy’ refers to a group of inherited blood disorders causing defective red cell production. These conditions can be broadly divided into sickle cell disease and thalassaemia. Both of these conditions cause problems from early childhood, affect the patient throughout life and cause a significant reduction in life expectancy. Sickle Cell Disease (Hb-SS, HbSC, HbS/Beta thalassaemia and other sickling disorders)

Sickle cell disease is an inherited blood disorder primarily arising in people of African-Caribbean origin and less frequently in those from India, Pakistan and the Middle East. It is characterised by a chronic anaemia, an increased susceptibility to infection and a propensity to acute vaso-occlusive crisis which can be painful and can cause widespread organ damage. Acute episodes can be life-threatening and require prompt expert attention. Recurrent episodes result in chronic ill health affecting almost every organ. The morbidity associated with this organ damage can be lessened with appropriate early interventions, clinical assessment and specialist management. Beta thalassaemia

Beta thalassaemia affects people of primarily South Asian and Southern Mediterranean origin and results in a lifelong requirement for regular red cell transfusion every few weeks. The major health issues associated with thalassaemia relate to transfusional iron overload and resulting organ damage. Life expectancy for both sickle cell disease and thalassaemia is progressively improving and is now likely to be in excess of 50 years with good clinical care. 6.0 Screening Programme

The likelihood of a baby being born with a major haemoglobinopathy either thalassaemia or sickle cell disease can be predicted by antenatal haemoglobinopathy screening (both parents will usually be carriers for the condition) and these conditions can usually be diagnosed in an affected baby at birth. The Antenatal and Newborn Haemoglobinopathy Screening Programme was implemented in Scotland in October 2010.

The objective of antenatal screening is to offer sickle cell and thalassaemia screening to all women and couples in a timely manner during early pregnancy. Couples identified as being high risk of having a child affected by a haemoglobinopathy can then be counselled regarding this risk and offered appropriate choices regarding ongoing management.

The objective of the newborn screening programme is to identify babies with sickle cell disease during the neonatal period in order to reduce morbidity and mortality through early diagnosis and treatment.

7.0 Incidence /Prevalence 7.1 Populations affected & demographics in Scotland

Sickle cell disease predominantly affects people of African, African-Caribbean origin and less frequently those from India, Pakistan and the Middle East, whereas thalassaemia is more common in those from South Asia and the Southern Mediterranean. Over the past decade it has become apparent that the number of adults and children with these conditions attending centres in Scotland is increasing. This reflects significant changes in population demographics over this period occurring as a consequence of immigration and movement within the UK. While figures from the


2001 census showed significantly less ethnic diversity in Scotland as compared to England, more recent data taken from newborn bloodspot cards detailing the ancestry of babies shows that since 2001 ethnic diversity in Scotland has increased significantly (Tables 1 & 2). Data from the 2011 census is awaited for England which is not available until November. Table 1 Ethnic diversity England and Scotland from 2001 census

Scotland England Scotland

Ethnic group 2001 percentage

2001 percentage

2011 percentage

White (UK, European & other) 97.99 90.92

96.00

Asian 1.09 4.58 1.60

African/African- Caribbean 0.16 2.30

0.70

Mixed 0.25 1.31 0.40

Chinese/ South East Asian

0.32 0.45 1.00

Other 0.19 0.44 0.30

Table 2 Ethnic diversity in Scotland 2009-2011 from Newborn Screening Data

Ethnic group 2009 (%) 2010 (%) 2011 (%) 2012(%)

White(UK, European & other) 87.81 88.47 83.4

83.92

Asian 2.79 3.32 3.14 3.19

African/African- Caribbean 1.96 1.38 3.16 2.62

Mixed 2.35 2.33 3.31 3.42

Chinese/South East Asian 0.66 0.77 1.1 1.03

Other(Inc.declines) 4.43 3.73 5.89 5.82

7.2 Results from Newborn Screening

Given this data it is not surprising that the number of babies detected as having a significant haemoglobinopathy as part of the newborn screening programme has also been much higher that anticipated (previous estimates suggested 3 new cases per year (0.5/10,000 births) (1).


In 2012, 55,871 babies were screened in Scotland. 9 clinically significant haemoglobinopathy cases were detected as well as 244 carriers. This gives a detection rate in Scotland of 1.6/10,000 with the majority of these cases detected in NHS Grampian (incidence 3/10,000) and NHS Greater Glasgow and Clyde (GGC) (incidence 2.6/10,000). These figures indicate that Scotland reaches the threshold for a high prevalence area (‘High prevalence’ is defined as an area where the fetal prevalence of sickle cell disease is 1.5 per 10,000 pregnancies or greater ≥1.5/10,000) (2). 7.3 Estimated prevalence Prior to the establishment of the SPAH MCN details on the number of patients with haemoglobinopathies attending Scottish centres for treatment were not readily available. Using the Clinical Audit System (CAS) a patient registry and database has been established providing much more robust data on patient numbers than has previously been available. Current patient numbers extracted from CAS for the major treatment centres are shown below and demonstrate an ongoing increase in this patient population since data collection began in 2011. As with newborn screening the numbers are highest in Grampian and GGC.

Adults Centres

SICKLE CELL 2012

THALASSAEMIA 2012

SICKLE CELL 2013

THALASSAEMIA 2013

Aberdeen 31 1 31 1

Dundee 9 3 9 3

Edinburgh 18 6 17 4 Glasgow * 22 3 17 1

Forth Valley 0 0 1 0 TOTAL ADULTS

80 13 75 9

* These numbers do not include patients from Southern General Hospital, Glasgow

Paediatric Centres

SICKLE CELL 2012

THALASSAEMIA 2012

SICKLE CELL 2013

THALASSAEMIA 2013

Aberdeen 25 0 26 0

Dundee 4 2 4 2

Edinburgh 8 2 10 3

Glasgow 45 10 42 11 TOTAL PAEDIATRICS

82 14 82 16

8.0 Nature and Pattern of Service


The pattern of service for patients with major haemoglobinopathies varies depending on the underlying diagnosis. Patients with sickle cell disorders are likely to have a greater requirement for unpredictable acute care services, whereas patients with thalassaemia are more likely to require regular outpatient/day care based services. Both groups will require access to specific specialist investigations and at least annual review at a tertiary care centre. National guidelines suggest that the optimal model for care of these patients is a comprehensive care network consisting of a specialist haemoglobinopathy centre with links to local acute care services and primary care (Section 12.1). All patients should have access to a consultant haematologist or (paediatric haematologist) with experience of haemoglobinopathy management. This person may not be responsible for the delivery of all acute care but would be responsible for liaising with the local service providers. 8.1 Primary Care/Community/Schools

GPs together with other members of the primary health care team e.g. health visitors, school nurses have an important role to play in the management of these chronic conditions; the recruitment of a GP to the Steering Group is planned as a means to facilitate provision of the required level of support fro primary care colleagues in terms of good communication, provision of treatment plans and education materials. 8.2 Acute care/local hospitals

Patients with haemoglobinopathies should receive acute care for as close to home as possible. In the event of acute problems patients require prompt access to acute services which may be via a local A&E or via direct access to a local/specialist haematology unit. Acute pain management is an important issue for these patients and it is important that local services have access to appropriate protocols. Acute crises can be potentially life-threatening and can require referral for specialist care and access to PICU/ICU facilities. Patients with thalassaemia and sickle cell disease may attend either a local centre or a specialist centre for regular blood transfusions.

8.3 Specialist Care

Patients should be able to access a full range of specialist services at a tertiary centre. When a new case is diagnosed either via newborn screening or beyond the newborn period the diagnosis should be confirmed and a management plan formulated by a specialist centre. It is recommended that all patients have an annual review which may be face to face or part of an MDT, to review their care and the results of specialist monitoring investigations which may include e.g. Transcranial Dopplers, MRI scanning.

8.4 Interdependency with other Specialties

The specialist centre will also be expected to provide access to other relevant sub-specialties e.g. growth clinics, cardiac services and access to stem cell transplant services. “Routine” Obstetric/Surgical/Orthopaedic care is significantly more complicated in these patients and specialists with an interest in the care of these patients must be identified. 8.5 Psychological & Social services


These conditions are associated with a significant psychological burden for patients who may therefore benefit from access to a range of support services which may be either NHS based or associated with external bodies including patient charities e.g. sickle cell society. The significant proportion of patients (particularly in the West of Scotland) who are seeking asylum adds another layer of complexity to these issues.

8.6 Genetic Counselling

Haemoglobinopathies are inherited as autosomal recessive conditions and patients and their families should have access to genetic counselling. This should be available for affected individuals and for carriers. In Scotland genetic counselling services should be made available via regional genetics centres. 9.0 Estimate of Likely Need For Services Within the Network:

Patients with haemoglobinopathies, particularly those with SCD will access NHS services on both a planned and unplanned basis. 9.1 Planned Services

Clinics & Day Care

Routine clinical review

Annual clinic review at a specialist centre

Review specialty clinics e.g. cardiac, endocrine, ophthalmology, ENT

Day care or inpatient attendance for blood transfusion

Patients with haemoglobinopathies are seen on average four to six times per year in the outpatient clinic. This varies greatly depending on the needs of the patient, with some attending more frequently if requiring medication or close follow up. All thalassaemia patients and a proportion of those with SCD will require to attend for regular blood transfusion.

Specialist Investigations & Treatments

Annual liver & cardiac MRI (transfused patients aged 6 and above)

Transcranial Doppler (TCD) scanning (children with SCD age 2-16 yrs)

Cerebral MRI/MRA (SCD patients with clinical problems or abnormal TCDs)

Echocardiography (all transfused patients)

Automated RBC exchange transfusion

Stem cell transplantation Paediatric patients have Transcranial Doppler scanning every year, or more frequently if required. Annual MRI/Ferriscan® imaging, echocardiography and endocrinology assessment is recommended for all patients on transfusion. 9.2 Unplanned Services The majority of patients with SCD will access acute services on a regular basis for the management of acute sickle crises and other acute complications. The number of emergency attendances is difficult to quantify however this data is now being collated via the CAS database. A reasonable estimate would be 1-2 admissions per patient per year, equating to 5-10 bed days per patient per year.


Once fully populated over a longer period of time, the SPAH CAS database will provide more accurate figures relating to the planned and unplanned visits, which will facilitate service planning. 10.0 Capacity

Capacity issues exist both in diagnostic and monitoring services which are currently limited and not universally accessible and in the quality of clinical care which is provided to this patient group. The following are of particular concern:

Measurement of cerebral blood flow using transcranial doppler scanning

(TCD) is important for the prevention of stroke in children. TCD has been established as a service in Royal Hospital for Sick Children, Glasgow and is available for all children in Scotland prepared to travel to Glasgow. A recent audit has shown that uptake of the service from patients in Grampian remains poor. The network is currently looking at how this can be improved

Annual MRI scanning to assess iron overload in transfused patients is a national standard for adults and children. Ferriscan is now available at the Royal Hospital for Sick Children, Glasgow for paediatric patients but the assessment of iron loading in adult patients is limited and falls out with what is recommended for these patients. The network is currently collating data of the requirement for this service.

Automated Red cell exchange (a therapeutic procedure for both acutely ill SCD patients and those on chronic transfusion) is not universally available in centres in Scotland.

Patients with haemoglobinopathies benefit from dedicated clinic facilities, medical input, and specialist nursing care, which is currently variable and on the whole limited across sites, particularly in the adult service.

Availability of tertiary care/annual specialist review for all adult patients is currently lacking and requires the development of appropriate regional services for these patients. This particularly applies to adult patients in the West of Scotland where there is no designated regional specialist centre. At present, the network MDT aims to address this issue.

11.0 Impact on Equality and Diversity

Haemoglobinopathies largely affect ethnic minority communities whose access to healthcare may be constrained by several issues including language, culture and socio economic status. The intention of the Network is to promote access to appropriate health care for these groups of patients who may themselves lack a strong political voice. Included in this is the need to provide information in a format that is accessible and comprehensible to patients for whom English is not their first language. Equity of access to Specialist Centres for patients with SCD and Thalassaemia is a significant issue in Scotland due to the geography of the country and patients frequently having to travel longer distances to access services. In some of the larger health board areas, the referral pathways and definition of ‘comprehensive care


centres’ for adult patients are ill-defined. Standards of care, both within these Centres, and within local DGH / Primary Care services can vary enormously. The establishment of the Network has allowed health care professionals to work together and start to establish local, regional and national guidelines. By building on these, we would hope to ensure all patients are able to access services in a more convenient and timely manner. 12.0 Clinical Effectiveness of the Service. 12.1 Summary of Applicable National Standards of Care Available from the National http://sct.screening.nhs.uk

Standards & Guidelines:

- Sickle Cell Disease in Childhood – standards and guidelines for clinical care – second edition (2010). First edition 2006.

- Trans-cranial Doppler Scanning for Children with Sickle Cell Disease – standards and guidance (2009).

- Standards for the Clinical Care of Adults with Sickle Cell Disease in the UK (2008).

- Standards for the Clinical Care of Children and Adults with Thalassaemia in the UK (2008) – second edition. First edition, 2005.

Available from the British Committee for Standards in Haematology http://www.bcshguidelines.com

Standards & Guidelines

Significant haemoglobinopathies: guidelines for screening and diagnosis (BCSH 2009)

Management of Acute Painful Crisis in Sickle Cell Disease (BCSH 2003)

Available from NICE http://www.nice.org.uk

Standards & Guidelines

Sickle cell acute painful episodes: management of an acute painful sickle cell episode in hospital (June 2012)

Other documents: Royal College of Nursing – Caring for people with sickle cell disease and thalassaemia syndromes – a framework for nursing staff (2011).

The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) report, A Sickle Crisis? (2008) http://www.ncepod.org.uk/2008report1/Downloads/Sickle_report.pdf#search='prophylaxis'

http://www.bcshguidelines.com/

http://www.nice.org.uk/

http://www.nice.org.uk/

http://www.ncepod.org.uk/2008report1/Downloads/Sickle_report.pdf#search='prophylaxis

http://www.ncepod.org.uk/2008report1/Downloads/Sickle_report.pdf#search='prophylaxis


Applicable National Standards for Screening

Standards for the Linked Antenatal and New-born Screening Programme Second Edition (2011), NHS Sickle Cell and Thalassaemia Screening Programme.

Sickle Cell and Thalassaemia – Handbook for Laboratories third edition (2012), NHS Sickle Cell and Thalassaemia Screening Programme

13.0 Network Arrangements

The establishment of Scottish Paediatric and Adult Haemoglobinopathy (SPAH) Managed Clinical Network in April 2011 has created invaluable links between health professionals across Scotland involved in the care of this patient group and with those involved with the recently introduced antenatal and newborn screening programmes. 13.1 Management Structure

Current management structure:

Lead Clinician – Dr. Beverley Robertson, Consultant Haematologist, Aberdeen Royal Infirmary

Network Co-ordinator – Mrs Laura Craig, Royal Hospital for Sick Children, Glasgow.

Network Management is provided by Karyn Robertson through an existing resource in the Managed Clinical Network Department.

Network Steering group

The Network Steering Group includes representation from various different disciplines and professions involved in the care of patients with haemoglobinopathies and the Pregnancy and Newborn Screening Programme. Patients and families are also represented. The purpose of the steering group is to direct and support the development of the network and the services it encompasses. It has the remit to approve work streams which will deliver on the network’s designation objectives. The Network also has 5 working groups which are leading on delivering the network objectives. Communication pathways are in place between the Steering Group, Pregnancy Screening Group and Newborn Screening Group, through shared membership of the Network. Current Steering Group

Elizabeth Chalmers Consultant Paediatric Haematologist

Laura Craig Network Co-ordinator

Beverley Robertson Consultant Haematologist

Louisa McIlwaine Consultant Haematologist

Angela Iley Genetic Counsellor

Ruth Allen Consultant Paediatric Radiologist

Hazel Douglas Haemoglobinopathy Screening Midwife

Sarah Smith Principal Healthcare Scientist, Newborn Screening


Aileen Gibson Clinical Nurse Specialist

Vicki Brace Consultant Obstetrician

Esther Abiola Idowu Parent representative

Helen MacTier Consultant Neonatologist

Trina Stewart Patient representative

Linda McErlean Pregnancy & Newborn Screening Co-ordinator/Midwife

Lyn Hutchison Programme Manager, NSD

Nicole Priddee Consultant Haematologist

14.0 Costs and Cost Effectiveness

Costs will be subsumed within the national network management service. Specific costs associated with this network are: NMCN SPAH Lead Clinician Backfill 1 session £10,500 NMCN SPAH Network manager (July 2014 onwards) £22,500 NMCN SPAH Administrator £13,000 Other costs supplies, training, travel, conferences £ 5,000 Total £ 51,000

Alternative Network Arrangements

National MCNs provide a mechanism for ensuring equity of access to and quality of specialist care for the people of Scotland. Without ongoing funding there is a significant risk that the added value that SPAH has delivered so far in terms of safe, effective, person centred care for this group of patients will be compromised. There is also a risk that the additional needs and priorities for patients, staff and services that have been identified in the current work plan will not be addressed effectively. The MCN is best placed to facilitate and co-ordinate monitoring of outcomes both in relation to the relevant screening programmes and patient care. Failure to secure

Network Management Group

(Steering Group)

Sub-Group 5 Nursing

Sub-Group 4 Clinical standards

Paediatric protocols & guidelines

Sub-Group 3 Clinical standards

Adult protocols & guidelines

Sub-Group 2 Education for

Healthcare professionals and

patient/families

Sub-Group 1 IT/Audit


ongoing funding will significantly impact the ability to effectively monitor these interventions, and implementation of SPAH’s recommendations and improvements. Support

Endorsement of this application has been sought and agreed from:

Directorate of the host board (NHS Greater Glasgow & Clyde)

Multidisciplinary members of staff with an interest in this Network

Patient and Parent representatives

Representatives from national charities – Sickle Cell Society & UK still waiting on SC to reply Thalassaemia Society

Scottish Newborn Screening Laboratory

Pregnancy & Newborn Screening Co-ordinators / Consultants in Public Health Medicine

Please also see Appendix 1 for Testimonies as written evidence of support. References

1. National Resource Centre for Ethnic Minority Research (2004). Screening for Sickle Cell Disorder and Thalassaemia in Scotland. Report December 2004

2. 18 Month evaluation study: Evaluation of a selective screening strategy for sickle cell disorder in the Scottish newborn population. (2012)


Appendix 1

STAKEHOLDER TESTAMENTS

I am a parent to a child with sickle cell disease, and also the chairperson of the

Scottish Sickle Cell and Thalasssaemia charity that provides support to parent, patient and carers in Scotland.

This group has benefited immensely from being a part of the SPAH MCN. The MCN has provided the necessary support that we need as a group to help to reduce the effect

of isolation that many parents had when they did not have any form of support group in place.

We got the idea of the support group from one of the family events that was organised by SPAH and we have been able to get the opportunity to attend the steering group

meeting to tell them of any concern in relation to care and well being of patient, parent and carers.

The importance of the SPAH MCN to the creation and the formation of our charity and we are very grateful that we have been given a chance to be part of all that is been

done to make the life of the patient better through the provision of information, support at events that we organise as well as our inclusion in any form of event that

can help to increase awareness of the impact of Sickle Cell and Thalassaemia in Scotland. Esther Idowu, Parent

SPAH MCN has allowed close liaison with haematology colleagues in tertiary centres and sharing of clinical expertise and knowledge of the Scottish medical system. The development of national guidelines for clinical management of sickle cell disease has helped to improve patient care, especially as many local doctors are unfamiliar with this cohort of patients. These guidelines have been well received by my local ED colleagues and haematology registrars. The case reviews/ multidisciplinary sessions have been very educational and aid complex patient management. The educational programme in 2012 was well received by haematology registrars and provided knowledge required to pass MRCPath exams on their way to consultancy. SPAH MCN is currently continuing work to ensure that Scottish haemoglobinopathy patients have access to monitoring investigations on par with patients elsewhere in the UK.


For the reasons stated above, I would be very keen for the work of the SPAH MDT to continue. Dr Nicole Priddee, Consultant Haematologist, Royal Infirmary of Edinburgh, Edinburgh I would be pleased to endorse the important work of the SPAH network in its contribution to improving the knowledge base and quality of both the pregnancy and newborn screening programmes and the provision of services to affected patients and their families. Theresa Carswell, Associate Specialist Public Health, NHS Aryshire & Arran

The UK Thalassaemia Society is pleased to offer their support for the continuation of the SPAH MCN. Elaine Miller, Project Co-ordinator (North) UK Thalassaemia Society I can confirm from a public health/child health commissioner and remote and rural health board that the network works adds value and enhances care for children and young people across NHS Highland with haematological conditions. Though these may be infrequent it is more important that clinical colleagues can access information from peers and that there are clear evidenced pathways. I also know that the teaching and CPD is also valued Sally Amor, Child Health Commissioner, NHS Highland

The Scottish Newborn Screening Laboratory supports the application for continued funding for this service. Networks are valuable assets as they collect and collate information on all cases detected through newborn blood spot screening and are a main source of data on cases throughout Scotland. Moira Fitch, Senior Healthcare Scientist, NHS Greater Glasgow & Clyde The SPAH MCN has been particularly valuable to us here in Tayside. Although we have seen a substantial increase in our sickle and thalassaemia patient numbers over the last few years, they remain very small in absolute terms when compared to large population centres in England. Therefore it is hard to provide the specialised care these patients require without having a network of colleagues to discuss with when complex decisions need to be made. The MCN provides a framework to maintain and enhance the care of this vulnerable group of patients. Already much has been achieved with relatively limited resources, but there remains a great deal of scope to further improve our service. In the MCN's absence it is likely that there would be a detrimental effect on patient care. Dr Gordon Marron, Consultant Haematologist, NHS Tayside


Appendix 2 SPAH work plan for July 2013 – Ongoing

Action Outcome Date

Develop information leaflets for patients/families on use of “Hydroxycarbamide in children” and “Sickle Cell management at home”

Provide specific information to patients and families which is currently unavailable in Scotland

Ongoing throughout 2013/early 2014

Deliver Annual Education meetings across Scotland to assist with implementation of recommendations and update their knowledge. Target audiences will rotate year on year

Improve and update current knowledge for all health professionals, which will improve haemoglobinopathy provision for patients and families

Ongoing throughout 2013/ 2014

Continue annual delivery of Laboratory Education Events, based on success of pilot event.

Development of a rolling Laboratory education and training programme

2014 / ongoing

Continue to record audio from all events to provide additional educational resource on the SPAH website www.spah.scot.nhs.uk

Provides useful resource library for all clinicians to refer to

2013 / ongoing

Develop and deliver a framework of education for Primary Care e.g. GP’s

To provide basic but essential information on haemoglobinopathy conditions to primary care via the Managed Knowledge Network (MKN)

2014 / ongoing

Continue to deliver quarterly Multidisciplinary Team meetings (MDT) with colleagues across Scotland with the ability to access via video conferencing links

To provide a forum to discuss complex cases, and to offer peer to peer support

Ongoing throughout 2013 / 2014

Audit against our Quality Indicators from both the Clinical Audit System (CAS)

Produce demonstrative data against our Quality Indicators to ensure provision of our aims to improve the

2014 / ongoing

http://www.spah.scot.nhs.uk/


and through paper audits haemoglobinopathy service Continue to input and maintain CAS as a functioning patient registry and collect qualitative and quantitive data to report against

To provide measurable data collection on haemoglobinopathies in Scotland

Ongoing

Identified gaps in service for Protocols, Guidelines and Pathways, which we will now address

Priapism and Acute Neurological presentation/Stroke guidelines for adults will be developed. Stroke and other CNS manifestations and Protocol for manual exchange for paediatrics will be developed. Additional guidelines and pathways to be scoped for the future

Ongoing

Submit a funding application for a national adult Ferriscan service to address the inequities of a scanning service

Provision of a national Ferriscan service available from one or all main centres in Scotland, in line with current paediatric service

2013 / early 2014

Continue to support and liaise with Sickle Cell and Thalassaemia Family Support Group Scotland

To assess and evaluate any improvements to patient care as a result of feedback from service users

Ongoing

Maintain and further develop SPAH website

Improved access to clear and consistent haemoglobinopathy information

Ongoing

Develop the newly established Nursing sub group

Develop educational resources for Nursing, knowledge sharing and peer to peer support

2013 / ongoing

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1. Background

The Scottish Adult Neuro-Oncology Network (SANON) was designated as a National Managed Clinical Network in 2006 following an application for designation and launched in November 2006. It is hosted by the West of Scotland Cancer Network (WoSCAN) which in turn is hosted by the NHS Greater Glasgow and Clyde. Funding for the National Clinical Lead and Network Manager is provided by National Services Division. The network includes people with an interest in the management and support of patients with brain or central nervous system (CNS) tumours across Scotland and a desire to work together to improve existing services. The Network is integrated with the North of Scotland Cancer Network (NoSCAN) and the South East of Scotland Cancer Network (SCAN) to ensure complete national coverage. A desk-top review of the Adult Neuro-Oncology Network has been undertaken and the review report is attached. This has been shared with the network Manager and Clinical Lead, Regional Cancer Networks and Regional Planning Leads. 2. Current Context for the Desk-Top Review

In October 2013 the National Planning Forum supported a proposal from the Radiotherapy Programme Board that there was a need to consider national planning models for some clinical oncology service provision in Scotland. This proposal had Cabinet Secretary for Health and Wellbeing support as well as support from the clinical oncology community. This was as a result of service challenges being faced in clinical oncology across Scotland. The most immediate pressures are in the north of Scotland but all cancer centres have key vacancies in the clinical oncology workforce and in the medical physics workforce. The NPF noted the contingency planning and new referral pathways in place for neuro-oncology patients. A short-life working group is being established by the Deputy Chief Medical Officer to take this work forward with meetings planned up until the end of 2013. The findings of the desk-top review will form part of the data collection for this work. The recommendation that a major network review be carried out in 1 year’s time will enable the SLWG to conclude and feed into the network review. 3. Review report In summary the review concluded at the time of the desk-top review that

reports and information from SANON evidence that there is a robust network infrastructure through;

key appointments to Lead Clinician and Network Manager posts at the time of the desk-top review were in place – however it is recognised as an increasing challenge to attract applicants to Network Lead Clinician posts across many disciplines;

there is an Executive Committee and supporting infrastructure in place;

there is clear, Scotland-wide, multidisciplinary membership of SANON;

there is input of the voluntary sector, industry and patients to the work of the network;

annual objectives and performance monitoring and reporting mechanisms are in place;

communication network across Scotland via network website and other mechanisms (e-mail);


NSSC

NSSC PAPER 2013/43

Adult Neuro-Oncology Network Review

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that the network is embedded in the regional cancer network structures ensuring economies of scale and also links to the regional planning mechanisms.

The network has helped increase recruitment into clinical trials for Scottish patients in the most recent reported year. This has been achieved through working collaboratively with the Scottish Cancer Research Network and the Scottish Government Chief Scientist Office. A collaborative approach is embedded in the network agenda and this is evidence by the membership of the network and the national groups that SANON links with in order to take forward their work programme. In summary SANON’s past, current and future work programme is embedded in the strategic continuous quality improvement programme. Whilst there are recognised challenges around the collection, collation and reporting of data in order to drive forward the continuous clinical quality agenda, the development of Quality Performance Indicators is to be commended and it is hoped that this will aid and facilitate activity and reporting in this area. The desk-top review recommended that

NSD continue to work with the network to encourage data collection and reporting in the pursuance of a continuance quality improvement agenda;

national network designation be continued;

the network continues to work with regional and national planning mechanisms in order to assist with current service delivery planning challenges; and

that a major network review be carried out in 1 years time.

4. NPPPRG considered the findings, conclusions and recommendations of the Desk Top Review.

5. NPPPRG welcomed the recommendations of the Desktop Review and supported them. In relation to the timing of a major review of the network, they considered it was important to tie this into the wider work on radiotherapy now underway under the National Planning Forum and recognised that it would take time to undertake a full review informed by that wider work. The agreed timescale was for the major review to take place within the next 18 months, part of the review should ensure that the guidelines being developed by the network were used and the reporting arrangements by the 4 MDT’s should be within scope of the review.


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07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-43A Adult Neuro-Oncology Network - Final

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NSSC 2013/43A

Managed Clinical Network Review of the Scottish Adult Neuro-

Oncology Network

National Services Division

A Division of National Services Scotland

July 2013

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Contents

Page No.

1 Introduction

1.1 Background to Review 3 1.2 Aim of Review 3

1.3 Approach 3 2 Background to Network

2.1 Network and Designation 4 2.2 Current Configuration 4

2.2.1 Descriptions of conditions covered by network 5 2.3 Network aims at outset and reported progress 6

3 Trends and Projections 11

4 Network Core Principles CEL 29 (2012) 12 4.1 Assessment of Achievement 12

5 Continuous Quality Improvement 15 5.1 Overarching Policy and Strategy 16

5.2 Clinical Quality Indicators 16 5.3 Assessment against quality assessment framework 17 5.4 Guidelines 17

5.5 Protocols 17 5.6 Outcome measures, benchmark and comparisons 17

6 Non-clinical Quality 6.1 Patient access 17

6.2 Support for patients/carers 18

7 Costs 17 8 Future Developments/Work plan 18

9 Issues 18

10 Conclusions and Recommendations

19 - 20

11 Annexes 21 - 39

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1. Introduction

1.1 Background to the review

National Services Division (NSD) is a Division within NHS National Services Scotland. Each year

NSD receives top-sliced ring-fenced funding from the Scottish Government Health and Social Care Directorate (SGHSC) to commission and performance manage National Screening Programmes,

Specialist Clinical Services and national Managed Clinical Networks (NMCNs) on behalf of NHS Scotland. This includes the Scottish Adult Neuro-Oncology Network which is a National Cancer Managed Clinical Network.

As part of NSD’s role in performance management, the review of networks with a national

designation is carried out every five years.

This review will be undertaken as a minor review which takes stock of the network as currently being delivered benchmarked against the criteria for continuing as a network. 1.2 Aim of Review

In recognition that the Network has not yet been reviewed it is incumbent upon National Services

Division to facilitate a review of the Network, its work programme and impact on patients and to confirm future commissioning arrangements.

The aims of the review are to establish:

Assess the management of the network against the requirements of Health Department

Letter (HDL) (2002)69 and HDL (2007) 21;

The development of the quality assurance framework;

Assess progress toward achieving the original aims

Assess the value for money;

Assess the added benefit to patient care.

1.3 Approach

The review will follow NSD’s standard procedural guidelines for the conduct of a Managed Clinical Network Review by working with the Lead Clinician, Network Manager, and Network Steering

Group and stakeholders to consider whether the network still requires National Designation. NSD needs to determine that:

The care of all appropriate patients is being covered by the network;

All appropriate clinicians and health care professionals are involved in the network;

Standards, protocols and care pathways are being/have been developed and audited;

The care and clinical outcomes of care coming under the auspices of the network are

equivalent to those achieved elsewhere in the UK and Europe;

Patients, service users and the public are aware of the network and how it functions and

have the opportunity to contribute;

The wider Health Service particularly referring clinicians and NHS Boards are kept up to date with the work of the network.

The context within which this Review took place was

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Health Department Letter (2007) 21 – Strengthening of Role of Managed Clinical Networks1

The Healthcare Quality Strategy for NHSScotland2.

Chief Executive Letter (CEL) 29 (2012) – Managed Clinical Networks: Supporting and Delivering the Healthcare Quality Strategy

National Planning Forum – Report on Review of National and Scotland wide Managed Clinical Networks 2011 (approved by the National Planning Forum on 13 December 2011)

The Service Specification of the National Network Management Service (May 2013)

The evidence included data collected, network annual reports covering the last five years, statistics from Information Services (ISD) Scottish Government Health and Social Care Policy and commissioned Review publications.

2. Background 2.1 Network and Designation

The Scottish Adult Neuro-Oncology Network (SANON) was designated as a National Managed Clinical Network in 2006 following an application for designation and launched in November 2006. It is hosted by the West of Scotland Cancer Network (WoSCAN) which in turn is hosted by the

NHS Greater Glasgow and Clyde. Funding for the National Clinical Lead and Network Manager is provided by National Services Division. The network includes people with an interest in the

management and support of patients with brain or central nervous system (CNS) tumours across Scotland and a desire to work together to improve existing services. The Network is integrated with the North of Scotland Cancer Network (NoSCAN) and the South East of Scotland Cancer

Network (SCAN) to ensure complete national coverage.

At the time of designation it was noted that Neuro-oncology was a cancer type where the number of cases and clinicians involved was small enough to require a national approach. The benefit to be derived from the establishment of an adult neuro-oncology network related to the view of the

applicant group that, at the time of designation, there was a lack of uniformity of clinical care and achievement in outcomes of multidisciplinary clinical management of brain/CNS tumours across

Scotland. The aim of the network would be to optimise care and outcomes through the standard setting and audit processes that are core functions of managed clinical networks (MCNs). Brain tumours include a number of tumour types where the difference between best and sub-optimal

practice can have a material impact on survival and post-treatment morbidity. 2.2 Current Configuration

There are five recognised Neuro-Oncology Centres in Scotland in Aberdeen (Aberdeen Royal Infirmary), Dundee (Ninewells Hospital), Edinburgh (Western General Hospital), Glasgow

(Southern General and Beatson West of Scotland Cancer Centre) and Inverness (Raigmore Hospital) that are closely aligned with respective cancer centres. The services covered by these

Centres included, up until June 2013, the following:

Neuro-radiology

Neuro-Oncology Specialist Nurses

Neurology

1 Scottish Executive Health Department (2007) HDL 21 – Strengthening of Role of Managed Clinical Networks [accessed 24 May

2013] availab le at http://www.sehd.scot.nhs.uk/mels/HDL2007_21.pdf 2 Scottish Government Health and Social Care Directorates The Healthcare Quality Strategy for NHSScotland (May 2010)

available at www.scotland.gov.uk/Resource/Doc/311667/0098354.pdf

http://www.scotland.gov.uk/Resource/Doc/311667/0098354.pdf

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Neurosurgery

Neuro-pathology

Clinical Oncology

Palliative Care

Clinical Psychology

Nursing and Allied Health Professionals

Over 2012 and 2013 medical resource challenges for this specialty evolved in the North of

Scotland Cancer network area encompassing the Centres in Aberdeen, Dundee and Inverness. Treatment for NOSCAN adult patients is now provided or supported by the Edinburgh Centre.

SANON consists of an Executive Committee and a number of sub -groups, which are listed below. There are also a number of patient and carer representatives who have become involved in the

Network.

The Executive Committee comprises:

SANON Lead Clinician SANON Network Manager

Section Leads Cancer Network links (SCAN/WOSCAN/NOSCAN) Patient Representative

Members of the Executive Committee are leads of sub-committees (see below), have a

geographical spread and spread of services and include voluntary sector and patient involvement. The role of the Executive Committee is to agree and monitor the implementation of the work-plan

and inform strategy for SANON. The Executive Committee hear reports from the sub-committee Leads every four months and accept suitable proposals as SANON recommendations. Each

Section lead will contribute to the Annual Report, which will be drawn together by the Lead Clinician and the Network Manager.

The national network sub-committees are:-.

Supportive and Psychological care

Standards, audit and IT

Protocols & Guidelines

Patient communication

Palliative care

Education and Training

Pathways

Research

The Network works closely with the Scottish Neurosurgery Managed Service Network, the Scottish managed Service Network for Children and Young People with Cancer, the British Neuro-

Oncology Society (BNOS) and international colleagues. SANON is one of three National Managed Cancer Networks in Scotland.

2.2.1 Description of condition(s) covered by network

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Neuro-oncology is the speciality dealing with cancer involving the nervous system. The specialty is multi-disciplinary as patients require expertise of many specialists (e.g. neurologists, neuro-

surgeons, oncologists, palliative care, neuro-radiology, neuro-pathology) and new technologies and treatment modalities (e.g. stereotactic radiotherapy, intra-tumoral chemotherapy

/immunotherapy/ molecular and biological therapies) are making management more comp lex and hence more specialised. This in turn requires expert knowledge and improved communication. The predominant role of neuro oncology is the management of brain tumours (e.g. malignant glioma,

metastases, primary CNS, lymphomas, etc). Patients with brain tumours can present to a variety of clinicians. The referral occurs at a time of great uncertainty for patients and family and close

collaboration between clinicians at an early stage is essential to reduce anxiety. A clear explanation to the patient and family should be consistent between specialists. Communication with patient, family, general practitioner and secondary care services, should be unambiguous and

supportive. (Davies et al, 1997a)3 2.3 Network aims at the outset and reported progress

The original aims of the network4 at designation were to:

Improve patient care and access to the best treatment.

The aim of SANON was to optimise the management of people with primary brain tumours in

Scotland to produce a single Scottish service with accessible regional teams in the network bringing together the existing Clinical Neuro-Oncology services in Scotland in a planned, co-ordinated single system for delivery of quality patient care through common protocols.

SANON aimed to link groups of health professionals and organisations from primary, secondary

and tertiary care, and promote working in a coordinated manner to deliver high quality, clinically effective and equitable care to patients irrespective of their geographical location.

In summary and based on the Scottish Office Clinical Resource and Audit Group (CRAG) report on management of brain tumours, the network premise was to reduce the numbers of surgeons

performing complex intracranial brain tumour surgery and oncologists performing complex treatment such as stereotactic radiotherapy. The desire of establishment of a network was that rare tumours were managed in agreed specialist centres to :-

focus experience;

improve patient outcome; and

stimulate research.

It was envisaged at the outset that this might be achieved through

a central referral model of patients with very rare tumours with supra-specialisation likely to occur;

development of a clinical useful database to provide an environment where there may be cooperation to develop a brain tumour tissue bank to act as a stimulus to basic science and

3 Application to National Serv ices Div ision to establish a Managed Clinical Network in Scotland for Adult Neuro-Oncology

Patients; Davies et al, 1997 a; Scottish Office Health Department Clin ical Resource and Audit Group Report 2000; Royal Colleg e

of Physicians (London) Guidelines 1997. 4 Annual Report for 2007-2008, accessed at:

http://www.neurooncology.scot.nhs.uk/joomla/ images/stories/documents/NSDSANONReport2008Final.pdf

http://www.neurooncology.scot.nhs.uk/joomla/images/stories/documents/NSDSANONReport2008Final.pdf

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molecular research as well as improving pathological diagnosis by central pathological review;

the enrolment of patients into national/international research trials.

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Ensure equity of access through the production and implementation of national

guidelines.

SANON has developed a website for both professionals and patients.5 Guidelines and developed standards are published on the website.

The following guidelines have been agreed and are available on the SANON website6:

GP referral guidelines and first 31 and 62 days generic pathway/standard – These are

being measured in Quarter 1 and Quarter 4 2013.7

SANON Glioma Clinical Management Guideline (due to be updated 2013/14)

SANON Neuropathology Guidelines

SANON Gliadel guideline

SANON Gliolan guideline

SANON guideline to the management of Epilepsy

SANON guideline to the medical treatment of Epilepsy

SANON guideline to Genetics

SANON Guidelines for the Management of Meningiomas (due to be published on the

website 2013)

These guidelines outline the recommended treatment pathway for patients promoting the equitable provision of high quality care recognising that guidelines are aimed to support the most

appropriate treatment decisions taken within the multidisciplinary team. In addition the National Institute for Health and Clinical Excellence (NICE) – Improving Outcomes

for Patients with Brain and other CNS Tumours as well as a link to the DVLA website so that driving guidelines can be accessed.

A clinical management guideline (CMG) for meningioma to be created.

Follow up guidelines have been updated, approved and are in use across NHSScotland.

Establish and agree pathways of care for patients across Scotland, so they are seen in a timely manner and by the correct clinical teams.

As noted in the 2011-12 SANON Annual Report8 it remains an objective of the NMCN to work with each Board to improve their brain/CNS tumour patient pathway to one of the recognised centres.

NHS Forth Valley has implemented and audited their patient pathway for suspected brain tumour, NHS Ayrshire and Arran is finalising its pathway, NHS Fife is initiating theirs and NHS Greater Glasgow and Clyde will initiate theirs in July 2012. The other NHS Boards are currently confirming

5 Scottish Adult Neuro-Oncology Network (SANON) website accessible at http://www.neurooncology.scot.nhs.uk/

6 SANON guidelines, accessed at:

http://www.neurooncology.scot.nhs.uk/joomla/ index.php?option=com_content&task=view&id=22&Itemid=21 7 Scottish Government HEAT Target that 95% of a ll patients diagnosed with cancer to begin treatment within 31 days of decision

to treat, and 95% of those referred urgently with a suspicion of cancer to begin treatment within 62 days of receipt of refer ral

(accessed 22 May 2013) availab le at

http://www.scotland.gov.uk/About/Performance/scotPerforms/partnerstories/NHSScotlandperformance/Cancerwait ingtimesStand

ard . 8 Nat ional Managed Clin ical Network for Adult Neuro-Oncology Annual Report 2011-12, accessed at:

http://www.neurooncology.scot.nhs.uk/joomla/ images/stories/Documents/nsd_sanon_report_2011_12_v1_0_29th_may_2012.pdf

http://www.scotland.gov.uk/About/Performance/scotPerforms/partnerstories/NHSScotlandperformance/CancerwaitingtimesStandard

http://www.scotland.gov.uk/About/Performance/scotPerforms/partnerstories/NHSScotlandperformance/CancerwaitingtimesStandard

http://www.neurooncology.scot.nhs.uk/joomla/images/stories/Documents/nsd_sanon_report_2011_12_v1_0_29th_may_2012.pdf

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when they will be able to initiate their pathways. An example of an NHS Board pathway is attached at Annex A.

Performance against the 31 and 62 day Scottish Government HEAT target is published by

Information Services Division of NHS National Services Scotland. The waiting times of brain/central nervous system tumour patients will be measured as part of a rolling programme of short term surveys/audits and reported for performance management purposes (to ensure the 31

and 62 days targets are being met) only, and will not be published. See 5.2 for more information.

The North of Scotland Cancer Centres in Aberdeen, Inverness and Dundee have experienced challenges in staffing capacity in this specialist area for a variety of reasons. The situation initially arose through a key retirement in Aberdeen during 2012, followed

by a scarcity of trained Neuro-oncology consultants to recruit into the vacant position. A number of shorter term absences of key members of the clinical team have compounded the present

position. The Network played a key role in strategic discussions to identify possible solutions within Scotland. Adult neuro-oncology patients are now being referred to Edinburgh for treatment or treatment support in the interim pending a more permanent solution.Network colleagues will

continue to work across Scotland and with Scottish Government Health Directorates to help secure a longer-term solution to the current challenges.

Identify gaps in the evidence base to inform clinical trials portfolio.

The network recognises that in order to increase the number of patients participating in clinical trials it is necessary to have as many of the five recognised neuro-oncology centres as possible

taking part. SANON reports that it is working with the Scottish Cancer Research Network to simplify the process for participation by the centres with a view to having all five participating.

SANON is also working with the Scottish Government Chief Scientst Office (CSO) to develop Scotland-wide approval for trials to facilitate all five centres can participate and apply as a single

centre. Voluntary sector organisations are also pooling research funding to fund larger research projects.

Produce nationally comparative data on agreed clinical outcomes to identify variations, and where appropriate put in place plans to manage these variances.

The Network aims to ensure the delivery of high-quality treatment and care to all patients in Scotland. To do this it must be able to regularly assess how well services a re delivered nationally.

Clinical audit is a process which allows those providing treatment and care to assess how well this is being done and to identify where improvements in service delivery and patient outcomes could

potentially be made. The Scottish Cancer Taskforce has established a National Cancer Quality Steering Group

responsible for

the development of small sets (approximately 10-15 indicators) of tumour specific and generic national quality performance indicators (QPIs)

overseeing the implementation of the national governance framework that underpins the reporting of performance against national QPIs, and

ensuring sustainability of this work programme.

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The QPIs have been developed collaboratively with the three Regional Cancer Networks, Information Services Division (ISD), and Healthcare Improvement Scotland. QPIs will be kept

under regular review and be responsive to changes in clinical practice and emerging evidence.

The national cancer networks, including SANON, are utilising this methodolog y and model to develop national QPIs. The overarching aim of the cancer quality work programme is to ensure

that activity at NHS board level is focussed on areas most important in terms of improving survival and patient experience whilst reducing variance and ensuring safe, effective and person-centred cancer care9.

SANON is using eCase, the web-based clinical Audit IT application which was developed in the West of Scotland and now used across the regional cancer network tumour groups and the other national cancer networks to capture and report outcome data.

Dundee and Edinburgh centres captured 2010 audit data into eCase and analysed their data.

Glasgow analysed their MDT activity data for all patients cared for during 2008, 2009 and 2010. All centres captured 2011 audit data into eCase and measurability criteria agreed for 2011 audit data analysis, the first for the whole of Scotland, but case ascertainment was too low to be used for

service improvement. Quality Performance Indicator (QPI) development began in May 2012 and utilised the 2011 clinical audit analysis, with an expected completion of late 2013 and all Boards

will capture audit data into eCase from the start of 2014. NHS Highland and NHS Tayside have already assigned Audit Facilitators to this process.

Increase the number of patients in research studies irrespective of geography.

In collaboration with the Scottish Cancer Research Network SANON has confirmed that 22% of patients participated in clinical trials during 2011-12, compared to 5% in 2010-11 and 8% in 2009-10. Currently the process for each centre to take part is challenging and the network is working

with the Scottish Cancer Research Network and the Scottish Government CSO to simplify the process and ideally have all 5 centres participating in each trial.

Improve teaching of neuro-oncology on a Scotland wide basis, improve training at all

levels, undergraduate and post graduate in all areas pertinent to neuro-oncology.

The Network holds quarterly meetings to review progress and provide education.

An educational video on the diagnosis of ‘headaches and papilloedema’ for GPs and Optometrists has been produced and is being trialled on the SANON website.

Generate better value for money.

The NPF Report on Review of National and Scotland wide Managed Clinical Networks restates that the National MCNs cut across local and regional NHS Board boundaries and facilitate the

necessary structures, systems and processes to ensure equity of access to and standards of specialist care for all patients in Scotland and their carers, regardless of where they live in relation to a specialist centre. Thus a patient in a remote and rural area will have access to specialist care

through a formal networked arrangement between local and specialist clinicians and services, even when the care is delivered locally.

9 Healthcare Improvement Scotland (2013) website available at

http://www.healthcareimprovementscotland.org/our_work/cancer_care_improvement/programme_resources/cancer_qpis.aspx

http://www.healthcareimprovementscotland.org/our_work/cancer_care_improvement/programme_resources/cancer_qpis.aspx

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The NPF commissioned review of MCNs subsequently noted that ‘all Scotland’ networks provided considerable added value to NHS Scotland and considered that there was a continuing role for

MCNs at a national level within NHS Scotland. Economies of scale and improvements in the quality of support when networks share network management and support arrangements.

The three national cancer networks (including the adult neuro-oncology network), hosted by NHS GG & C, sit within the West of Scotland Regional Cancer Network office arrangements for

management purposes and within the wider Scottish regional cancer structure encompassing the North and South East of Scotland Cancer networks. The three Regional Cancer Networks are

governed by respective Regional Planning Groups. This allows for links to be made with other related tumour groups and specifically for this group of tumours with the regional Head and Neck Cancer networks. One whole time equivalent MCN Manager supports all three national cancer

MCNs while 0.8 wte Administrator provides support for the three national MCNs. This enables flexible use of resource across the 3 national MCNs taking account of variable workloads.

This national resource is supplemented by resource from the West of Scotland Cancer Network core team to support audit data analysis and national comparative reporting, IT/audit database

management. Senior management input is also provided by the WOSCAN Regional Manager (Cancer). This close alignment with regional structures helps ensure integration of

national/regional functions and brings with it economies of scale that would not be realised if national cancer MCNS were established as ‘stand alone’.

The added value that SANON realises includes that:-

Patients are referred to their closest specialist centre (Aberdeen, Dundee, Edinburgh, Glasgow or Inverness) where the weekly MDT meeting (Aberdeen and Inverness is a joint MDT) coordinates their specialist cancer care (investigation, diagnosis, staging, surgery,

chemotherapy, radiotherapy and follow-up);

Equity of access for patients to specialist care and treatment via the development of

national guidelines and local patient pathways.

The data collection tool eCASE is being used for the QPIs for all cancers. Analysis is

possible by Board, region and nationally and the Information Officers who perform this analysis are based in the WoSCAN team. This close alignment with regional structures provides value for money for the national cancer networks including SANON.

Improve communication for patients on a Scotland wide basis

A patient information booklet is available, and has recently been updated and is available via the 5 centres. The network is working with NHS Inform to make this booklet available via their website.

The SANON website contains links to a number of patient information websites. In addition patient

information specific to each Neuro-Oncology centre is contained within that centre’s web page. There is a Supportive and Psychological Care subgroup which meets quarterly with the three

major charities in Scotland (brainstrust, Brain Tumour Action, and The Brain Tumour Charity) to maximise support services to patients across Scotland. Brain Tumour UK with Maggie’s Centres

and CLAN Cancer Support has further developed patient support groups across Scotland.

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Provide a group expertise on which stakeholders groups can draw advice from.

The SANON website evidences that the national network is established and outward facing

publishing information including guidelines and standards for professional and patients. There is a Lead Clinician and Manager in post on which expertise and advice can be sought. A wider MDT network membership is also available to view on the website.

3. Trends and Projections

It is estimated that more than 2 in 5 people in Scotland will develop some form of cancer during

their lifetime, and that around 1 in 8 males and 1 in 11 females will develop some form of cancer before the age of 65.10

For brain and other Central Nervous System (CNS) tumours the risk for

Males – 1 in 140 lifetime risk of developing a brain and other CNS tumour Females 1 in 183 lifetime risk of developing a brain and other CNS tumour

Most recent Cancer in Scotland statistics published in Apri l 2013 report that Summary statistics – All primary brain and CNS tumours (malignant and non malignant) :ICD-10 C70-C72, C75.1-C75.3, D18.0, D32-D33, D35.2-D35.4, D42-D43, D44.3-D44.5

Scotland Males Females

Rank - incidence 14 18

Rank - mortality 12 12

Percentage frequency of all cancers 1.7% 1.1%

Number of new cases diagnosed in 2011 244 171

Number of deaths recorded in 2011 192 155

Change in incidence from 2001 to 2011 -7.4% +10.3%

Change in mortality from 2001 to 2011 -3.9% -6.4%

1 year relative survival for patients diagnosed between 2003 and 2007 33.4% 34.8%

5 year relative survival for patients diagnosed between 2003 and 2007 13.5% 16.7%

Notes: 1. Survival figures are not age standardised. 2. Change in incidence and mortality is estimated by Poisson regression.

Brain/CNS tumours are projected to increase form 1,976 between 2006 and 2010 to 2,298 between 2016 and 2020. 11 This equates to 460 new primary diagnoses and a similar number of

secondary diagnoses each year.

10

Information Services Division NHS National Services Scotland Cancer in Scotland (April 2013) 11



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Cancer Site Projected new cases

2006-10 2011-15 2016-20 Difference in total (number) projected new cases between 2006-10 and 2016-20

Brain,

meninges and CNS

1,976 2,122 2,298 322

4. Network Core Principles CEL 29 (2012)

4.1 Assessment of achievement

SANON is a National Managed Clinical Network as defined by the NHS MEL (1999) 10, NHS HDL (2007) 21 and CEL 29 (2012).

The core principles of networks (as detailed in CEL 29 (2012)) are summarised below along with evidence and data drawn from network publications:

Each MCN must have clarity about its management arrangements, including the appointment of a person, usually known as the Lead Clinician (or ‘Lead Officer’ If it is a

multi-agency Network), who is recognised as having overall responsibility for the functioning of the Network. Each Network must also produce an annual report to the

body or bodies to which it is accountable, and that annual report must also be available to the public.

A clear structure that, at the time of the Desk-top Review, included a Lead Clinician and Executive Group as well as sub-groups and short life working groups which are set up for specific pieces of

work has been established from the outset. The Network submits a written annual and a mid-year report to NSD and these are available on the Network and NSD websites.

A recruitment process to appoint a Network Lead Clinician was pursued over the spring/summer 2013 however there were no applicants despite the process being undertaken on two separate

occasions. The reasons behind the lack of application(s) may be multifactorial and may include changes to Consultant Contract and recruitment challenges to clinical positions.

Each Network must have a defined structure that sets out the points at which the service is to be delivered, and the connections between them. This will usually be

achieved by mapping the journey of care. The structure must indicate clearly the ways in which the Network relates to the planning function of the body or bodies to which it is accountable.

. There are five recognised adult neuro-oncology centres along with four associated weekly multi-

disciplinary team meetings (Aberdeen, Aberdeen, Glasgow and Edinburgh) with Edinburgh (at the time of the desk-top review)providing specialist input to the Aberdeen/Dundee MDTs in respect of

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adults. As noted in the 2011-12 Annual Report12 it remains an objective of SANON to work with each Board to improve their brain/CNS tumour patient pathway. NHS Forth Valley have

implemented and audited their patient pathway for suspected brain tumour, NHS Ayrshire and Arran is finalising its pathway, NHS Fife is initiating theirs and NHS Greater Glasgow and Clyde

will initiate theirs in July 2012. The other Boards are confirming when they will be able to initiate their pathways.

Each Network must have an annual plan, setting out, with the agreement of those with statutory responsibility for the delivery of services, the relevant standards, the intended

quality improvements and , where possible, quantifying the outcomes and benefits to those for whom services are provided, as well as their families and carers. The social work Performance Improvement Framework and developing work on joint inspection

will be relevant to multi-agency Managed Care Networks.

The network produces and publishes an annual Work plan that sets out SMART (Specific, Measurable, Achievable, Realistic and Timebound) objectives, deliverables/outcomes, network responsible lead, timescales and aligns objectives with the Quality Strategy. The 2013 – 2014 Annual Work plan is attached at Annex B.

The network publishes a report annually that reports progress against objectives set at the beginning of the reporting year. The 2011 – 2012 Annual Report is attached at Annex C.

Each Network must use a documented evidence base, such as SIGN Guidelines where these are available, and should draw on expansions of the evidence base arising

through continuous quality improvement and audit, which all MCNs are encouraged to undertake, as well as relevant research and development. All the professionals who

work in the Network must practice in accordance with the evidence base and the general principles governing Networks.

The network has developed specific related clinical guidelines and published these on the SANON website that aim to ensure equity of access to consistent high quality care. Some, not all, of these

guidelines have the relevant evidence referenced as well as citing where the guidance is based on existing UK clinical good practice guidance for patients.

The Network has adopted the regional approval process for brain/central nervous system Clinical Management Guidelines (CMGs).

SANON fed back comments to NICE on their guidelines for rare brain tumours: optic nerve glioma; PNET; Pineal Region Tumours: Primary CNS Lymphoma.

Each Network must be multi-disciplinary and multi-professional, in keeping with the

Network concept. Mutli-agency Networks will cover local authority services such as social care. There must be clarity about the role of each member of the Network,

particularly where new or extended professional roles are being developed to achieve the Network’s aims.

12

Nat ional Managed Clin ical Network for Adult Neuro-Oncology Annual Report 2011-12, accessed at:

http://www.neurooncology.scot.nhs.uk/joomla/ images/stories/Documents/nsd_sanon_report_2011_12_v1_0_29th_may_2012.pdf

http://www.neurooncology.scot.nhs.uk/joomla/images/stories/Documents/nsd_sanon_report_2011_12_v1_0_29th_may_2012.pdf

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Membership of the network is drawn from across the multi-disciplinary team and includes input from the voluntary sector, patients and their families. This is evidenced through input and

attendance at network meetings from a variety of professional disciplines, the voluntary sector and patients and carers.

The network has a constitution that sets out that all individuals interested in brain and CNS tumours in Scotland are eligible to join the MCN. These include, but are not limited to;

neurologists, neurosurgeons, neuroradiologists, neuropathologists, medical and clinical oncologists, nurses, allied health professionals, associated charities, patients and their families,

researcher etc. SANON works closely with the Scottish Neurosurgery Managed Service Network, the Scottish

Managed Service Network for Children and Young People with Cancer, the Scottish Primary Care Cancer Group, the Scottish Imaging Network (SINAPSE), the Scottish Pathology Network (SPAN),

the Scottish Managed Diagnostic Imaging Clinical Network, the British Neuro Oncology Society and international colleagues.

Four adult neuro-oncology weekly MDT meetings are held in Scotland. The 2011/12 SANON Annual Report confirms that during 2010 Dundee, Edinburgh and Glasgow MDTs analysed data

relating to patients under their care. The Aberdeen/Inverness MDT was unable to do this. During 2011 all MDTs were able to analyse data but the clinical audit report was not published due to low case ascertainment, but was utilised to inform the development of the QPIs.

A Service Agreement is in place between National Services Division and the Network setting out

the role of the Network Lead Clinician, network accountability and responsibility,

Each Network must include meaningful involvement of those for whom services are provided, and by the voluntary sector, in its management arrangements, and must

provide them with suitable support and build the capacity of these individuals to contribute to the planning and management arrangements. Each Network should develop mechanisms for capturing the views and experiences of service users and their

carers, and have clear policies on: improving access to services; the convenience of services; addressing health inequalities; the dissemination of appropriate, up-to-date

information to service users and carers; and on the nature of that information. The ‘Voices’ programmes run by Chest, Heart & Stroke Scotland and the Neurological Alliance of Scotland can support MCNs in achieving this aim.

The membership of the Network Executive Group and wider network is provided each year with

the Network Annual Report – this demonstrates clearly the extensive nature of membership including patient, carers, voluntary sector, audit facilitators, NHS Scotland staff and industry.

Regular consultation with service users in order to capture views and experiences has not been reported by the Network. There is a Supportive and Psychological Care subgroup which meets

quarterly with the three major charities in Scotland (brainstrust, Brain Tumour Action, and The Brain Tumour Charity) to maximise support services to patients across Scotland. Brain Tumour UK with Maggie’s Centres and CLAN Cancer Support has further developed patient support groups

across Scotland.

As noted above there is a patient information leaflet; and links to a vast range of information and support on the SANON website. In addition the Supportive and Psychological Care sub-group

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meets quarterly with a number of charities to minimise duplication of effort and maximise the support to patients and their families.

Networks’ educational and training potential should be used to the full, in particular

through exchanges between those working in the community and primary care and those working in hospitals or specialist centres. All Networks should ensure that professionals involved in the Network are participating in appropriate appraisal systems

that assess competence to carry out the functions delivered on behalf of the relevant NHS Board or governing body, and that the participating healthcare professionals are

involved in a programme of continuous professional development.

The network holds quarterly meetings to review progress and provide education. One of these

meetings is also the annual national meeting. A summary report from these meetings along with actions is prepared and circulated widely to all network members.

Each Network must demonstrate continuing scrutiny of opportunities to achieve better

value for money through the delivery of optimal, evidence-based care that adds value from the patient’s perspective, optimises productivity and reduces unwarranted variation. Networks should be supported to deliver continuous quality improvement.

The value Networks add should also be assessed in terms of their contribution to an organisational culture that promotes learning, quality improvement, collaborative

interprofessional and team-based working, adherence to agreed and evidence-based protocols to improve outcomes, equity of access and quality of life.

The network uses eCASE, the web-based clinical audit IT application which was developed in the West of Scotland. For the national networks an IT application that the North of Scotland and the

South East of Scotland could also use was required and eCASE was the most suitable solution. eCASE is now used for HPB, Neuro-Oncology and Sarcoma and also for the QPIs for all cancers. Analysis is possible by Board, region and nationally and the Information Officers who perform this

analysis are based in the WoSCAN team. The Scottish Government NPF Review reported this as evidence of value for money.

To date no data, establishing a baseline and reporting improved clinical outcomes, has been published by the network.

5. Continuous Quality Improvement 5.1 Overarching Policy and Strategy

The Healthcare Quality Strategy for NHS Scotland provides a framework that underpins the way in which healthcare services are provided in Scotland. All healthcare policy is being aligned to drive

the delivery of the three Quality Ambitions: Person-centred: Mutually beneficial partnerships between patients, their families and those

delivering healthcare services which respect individual needs and values and which

demonstrate compassion, continuity, clear communication and shared decision-making. Safe: There will be no avoidable injury or harm to people from healthcare they receive, and

an appropriate, clean and safe environment will be provided for the delivery of healthcare services at all times.

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Effective: The most appropriate treatments, interventions, support and services will be

provided at the right time to everyone who will benefit, and wasteful or harmful variation will

be eradicated.

The Scottish Government’s 20:20 Vision provides the strategic narrative and context for taking forward the implementation of the Quality Strategy. This Vision is that:

“by 2020 everyone is able to live longer healthier lives at home, or in a homely setting and, tha t Scotland will have a healthcare system with integrated health and social care, a focus on

prevention, anticipation and supported self management. When hospital treatment is required, and cannot be provided in a community setting, day case treatment will be the norm. Whatever the setting, care will be provided to the highest standards of quality and safety, with the person at the

centre of all decisions. There will be a focus on ensuring that people get back into their home or community environment as soon as appropriate, with minimal risk of re-admission.”

5.2 Clinical Quality Indicators

All patients to be diagnosed within 31 and treated within 62 days of referral

The waiting times of brain/central nervous system tumour patients will be measured as part of a

rolling programme of short term surveys/audits and reported for performance management purposes (to ensure the 31 and 62 days targets are being met) only, and will not be published. The

waiting times for 30 patients were sampled in 2010/11 and the National Cancer Waiting Times team were using the outcome of this audit to decide how brain/central nervous system tumour patients would be measured going forward.

The network 2013 – 2014 workplan sets out that the 14 NHS Boards are to capture the waiting

times of brain/CNS tumour patients diagnosed during January to March 2013 and again during October to December and ISD will analyse them (data available July 2013);

All patients to be included in a national prospective audit

Patient data is being captured into eCASE. Quality Performance Indicators, measurability documents and datasets for brain/CNS tumours being developed between April 2013 and March 2014 to ensure that quality improvement activity is focused on those areas that are most important

in terms of improving survival and patient experience whilst reducing variance and ensuring safe, effective and person centred cancer care13.

No national network data has yet been published.

All patients should be discussed at a regional or multi-regional MDT meeting

All patients who are referred to the MDTs are managed by the MDTs and the network carried out a first calculation of case ascertainment (as part of the 2011 audit analysis) to demonstrate whether

all patients are being referred to an MDT. It is envisaged that it will take about 3 years to maximise case ascertainment.

13

SANON Work Plan : April 2013 – March 2014

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The 2011-12 work plan included an objective to optimise effectiveness and efficiency of MDT review meetings by implementing agreed actions to address gaps and deficiencies identified

during the 2010/11 West of Scotland regional review.

Progress against this objective confirms that the nMCN continued to improve the operation of the four, weekly MDT meetings with the coordination of the Edinburgh MDT sustained through utilisation of existing local expertise. MDT operational policies are in place for each of the 4

MDTs.

All patients should have access to other disciplines as required (eg. Dietetics, Palliative Care, etc)

The MDT will refer the patient to a Palliative Care Consultant or AHP if they are unable to participate in the MDT.

All patients should have access to approved clinical trials

In collaboration with the Scottish Cancer Research Network it was confirmed that 8% of patients participated in clinical trials during 2009-10. The 2011-12 SANON Annual report confirmed that

5% of patients participated in clinical trials during 2010-11. In 2011-12 22% of patients participated in clinical trials.

5.3 Assessment against quality assessment framework

No data has yet been published by the network.

5.4 Guidelines already agreed/Professional recommendation

See Section 2.3 above.

5.5 Description of protocols developed by network and rate of compliance across

Scotland with protocols

The following protocol has been developed:

Imaging Protocols for High and Low Grade Gliomas

See Section 2.3 above.

5.6 Outcome measures and results of audit/comparisons with literature elsewhere

The 2011 patient data was captured into the electronic Cancer Support Environment (eCASE) by the Audit Facilitators from the Scottish Neurosurgery Managed Network analysed by the West of

Scotland Cancer Network Information Team. The analysis was presented at the 2012 national meeting in Glasgow but these data have not been published.

6. Non-Clinical Quality 6.1 Patient Access

Patients are referred to their closest specialist centre (Aberdeen, Dundee, Edinburgh, Glasgow and Inverness. Each site delivered Chemotherapy and Radiotherapy, however, only four

Neurosurgery (Aberdeen, Dundee, Edinburgh and Glasgow). However from June 2013 and due to

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the recruitment challenges to key appointments, north of Scotland adult patients from the Aberdeen and Inverness centres are being referred to Edinburgh for their non surgical treatment .

From August, those from the Dundee Cancer centre are being managed locally where possible but complex cases will be referred to either Edinburgh or Glasgow. This is a short-term measure with

work underway via national groups to secure a longer term solution.

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6.2 Support for patients/carers

The Network links patients, families/carers, charities, external organisations, Universities and NHS professionals together; and works in a coordinated manner to deliver high quality, clinically

effective and equitable care to patients across Scotland. The patient information booklet has been updated and was available to all patients across

Scotland via the 5 centres in July 2012.

Following on from the patient support groups led by the Clinical Nurse Specialists, Brain Tumour UK and Maggie’s Centres have developed patient support groups in Dundee, Edinburgh, Glasgow and Inverness. Brain Tumour UK and CLAN have developed a patient support group in Aberdeen.

The Supportive and Psychological Care sub-group now has quarterly meetings with the 3 major

charities in Scotland (brainstrust, Brain Tumour Action and The Brain Tumour Charity) to minimise duplication of effort and maximise the support to patients and their families or carers.

7. Costs

Please see Annex D for an extract from the National Planning Forum’s Review of National and

Scotland wide Managed Clinical Networks, which includes a breakdown of costs for the Glasgow Cancer Networks hosted by the WoSCAN office.

8. Future Developments – future work plan See 2012-13 Workplan at Annex B

9. Issues Data collection, collation and reporting has continued to be a challenge throughout the

lifetime of the network. Reasons reported by the network include limited resource and capacity across the network with many of the posts funded via soft or non-recurring monies

from the nMSN for Neuro-surgery. Responsibility for data collection sits with NHS Boards. Notably, no dedicated audit resource sits within the Cancer Network/MCNs to support this

activity. Without this the national MCNs will not be able to fulfil their role of assuring the quality of service provision or accurately report activity data. It is hoped that the development of Quality Performance Indicators will help move this issue forward.

Reported SANON data to evidence of improved patient outcome is currently limited due to the absence of reported data. However the network report that the NHS Forth Valley

patient pathway work confirmed that 75% of patients received treatment in Edinburgh and 25% in the Glasgow Centre. As the patient pathway work rolls out this evidence and data will grow and help determine the experience of Scotland in terms of equity of access to the

recognised Centres.

There is currently limited evidence to support supra-specialisation across the network

however the network advises that this is being driven through the Clinical Management Groups.

Development of a tissue bank through the Chief Scientist Office (CSO) and National

Research Scotland collaborative tissue bank model and regional biorespository’s in Grampian, Glasgow, Lothian and Tayside. More information about tissue banking is

available at http://www.nhsresearchscotland.org.uk/186_Biorepositories+.html The

http://www.nhsresearchscotland.org.uk/186_Biorepositories+.html

V1.0


21

network will wish to provide more information on how, collectively across Scotland, this is pursued.

Website – the network report that this currently being upgraded. There are obvious issues

with some of the website links provided on the current site.

4 MDT meetings – it is unclear if and how outputs are pulled together nationally however

the network reports that current specialist oncology staffing vacancies in one Scottish

Centre are being supported by two of the other centres in Scotland particularly for the provision of radiotherapy.

The North of Scotland Cancer Centres in Aberdeen, Inverness and Dundee have

experienced challenges in staffing capacity in this specialist area for a variety of reasons. The situation initially arose through a key retirement in Aberdeen during 2012, followed

by a scarcity of trained Neuro-oncology consultants to recruit into the vacant position. A number of shorter term absences of key members of the clinical team have compounded the present position. The Network played a key role in strategic discussions to identify

possible solutions within Scotland. Adult neuro-oncology patients are now being referred to Edinburgh for treatment or support in the interim pending a more permanent

solution.Network colleagues will continue to work across Scotland and with Scottish Government Health Directorates to help secure a longer-term solution to the current challenges.

10. Conclusions Reports and information from SANON evidence that there is a robust network infrastructure

through:-

Key appointments to Lead Clinician and Network Manager posts at the time of the desk-top review were in place – however it is recognised as an increasing challenge to attract

applicants to Network Lead Clinician posts across many disciplines ;

Establishment of an Executive Committee and supporting infrastructure;

Clear, Scotland-wide, multidisciplinary membership of SANON;

Input of the voluntary sector, industry and patients to the work of the network;

Annual objectives and performance monitoring and reporting mechanisms are i n place;

Communication network across Scotland via network website and other mechanisms (e -

mail);

That the network is embedded in the regional cancer network structures ensuring economies of scale and also links to the regional planning mechanisms.

The network has clearly driven up recruitment into clinical trials for Scottish patients in the most

recent reported year and again this is to be commended. This has been achieved through working collaboratively with the Scottish Cancer Research Network and the Scottish Government Chief Scientist Office.

A collaborative approach is embedded in the network agenda and this is evidence by the

membership of the network and the national groups that SANON links with in order to take forward their work programme.

In summary SANON’s past, current and future work programme is embedded in the strategic continuous quality improvement programme. Whilst there are recognised challenges around the

collection, collation and reporting of data in order to drive forward the continuous clinical quality agenda, the development of Quality Performance Indicators is to be commended and it is hoped that this will aid and facilitate activity and reporting in this area.

V1.0


22

It is recommended that

NSD continue to work with the network to encourage data collection and reporting in the pursuance of a continuance quality improvement agenda;

national network designation be continued;

the network continues to work with regional and national planning mechanisms in order to assist with current service delivery planning challenges; and

that a major network review be carried out in 1 years time.

North, South East and West of Scotland Cancer Networks

Final – Published Brain and Central Nervous System Tumours NMCN Work Plan 2012 -13 25/0/2012

23

Annex A

Patient presents

GP

A&E

Incidental

CT

Urgent MRI

with Gadolinium

and volumetric

studies

CT

Chest

Abdomen

Pelvis

Cancer

Support

Team

informed

Neurology

Referral

Key worker

identified

If primary tumour

identified refer to

appropriate cancer

team

Neurology

NHS Forth Valley

Neuro surgical

Western General

Meningeoma

Refer straight to

neurology NHS FV

If primary not

identified refer to

Neurology Team

NHS Forth Valley

Strathcarron *

ECNO ***

Epilepsy CNS *

REACH Team *

Neurosurgical *

Inform the

referrer

Brain

tumour

suspected

BRAIN TUMOUR PATHWAY

E-Mail Distribution List:

[email protected]

(To add or remove members contact Forth

Valley IT Department)

Referral

Patients may present

with headaches or

seizures. Please see

referral guidance on

SID (Service

Information Directory).

Direct access to CT

Head is available and

if tumour confirmed

please refer urgently

by SCI Gateway

cancer mailbox

Communication

Between MDT

Once Neurology Team

aware of diagnosis all

communication thereafter

will be via e-mail

distribution list . At this

point the Cancer &

Palliative Care Facilitator

for Primary Care will pick

up support for patient.

All patients will have a Key Worker

All patients will have a Lead Clinician : Malcolm MacLeod unless already a patient of Dr Neumann, in which case he is Lead Clinician

* All liaise with Neurology Consultant

** ECNO – Edinburgh Centre for Neuro Oncology

Neuro-Oncology

MDT

(All patient with a

confirmed primary

brain tumour

should be

discussed)

Unknown Primary

Brain Metasteses

Suspected



24

Annex B

North, South East and West of Scotland

Cancer Networks

Brain and Central Nervous System Tumours National Managed Clinical Network

Work Plan: April 2012 – March 2013



25

North, South East and West of Scotland Cancer Net works Final – Published Brain and Central Nervous System Tumours NMCN Work Plan 2012 -13 25/05/2012

26

Brain/CNS Tumours NMCN Work Plan 2012-13

Objective Deliverables / Outcomes Lead Planned

Timescales

Start End

Alignment with Quality Strategy

1. Optimise effectiveness and efficiency of MDT

review meetings by continuing improvements identified in 2011-12.

All 4 MDTs coordinated and with

operational policies.

MDT Chairs /

National Clinical Lead / NMCN Manager

c/f Mar

2013

Addresses recognised national

and international priority to ensure all cancer patients are efficiently managed by an MDT,

and safe and effective governance arrangements are in place for MDT review meetings.

1.1 In collaboration with NHS Lothian improve the coordination of the Edinburgh MDT.

MDT effectively and efficiently coordinated.


c/f Mar 2013

1.2 In collaboration with NHS Grampian and NHS Tayside finalise and implement the MDT operational policy for the

Aberdeen/Inverness and Dundee MDTs.

Draft MDT operational policies finalised and implemented to match Edinburgh and Glasgow centres.

MDT Chairs / National Clinical Lead / NMCN

Manager

c/f Sep 2012

2. Create the meningioma clinical management guideline (CMG).

Scotland-wide CMG for meningioma approved by

regional PASGs and distributed to Board ADTCs.

Lead Clinician and NMCN

Manager

May 2012

Feb 2013

The creation of the CMG will ensure safe and equitable

management of patients across Scotland whilst optimising the effectiveness of treatment and

care. 2.1 Scotland-wide meningioma CMG drafted,

finalised, approved and circulated.

Scotland-wide meningioma CMG

created and available for use across Scotland.

Lead Clinician /

NMCN Manager

May

2012

Feb

2013

3. Implementation of National Follow Up

Consensus Guidelines.

Optimal follow up practice

standardised across Scotland.

NMCN Manager /

Clinical Lead

c/f Mar

2013

Equitable and efficient treatment

and care for all patients across Scotland regardless of treatment centre.

3.1 Identify the requirements for ‘supportive’

processes/materials, and where appropriate

initiate development of same to support

agreed models, e.g. end of treatment

summaries and rapid access post discharge

for brain/CNS tumours.

Shift away from traditional

secondary care based models of follow up to follow up models that are more patient centred.

NMCN Members /


c/f Jun

2012


27


Timescales

Start End


3.2 Monitor Implementation to ensure

anticipated benefits are realised.

Optimise use of capacity through reduction in follow up appointments and investigations. Improve

new/follow up ratio within outpatient clinics.

Clinical Lead / NMCN Manager

c/f Mar 2013

3.3 Initiate the planning required to undertake

the review of implementation of the

guideline 24 months following launch.

Summary report on the

implementation of the guideline across Scotland.

NMCN Manager Mar

2013

c/f

4. Support delivery of the national clinical audit

work programme for 2012-13.

National clinical audit work

programme delivered in line with agreed download schedule, regional/national outcome

measures and governance processes. Clinical and service issues are escalated and

actioned appropriately.

Information

Manager

Jun

2012

Mar

2013

Performance monitoring through

national comparative analysis is essential to ensure the safe and effective delivery of equitable

care and drive continuous improvement of services across Scotland.

4.1 Support the data verification process as defined by national/regional/local

governance framework.

Audit data reports verified by Health Boards. Board comments returned

for inclusion in annual NMCN Audit Report

Information Manager / NMCN


c/f Jun 2012

4.2 Input to the production of the annual audit

report.

NMCN Audit report issued in line

with agreed schedule. Report contains clearly defined

national/regional/local actions to address areas where performance requires to be improved.

Information

Manager / NMCN Clinical Lead / NMCN Manager

Jun

2012

Aug

2012

4.3 Monitor progress against agreed

local/regional/national action/improvement plans, assuring actions identified are progressed and outcomes documented and

reported.

2011 audit presented to 9th

November 2012 SANON national meeting.

Information

Manager / NMCN Clinical Lead / NMCN Manager

Nov

2012

Mar

2013


28


Timescales

Start End


5. Continue the creation and implementation of the brain/CNS tumour patient pathway in each Board, building on the achievements of 2011-

12. All Boards expected to be completed by end of 2013-14.

Board-specific brain/CNS tumour patient pathway to optimise care of brain/CNS tumour patients

between their Board and specialist centres.

Board Key Contact / National Clinical

Lead / NMCN Manager

c/f Mar 2013

Implementation of patient pathways will help to ensure safe and equitable management

of patients across Scotland whilst optimising the effectiveness of treatment and

care. 5.1 NHS Forth Valley act on audit of their

brain/CNS tumour patient pathway.

NHS Forth Valley brain/CNS tumour

patients have their care optimised with Edinburgh centre.

Board Key

Contact / National Clinical Lead / NMCN Manager

c/f Mar

2013

5.2 NHS Ayrshire and Arran finalise and operate their brain/CNS tumour patient pathway.

NHS Ayrshire and Arran brain/CNS tumour patients have their care optimised with Glasgow centre.

Board Key Contact / National Clinical Lead /

NMCN Manager

c/f Mar 2013

5.3 NHS Greater Glasgow and Clyde draft, finalise and operate their brain/CNS tumour

patient pathway.

NHS Greater Glasgow and Clyde brain/CNS tumour patients have

their care optimised with Glasgow centre.

Board Key Contact / National


Jul 2012

Mar 2013

5.4 NHS Fife draft, finalise and operate their brain/CNS tumour patient pathway.

NHS Fife brain/CNS tumour patients have their care optimised with Edinburgh centre.

Board Key Contact / National Clinical Lead /

NMCN Manager

c/f Mar 2013


29


Timescales

Start End


6. Assess potential for application of enhanced recovery (ER) techniques and practices in the management of cancer.

Documented enhanced recovery pathways suitable for application within Scotland services.


Apr 2012

Mar 2013

ER pathways can deliver improvements in efficiency through reduced length of

inpatient stay, reduction in HDU/ITU requirement and lower rates of post-operative

complications and morbidity requiring re-admissions. Additionally overall patient

experience is improved, indicating a better quality of care.

6.1 Assess current and planned ER activity in the Scotland, including plans submitted against Cancer Modernisation funding and

learning gained through the national initiative, identifying variance in practice, barriers to implementation and potential

areas for further extending use of ER - in the absence of national activity reference other areas of the UK to help determine

applicability of ER.

Collated information describing current and planned regional ER activity, potential for further

application for ER techniques and practices and learning from national programme to inform regional ER

development work. *ER pathways may not be considered applicable to the management of all

cancers/patient groups .


Apr 2012

Sep 2012

6.2 Agree priority areas to target, responsible

leads and timelines for delivery.

Outline national ER development

plan.

Regional Lead

Cancer Clinicians / Regional Cancer Advisory Groups

Oct

2012

Oct

2012

6.3 Determine and define components of an ER pathway, identifying resource requirements and changes in practice that are necessary

for implementation.

Documented brain/CNS tumours ER pathway.


Oct 2012

Dec 2012

6.4 Agree optimal ER pathway with key stakeholders.

Nationally endorsed ER pathway circulated to Health Boards for

implementation.

Regional Lead Cancer Clinicians

/ Regional Cancer Clinical Leads Groups / National

Clinical Lead

Jan 2013

Mar 2013

6.5 Support implementation of agreed new care

pathways incorporating ER techniques and practices in those areas where it has been agreed by NHS Boards to progress.

Education and awareness raising to

support wider understanding of ER and requirements for implementation.

National Clinical

Lead / MCN Man (KC) / NMCN Manager

Apr

2013

-


30


Timescales

Start End


7. To develop a national service map for brain/CNS tumours service provision, detailing the points of service delivery and the

connections between them.

Cancer service maps generated for all tumour specific networks as a component of an overall

service profile document.

Regional Manager (Cancer) /

Information Manager / National Clinical

Lead / NMCN Manager

Apr 2012

Mar 2013

To ensure equity of care for cancer patients in Scotland by using information to improve

quality and outcomes.

7.1 Draft high level service map for all tumour specific networks.

Service map drafted for all tumour specific networks.

MDT Chairs / National Clinical Lead / NMCN

Manager / Cancer Services Managers

Aug 2012

Nov 2012

7.2 Verify the information presented in the draft service map, collating additional information

and revising map as required.

Nationally agreed high level service map for all tumour specific networks

as a component of an overall service profile document which will be utilised to inform future cancer

service provision.

MDT Chairs / National Clinical

Lead / NMCN Manager

Dec 2012

Mar 2013

7.3 Support document review process for NOSCAN, SCAN and WoSCAN documents and ensure robust document control is in

place to facilitate future annual refresh.

Service map updated and aligned to future refresh of overall service profile.

Information Manager / National Clinical

Lead / NMCN Manager

Apr 2012

c/f


31


Timescales

Start End


8. Support delivery of the national cancer quality performance indicator development programme.

National implementation of nationally agreed cancer QPIs.

QPI Development Project Lead

National Clinical Lead

May 2012

Mar 2013

National cancer QPIs will ensure that quality improvement activity is focussed on those areas that

are most important in terms of improving survival and patient experience whilst reducing

variance and ensuring safe, effective and person centred cancer care.

8.1 Support the development, implementation

and reporting of national cancer Quality Performance Indicators (QPIs) in line with the national programme.

Nationally agreed QPIs,

measurability documents and datasets for brain/CNS tumours implemented in NOSCAN, SCAN

and WoSCAN.

QPI Development

Project Lead / Clinical Lead

May

2012

Dec

2012

8.2 Assess the potential impact of nationally agreed QPIs for brain/CNS tumours and

identify any national/regional/local actions necessary to ensure progress towards specified quality measures.

Impact assessment of nationally agreed QPIs for brain/CNS

tumours.

NMCN Manager Oct 2012

Mar 2013

North, South East and West of Scotland Cancer Net works


32



33

Annex C

NATIONAL MANAGED CLINICAL NETWORK FOR ADULT NEURO-ONCOLOGY

ANNUAL REPORT 2011-12 Hosted by West of Scotland Cancer Network (WoSCAN)



34

Contents

Contents ........................................................................................................................................................... 34

Executive summary.......................................................................................................................................... 35

Introduction ...................................................................................................................................................... 36

Aim and purpose of network ............................................................................................................................ 36

Plans for the year ahead.................................................................................................................................. 36

Network governance ........................................................................................................................................ 37

Detailed description of progress over the reporting period ............................................................................. 38

Appendix 1: Network membership................................................................................................................... 40

Appendix 2: Finance ........................................................................................................................................ 40

35

Executive summary

Dr Robin Grant stepped down as National Clinical Lead in June 2011, with Professor Roy Rampling taking over. The 4 MDTs across Scotland continue to be challenged to maintain their operations. The Glasgow operational policy is being updated and

both Aberdeen/Inverness and Dundee are drafting theirs. Edinburgh is replacing their MDT Coordinator. The radiology guideline for high grade gliomas was created and circulated. A clinical management guideline (CMG) for meningi oma will be

created in 2012-13. Follow up guidelines were updated, approved and their impact is being assessed by Boards before being circulated. Dundee and Edinburgh centres captured 2010 audit data into eCase and analysed their data. Glasgow analysed their MDT data fo r all

patients cared for during 2010. All centres have captured 2011 audit data into eCase and measurability criteria have been agreed for the 2011 audit data analysis, the first for the whole of Scotland. Quality Performance Indicator (QPI) development will begin in May 2012 with

the requirement that all Boards will capture audit data into eCase from the start of 2013. NHS Highland and NHS Tayside have already assigned Audit Facilitators to this process. In collaboration with the Scottish Cancer Research Network it was confirmed that 5% of patients participated in clinical trials during 2010-

11, compared to 8% in 2009-10. This decreasing pattern of recruitment is seen in other rare cancers and steps have been taken to address the problem.

NHS Forth Valley have implemented and audited their patient pathway for suspected brain tumour, NHS Ayrshire and Arran is finalising its pathway, NHS Fife is initiating theirs and NHS Greater Glasgow and Clyde will initiate theirs in July 2012. The other Boards are confirming when they will be able to initiate their pathways.

The patient information booklet was successfully trialled in the Glasgow Centre and is being updated for use across Scotland. The Supportive and Psychological Care subgroup is meeting quarterly with the 4 major charities in Scotland (brainstrust, Brain Tumour

Action, Brain Tumour UK and Samantha Dickson Brain Tumour Trust) to maximise support services to patients across Scotland. B rain Tumour UK with Maggie’s Centres or CLAN Cancer Support has further developed patient support groups across Scotland.

36

Introduction

Brain and Central Nervous System (CNS) tumours have an incidence of approximately 6.5/100,000 and account for less than 2% of all tumours14.

The lifetime risk of developing a brain tumour is 1 in 1721. The 1 year relative survival for patients diagnosed with a brain/CNS tumour between 2003 and 20071 is 33.4% for males and 34.8% for

females; the 5 year survival 13.5% for males and 16.7% for females. Brain/CNS tumours are projected to increase from 1,791 between 2001 and 2005 to 2,298 between 2016 and 202015. During 2010 the Dundee, Edinburgh and Glasgow MDTs were able to analyse data relating to patients under their care. The

Aberdeen/Inverness MDT was unable to do this. During 2011 all MDTs were able to analyse their data. Dr Robin Grant (Edinburgh) was the National Clinical Lead until July 2011, when Professor Roy Rampling (Glasgow) took over.

Lindsay Campbell is the Network Manager. Lynsey Connor provides administrative support and Douglas Grattan and Kris McAlpine provide web site support from the West of Scotland Cancer Network (WoSCAN). Joannie McCutcheon is our Patient Participant and also manages our web site (www.neurooncology.scot.nhs.uk).

The Network is hosted by the West of Scotland Cancer Network (WoSCAN) which in turn is hosted by NHS Greater Glasgow and Clyde. Funding for the National Clinical Lead, Network Manager and WoSCAN support is provided by National Services Division. The Network

comprises persons with an interest in the management and support of patients with brain and central nervous system tumours across Scotland and a desire to work together to improve existing services. The Network also includes links and support from patients, carers, charities and external companies. The Network is integrated with the North of Scotland Cancer Network (NOSCAN) and the South East of

Scotland Cancer Network (SCAN).

Aim and purpose of network

The Network’s aim is the delivery of high quality, clinically effective and equitable care to brain/CNS tumour patients irrespective of where they reside in Scotland. The purpose of the Network is to continually improve the quality of care to patients through partnership working with patients, their families

or carers, charities, external Companies and the NHS Scotland staff who care for patients with brain/central nervous system tumours.

Plans for the year ahead

The 2012-13 work plan objectives are to; 1. Review, optimise and maintain the effectiveness and efficiency of Multi -Disciplinary Team (MDT) review meetings.

2. Create and circulate a clinical management guideline (CMG) for meningioma.

14

http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Brain-and-Central-Nervous-System/ 15


http://www.neurooncology.scot.nhs.uk/

http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Brain-and-Central-Nervous-System/


37

3. Continue to develop improvements in the follow up of brain/CNS tumour patients in Scotland.

4. In collaboration with the Boards analyse the 2011 audit data, present the analysis to the 9th November 2012 national meeting in

Glasgow and agree continual improvements with the centres.

5. Continue working with each Board to realise or improve their brain/CNS tumour patient pathway.

6. Assess potential enhanced recovery techniques and practices for brain/CNS tumour patients across Scotland.

7. Create the service map for brain/CNS tumour care in Scotland.

8. Develop the Quality Performance Indicators (QPIs) during 2012 for implementation at the start of 2013.

Network governance

Dr Robin Grant, Consultant Neurologist, Department of Clinical Neurosciences, NHS Lothian was the National Clinical Lead for the Network unti l July 2011. Professor Roy Rampling, Emeritus Professor, University of Glasgow (and retired Clinical Oncologist) is the National Clinical Lead as of July 2011 for 2 years.

The Network holds quarterly meetings to review progress and provide education. One of these meetings is also the annual nati onal meeting. The constitution has been updated.

Mr Pragnesh Bhatt is the lead for the Aberdeen Centre, Dr Hannah Lord for Dundee, Dr Sara Erridge and Dr Sharon Peoples for Edinburgh, Mr Jerome St George and Dr Allan James for Glasgow, and Dr Kay Kelly for Inverness. Dr Julie Read leads for Primary Care, Dr Shona Olson for Radiolog y, Dr Colin Smith for Pathology, Professor Ian Whittle for Surgery, Dr

David Hurman for the Scottish Medicines Consortium (SMC), Dr Allan James for Oncology, Dr Alison Mitchell for Palliative Care , Dr Ally Rooney for Supportive and Psychological care, Dr Robin Grant for Audit, Dr Hannah Lord for Education and Training, Professor Anthony

Chalmers for Research, Shanne McNamara for Nursing and Allied Health Professionals and Pathways, and Joannie McCutcheon for t he Website. These positions will be reviewed in the light of activity over the last 2 years. The Network works closely with the Scottish Neurosurgery Managed Service Network, the Scottish Managed Service Network for Children

and Young People with Cancer, the British Neuro Oncology Society and our international colleagues. The Network is governed by the West of Scotland Cancer Network, in partnership with the North and South East of Scotland Cancer Networks; with an annual report presented to their Regional Cancer Advisory Group (WoS in December 2011, SEoS in May 2012 and NoS

in June 2012). The Regional Cancer Networks are governed by the Regional Planning Groups.

38

Detailed description of progress over the reporting period

RAG status Description

RED (R) Little/no progress been made to date to achieving network objective/standard

AMBER (A) Significant progress been made to date to achieving network objective/standard, however further work is required to fully achieve the network objective

GREEN (G) The network has been successful in achieving the network objective/standard

Objective Planned

start/ end

dates

Description of progress towards

meeting objective

Outcome / evidence RAG

status

EFFECTIVE: Providing services based on scientific knowledge

Support development and implementation of approval

process for brain/central nervous system CMG.

Apr 2011 /

Mar 2012

Radiology guideline created and

circulated on 10/2011. WoS CMG approval process being replicated in NoS

and SEoS, using the 2/2011 Glioma guideline.

Implemented

guidelines available on the SANON website.

A

Complete review of evidenced based guidelines for follow up of all cancer patients in Scotland.

Apr 2011 / Mar 2012

The 2/2011 Glioma guideline was updated and approved, with meningioma

and pituitary added.

Follow up guidelines with Boards for

implementation.

G

EFFICIENT: Avoiding waste, including waste of equipment, supplies, ideas, and energy

Optimise effectiveness and efficiency of MDT review meetings by implementing agreed actions to address

gaps and deficiencies identified during the 2010/11 WoS regional review.

Apr 2011 / Mar 2012

Aberdeen/Inverness and Dundee operational policies being drafted,

Edinburgh’s still current, Glasgow being updated. Edinburgh MDT Coordinator

being replaced.

Weekly MDTs maintaining or

improving their operation.

A

EQUITABLE: Providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geogra phic location or

socio-economic status

Use the Forth Valley pathway to guide the other 13 Boards in creating and implementing the

corresponding Board specific pathways for brain/central nervous system patients.

Apr 2011 / Mar 2012

NHS Forth Valley audited their pathway. NHS Ayrshire and Arran finalising their

pathway. NHS Fife initiating their pathway. NHS Greater Glasgow and

Clyde initiating their pathway in July 2012.

Reviewing results of audit in Forth Valley

and progression in other Boards.

A

SAFE: Avoiding injuries to patients from care that is intended to help them

39

Support delivery of the national clinical audit work

programme for 2011/12.

Apr 2011 /

Mar 2012

Dundee and Edinburgh centres analysed

patients diagnosed with primary tumours during 2010. Glasgow centre analysed all

patients cared for during 2010. Cancer Registry provided patients diagnosed with primary tumours during

2009 across Scotland. Measurability criteria have been agreed to

enable 2011 to be analysed for all primary tumours across Scotland. QPIs are scheduled for creation during

2012 and patients are expected to be captured into eCase from the start of 2013

by each Board.

2010 analyses

presented at the 2011 national

meeting by the National Clinical Lead.

G

Meningioma will be the next clinical management guideline (CMG) to be created, during 2012-13. The educational videos on the diagnosis of “headaches and papilloedema” for GPs and Optometrists are being trialled on the SANON website.

The waiting times of brain/central nervous system tumour patients will be measured as part of a rolling programme of short term surveys/audits and reported for performance management purposes (to ensure the 31 and 62 days targets are being met) only, and will not be published. The date for the

first survey/audit is to be confirmed. The patient information booklet has been updated and should be available to all patients ac ross Scotland via the 5 centres by mid-2012. Following on from the patient support groups led by the Clinical Nurse Specialists, Brain Tumour UK and Maggie’s Centres have developed patient

support groups in Dundee, Edinburgh, Glasgow and Inverness. Brain Tumour UK and CLAN have developed a patient support group in Aberdeen. The 2011 national meeting in Edinburgh on 4th November 2011 was well attended and evaluated well. Professor David Walker gave an update on

HeadSmart, the UK initiative to raise awareness of brain tumours in children and young people and detect these tumours early. The patient, family and charity afternoon session ran in parallel with the NHS afternoon session again. External companies demonstrated their latest technology, including a 3D viewer that did not require 3D glasses and ultrasound scanner that enables intraoperative scans.

The Supportive and Psychological Care sub-group now has quarterly meetings with the 4 major charities in Scotland (brainstrust, Brain Tumour Action, Brain Tumour UK and Samantha Dickson Brain Tumour Trust) to minimise duplication of effort and maximise the support to patients and their families

or carers. Professor Roy Rampling visited Aberdeen, Dundee, Edinburgh, Glasgow and Inverness centres as part of his induction and identified improvements for all 5 centres that will be discussed, developed and implemented during 2012-13.

40

Appendix 1: Network membership

Y:\MCN\Working Directory\MCNs - Disease Specific\Neuro\Annual and Mid-Year Reports\Annual Reports\2011-12\NSD_SANON_Report_2011_12_Appendix_1_Distribution_List.rtf

Appendix 2: Finance National Clinical Lead is funded for 2 sessions per week. West of Scotland Cancer Network funds 1 WTE Manager (Band 6) and 30 hours Administration / Information Management support (Ba nd 4/5), to

support 3 National Networks.

41

Annex D

Extract from National Planning Forum Report:

Network Management and Support for National MCNs commissioned by NSD

Yorkhill Network Office, NHS

Greater Glasgow and Clyde Lothian Tayside

Glasgow Cancer Networks

hosted by WoSCAN Office, NHS

Greater Glasgow and Clyde

Number of MCNs 9 3 5 3

Total Staffing 265,377 92,509 197,547 57,924

travel, training, conferences, supplies 73,075 34,500 62,827 10,770

total staffing and other costs 338,452 127,009 260,374 68,694

Backfill for Lead Clinicians (based on actual

funded value for 2010/11) 51,365 42,734 90,050 61,362

Total staffing, other costs and Lead Clinician backfill

389,817 169,743 350,424 130,056

Total cost per NMCN (excluding Lead Clinician

backfill) 37,606 42,336 52,075 22,898

Total cost per MCN (including backfill) 43,313 56,581 70,085 43,352

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013\2013-11-26\NSSC 2013- Hyperbaric 1

Review of National Hypberbaric Service Configuration

1. Background

National Services Division reviews all nationally commissioned services on a rolling programme to ensure that each service is meeting its original designation objectives, is clinically effective and delivers value for money. The Hyperbaric Medicine Service was designated as a national service in 1979, and the nationally designated service has been provided by the National Hyperbaric Unit based at Aberdeen Royal Infirmary since then. Over the period of designation the service has been reviewed many times. Prior to the most recent review of the service in 2011 (copy of review report attached as NSSC 2013-44B), there was recognition of the inter-relationship between the national service and the independent hyperbaric chambers located in Millport, Oban and Orkney which also provide treatment for patients suffering diving decompression illness but are outwith the nationally designated service and receive their funding on a cost per case basis from the NHS Board/ English Health Authority of residence of the patient treated. This caused growing concern amongst NHS Boards in Scotland who perceived that they were paying twice for a national service. The review was carried out in 2010/11 and involved an expert Review Group Chaired by Ian Ross, Chief Executive, NHS Lanarkshire. It evaluated evidence gathered from both the nationally designated service and the independent chambers, and also from NHS Boards who fund both aspects of the service. The process also included user engagement through surveys of the diving community, and there was representation on the review group from respected recreational diving organisations. The Review Group considered a range of options for the configuration of the service to produce the most sustainable and cost and clinically effective service. The Review Report was presented to NSAG in June 2011 and found that because of the low and unpredictable volume of diving decompression illness; the emergency nature of the care required; the importance of time to treatment on quality of outcomes; and the nature of the Scottish geography, that there was a need for a solution that concentrated clinical skills and activity but that one facility was not a suitable option. Therefore the existing configuration of the national service did not meet with the criteria for national designation because it did not meet the needs of the national caseload. The Review recommended that:

National designation should be extended to incorporate one or more of the independent chambers as long as the cost of the service did not exceed the current cost of hyperbaric provision (including those of the independent chambers) whilst seeking to pursue efficiencies to reduce the cost of the service for NHS Scotland .


NSSC

NSSC PAPER 2013/44


NSAG agreed in principle with this recommendation although noted that an additional £300k required to provide wider designation over and above the £990K for the Aberdeen service would need the approval of the NHS Board Chief Executives.

The Board Chief Executives agreed with the principle of wider designation but felt that this should be funded out of the funding for the Aberdeen Unit by releasing resources from within this through reducing the cost of the agreement with NHC Ltd for hosting and technical support to the chamber and other efficiencies within the Aberdeen service. Despite negotiations with NHC Ltd and consideration of further efficiencies within the service provided by NHS Grampian only £60k of savings has been identified which is insufficient to provide wider designation. Due to the continuing falling number of patients since the 2011 review, the North of Scotland Planning Group has been developing a proposed model of delivery that would seek to ensure clinical sustainability and cost effectiveness. The last meeting of the Board Chief Executives in February 2013 indicated that more radical options should be considered and requested that a paper be presented to the National Specialist Services Committee with a range of options. Directors of Planning: Consideration of Options Subsequently a paper detailing options produced by an NHS Grampian/NHS Orkney collaboration and National Services Division (on behalf of the Directors of Planning) detailing the original recommendation from the 2011 Review Group; a two-centre model based in Aberdeen and Orkney and de-designation of the national service was presented and considered by the Directors of Planning in September. The paper highlighted the high level benefits and dis-benefits of each option and invited the Directors of Planning to consider which option represented the best option for a safe, sustainable and effective service for NHS Scotland for the future. The Directors of Planning meeting felt that the a two centre model based in Aberdeen and Orkney was not a person centred solution to the provision of this service and was not suitable for diving incidents in the west coast. At this point Millport has closed to operation and therefore at present Scotland only has the three operational chambers, one in the west, one in Orkney and one in Aberdeen. This was the preferred model of the original review recommendation. Nonetheless NHS Grampian/NHS Orkney have not been able to agree an extension to include a west coast chamber within acceptable costs. Therefore NSSC are asked to consider the options as they stand and agree which option is preferred for NHS Scotland. The paper presented to the Directors of Planning is attached at Annex A. Mr David Steel NSSC Secretariat 18 November 2013


ANNEX A

Paper Considered by Directors of Planning October 2013 Scottish Hyperbaric Medical Service – Service Provision Options Combined

Strategic Context

1.1 The Hyperbaric Medicine Service was designated as a national service in 1979, and the nationally

designated service has been provided by the National Hyperbaric Unit based at Aberdeen Royal Infirmary since then.

1.2 A review was undertaken in 2011 of the Hyperbaric Medicine Service which involved an expert Review Group. The Review Report was presented to NSAG in June 2011 and found that because of the low and unpredictable volume of diving decompression illness; the emergency nature of the care required; the importance of time to treatment on quality of outcomes; and the nature of the Scottish geography, that there was a need for a solution that concentrated clinical skills and activity but that one facility was not a suitable option.

1.3 The Review recommended that national designation should be extended to incorporate one or more of the independent chambers as long as the cost of the service did not exceed the current cost of hyperbaric provision (including those of the independent chambers) whilst seeking to pursue efficiencies to reduce the cost of the service for NHS Scotland.

1.4 More recently the NHS Scotland Board Chief Executives have requested that all options for the provision of Hyperbaric Medicine be reviewed and that a paper is presented to the National Specialist Services Committee. Description of the current national designated service – Aberdeen Royal Infirmary

1.5 The nationally designated hyperbaric service is provided within The National Hyperbaric Unit on

the site of Aberdeen Royal Infirmary. The National Hyperbaric Unit currently provides a comprehensive specialist Hyperbaric Service to NHS Scotland delivering treatment for all severity of diving related injuries, hyperbaric emergencies and Hyperbaric elective needs. It provides a 24/7 hour consultant run diving and hyperbaric advice line to the public, the NHS, emergency providers and other chambers. It supports the private chambers in their treatment of diving injuries and takes all patients requiring category 1 level care or helium saturation treatment.

1.6 The service in Aberdeen also provides:

co-ordination of the management of diving emergencies in Scotland providing a 24/7

consultant advice service for patients, HM Coastguard, SAS and other independent chambers

operational support for emergency treatment for any diving related incidents across Scotland;

a Scottish National Registration Service for non-NHS hyperbaric chambers; and

National diving medicine courses, an annual Scottish hyperbaric education meeting and training for other Scottish chamber staff.

1.7 The level of clinical knowledge and expertise for Hyperbaric Oxygen treatment for diving

decompression illness is embedded within NHS Grampian, and the independent chambers continue to rely on the Aberdeen service for advice, guidance and training.

1.8 The chamber in Grampian is the only “Category One” Chamber in Scotland – which is capable of

receiving patients who may require Advanced Life Support either immediately or during hyperbaric treatment. This covers patients who may require access to ITU.


Other hyperbaric medicine provision – independent chambers

1.9 In addition to the national designated service there are three independent hyperbaric chambers

registered to treat diving decompression illness. The independent chambers only provide service at Category 2 or below, which is for patients of less severity who do not require access to advanced life support:

Hyperbaric Unit, University Marine Biological Station, Millport, Isle of Cumbrae (currently closed but expected to re-open in 2014) National Diving Research Centre, Scottish Association for Marine Science, Oban

Orkney Hyperbaric Trust, Stromness, Orkney 1.10 There are other single patient chambers in Scotland, one of which is in Ninewells Hospital, which

do not currently meet the national standards to provide treatment for diving decompression illness.

1.11 On average the independent chambers treat around, in total, 18 Scottish NHS Board residents

each year although this has fallen dramatically in the last two years where the figures have been 7 for 2011 and 7 in 2012 whilst Aberdeen has treated 1 and 3 Scottish residents for the same period.

1.12 There are also, on average, 3 EU/EEA patients treated each year - the cost of which is picked up

by the host NHS Board where patient is treated. Due to the fact that Scappa Flow is an internationally renowned diving site and therefore brings many EU and non-EU divers the cost of this is borne almost exclusively by NHS Orkney currently.

Summary

1.13 As acknowledged by the national review group and the Board Chief Executives, and Directors of

Planning, there is a requirement to review alternatives to the current model for the provision of the nationally designated service.

1.14 This requirement has been increased by the continued fall in the number of patients requiring

hyperbaric oxygen therapy for diving decompression illness even since the end of the last review which raises further questions for providing an effective, efficient and sustainable service that meets the needs of the patients and NHS Scotland.

Divers Treated

Aberdeen Oban Millport Orkney Total

2003 38 19 9 19 85 2004 12 12 11 19 54 2005 16 14 11 17 58 2006 9 18 16 20 63 2007 15 18 6 20 59 2008 14 15 11 25 65 2009 17 6 3 22 47 2010 14 13 4 16 48 2011 7 8 2 19 36 2012 4 6 4 15 29

These figures do not include the figures for patients seen and not recompressed 1.14 This paper sets out the three options for the model of configuration for consideration

The original review recommendation - extension of nationally designated service and clarity over national access;


The NHS Grampian/NHS Orkney proposal for a two centre model based in Aberdeen and Orkney within the current cost of the Aberdeen service;

De-designation

1.15 For information these have been compared with a high level cost and risk/benefits analysis of all

the options based on meeting certain criteria.

Original Review Recommendation Option – Extended Designation of the Service

2.1 Due to the low and unpredictable volume of diving decompression illness and the costly and

complex nature of the Hyperbaric Oxygen Therapy required to treat this illness there is a requirement for a clinical and cost effective solution involving concentration of clinical skills and activity in only a few sites.

2.2 The emergency nature of the care required, and the importance of time to treatment on the quality

of outcomes, balanced against the geography of Scotland and that patients present after incidents all over Scotland, strongly suggest that one facility alone in Scotland is not a suitable option.

2.3 The level of clinical knowledge and expertise for HBOT for diving decompression illness is

embedded within NHS Grampian and supports good provision of care within the independent chambers through advice and guidance and supportive clinical governance.

2.4 The current configuration of service cannot be sustained as a designated service because it does

not meet the needs of the national caseload.

2.5 The configuration of the service should be considered against activity levels, to ensure that there is appropriate level of service provision within Scotland for equitable access. It is proposed that this should be led by NSD working with the Board Directors of Planning Group. Consideration should be given to the level of provision required for the West Coast of Scotland in particular, that is, whether one or two chambers would be required

2.6 NSD should work with the NHS Board Directors of Planning to explore the potential for wider

designation to achieve greater efficiency and equity in hyperbaric provision in Scotland.

2.7 National designation should be extended to incorporate one of more of the local independent chambers to improve access and ensure that the national service can meet the needs of the national caseload, as long as the cost of the service does not exceed the current cost of hyperbaric provision and efficiencies are pursued as a whole for NHS Scotland.

2.8 NSD should work with NHS Grampian to identify efficiencies from within the current Service

Agreement between NHS Grampian and NSD to identify resources to help widen the designated service.

2.9 If national designation is to continue then the limited number of elective treatments approved by

NHSQIS should be included within the nationally designated service within Aberdeen. The level of geographical uptake would require to be monitored to assure to equity of access. Discussions with NHS Grampian regarding the management of the agreed elective work.

2.10 If wider designation within acceptable costs to NHS Scotland cannot be achieved, then the service

should be de-designated and NSD would need to work with NHS stakeholders and service providers to agree commissioning guidance for future hyperbaric care for NHS Scotland.

2.11 The benefits and risks of this option of extending designation to Orkney and a chamber in the

West of Scotland.


Benefits

Provision of recompression facilities across Scotland therefore reduced transit time

Controlled private chamber costs

Sustain National Service with medical interest and competence in Scotland

Ensure clinical governance arrangements through National Registration Scheme

Continued support for key industries (oil and gas, fishing, police and diving tourism)

Maintenance and availability of national expertise and category 1 care within Scotland

Continuation of the elective Hyperbaric service in Aberdeen Risks/ Weaknesses

Continued dilution of medical expertise and deskilling due to reducing numbers

Costs would increase despite the falling activity, therefore cost per episode would increase

Continued over capacity for demand

Would cost around £1.3 million pounds to manage but this is similar to the current overall cost

NHS Grampian/ NHS Orkney Proposal (Detailed in Annex A) 3.1 Under this option the national designation would be extended to cover Aberdeen and Orkney, with

NHS Grampian retaining the lead designation and working with NHS Orkney to manage incidents within their geographical area. In 2011 and 2012, 70% of all diving treatments were provided in Aberdeen or Orkney.

All diving incidents would be referred to either Aberdeen or Orkney, with no use of independent chambers at Oban and Millport.

3.2 The strengths of this model are namely that it preserves the following:

Retention of the Category 1 HBOT care – this is highly specialised intensive care provided by a specialist multi-disciplinary team in hyperbaric conditions. This element can ONLY be delivered in Scotland by the chamber / team in Aberdeen. Whilst recent usage has been relatively modest (1-2 cases / year), loss of this service would mean that would be unable to provide vital lifeline support for major diving incidents in the North Sea. In the event of de-designation this service would need to be commissioned from an alternate provider – at present the nearest Cat 1 chambers are in Hull and at The Wirral (Liverpool).

Retention of Category 2 clinical advice - the other independent centres use the expert support and clinical back up of Aberdeen when offering Cat 2 care. There have been a number of Cat 2+ cases which have either been transferred to Aberdeen for greater medical supervision or indeed have been transferred to Aberdeen for supplementary treatment when the first cycle, delivered in one of the other chambers, has been recognised as insufficient. The loss of the specialist team in Aberdeen may lead to a significant lowering of willingness by these independent chambers to accept cases in leading to a significant increase in the numbers requiring to be transferred to an English provider. As a significant number of the category 2 patients are treated in Orkney, retention of the two centres would secure access to comprehensive clinical expertise in Scotland at a cost comparable to that of the designation option.

Retention of specialist HBOT advice service – this specialist advice delivered by the clinical team in Aberdeen and is principally used by the teams in the ‘other’ cat 2 chambers; by the MCA/coastguard and SAS as they determine where best to manage a diving casualty; and by Emergency medicine colleagues across Scotland when a diver presents at A&E (sometimes delivered by SAS).


Retention of the elective HBOT treatments – these are, by volume, the largest group of

patients and reflect a difficult cohort in that the HBOT is being used to promote healing in cases with a chronic, sometimes post radiotherapy, wound. The treatment is delivered in short planned HBOT sessions over a period of weeks.

Retention of the NRS (National Registration Service) of the ‘other’ Scottish HBOT chambers.

The likelihood of significant diving accidents is potentially heightened in the marine energy sector than in the highly regulated, and generally more stable and supported saturation diving environments of the oil and gas sector. This is a particular issue for Orkney at present and may be relevant to other areas of Scotland in the future.

Police Scotland has also recently sought medical support for hyperbaric care to support their diving operations in line with HSE requirements for diving at work regulations.

3.3 Proposed Benefits and Risks

Benefits

This would mean the abolition of the private chamber costs


Ensure clinical governance is provided in ARI & Orkney

Cost saving by stopping referrals to other private chambers

Continued support for key industries (oil and gas, fishing, Police Scotland and diving tourism) and offers a helium capability if required.

Maintenance and availability of national expertise and category 1 care within Scotland.

Continuation of the elective Hyperbaric service in Aberdeen

NHS Grampian and Orkney have committed to providing this service for £974k per annum which is lower than the total current costs of providing the service for patients resident in Scotland

Risks/Weaknesses

There would be an increase in transfer costs from West to East coast but not a prohibitive sum nor timescale to treatment. This would be 10 divers requiring transfer from the 2012 figures.

Need to engage with transport agencies / coast guard & SAS to ensure use of private chambers was to cease

Challenge from Oban for exclusion from providing services

Does not provide national coverage – gap in South West Scotland

Costs would continue to be high for falling activity particularly for NHS Scotland patients

De-designation Option (Detailed in Annex B) 4.1 This would mean the removal of designated funding for the Aberdeen service from NHS

Grampian and its return to NHS Boards within an agreed timescale (six months notice). NHS Grampian have confirmed that this would result in the loss of the Category One level service from Scotland, because it could not sustain the service without ear-marked national funding. It would also lose any Category 2 care from Aberdeen for DCI, Gas Embolism and CO poisioning.

4.2 It would also mean the loss of the co-ordinated telephone guidance service and the NationaI

Registration Service from Aberdeen as well.


4.3 Category 2 care provision would continue within the independent chambers across Scotland. This would most likely to be in Oban and Orkney due to the uncertainty of the future of the Millport chamber, although it would not be excluded if its future became more certain. The outcome of care from these chambers is currently as good as Aberdeen.

4.4 This would mean that having chambers in both the West and North East of Scotland would be

retained allowing for timely transfer to category 2 chambers. 4.5 Cost would be uncertain but the NHS could require the chambers to publish their tariffs on an

annual basis to allow adequate provision for funding by the NHS Boards. If NSD/NSS were allowed to negotiate then this could possibly be managed through a risk share with caps on treatment costs being agreed with the independent chambers.

4.6 The independent chambers would need to be members of the British Hyperbaric Association

and participate in their audits to ensure comparison on their care outcomes with the rest of the chambers in England.

4.7 All Category One patients would require to be transferred to a chamber in England. This would

most likely be either Hull or the Wirral due to their proximity to Scottish waters. This would probably be for about 1 or 2 patients per year. It has been stated that some complex Category 2 patients may also require transfer in the future but again this is only likely to be 1 or 2 patients per annum.

4.8 The average costs for treatment in England for all DCI cases are about £16,900 per case so

probably be more for Category One care but should be no more than between £20K and £25K per case.

4.9 The emergency telephone advice line would need to be re-provided as Aberdeen could no

longer provide this. This could be provided on one of three options:

i. One of the independent chambers provides this with a fully developed protocol/algorithm on decision to transfer to treatment and which chamber to transfer to.

ii. A fully developed protocol/algorithm for patients with suspected DDI provided to NHS24 helpline with agreement on transfer to treatment and where.

iii. Negotiate with the provider of the diving emergency helpline in England to provide the service for Scotland as well. This is currently provided by the DDRC Healthcare (DDRC) (formerly known as Diving Diseases Research Centre) in Plymouth who took this over from the Institute of Naval Medicine in January 2013.

4.10 There would be no elective treatment provided by the Aberdeen service. Currently the Clinical

Reference Group in England is considering a recommendation that ONLY DCI and Gas Embolism if funded under the NHS and all other emergency and elective treatments are excluded. Nevertheless other NHS Boards in Scotland do have access to elective treatments and all NHS Boards would be free to consider contracting for elective treatments separately in the future.

4.11 Benefits and Risks of De-designation

Benefits

Provision of recompression facilities for Category 2 treatment close to diving sites in North East and West of Scotland (the most popular recreational diving areas).

Costs would be directly related to activity – significantly less than current costs and should not exceed £500K for providing care for NHS Scotland patients given current activity levels

Concentration of Cat 2 treatment in fewer chambers therefore sustaining skill of staff in these facilities

Reduces need for transfer across Scotland from West to East of two centre model based in Aberdeen/Orkney


Risks/Weaknesses

Loss of Category One Chamber in Scotland therefore patients requiring Category 1 treatment would need transfer to England (should only affect a small number of patients per year)

Loss of clinical expertise from Scotland to support private chambers for divers

Longer time to treatment for seriously injured divers

Loss of the Hyperbaric elective service which currently provides over 500 patient treatments per year.

Loss of the quality assurance and clinical governance process for these chambers & service provided to monitor effectiveness of outcomes

Some degree of control over the tariffs of the independent chambers would be required.

Potential issue for diving medicine support of Diving Industry (Oil /gas, wind farm, fish farming and scallop diving)

Loss of teaching and training facilities in diving medicine in Scotland. 5. Summary of Benefits and Costs

5.1 The following is a high level assessment of the three options. Option 1: Extended national designation – three centres (Aberdeen/Orkney/West) Option 2: Extended national designation – two centres (Aberdeen/Orkney) Option 3: De-designation

5.2 Assessment of against the following criteria:

Retention of diving medicine skills within NHS Scotland

Access to 24/7 specialist clinical support to respond to diving incidents

Access to category 1 chamber for the most severe diving incidents (within clinically appropriate timescales

Access to category 2 chamber for decompression (within clinically appropriate timescales and within national designation)

Reduction in current cost of service

5.3 In terms of the options we set out below our assessment as to how each option meets the criteria above and preferred solution

Retention of diving medicine skills (Scotland)

Access to 24/7 emergency

cover

Timely access to category 1

chamber


chamber

Reduction in current cost of

service

Option 1 Similar

Option 2 Less than option

1

Option 3 Less than options 1 & 2

Less than option 1 & 2

Better than option 2

Better than option 1 & 2


5.4 With regard to costs the following table sets out estimated costs of each option:

Option 1 Option 2* Option 3

£000 £000 £000

NHS Grampian 954 954 0

Independent chambers 320 0 500

Additional transport 0 20 110

NHS site provision (without NHC Ltd) 0 0 0

Total 1,274 974 610

*Option 2 is Grampian/Orkney combined

5.5 The Directors of Planning are invited to consider which option represents the best option for a

safe, efficient, effective and sustainable service for NHS Scotland going forward.


Annex A - North of Scotland Scottish Hyperbaric Medical Service Proposal

Strategic Context

1.1 The Hyperbaric Medicine Service was designated as a national service in 1979, and the nationally

designated service has been provided by the National Hyperbaric Unit based at Aberdeen Royal Infirmary since then.

1.2 A review was undertaken in 2011 of the Hyperbaric Medicine Service which involved an expert Review Group Chaired by the Chief Executive (NHS Lanarkshire). The Review Report was presented to NSAG in June 2011 and found that because of the low and unpredictable volume of diving decompression illness; the emergency nature of the care required; the importance of time to treatment on quality of outcomes; and the nature of the Scottish geography, that there was a need for a solution that concentrated clinical skills and activity but that one facility was not a suitable option.

1.3 The Review recommended that national designation should be extended to incorporate one or more of the independent chambers as long as the cost of the service did not exceed the current cost of hyperbaric provision (including those of the independent chambers) whilst seeking to pursue efficiencies to reduce the cost of the service for NHS Scotland.

1.4 More recently the NHS Scotland Board Chief Executives have requested that all options for the provision of Hyperbaric Medicine be reviewed and that a paper is presented to the National Specialist Services Committee. As part of this process of review, the North of Scotland Planning Group was invited to present its assessment of options for the national hyperbaric service. Description of the current national designated service – Aberdeen Royal Infirmary

1.6 The nationally designated hyperbaric service is provided within The National Hyperbaric Unit on

the site of Aberdeen Royal Infirmary. The National Hyperbaric Unit currently provides a comprehensive specialist Hyperbaric Service to NHS Scotland delivering treatment for all severity of diving related injuries, hyperbaric emergencies and Hyperbaric elective needs. It provides a 24/7 hour consultant run diving and hyperbaric advice line to the public, the NHS, emergency providers and other chambers. It supports the private chambers in their treatment of diving injuries and takes all patients requiring category 1 level care or helium saturation treatment.

1.6 The service in Aberdeen also provides:

co-ordination of the management of diving emergencies in Scotland providing a 24/7 consultant advice service for patients, HM Coastguard, SAS and other independent chambers

operational support for emergency treatment for any diving related incidents across Scotland;

a Scottish National Registration Service for non-NHS hyperbaric chambers; and

National diving medicine courses, an annual Scottish hyperbaric education meeting and training for other Scottish chamber staff.

1.7 The level of clinical knowledge and expertise for Hyperbaric Oxygen treatment for diving

decompression illness is embedded within NHS Grampian, and the independent chambers continue to rely on the Aberdeen service for advice, guidance and training.

1.8 The chamber in Grampian is the only “Category One” Chamber in Scotland – which is capable of

receiving patients who may require Advanced Life Support either immediately or during hyperbaric treatment. This covers patients who may require access to ITU.


Other hyperbaric medicine provision – independent chambers

1.9 In addition to the national designated service there are three independent hyperbaric chambers

registered to treat diving decompression illness. The independent chambers only provide service at Category 2 or below, which is for patients of less severity who do not require access to advanced life support:

Hyperbaric Unit, University Marine Biological Station, Millport, Isle of Cumbrae

National Diving Research Centre, Scottish Association for Marine Science, Oban Orkney Hyperbaric Trust, Stromness, Orkney

1.10 There are other single patient chambers in Scotland, one of which is in Ninewells Hospital, which

do not currently meet the national standards to provide treatment for diving decompression illness.

1.11 On average the independent chambers treat around, in total, 18 Scottish NHS Board residents

each year (not including the 2012 activity figures) – Appendix 1. 1.12 There are also, on average, 3 EU/EEA patients treated each year - the cost of which is picked up

by the host NHS Board where patient is treated. Due to the fact that Scappa Flow is an internationally renowned diving site and therefore brings many EU and non-EU divers the cost of this is borne almost exclusively by NHS Orkney currently.

Summary

1.13 As acknowledged by the national review group and the Board Chief Executives, there is a requirement to review alternatives to the current model for the provision of the nationally designated service.

1.14 This paper sets out our assessment of our preferred option and the risks and benefits compared

to the designation option; namely

Extension of nationally designated service and clarity over national access;

Retention of the clinical skills required to support the delivery of a comprehensive national Hyperbaric Medicine Service within NHS Scotland; and

Cost effectiveness compared to other alternative options

1.15 For information we have also set out within Appendix 1 a high level cost and risk/benefits analysis of all the options that we considered as part of our evaluation process.


Preferred Option

2.1 Under this option the national designation would be extended to cover Aberdeen and Orkney, with

NHS Grampian retaining the lead designation and working with NHS Orkney to manage incidents within their geographical area. In 2011 and 2012, 70% of all diving treatments were provided in Aberdeen or Orkney (Appendix 1).

All diving incidents would be referred to either Aberdeen or Orkney, with no use of independent chambers at Oban and Millport.

2.2 The strengths of this model are namely that it preserves the following:

Retention of the Category 1 HBOT care – this is highly specialised intensive care provided by a specialist multi-disciplinary team in hyperbaric conditions. This element can ONLY be delivered in Scotland by the chamber / team in Aberdeen. Whilst recent usage has been relatively modest (1-2 cases / year), loss of this service would mean that we would be unable to provide vital lifeline support for major diving incidents in the North Sea and for any divers requiring referral from Orkney. In the event of designation this service would need to be commissioned from an alternate provider – at present the nearest Cat 1 chambers are in Hull and at The Wirral (Liverpool). Given the potential distances involved in transporting patients from the waters to the north of Scotland, where there is significant offshore activity.

Retention of Category 2 clinical advice - the other independent centres use the expert support and clinical back up of Aberdeen when offering Cat 2 care. There have been a number of Cat 2+ cases which have either been transferred to Aberdeen for greater medical supervision or indeed have been transferred to Aberdeen for supplementary treatment when the first cycle, delivered in one of the other chambers, has been recognised as insufficient. The loss of the specialist team in Aberdeen would lead to a significant lowering of willingness by these independent chambers to accept cases in leading to a significant increase in the numbers requiring to be transferred to an English provider. As a significant number of the category 2 patients are treated in Orkney, retention of the two centres would secure access to comprehensive clinical expertise in Scotland at a cost comparable to that of the designation option.

Retention of specialist HBOT advice service – this specialist advice delivered by the clinical team in Aberdeen and is principally used by the teams in the ‘other’ cat 2 chambers; by the MCA/coastguard and SAS as they determine where best to manage a diving casualty; and by Emergency medicine colleagues across Scotland when a diver presents at A&E (sometimes delivered by SAS). During the NRS appraisal visit to Orkney Hyperbaric Trust in 2011 and the National Diving Research Centre Scottish Association for Marine Science in Oban in 2012 local medical staff (GP’s) expressed clearly that advice received form Aberdeen and possibility of redirection or referral for further treatment or diagnostics to Aberdeen Hyperbaric Medicine Unit is fundamental for providing their independent recompression services.

Retention of the elective HBOT treatments – these are, by volume, the largest group of patients and reflect a difficult cohort in that the HBOT is being used to promote healing in cases with a chronic, sometimes post radiotherapy, wound. The treatment is delivered in short planned HBOT sessions over a period of weeks.

Retention of the NRIS (National Registration and Inspection Service) of the ‘other’ Scottish HBOT chambers.

The likelihood of significant diving accidents is potentially heightened in the marine energy sector than in the highly regulated, and generally more stable and supported saturation diving environments of the oil and gas sector. This is a particular issue for Orkney at present and may be relevant to other areas of Scotland in the future.


2.3 If the Aberdeen centre were to be decommissioned, all aspects of HBOT - other than Cat 2 care

would be ‘at risk’. Aberdeen will accept any patient from the independent chambers where the level of care provided is potentially beyond the capability or expertise available to the local GP;s who cover the independent chambers. This includes those requiring critical care, but also those with severe decompression illness or medical concerns requiring hospital support (Category 2+). These are patients with complex medical backgrounds, trauma patients and patients with failed treatments from other chambers. None of the approved chambers in Scotland have access to CT scanner, trauma services or ITU.

2.4 The de-designation option would present a number of significant issues for the NHS, namely

Fragmentation and loss of a specialist service for Scotland. The independent chambers have explicitly stated in their audit process their position that the medical support provided from Aberdeen is fundamental to their continued operation. Loss of the specialist clinical skills in Aberdeen would have an impact of the extent of treatments that could be offered by the independent chambers.

Given that the independent chambers are remote from major hospitals, issues of governance and accessible medical support services require exploration before elective patients could be treated in the independent sector. It is unlikely that these isolated chambers could be up skilled to take critically ill patients.

Loss of national quality control, audit and shared education, inevitably leading to divergence in practice and more variable outcomes.

De-designation costs need to be explicit, particularly the costs of critical care in England and the cost of upgrading a remote isolated chamber miles from hospital back up into a safe intensive care environment need exploration.

Concern that medical expertise will be lost from Scotland with de-designation to such an extent that any remaining services will become extremely vulnerable.

Lack of support from a designated Scottish Hyperbaric Medical Unit to industry, commercial diving, tourist and fish farming, could potentially be problematic.

2.5 In terms of the options open to having the Aberdeen emergency telephone number re-provided we could comment as follows. 1. One of the independent chambers provides this with a fully developed protocol/algorithm on

decision to transfer to treatment and which chamber to transfer to - this would require funding and agreement to take on the service. These units currently phone Aberdeen for advice and support with treatment decision making for the less seriously injured and complex medical or decompression advice. Moreover, this is more complex than simple algorithm/protocol activity, requiring experience and knowledge of diving modes, medical skills and follow- up.

2. A fully developed protocol/algorithm for patients with suspected DDI provided to NHS24

helpline with agreement on transfer to treatment and where - One of the benefits of an experienced consultant advice line is that point of care advice can be offered which will enable a high level clinical decision to be made around patient transfer. This will enable local treatment under consultant supervision without transfer where appropriate. NHS 24 is currently unable to appropriately direct diving accidents due to lack of necessary knowledge and experience.

3. Negotiate with the provider of the diving emergency helpline in England to provide the service

for Scotland as well – the service in England is in a current state of flux with the Navy shutting


the national advice line. This may not be a robust solution for Scotland given both the vulnerability of the advice line and the lack of local Scottish geographic knowledge.

Costs

2.3 As set out in Appendix 1, NHS Grampian and NHS Orkney would commit to delivering the national designated service at £994,000 per annum, compared to the current cost of £1.3m for the overall HBoT service (including the use of the private chambers at Oban and Millport). The only uplift that would made annually would be in line with the annual baseline increases for NHS Boards.

2.4 With regard to the annual contract with the private operator of the Aberdeen HBOT chamber, we

can confirm that we will continue to consider alternatives, including making a business case for national funding for establishing an NHS hyperbaric centre. NHS Grampian would also commit to exploring further the potential to further the links with the oil and gas sector and potential for investment from the sector in the service and its future development. The cost of upgrading one of the peripheral independent chambers to category 1 including the provision of staff and equipment is probably considerable. From a clinical perspective creating a chamber capable of intensive care that are not on a hospital sites with full hospital resources immediately available would not represent an optimum solution. The chamber in Aberdeen works from a hospital base with consultants and intensive care nurses who have proven ability and skills to deliver hyperbaric critical care. The independent chambers are not even on a hospital site nor have access to even basic diagnostic facilities.

2.5 Under the preferred option there would require to be an absolute understanding that no other

HBOT care would be funded for an NHS Scotland resident – if a diver required care they would need to be transferred to one of the commissioned chambers. Whilst this may have an impact on SAS / MCA Coastguard, the process and arrangements for the transfer of casualties has improved and any associated risks reduced.

2.5 When compared with other options, the preferred NHS Grampian and NHS Orkney model is the

lowest and retains important clinical skills in Scotland to support two key industries – oil and gas and tourism.

Summary

Benefits

This would mean the abolition of the private chamber costs


Ensure clinical governance is provided in ARI & Orkney

Cost saving by stopping referrals to other private chambers

Continued support for key industries (oil and gas, fishing and diving tourism) and offers a helium capability if required.

Maintenance and availability of national expertise and category 1 care within Scotland.

Continuation of the elective Hyperbaric service in Aberdeen Risks

There would be an increase in transfer costs from West to East coast but not a prohibitive sum nor timescale to treatment. This would be 10 divers requiring transfer from the 2012 figures.

Need to engage with transport agencies / coast guard & SAS to ensure use of private chambers was to cease


Appendix 1

3.1 The following options as specified by NHS National Services Division have been considered and within this section we set out our evaluation of these options and preferred solution.

Option 1: No Change Option 2: Extended national designation – two centres (preferred option set out above) Option 3: Centralisation of hyperbaric medicine in Aberdeen (no use of independent chambers) Option 4: Re-provision at national designated service in another NHS Scotland hospital Option 5: De-designation

3.2 Whilst we have not undertaken a formal scoring of each option we have formally considered

whether each option meets the following criteria:

Retention of diving medicine skills within NHS Scotland

Access to 24/7 specialist clinical support to respond to diving incidents Access to category 1 chamber for the most severe diving incidents (within clinically

appropriate timescales

Access to category 2 chamber for decompression (within clinically appropriate timescales and within national designation)

Reduction in current cost of service Executive summary

3.3 In terms of the options we set out below our assessment as to how each option meets the criteria

above and preferred solution

Retention of diving medicine skills (Scotland)

Access to 24/7 emergency

cover


chamber


chamber

Reduction in current cost of

service

Option 1 x -

Option 2 1

Option 3 x

Option 4 x 2

Option 5 x x

3.4 Taking into consideration the above factors and our desire to preserve a comprehensive and cost effective nationally designated hyperbaric service in Scotland our preferred option is Option 2 - the two centre model (extending the existing designated service to include the private chamber at Orkney). Given the extent of coastal waters around Scotland, the significant diving activit y at Scappa and the strategic importance of the oil and gas sector in the North Sea, de-designation and a loss of the specialist clinical diving medicine skills currently in Aberdeen would present challenges in terms of the safe and effective management of diving incidents.

3.5 As set out below NHS Grampian and NHS Orkney are committed to delivering the two centre

model at a lower cost than the current service. In addition there would be the potential to retaining and indeed expanding access to the elective hyperbaric service.

1 If a nationally funded hyperbaric chamber could be constructed in Aberdeen there would be the potential to withdraw

from the current contract with the private provider (saving of c£200k per annum) 2 However this option would require approval o f business case to build an NHS chamber at a cost of c£1.5m.


3.6 With regard to costs the following table sets out our estimation of the costs of each option:

Option 1 Option 2 Option 3 Option 4 Option 5

£000 £000 £000 £000 £000

NHS Grampian and NHS Orkney3 954

4 954

5 954

6 200

7 200

8

Independent chambers 320 0 0 0 700

Additional transport 0 20 40 80 110

NHS site provision (without NHC Ltd) 0 0 0 800 0

Total 1,274 974 994 1,0809 1,010

3.7 Under the designation option, the costs of the independent chamber are based on those

estimated by the National Specialist Services Committee. As these services are provided outwith the NHS there is risk of introducing a higher degree of variability into the costing of services than currently under the national designation.

Overview of options

Option 1 – No Change

3.8 NHS service provision maintained as it stands for the national service with treatments still undertaken in private chambers at Orkney, Oban and Millport Benefits

Provision of recompression close to dive sites with reduced transit time Risks

Continuing dilution of medical expertise and deskilling given the reduction in numbers

Continued charging from the private sector chambers to Boards will mean continuing to pay twice for a national service.

3 Including the cost of the contract with the National Hyperbaric Centre Limited

4 Net of income received for t reatment of patients with England / Wales residences

5 We would redesign the service to accommodate the two centre model within existing national funding

6 Under this option we would fund any increase in activity transferred from Orkney within existing capacity

7 There would need to be retention of clin ical input with Scotland to assist with assessment and potential treatment, prior to

transfer to alternative location 8 There would need to be retention of clin ical input with Scotland to assist with assessment and potential treatment, prior to

transfer to location outwith Scotland 9 Would require an approved business case for an NHS chamber – c£1.5m


Option 3 – Centralisation within Aberdeen

3.9 Centralisation was the preferred option of the management representatives within the Review Group as it would meet the normal criteria of providing a national service for the whole of Scotland. This would mean transferring all patients requiring recompression to Aberdeen from all over Scotland and a few of these may not require treatment following assessment.

3.10 It is however unlikely that this would be a significant number given that specialist advice is

available from Consultant run diver helpline and the usual practice is to seek local assessment if appropriate. This was not the favoured option of clinicians at the time of the review. Similarly the diving community were strongly opposed to this. Benefits

This would mean the abolition of the private chamber costs.

It would maintain and sustain the clinical expertise in one centre with access to all the activity to sustain accreditation, clinical interest and revalidation.

Aberdeen service would meet the terms of NSD contract as single provider

Aberdeen would continue to support cases of severe industrial decompression illness and offers a helium capability if required. There have been 2 such cases in 2013

Risks

This option would increase the transport costs and potentially time to treatment with the cost of ambulance transport being around £600 per journey (from original review assessment) and helicopter transfer costs being around £5 to £7k per journey for a minority of cases. For the year 2012 this figure was 25 divers.

The issue of availability of transport to transfer would need to be considered particularly from Orkney who provide half the activity. This figure was 15 divers last year.

This would threaten the future of private chambers if they could not continue to charge residents from other Scottish boards to sustain their funding base.

Orkney Chamber was opened on basis of an FAI and closure will be challenged.

Option 4 – Re-provide service within another NHS Hospital at lower costs

3.11 In order to reduce the cost associated with the Aberdeen service through the NHC Ltd contract

and service could be provided from an NHS Hospital either in Aberdeen or elsewhere in Scotland. 2.12 Whilst there is a monoplace chamber in NHS Tayside (Ninewells) it does not meet the standards

for treating diving decompression illness and has not treated divers for well over a decade. Therefore any re-provision within an existing NHS hospital in Scotland will require procurement and installation of a suitable chamber with the associated capital costs.

Benefits

This would allow potential investment in an NHS facility and withdrawal from the NHC Limited contract

Risks

The clinical knowledge and skills would not be easily transferable from Aberdeen and so there would be a requirement for investment in training and development of staff to provide service

Challenge around gaining approval for capital funding

Loss of clinical expertise in Aberdeen


Option 5 – De-designation

2.13 It would mean the closure of the Scottish national service in Aberdeen as NHS Grampian could

not sustain the level of service without national funding. The result of this would be the loss of the Category One level service from Scotland, the coordinated guidance provided by the National Advice line and the chamber appraisal service.

2.14 Any patients requiring Category One chamber care, following assessment at the dive site or independent chamber, would need to be transferred further to a Category One facility in England, either in Hull or the Wirral. This would potentially lead to prolonged transfer for sicker patients, around 2 per year.

2.15 The telephone helpline provided by Aberdeen would also be lost. Therefore a more rigorous protocol for patients presenting following a diving incident would need to be followed by A&E Departments and the NHS 24 helpline or a negotiation for the helpline for the rest of the UK to take calls from Scotland. The Navy have just closed the E&W advice line and another provider has taken this on for a trial period.

2.16 There would be some uncertainty over the costs of the service being provided by the independent

chambers but if NSD or other organisation were allowed to negotiate a tariff range with the independent chambers then these costs could be controlled and possibly managed through a risk share scheme - e.g if a cap on treatment was set at £20k per patient and including a couple of patients requiring to be treated in England then the costs could be contained within £700K per year (given around 30-40 patients treated each year, a signif icant proportion of which would not need the total cost). However, if diving activity level returns to pre economic downturn levels, then these costs may elevate sharply. This does not include the current workload of the elective service (currently around 500 patient treatments per year) as developed and supported with NSD.

Risks

Loss of clinical expertise from Scotland to support private chambers for divers

Longer time to treatment for seriously injured divers

Loss of the Hyperbaric elective service which currently provides over 500 patient treatments per year. (see Appendix 1)

Loss of the quality assurance and clinical governance process for these chambers & service provided

Financially the Scottish private chambers in recent years have charged boards full cost recovery. There would be reduced control over the costs charged.

Potential issue for diving medicine support of Diving Industry (Oil /gas, wind farm, fish farming and scallop diving)

Loss of teaching and training facilities in diving medicine in Scotland.

Loss of a chamber facility on a major hospital site.


Appendix 2: Location of residence of patients receiving Elective HBO treatment

Health Board

05/0

6

06/0

7

07/0

8

08/0

9

09/1

0

10/1

1

11/1

2

12/1

3

Ayrshire & Arran 4 3 3 1

Dumfries & Galloway 2 1 1 1 1

Grampian 19 20 11 14 11 17 15 14

Greater Glasgow 1 1 3 8 4 3 4 4

Highland 1 3 4 5 5 4 3

Lanarkshire 1 2 1 2 4 1

Lothian 1

Orkney 1 1 2

Shetland 1 1 1

Tayside

Total patients 32 29 23 28 23 28 26 23

Total no of individual treatments 752 740 671 634 475 496 511 555

Treatment activity

Divers Treated


2003 38 19 9 19 85 2004 12 12 11 19 54 2005 16 14 11 17 58 2006 9 18 16 20 63 2007 15 18 6 20 59 2008 14 15 11 25 65 2009 17 6 3 22 47 2010 14 13 4 16 48 2011 7 8 2 19 36 2012 4 5 4 13 26

These figures do not include the figures for patients seen and not recompressed.


ANNEX B - National Hypberbaric Service Configuration - De-designation

2. Background The NSSC meeting in March 2013 agreed that this service did not meet the criteria for national designation and asked that the options for the future configuration of the Hyperbaric Services be considered by the Directors of Planning Group following consideration of paper NSSC 2013/07. The Directors of Planning Group subsequently discussed the options at their meeting on 17 April 2013 and agreed that the de-designation option be worked up to describe how this would work in practice and highlight the potential costs, benefits and risks that would need to be managed in relation to this option. This option would then be considered against the proposal from NHS Grampian/NHS Orkney that was being developed for consideration around providing the service within the current envelope of funding for the National Service within NHS Grampian.

3. Description of Current Service

Hyperbaric oxygen treatment (HBOT) involves the delivery of 100% oxygen inside a treatment chamber at a pressure of 2 atmospheres or more as defined by the European Committee of Standardisation (CEN). Treatment is provided in a chamber capable of accommodating one or more occupants, including attendant clinical staff, pressurised with compressed air within which the patient breathes 100% oxygen via a mask, head tent or endotracheal tube The most recent NHS QIS Health Technology Assessment for hyperbaric medicine indicated that HBOT should be recommended for emergency treatment of:

Decompression illness; Carbon Monoxide Poisoning;

Air/Gas Embolism.

This assessment also recommended HBOT for elective treatment of:

Diabetic lower extremity ulcers;

Osteo radionecrosis and deep soft-tissue radionecrosis including proctitis

The current service with NHS Grampian provides a service for the diagnosis, treatment and on-going management of diving related illness where recompression/decompression treatment is required. The chamber in Grampian is the only “Category One” Chamber in Scotland – which is capable of receiving patients who may require Advanced Life Support either immediately or during hyperbaric treatment. This covers patients who may require access to ITU. Therefore Aberdeen can provide care for the more severely ill patients in Scotland.

The service in Aberdeen also provides:

co-ordination of the management of diving emergencies in Scotland providing a 24/7 consultant advice service for patients, HM Coastguard, SAS and other independent chambers

operational support for emergency treatment for any non-diving related incidents

a Scottish National Registration Service for non-NHS hyperbaric chambers

The level of clinical knowledge and expertise for HBOT for diving decompression illness is embedded within NHS Grampian, and the independent chambers continue to rely on the Aberdeen service for advice, guidance and training.

The cost of the Aberdeen service was £994,000 per year (2011/12) but income of £132K was secured from outside Scotland to offset these costs. The Aberdeen service is a 24/7 Consultant led service with facilities and staffing ready to provide care for patients that may require access to ITU.


Whilst the nationally designated hyperbaric service is provided within The National Hyperbaric Unit on the site of Aberdeen Royal Infirmary, there are three independent hyperbaric chambers registered to treat diving decompression illness:

Hyperbaric Unit, University Marine Biological Station, Millport, Isle of Cumbrae

National Diving Research Centre, Scottish Association for Marine Science, Oban

Orkney Hyperbaric Trust, Stromness, Oban There are other single patient chambers in Scotland, one of which is in Ninewells Hospital, which do not currently meet the national standards to provide treatment for diving decompression illness but which the NHS Boards use to treat a range of elective conditions both included in the conditions above and for others not included such as MS. The independent chambers only provide service at Category 2 or below, which is for patients of less severity who do not require access to advanced life support. These chambers, however, provide the majority of treatments, with the Orkney Chamber consistently treating the most patients per annum. The independent chambers depend on consultant advice and guidance from the service in Aberdeen.

On average the independent chambers treat around, in total, 18 Scottish NHS Board residents each year (not including the 2012 activity figures). However there are also, on average, 3 EU/EEA patients treated each year - the cost of which is picked up by the host NHS Board where patient is treated. Due to the fact that Scappa Flow is an internationally renowned diving site and therefore brings many EU and non-EU divers the cost of this is borne almost exclusively by NHS Orkney currently. The figures below demonstrate the falling activity for all patients treated within Scotland (not just residents of Scotland)

Continuing Falling Activity/Clinical Sustainability

Divers Treated


2003 38 19 9 19 (1) 85 2004 12 12 11 19 (2) 54 2005 16 14 11 17 (1) 58 2006 9 18 16 20 63 2007 15 18 6 20 59 2008 14 15(2) 11 25 65 2009 17 6(1) 3 22 47 2010 14 13 4 16 48 2011 7 8 2 19 36 2012 4 6 4 15 29

() Figures in parenthesis can not be verified.

These figures do not include the figures for patients seen and not recompressed Aberdeen however remains the only Category One chamber within Scotland, which is capable of providing treatment of patients with diving decompression illness who may require advanced life support during treatment. It has been noted that the number of patients requiring Category One treatment is only around one to two patients per annum.

4. What would de-designation mean?

3.1 Loss of Aberdeen Service This would mean the removal of funding for the Aberdeen service from NHS Grampian and its return to NHS Boards within an agreed timescale (six months notice). NHS Grampian has stated if this happens they would definitely close the Aberdeen service as adequate funding could not be


assured. The immediate results of this would be the loss of the following levels of service for Scotland:

Category One level service from Scotland. Other emergency capacity for DDI, Carbon Monoxide poisoning and Air/Gas embolism

from Aberdeen. Clinical knowledge and expertise in HBOT within the Aberdeen service which supports

advice, guidance and training within Scotland and the UK. The emergency telephone helpline for divers and co-ordination of the diving incidents from

Aberdeen but treated elsewhere. The elective service for approved conditions within Aberdeen. The National Registration Service which provides peer review and audit of cl;inical

outcomes for all chambers within Scotland. 3.2 Funding The funding for the national hyperbaric services would be returned to NHS Boards (£981k) and they would have to pick up all cases on the basis of cost per case from the independent chambers.

All hyperbaric treatments (at least Category 2 and 3) would be carried out in the independent chambers in Scotland and this would probably be in Oban and Orkney as the future availability of the chamber on the Isle of Cumbrae is very much in doubt following the decision by the University of London to withdraw funding from the Marine Biological Station in Millport (the Millport chamber is currently closed due to shut down of the facility whilst it transfers to new ownership in January 2014). These chambers would probably bill for these patients on the same basis as currently. However the provision of service for patients requiring Category One treatment would need to be considered.

The cost of the nationally designated service in Aberdeen is budgeted at £981k per annum but in 2012/13 was just over £1million in total. NSD sought to find the current payments made by NHS Boards in Scotland to the independent chambers within Scotland and the returns although not complete show the following below.

NHS Boards 2011/12 2012/13 Cost of Aberdeen

Ayrshire & Arran 13650 1400 77208

Borders 0 0 22490

Dumfries & Galloway 13650 0 32229

Fife 0 0 67871

Forth Valley 0 2500 53212

GG&C 198834 69075 252809

Grampian 0 0 91566

Highland* 0 0 65060

Lanarkshire 13650 0 107730

Lothian 0 0 136746

Orkney 115,000 115,000 4217

Shetland 0 0 5020

Tayside 0 0 80120

Western Isles 0 0 7831

Total 354784 187975 1004109


This is on the back of a falling incidence of diving decompression illness across the piece and falling number of Scottish residents being treated. In 2010 there were 45 patients treated in Scottish chambers 22 of whom were Scottish residents. In 2011 it was 36 and 8 respectively and 2012 the figures were 29 and 10 respectively. The number of patients from outwith GB that the host NHS Board needs to cover the costs for were; 4 in 2010, 3 in 2011 and 1 in 2012. If this pattern remains the same then the costs of the care for NHS Scotland patients (including the non GB patients) could be low. If we take a worst case scenario of £25k per case for each patient, then the costs could have been £650,000 for 2010, £275,000 for 2011 and £275,000 for 2012, based on a cost per case. This includes the costs for 2 category one patients being treated in England and potentially two category 2+ patients as well. The costs of transportation of these patients would need to be added. Also the cost of the baseline funding provided by NHS Orkney to the Orkney chamber would need to be considered but given the level of current activity the costs are unlikely to exceed £500K for the treatment of Scottish residents and EU patients.

4. How could the De-designated Service be Configured? 4.1 Emergency telephone helpline

Aberdeen provide a 24/7 service including the helpline for divers to call if they had suspected DDI. However all of the independent chambers provide a 24/7 call out service as well supported by local General Medical Practices who support this through their own on call arrangements. There are therefore a number of options open to having the Aberdeen emergency telephone number re-provided.

4. One of the independent chambers provides this with a fully developed protocol/algorithm on decision to transfer to treatment and which chamber to transfer to.

5. A fully developed protocol/algorithm for patients with suspected DDI provided to NHS24 helpline with agreement on transfer to treatment and where.

6. Negotiate with the provider of the diving emergency helpline in England to provide the service for Scotland as well. This is currently provided by the Diving Diseases Research Centre (DDRC) in Plymouth who took this over from the Institute of Naval Medicine in January 2013.

4.2 Provision for Emergency DDI patients NOT requiring Category One treatment The majority of Aberdeen’s DDI patients come from the East Coast and in particular around the South East at St Abbs/Eyemouth area. These patients would need to be transferred to one of the independent chambers. If these patients have their incidents from Tayside to the Borders it is probably beneficial that these patients be transferred to a chamber in the West. Given the unlikely availability of the Millport chamber in the future this would probably be Oban. If these patients have their incidents from Grampian to the far North of Scotland then they would probably be better to be transferred to Orkney. 4.3 Provision for Emergency DDI patients likely to require Category One treatment

Any patients requiring Category One chamber, following assessment either by phone or at the independent chambers, would need to be transferred to a Category One facility.


There are two options for this:

Require one or all of the independent chambers upgraded to provide Category One service. The costs and feasibility of this are not known.

Negotiate with one of the providers in NHS England that can provide Category One service be able to take the patients from Scotland that require this level of service. This would be possibly 2 patients per annum or at most 4 if complex category 2+ cases require to be transferred as well This could be paid for on a cost per case basis if agreed with NHS England.

The recently formed NHS England have agreed block contracts with 8 providers in England for 2013/14 and will review the activity, capacity and cost in year to decide on future contracts thereafter. These chambers are based in Chichester, Great Yarmouth, Hull, London (Whipps Cross), Midlands (Rugby), Plymouth, Poole and the Wirral. In the last three years, 09/10-11/12 these chambers have treated on average 308 NHS patients per annum for DCI and Gas Embolism and an additional 51 patients per year for Carbon Monoxide poisoning. The cost of this has been just over £5m per year for DCI/GE patients with around £900k for CO poisoning patients. English commissioners report that the average cost for DCI treatment per episode in England was £16,975 but have had a maximum of £85,683. There is therefore no current tariff but given previous tariffs it would be unlikely to be more than £20-25K per patient requiring Category One treatment. In terms of proximity this would preferably be Hull or the Wirral chambers. All of the chambers provided 24/7 on call availability. Currently the Plymouth based DDRC Chamber specialist diving staff and hyperbaric doctors provide the British Hyperbaric Association’s (BHA) National Diving Accident Helpline to provide advice and guiding access to emergency recompression therapy within England and Wales. For both 4.2 and 4.3 scenarios above, the issue of transport would need to be negotiated with Scottish Ambulance Service and HM Coastguard. The patients currently transferred to Aberdeen for Cat 2 treatment would need to be transferred to one of the other independent chambers. Any patients requiring Category 2+ or Category One treatment would need to be transferred to a Category One chamber in England. None of the options require a large increase in transfer activity just in transfer destination but any transfers to England would need to be fully understood by the transport provider. There is a risk that without the Aberdeen specialist service the independent chambers in Scotland may feel less able to treat complex Category 2 patients (Cat2+) and may seek to have these transferred to England as well. Again this should only be small numbers of 2 to 3 per year. Whilst there would be no charge for this from HM Coastguard or RAF Search and Rescue, transfers by ambulance would need to be negotiated with the Scottish Ambulance Service. 4.4 Provision of Elective Services for conditions approved for HBOT

There would be no service for this provided by NHS Grampian. This is currently not part of the nationally designated service but available to all NHS Boards on a marginal cost per case basis. The uptake of this service due to proximity has mostly been by NHS Grampian but most other Boards have referred a small number of patients. Nonetheless some other Boards have used their own mono-place chambers for these treatments eg, Ninewells has two monoplace chambers – one in Dermatology and one in Maxillio-Facial/Head and Neck There are other chambers throughout Scotland which are managed by non-NHS facilities which would be able to provide elective services for a range of conditions and NHS Boards could continue to do this in the future. The other independent chambers which provide service for DDI may also wish to provide services for the elective treatments in the future as well. This would continue to be funded on a cost per case basis by the NHS Boards.


4.5 Peer Review and Audit

The absence of the National Registration Service will mean no planned audit of clinical outcomes and inspections within the chambers in NHS Scotland. It is unlikely that HIS will include this within the workplan for the foreseeable future and therefore it should be a requirement of the chambers that provide services for NHS Scotland to demonstrate their results benchmarked against other chambers across the UK. Therefore participation within the British Hyperbaric Association should be mandatory as well as any audit activity they require. However there would be a deficit of clinical governance arrangements around the provision of these services from the independent chambers from an NHS Scotland perspective. 4.6 Training

There is a lack of training courses across the UK for hyperbaric medicine and NHS Grampian were at the forefront of providing this with accreditation from the University of Plymouth. This was however not core activity for the nationally designated service and would not represent a risk if not continued. 4.7 Funding

As stated above the funding would be removed from NHS Grampian and transferred back to the NHS Boards. There may be some uncertainty over the costs over the costs of the service being provided by the independent chambers, however, the chambers could be asked to publish their tariffs at the beginning of each financial year so that NHS Boards can plan for the likely cost of the service based on their historical activity. Another option would be to agree a level of funding to cover the total activity and agree a level for risk share that could be administered on the NHS Boards behalf by NSD/NSS.

5. Conclusions

The DoPs are invited to give support to the proposal to plan for de-designation and advise on which options they wish to pursue for configuring the service. It is noted that any recommendations for future configuration will need to be agreed by the Cabinet Secretary

September 2013

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013\2013-03-07\NSSC 2013-11 Hyperbaric SAMS contribution. 1

Review of National Hypberbaric Service Configuration – Scottish Association for Marine Science (Oban) response to two centre option of Aberdeen and Orkney.

Summary

The Scottish Association for Marine Science (SAMS) which operates the hyperbaric chamber in Oban wanted to challenge the basis of the two centre model option of Aberdeen and Orkney. The summary of their challenge is based on the following considerations: Not Efficient

The main issue is the cost of the Aberdeen facility which attracts 100% of the nationally designated funding but only provides about 20% of the activity. Efficiencies have not been pursued vigorously enough to allow some of the national funding to be redirected to pay for the costs of the independent chamber. The two centre model based on Aberdeen and Orkney with the proposal that any diving illness incidents in the West be transferred to Aberdeen appears to be solely about improving the viability of the Aberdeen service. Not Effective

SAMS highlights that the last review and appraisals of the Aberdeen service have noted the chamber to be “not fit for purpose”, due to its size and accessibility into the chamber. This two centre model does not address that issue. SAMS challenges the assertion that “the level of clinical knowledge and expertise for HBOT for diving decompression illness is embedded NHS Grampian” and that the independent chambers are reliant on their support. They assert that their team have more experience in diving medicine than Aberdeen; they do not need support from Aberdeen to treat the patients they can treat and only receive minimal support from Aberdeen; and, also that the co-ordination service from Aberdeen for diving illness incidents has been inconsistent in the last 18 months. SAMS also challenges the availability of helium saturation treatment in Aberdeen as a strength of the service. They contend that no other facility in the UK (or to their knowledge in the world) provides helium saturation and believes the efficacy of this to be open to challenge.


NSSC

NSSC PAPER 2013/44A

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013\2013-03-07\NSSC 2013-11 Hyperbaric SAMS contribution. 2

Compromises Safety and Timeliness

SAMS notes that the basis for the chamber on Orkney was due to the recommendation of a Fatal Accident Inquiry into the death of a diver from DDI following transfer from Orkney to Aberdeen. Oban feels that time to treatment is important and that availability of transport to transfer patients from the west coast to Aberdeen may sometimes be challenging and therefore the west coast should be considered similarly to Orkney. Not Person-centred Transferring patients across Scotland when it is not necessary is not person-centred. SAMS Recommendation

SAMS suggests that the NHS should invite the private sector to see if it can provide an up to date facility within the current operational costs of Aberdeen on the east coast (if it cannot be done within Grampian on the NHS) whilst enabling the savings to cover the costs of the chambers in Oban and Orkney. Mr David Steel NSSC Secretariat 18 November 2013

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Review of the Hyperbaric and National Registration Service – Final v1.0

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q~ÄäÉ=çÑ=ÅçåíÉåíë=Table of contents .............................................................................................................. 1

Executive summary ........................................................................................................... 5

1. Introduction ................................................................................................................. 8

1.1 Aims and objectives ....................................................................................................... 8

1.2 Review scope ................................................................................................................. 9

In scope: ......................................................................................................................... ..... 9

Out of scope (exclusions): .................................................................................................... 9

1.3 Desired outcomes .......................................................................................................... 9

1.4 Time scale and approach ............................................................................................... 9

1.5 Evidence Gathering ...................................................................................................... 10

2. Literature Review ....................................................................................................... 15

2.1 INTRODUCTION TO HYPERBARIC OXYGEN THERAPY (HBOT) ........................................ 15

2.2 HBOT – CURRENT LIST of INDICATIONS ........................................................................ 15

2.3 NHS QIS Health Technology Assessment: The clinical and cost effectiveness of hyperbaric oxygen therapy~ July 2008 .............................................................................. 16

2.4 Conclusion ................................................................................................................... 18

3. Current Service............................................................................................................ 19

3.1 Quality ......................................................................................................................... 20

3.2 Clinical Efficacy ............................................................................................................ 21

3.3 Need for the Service .................................................................................................... 24

3.4 Costs ............................................................................................................................ 31

3.5 Changes Since Last Review........................................................................................... 39


2

4. Options for Service Provision ....................................................................................... 40

4.1 Options ........................................................................................................................ 40

4.2 Hyperbaric Scoring ....................................................................................................... 42

4.3 National Registration Scoring ...................................................................................... 43

5. Discussion of Options Appraisal Outcomes................................................................... 44

5.1 Hyperbarics .................................................................................................................. 44

5.2 National Registration Service ...................................................................................... 45

6. Conclusions & Recommendations ................................................................................. 47

6.1 Hyperbaric Service ....................................................................................................... 47

6.2 National Registration Service ...................................................................................... 48

Bibliography ................................................................................................................... 49

Acronyms Index .............................................................................................................. 50

=


3

=

ifpq=lc=q^_ibp===

Table 1.5.4.1 Emergency Ambulance Transport Cost Estimates 12

Table 1.5.4.2 Transport Times 12

Table 1.5.4.3 Transport Methods by Site 13

Table 1.5.4.4 Average Journeys Per Year 13

Table 3.2.1 Percentage of severe cases retaining significant sequelae on discharge from the three audit periods

21

Table 3.2.2 Severity of sequelae on discharge 22

Table 3.2.3 Patients seen but not recompressed 23

Table 3.3.1 Patients treated for DCI 2003‐2010 by NHS Board of Residence 25

Table 3.3.4 Number of Electives carried out in Aberdeen 2003 – 2010 30

Table 3.4.1.2 Indicative NRAC Cost per NHS Board for the Aberdeen Hyperbaric Unit (2003 – 2010)

33

Table 3.4.1.3 Cost per patient to NHS Board for the Aberdeen Hyperbaric Unit (2003‐2010)

34

Table 3.4.2.1 Cost of Independent Chambers to Each NHS Board 2003 – 2010 35

Table 3.4.3.1 Combined Cost of Both Independent and National hyperbaric provision by each NHS Board 2003 – 2010

37

Table 3.4.3.2 Combined Cost of Service, % Total Cost and Cost per patient for each NHS Board 2003 – 2010

38

Table 4.1.1 Weighting of Options 41

Table 4.2.1 Hyperbaric Service: Outcome of Scoring 42

Table 4.3.1 National Registration Outcome of Scoring 43


4

ifpq=lc=do^mep=

Graph 3.3.2 Analysis of East/West patients (from data 2003‐10) 27

Graph 3.3.3 Total hours of treatment within Aberdeen 2003‐10 28

Graph 3.4.1.1 Top Sliced Funding v Spend 2003 to 2010 31

ifpq=lc=^mmbkaf`bp=

Appendix 1 Review Group and Support Team Membership

Appendix 2 Evidence Document

Appendix 3 Evidence from National Registration Service Audit Database

Appendix 4 Options Appraisal SWOT Analysis

Appendix 5 Review of National Hyperbaric Service 2004

=

Executive Summary

bñÉÅìíáîÉ=ëìãã~êó= National Services Division (NSD) is a Division within NHS National Services Scotland. Each year NSD receives top‐sliced ring‐fenced funding from the Scottish Government Health Directorate (SGHD) to commission and performance manage National Screening Programmes, Specialist Clinical Services and national Managed Clinical networks (NMCNs) on behalf of NHSScotland. As part of NSD’s commitment to review all national services to ensure that that each service is meeting its original designation objectives, ensuring clinical effectiveness and delivering value for money; a review was undertaken of the National Hyperbaric Service which incorporates the National Registration Scheme, based in Aberdeen, from April 2010, with the aim of presenting a report on the commissioning of the Hyperbaric service to the National Services Advisory Group in June 2011. The review was conducted in partnership with the service and the host board and an inclusive approach was taken. This included engagement with key stakeholders throughout the process. The purpose of the review was to evaluate the service against the criteria for designation of a national service and to make recommendations for a cost‐effective service delivery that will address current and future predicted needs ensuring service sustainability. The review has found that the hyperbaric service is well thought of within the diving community and there is strong support for the continuation of hyperbaric medicine within Scotland. The Review Group considered the information gathered about the service and service provision across Scotland and then consider whether the current designated service meet with the criteria for national designation and also considered a number of options for the service that may provide a more sustainable, clinical and cost effective service for NHS Scotland. From the evidence gathered for consideration by the Review Group found the following: Clinical Effectiveness The NHS Quality Improvement Scotland Health Technology Assessment July 2008 provided the most robust systematic review of Hyperbaric Oxygen Therapy and that this report recommended that HBOT should be available for use on an emergency basis Decompression Illness (DCI), Carbon Monoxide Poisoning and Air/Gas Embolism. This report also acknowledged that there was sufficient evidence on the clinical effectiveness of HBOT in the treatment of, on a semi‐elective basis, Diabetic Lower Extremity Ulcers, Osteo Radionecrosis and Deep Soft‐tissue Radionecrosis including Proctitis. The Review Group noted that the current designated service covered the three emergency treatments recommended by the HTA Report. Current and Predicted need: There has been a decrease in the number of patients requiring treatment since 2003, falling from 84 to an average of 56 patients per annum over the next 6 years. This is a decrease since the last review when the average number of patients treated within the hyperbaric chambers was 74 per annum. Whilst the economic downturn may be a factor in the declining number of DCI patients, it is of note that the decrease in the number of divers treated for DCI commenced prior to the economic downturn.


5

Executive Summary

It would seem fair to conclude that the Scottish level of activity has reached its lowest level, and therefore it is unlikely the number of patients requiring treatment for DCI will fall any further than the 47 patients treated last year. If the number of patients is related to the economy then should the economy recover there is the possibility the number of patients treated will return to around the previous average of 50 – 60 patients per year, with the maximum not exceeding the peak of 1998 – 2003 of average 73 patients per year. The Review Group also concluded from the information provided that time to treatment was a key factor in terms of patient care and quality of outcomes. Therefore whilst the numbers of potential patients were low and possibly manageable in one Unit, the geography of Scotland and the fact that dive sites are located across the coast of Scotland, indicated that one chamber for the whole of Scotland would not be suitable for meeting the quality of care required. The service Currently there is one nationally funded service within NHS Grampian to provide treatment for DCI, in addition hyperbaric provision is provided in 3 independent chambers within Scotland who have been approved by the National Registration Service as fit to treat NHS patients for DCI. The service within Grampian is funded through National Services Division; in addition, the independent chambers are funded on a case by case basis by each of the NHS Boards. The Review Group acknowledged that the current model of service provision did not fit with national designation as the unit in Aberdeen treats more DCI patients’ resident within the east coast than the west coast whilst the majority of patients with DCI are treated outwith the national chamber. To ensure the service provided is more equitable and also manages the financial risk to NHS Scotland the Review Group are recommending extended designation to ensure the service provided is equitable for NHS Scotland and maintains acceptable times to treatment to ensure that there is no deterioration in the quality of outcomes for treatment. Geographical analysis will be carried out to ensure the correct amount of access is available at the most suitable point of contact. The Review Group also recommend that the elective conditions identified as having sufficient evidence to support treatment should be included ion the scope of the service agreement with the NHS Grampian service but must ensure and monitor equity of access across NHS Scotland. This will ensure greater value for money for NHS Scotland.

Performance of the service:

The service in Aberdeen is the only category 1 facility in Scotland. All of the chambers within Scotland have been quality assessed by the National Registration Service and operate to a very high standard. The review group wish to ensure this standard remains, and recognises that should extended designation be accepted, the most appropriate method of quality assurance would be independent. Therefore the review group recommends that NSD and the service liaise with Health Improvement Scotland (HIS) to enable HIS to undertake independent assessment of all hyperbaric chambers.


6

Executive Summary


7

Future Developments:

The chamber within Aberdeen would require modernisation in the medium term, however for the period until the next review remains fit for purpose. If the capital became available the review group accepts replacement or modernisation of the chamber would be beneficial for the NHS in Scotland. The independent chambers have recently renewed their chambers, Oban to the standard of a category 2 chamber and Millport to the standard of a category 3 chamber; the Review Group would not recommend undertaking any part of the maintenance or replacement of the independent chambers within extended designation. Future designation: The review group recommends extended designation of one or more of the independent chambers in Scotland to provide NHS Scotland with a more equitable and a continuing clinically effective service.

Introduction

NK==fåíêçÇìÅíáçå= National Services Division (NSD) is a Division within NHS National Services Scotland. Each year NSD receives top‐sliced ring‐fenced funding from the Scottish Government Health Directorate (SGHD) to commission and performance manage National Screening Programmes, Specialist Clinical Services and national Managed Clinical networks (NMCNs) on behalf of NHSScotland.

As part of NSD’s role in commissioning performance management, reviews of specialist clinical services with a National designation or NMCNs are carried out at least every five years with a report provided to the National Services Advisory Group (NSAG)

As part of National Services Division’s commitment to review all National services to ensure that each service is meeting its original designation objectives, ensuring clinical effectiveness and delivering value for money; a review of the Hyperbaric Service, incorporating the National Registration Service was undertaken in 2010.

This final review report was prepared for the June 2011 meeting of the National Services Advisory Group (NSAG) who are asked to make recommendations to NHS Board Chief Executives and the Scottish Government Health Directorates (SGHD) on the continuing designation of the service.

One Project Manager from within National Services Division (NSD) was allocated on a part‐time basis to the project with the support of a Programme Director within NSD.

NKN=^áãë=~åÇ=çÄàÉÅíáîÉë=

NSAG criteria state ‘Any services designated as national services will be highly specialised, uncommon and will meet a recognised need within a clearly defined clinical area. By their very nature, the need for these services will be relatively low and/or unpredictable’.

To this end the Aims and Objectives of the review were:

To assess the extent to which the National Hyperbaric Service was achieving the core criteria as set out by NSAG. The review considered whether the core criteria continued to be met. To do this the review assessed:

The current and predicted future need for the clinical service, and the National Registration Scheme (NRS).

The extent to which the service provided equitable access to all residents of Scotland, this was completed by examining geographical uptake.

Performance of the service in achieving clinical quality standards (including Health & Safety Executive requirements).

The extent to which the service adhered to current best practice and was clinically effective.

Whether the services was abreast of future developments.

How the service was viewed by stakeholders e.g. Service users, NHS Boards and referring clinicians.

Current and predicted future costs.

Potential to improve cost effectiveness and efficiency.

The contribution provided by the service in relation to training and research, and the quality control of local chambers.


8

Introduction

Whether there were any alternative or more appropriate sources of service delivery for the clinical service and for the National Registration Scheme.

=

NKO=oÉîáÉï=ëÅçéÉ==få=ëÅçéÉW=

The nationally designated Hyperbaric Medicine Unit.

Direct care of diving related illness for patients;

The tertiary service for other Category 2 and 3 recompression units in Scotland and the diving emergency telephone advice service.

The National Registration Scheme.

=

lìí=çÑ=ëÅçéÉ=EÉñÅäìëáçåëFW=

The performance of other hyperbaric units and their ability to carry out NHS treatment.

=

NKP=aÉëáêÉÇ=çìíÅçãÉë=

To identify:

Whether the Hyperbaric Medicine Unit, within NHS Grampian should continue to be designated as the provider of Hyperbaric medicine as a national service.

Whether the National Registration Service should continue to be designated as a national service.

=

NKQ=qáãÉ=ëÅ~äÉ=~åÇ=~ééêç~ÅÜ=

NKQKN=qáãÉëÅ~äÉ= The review was started in April 2010, with a final date of June 2011 for reporting to NSAG. To oversee the review, and score the options an expert Review Group was established who approved the Project Brief and the Review Initiation Document. The group membership is listed in Appendix 1.

A separate Review Support Team was established to assist with gathering evidence, provide advice and inform the review process. The Scottish Health Council and the Equality and Diversity Lead for NSS assisted the Project Manager with the design of communications and surveys sent out to users.

Throughout the review, the Project Manager and other stakeholders from National Services Division worked in partnership with service colleagues and met representatives of the service to provide information on the review process and to gain feedback. It was identified early in the process there was a cross‐over in service provision, in addition to the national service there was also independent chambers that provided hyperbaric medicine in Scotland. As this was an identified cost to NHS Scotland it was agreed the activity of the chambers would need


9

Introduction

to be taken into consideration, it was noted however that the review was not a review of Hyperbaric provision in Scotland, it was a review of the National Service.

The review process involved gathering of information from both the National and independent chambers, and from the NHS Boards who make payment for this service. The process also included surveys of the users of the service within Aberdeen, a wider survey of the diving community and providers of hyperbaric medicine in England. The surveys were distributed throughout the year and the results were added to an evidence document (Appendix 2) for the Review Group to consider prior to scoring available options.

At every stage in the evidence gathering process, the evidence was discussed and agreed by the Review Support Team and Review Group, after which time the evidence was added to the evidence document which was used by the Review Group to inform their decision making when asked to appraise the options.

The criteria, weighting and scoring of options was discussed by the Review Group and was then agreed at a meeting on 18th February 2011, following which members of the Review Group scored the available options. The Review Group then reconvened on 3rd March 2011 to assess the outcome of the scoring and agree the recommendation to NSAG.

NKR=bîáÇÉåÅÉ=d~íÜÉêáåÖ=

NKRKN=bîáÇÉåÅÉ=Ö~íÜÉêáåÖW=oÉîáÉï=çÑ=ëÉêîáÅÉ=ÇçÅìãÉåí~íáçå= A number of documents are submitted to National Services Division annually by national services for the purpose of performance management. These were reviewed as part of the evidence gathering and included:

Annual reports

Service agreements

Original designation documentation

Minutes of meetings with the service

As the review progressed, the service and the independent chambers provided a range of documentation to answer queries that arose. This included activity, clinical information, transport and training information.

NKRKO=bîáÇÉåÅÉ=Ö~íÜÉêáåÖW=k~íáçå~ä=oÉÖáëíê~íáçå=pÉêîáÅÉ=

The National Registration Service provided a range of information which was available through the continual audit of both the national and independent chambers in Scotland (Appendix 3). The audit information was submitted to both the Support Team and the Review Group and the most appropriate data was agreed and then taken forward into the evidence paper (Appendix 2). Regular dialogue was also maintained with key individuals.

NKRKP=bîáÇÉåÅÉ=Ö~íÜÉêáåÖW=pìêîÉóë=

The Review Support Team and the Review Group agreed that it would be useful to collate information on the diving community’s view of the National Hyperbaric Service in Aberdeen. The Project Manager worked collaboratively with the service to issue a patient questionnaire which was returned in September 2010. A good response was received from divers ‐ 75


10

Introduction

questionnaires were issued and 38 returned (a return rate of 50.7%). The response from patients was very favourable with regards the unit, their referral pathway and the treatment received. 65.5% of patients were treated within hours of the incident occurring with the remaining 34.5% being treated within days. It was acknowledged that those who were treated within days were due to the patient time to present with illness. The results of this survey were added to the evidence pack for consideration by the Review Group.

The Review Support Team identified the need to seek the views of the wider diving community regarding Hyperbaric Provision in Scotland. To this end advice was obtained from the British Sub‐Aqua Club (BSAC) and Scottish Sub‐Aqua Club (SCOTSAC) on the most appropriate method of engagement with the diving community. An on‐line survey was issued, the results were analysed and added to the Evidence Pack for consideration by the Review Group.

Analysis of this survey indicated that; the majority of divers had never needed to attend a unit; divers would mainly call either the diving emergency line or 999 if they found themselves in a diving emergency. Most of the divers questioned regularly dived in Scottish waters and most intend to dive within the next year in Scotland. The diving community are most concerned by the time to treatment and the quality of care; they are least concerned by whether the facility is run by the NHS or how close the unit is to their home address.

In addition, NSD conducted a survey of the other Category 1 hyperbaric units in England. The Hyperbaric service within England is no longer included in the national specialised services definitions set and is not nationally commissioned. Hyperbaric Medicine Units in England provide HBOT for a range of conditions, agreed with NHS commissioners in England and Wales on a cost per case basis; these results showed a difference in service configuration and costing, and were added to the evidence pack.

NKRKQ=bîáÇÉåÅÉ=Ö~íÜÉêáåÖW=qê~åëéçêí=

The review acknowledged that any change to service configuration would impact on transport provision and therefore the decision was taken to seek representation on the Review Group from the Scottish Ambulance Service (SAS) and the Maritime and Coastguard Agency (MCA). This was achieved and both the SAS and MCA provided the Review Group with evidence on costs associated with transfer of patients. Unfortunately, SAS were unable to provide auditable information in relation to the number of patient journeys therefore this information was provided by the National Service and the independent chambers.

Scottish Ambulance Service

The Review Group accepted there was a lack of reliable auditable data for the Scottish Ambulance Service (SAS) in relation to patient transport journey for HBOT care for diving decompression illness. The Review group accepted estimated patient transfer numbers from the hyperbaric units. The SAS were able to provide information on the cost profile for main journeys across Scotland shown in Table 1.5.4.1.


11

Introduction

Table 1.5.4.1 Emergency Ambulance Transport Costs Estimates

From/To Aberdeen Oban Millport

Glasgow £440 £331 £270

Edinburgh £374 £415 £378

Millport £654

Oban £572

The Review Group also considered the impact on transport times by road for possible journeys in the event of a different configuration being applied these are shown in Table 1.5.4.2. The times are an approximation based on an online mileage and time calculator. Table 1.5.4.2 Transport Times

From/To Aberdeen Oban Millport

Glasgow 3hrs 10mins 2 hrs 10 mins 1 hr 40mins

Edinburgh 2 hrs 50 mins 2 hrs 45 mins 2hrs 30 mins

Millport 4 hrs 50 mins

Oban 4 hrs

The small intra hospital journeys were estimated to cost on average about £50 per journey. The Review Group agreed transfer times by helicopter would be much shorter but would also be more expensive. It was estimated that the SAS helicopter from Orkney to Aberdeen would cost approximately £7k per journey and approximately £6k from Oban to Aberdeen.

Number of patients transferred

Table 1.5.4.3 details figures provided by the hyperbaric chambers to the Review Group estimating the number and methods of transport for patients who had attended their units from 2003/04 to 2009/10.


12

Introduction

Table 1.5.4.3 Transport methods by site

Ambulance Lifeboat Helicopter Local Ambulance

Aberdeen 18 0 24 107

Oban 12 32 31 254

Orkney* 90 14 1 28

Millport 18 51 33 185

Totals 138 97 89 574

*The figures in relation to Orkney are estimated based on percentages of their activity for the period.

The Hyperbaric providers advised that the vast majority of helicopter transfers are by either HM Coastguard or the Royal Navy with only one or two transfers been carried out by the Scottish Ambulance Service.

The Review Group concluded the average number of patient journeys per year, should a change in configuration be recommended as detailed in Table 1.5.4.4.

Table 1.5.4.4 Average journeys per year

Type Total

Emergency Ambulance 20

Local Ambulance 82

Helicopter 13

Lifeboat 14

Totals 129

It was agreed that should the service be centralised there would be between 15 and 25 additional helicopter transfers from Orkney to Aberdeen in a year.


13

Introduction


14

Emergency Medical Retrieval Service

During the course of the review, it was announced by the Cabinet Secretary for Health & Wellbeing, following an external evaluation of the 18 month pilot of the Emergency Medical Retrieval Service (EMRS) that a roll‐out of the service to cover all remote and rural areas of Scotland would commence from October 2010. The Review Group agreed the service has been involved in transfer of patients requiring HBOT in the pilot period and has a comprehensive protocol for dealing with potential DCI patients. EMRS advised they were keen to assist in whatever way appropriate in the provision of transfer and care of DCI patients in the future, this was acknowledged by the Review Group.

HM Coastguard

Mr Queen, HM Coastguard, advised the Review Group the baseline funding for the Maritime and Coastguard Agency covers all aspects of agency activities, including the transportation of divers to the hyperbaric chambers, this therefore made it difficult to identify individual areas of expenditure. Mr Queen however was able to ascertain the costs for naval search and rescue helicopters these were:‐

Vessel to chamber – No Charge Hospital to chamber ‐ £2,000 per hour

Literature Review

OK==iáíÉê~íìêÉ=oÉîáÉï=The Medical Director along with the Lead Clinician for the Hyperbaric Service in Aberdeen provided the literature report to inform the Review Group this was added to the evidence pack and is also detailed below:‐

OKN=fkqolar`qflk=ql=evmbo_^of`=luvdbk=qebo^mv=Ee_lqF=Hyperbaric oxygen treatment (HBOT) involves the delivery of 100% oxygen inside a treatment chamber at a pressure of 2 atmospheres or more as defined by the European Committee for Standardisation (CEN), the body recognised by the European Commission as competent in the area of voluntary technical standardisation. Treatment is provided in a chamber capable of accommodating one or more occupants, including attendant clinical staff, pressurised with compressed air within which the patient breathes a treatment gas (usually 100% oxygen) via a mask, head tent or endotracheal tube. The duration of a single treatment varies greatly in relation to the nature and severity of the condition being treated; some conditions require a series of treatments over a number of days.

There is little doubt that HBOT is, in appropriate circumstances, a safe intervention for most individuals and has been used as an adjunctive treatment for a wide variety of conditions on an elective basis despite very limited evidence of benefit being demonstrated to justify the treatment or in terms of improved outcome. There are a limited number of situations where the clinical experience and recorded improvement in outcomes justifies the use of HBOT. It is recognised that widespread and ad hoc use of HBOT has led to the treatment being denigrated in some quarters. A short list of indications has been adopted by most national commissioning bodies and is consistent with the current designation of the Hyperbaric Oxygen Therapy (HBOT) service provided by NHS Grampian for NHS Scotland.

OKO=e_lq=Ó=`roobkq=ifpq=çÑ=fkaf`^qflkp==On reviewing the literature available, including review of a number of major websites, including that of the Undersea and Hyperbaric Medicine Society (UHMS), which is referred to by many of the national commissioning bodies as a reliable source of information, the summary of indications as set out in the NSD review of 2003 is difficult to better. This is shown as an extract from the paper on the following page.

Emergency

Air or Gas embolism ref 1,2,3

Severe CO (Carbon Monoxide) poisoning ref 3

Decompression Illness (bends) ref 1,2,3 Necrotising soft tissue infections ref 2,3

rêÖÉåí=íêÉ~íãÉåí=ïáíÜáå=OQ=Üçìêë= Necrotising fasciitis ref 2,3

Gas gangrene ref 1,2,3


15

Literature Review

Elective

Delayed radiation injury to bone (osteo‐radionecrosis: ORN) and some soft tissue (including rectum) ref 2,3

Prophylaxis for implants in irradiated bone ref 3

Problem wounds as selected e.g. diabetic wounds ref 2

1. HBOT is widely accepted as standard clinical care for these conditions

2. HBOT is supported by the Australian Medicare Services Advisory Committee (2001) as an evidence based treatment for these conditions.

3. HBOT is supported by the European Committee for Hyperbaric Medicine (2001) as appropriate treatment for these conditions.

OKP=kep=nfp=eÉ~äíÜ=qÉÅÜåçäçÖó=^ëëÉëëãÉåíW=qÜÉ=ÅäáåáÅ~ä=~åÇ=Åçëí=ÉÑÑÉÅíáîÉåÉëë=çÑ=ÜóéÉêÄ~êáÅ=çñóÖÉå=íÜÉê~éóú=gìäó=OMMU=2.3.1 Background:

The most robust systematic review of the literature remains that undertaken in 2007/08 as a Health Technology Assessment (HTA) led and published by NHS QIS in July 2008. NHS QIS had been commissioned by the UK Specialised Services Public Health Network and the UK Commissioning Public Health Network to undertake this Health Technology Assessment of HBOT (http://www.nhshealthquality.org/nhsqis/4208.html) and it has been used to inform commissioning decision by a number of SHA in NHS England.

In summary the HTA Report seeks to classify conditions into one of four categories:

Of proven clinical benefit and cost‐effective: should be used in the NHS

Of proven clinical benefit but not cost‐effective: should not be used in the NHS

Of likely benefit but with evidence lacking – use in research trials only

Of proven lack of effectiveness – not recommended for use

It should be noted that following publication of the NHS QIS HTA report, Hyperbaric Oxygen Therapy was removed from the Specialised Services National Definition Set (SSNDS), and is no longer a nationally commissioned service within NHS England. HBOT is now commissioned on a variety of mechanisms including Primary Care Trusts (PCT) and regional Specialised Commissioning Groups (SCG).

2.3.2 Clinical Overview

The HTA Report confirms the use of HBOT for decompression illness, carbon monoxide poisoning and air / gas embolism. HBOT use for these indications is supported by having a good theoretical basis, and long‐standing evidence of both use linked to a clinical consensus of benefit, despite a lack of any formal randomised control trials evidence. The HTA report indicates it would not be justified to require further trials in this area of use and HBOT should be accepted as the standard treatment for these conditions.

The HTA report indicates a lack of RCT evidence for other elective treatments / treatment indications. For those conditions where RCTs have been conducted, the quality of reporting of many of the trials was considered too poor to provide robust conclusions. Thus the HTA concluded that for the majority of conditions there was insufficient evidence to support the


16

http://www.nhshealthquality.org/nhsqis/4208.html

Literature Review

routine use of HBOT. For some conditions observational studies have suggested that HBOT may be of some benefit, but conclusive evidence is not available.

The HTA also concluded that it was difficult to offer substantive evidence of cost‐effectiveness, with economic evaluations having been carried out on only a few conditions. The majority of these studies reported on diabetic foot ulceration, with a small number exploring non‐diabetic wound healing and osteo‐radionecrosis.

2.3.3 Indications where HBOT is recommended

The NHS QIS HTA Review therefore advises that HBOT should be available for use, under specialist clinical direction, in the following conditions:

Decompression Illness: Empirical evidence together with the theoretical basis and clinical consensus supports the use of hyperbaric oxygen treatment as standard care. There is also robust empirical evidence which indicates an optimal time to treatment for this condition. Further research on optimal treatment schedules is warranted.

Carbon Monoxide (CO) Poisoning: Empirical evidence together with theoretical basis and clinical consensus supports the use of HBOT as part of the algorithms for management of CO poisoning. This has been reinforced in recent communication from CMO in England (2010).

Air/Gas Embolism: Empirical evidence lacking, but the theoretical basis and clinical consensus supports the use of HBOT as standard care in severe cases.

Diabetic lower extremity ulcers: There was evidence which indicated that HBOT is effective in reducing the number of major amputations required. Ongoing large trials could provide further evidence to support routine use of HBOT.

Osteo Radionecrosis and Deep Soft‐tissue Radionecrosis including proctitis: There was evidence to support the use of hyperbaric oxygen therapy for patients with radiation‐induced bone damage, especially in maxillofacial cancer care and in deep soft tissue damage, including proctitis. SIGN used similar methodology to NHSQIS and made a level C recommendation that HBOT should be available for selected ORN (osteo radio necrosis) patients.

2.3.4 Indications where HBOT is not routinely recommended

Other conditions considered under the HTA; including Necrotising Wounds, Crush Injuries, compromised skin grafts/myocutaneous flaps and selected problem wounds ‐all identified in the NSD 2003 review, and strongly supported by the European Committee for Hyperbaric Medicine (2001) are advised as having insufficient evidence to support the routine use of hyperbaric oxygen therapy as an adjunct to standard clinical care.

There is also insufficient evidence to support the routine use of hyperbaric oxygen treatment as an adjunct to standard care for patients with soft‐tissue radio necrosis other than those defined above.


17

Literature Review


18

OKQ=`çåÅäìëáçå=Whilst other world wide organisations, such as the European Committee for Hyperbaric Medicine and the Undersea and Hyperbaric Medicine Society (USA), continue to recommend a wider scope of conditions / indications for treatment by HBOT; the NHS QIS HTA provides the most robust and objective basis for recommendations on the therapeutic uses of hyperbaric oxygen medicine. The NSD review therefore has used the NHS QIS report as the basis for advising on appropriate indications for use of hyperbaric oxygen treatment in NHS Scotland.

Use of Hyperbaric Oxygen Therapy, commissioned by any part of the NHS in Scotland, should be limited to use for conditions / indications identified as reasonable by the NHS QIS HTA Report 2008 until further RCT evidence supersedes its findings

NHS Scotland should continue to make provision for HBOT as an emergency care intervention for

Diving (sport, leisure and rarely industrial) related illness / decompression sickness;

Air/ Gas embolism; and

The emergency treatment of severe Carbon Monoxide poisoning. The evidence available suggests HBOT, where clinically indicated as above, should be provided within a short time period. This highlights the critical need for robust emergency transport arrangements to be put in place. The detail of emergency transport arrangements is beyond the scope of this review; however NSD is aware that SGHD have identified this as an issue for early action. At present the Scottish Ambulance Service and HM Coastguard undertake the majority of transfers. HBOT can be also considered on an elective basis for a further limited group of conditions.

Diabetic lower extremity ulcers

Osteo Radionecrosis and Deep Soft‐tissue Radionecrosis including proctitis These all have a common theme of seeking to increase oxygen concentration in damaged tissue, secondary to a reduced blood supply. Continued use of HBOT as an intervention in these circumstances is based on empirical evidence rather than from any controlled study. However, there is some evidence that indicates HBOT is effective in diabetic lower extremity ulcers and radiation induced injury although further clinical trials may provide support for the routine use of HBOT. It is recommended that these limited interventions should sit within the core HBOT service in Aberdeen and be part of the nationally designated service, if national designation is to continue.

All other treatments should be excluded from the scope of any HBOT service commissioned for NHS Scotland. The NHS QIS HTA review acknowledges that HBOT has been suggested, and is being used, in a wide variety of non urgent and non evidence based ways. This includes a wide range of interventions for long term degenerative disease where there is no correlation between the known patho‐physiology and the possible benefits from use of HBOT. Whilst it would be inappropriate for this review to comment on this practice in other settings (we have agreed that privately funded care is out of scope) it is possible to recommend that the NHS commissioned service should be limited to the conditions listed above.

Current Service

PK=`ìêêÉåí=pÉêîáÅÉ=Specialist emergency hyperbaric medical services for NHS patients within Scotland have been nationally commissioned since 1979. The national designated service has been provided by the National Hyperbaric Unit based in Aberdeen Royal Infirmary throughout that period.

The Service Agreement between NSD and NHS Grampian states that the objective of the Hyperbaric service is: To provide:

emergency diagnostic and therapeutic treatment for diving‐related illness requiring recompression/decompression therapy

co‐ordination of the management of diving emergencies in Scotland

operational support for emergency treatment for any non‐diving related incidents

a Scottish National Registration Service for non‐NHS hyperbaric chambers The service is for the diagnosis, treatment and ongoing management of diving‐related illness where recompression/decompression treatment is required. It is noted within the SLA that ‘this service does not include diving assessments, transfer costs are the responsibility of the patient's NHS Board of residence, treatment costs at other chambers are not part of this agreement, and elective treatments are excluded from this agreement’.

There are a number of sites within Scotland popular for the diving community. Scottish Sub Aqua club recommend areas within:‐

South West Scotland ‐ from Solway Firth to Ardnamurchan Point including the Sound of Mull,

Western Isles and St Kilda

North West – Ardnamurchan Point to Tongue Bay including The Isle of Skye

Northern Isles (Shetland and Orkney)

North East – Tongue Bay to Montrose

South East – Montrose to Eyemouth

There are a number of hyperbaric chambers situated across Scotland that provide different categories of service from Category 1 to Category 4 as defined by the British Hyperbaric Association.

Category 1 ‐ Facilities should be capable of receiving patients in any diagnostic category who may require Advanced Life Support either immediately or during hyperbaric treatment. Category 2 ‐ Facilities should be capable of receiving patients in any diagnostic category who are judged by the referring medical officer not to be likely to require Advanced Life Support during hyperbaric treatment. Category 3 ‐ Facilities should be capable of receiving emergency referrals of divers and compressed air tunnel workers. These facilities should also be capable of providing elective treatment of residual symptoms of decompression illness. Patients may be accepted, in the name of the Medical Director (whose role is defined in para 24 of the Cox Report), even when no Hyperbaric Duty Doctor is available at the time of referral provided, in the view of the referring clinician, the patient's condition demands immediate action. This does not obviate the need for discussion with the Hyperbaric Duty Doctor who should attend the patient as soon as is practicable.


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Category 4 ‐ Facilities should be capable of receiving elective and emergency referrals of patients in any diagnostic category who are judged by the referring medical officer, on the advice of the Hyperbaric Duty Doctor, not to be likely to require access during hyperbaric treatment. Normally monoplace chambers are not suitable for the immediate treatment of acute decompression illness.

The NHS chamber situated in Aberdeen is the only Category 1 chamber in Scotland. In England, there is a number of Category 1 chambers, the closest to Scotland would be either Hull or Wirral.

Category 2, hyperbaric medicine services can be provided within Aberdeen, in addition, this care is also currently provided by two independent chambers around Scotland. These independent chambers charge NHS Boards for care provided to NHS patients on a cost per case basis and are situated in Oban and Orkney. In addition, care is also provided within a Category 3 facility in Millport. The independent chamber within Millport also charges NHS Scotland on a cost per case basis. Although the performance of these chambers is outwith the scope, the activity and financial affect of these chambers has been considered within the review.

In addition to the commissioned service, the chamber within Aberdeen currently provides an elective service for patients. The cost for these elective procedures is then charged to the NHS board of residence.

PKN=nì~äáíó==The 2008 Review by NHS Quality Improvement Scotland (QIS) concluded that despite a lack of Randomised Control Trial clinical evidence to support the use of Hyperbaric Oxygen Therapy (HBOT) for decompression illness there was a good theoretical basis, long standing use and clinical consensus to support the use of HBOT as standard care for patients with decompression illness. Similarly as detailed within the literature report there was sufficient evidence of either a theoretical or empirical nature to support the use of HBOT for the other treatments provided within the unit in Aberdeen.

The National Registration Service, collates clinical audit data on all hyperbaric units in Scotland this allows them to audit the treatment of patients within Scotland. As part of this review Dr John Ross, retired Lead Clinician and Honorary Senior Lecturer at Aberdeen University, assessed the National Registration Service’s clinical audit database. The results were added to the Evidence Pack and concluded that a patient who has either complete resolution or a major response to recompression treatment is regarded as having a successful response. Most of the patients treated in Scotland fall into these categories with only 15% of patients having an unsatisfactory response to recompression therapy. A successful response to initial recompression treatment was obtained as follows: Aberdeen 69%; Oban 73%; Millport 73% and Stromness 66%. The overall success rate was 69%. As part of Dr Ross’s conclusions 15.7% of patients were listed under the category “no initial signs and no clinical change” these patients had resolved during transfer and were normal on admission. These people were recompressed in view of a perceived risk of recurrent symptoms and signs.

Condition on Discharge from Hyperbaric Care

The clinical score on discharge from hyperbaric care was assessed within Dr Ross’s report within the period assessed 93% of people left with either complete resolution or minor sensory symptoms thought to be short term. This is regarded as a successful outcome and was


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similar in both the NHS and Independent chambers. This can be compared with a figure of 94% in the 2000‐2003 review and 85% in the 1991‐1998 review. Complete resolution was less common for the Aberdeen Unit and this might be attributed in part to taking more severe cases for treatment than other units.

PKO=`äáåáÅ~ä=bÑÑáÅ~Åó= Clinical efficacy was assessed within the report in the same way as in the 2000‐2003 review. The clinical performance of a unit must be assessed in terms of its impact upon the patients’ disease. In decompression illness, outcome of treatment depends predominantly on severity of injury. Accordingly, to calculate the impact of treatment, the National Registration Service expressed the figures in terms of those presenting with motor problems or worse against those going home with residual motor problems or worse both in the periods 1991‐1998 and 2000‐2003. These conditions are termed severe and lesser conditions are termed mild. The indicator of performance is taken as the ratio of the two figures i.e. fraction of severe cases going home with a severe condition. The data collected allowed this assessment in 406 cases for the present audit period and is shown in Table 3.2.1.

3.2.1 Percentage of severe cases retaining significant sequelae on discharge for three audit periods

1991‐1998 2000‐2003 2003‐2010

Presenting (%)

Discharge (%)

Ratio Presenting (%)

Discharge (%)

Ratio Presenting (%)

Discharge (%)

Ratio

Mild 63 87 78 94 77 93

Severe 38 13 35% 22 6 26% 23 7 24%

Total 100 100 100 100 100 100

The impact of treatment can be best calculated on the fraction of severe presentations that go home retaining that condition. It seems that by this indicator the current assessment period has seen a further slight improvement in efficacy. The National Registration Service concluded that improvement between the 1991‐1998 and 2000‐2003 could well have been related to a reduction in the initial severity of the disease treated. This was not true for the 2000‐2003 and 2003‐2010 comparison since a similar proportion of severe cases were treated.


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22

Table 3.2.2 below notes that 27 cases were discharged from hyperbaric care with significant sequelae.

Table 3.2.2 Severity of sequelae on discharge

Non Significant Sequelae Significant Sequelae

Condition on discharge

Complete resolution

Mild pain or sensory

Mild motor or ataxia

Severe motor or ataxia

Urinary Catheter

Cerebral

Number of patients

279 94 20 2 3 2

Patients discharged with severe motor deficit, catheterised or with cerebral sequelae all presented with very severe disease indeed. Both cases discharged with a urinary catheter had been shellfish diving and this supports the observation that this category of diver tends to have a poor outcome. A further one case was discharged with severe sequelae (dense paraplegia) after spinal cord decompression illness. This was sustained and treated initially outwith the UK and the case is not therefore included in this audit. Of the 20 cases with mild motor or ataxic sequelae, 13 had presented with vestibular decompression illness affecting the inner ear.

Vestibular decompression illness

32 cases presented with this condition, 13 (41%) of whom were discharged with mild motor or ataxic sequelae. In the audit period 2000‐2003 the prevalence of this condition was 3.5%. The present prevalence is 8% and so has doubled.

Hypovolaemia

Hypovolaemia was recognised on admission in 24 cases, 15 of whom presented with severe disease. 4 (17%) of these patients were discharged with significant sequelae, 1 with severe motor sequelae and 3 with mild motor sequelae.

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Patients seen but not recompressed

Table 3.2.3 Patients seen but not recompressed

2003 2004 2005 2006 2007 2008 2009

Aberdeen 4 4 5 11 2 3 6

Millport 5 5 2 6 11 6 4

Oban 6 12 5 5 8 4 6

Stromness 13 13 13 7 16 8 14

Table 3.2.3 showed each unit cared for patients who did not require recompression therapy. These patients were generally cases of barotrauma, rapid uncontrolled ascent from depth, omitted decompression or concurrent illness unrelated to diving. The figures may be underestimated since patients at each unit could be seen outwith the hyperbaric unit and not, therefore, recorded on the Unit records accessed by this audit. In addition, there may be cases from 2010 which were unreported to NRS at time of writing the report.

=


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PKP=kÉÉÇ=Ñçê=íÜÉ=pÉêîáÅÉ==As the service within Scotland is provided by both an NHS chamber and independent chambers, the Review Group analysed activity from all chambers in Scotland. The activity data was collated from the clinical audit database of the National Registration Service for the period 2003/04 to 2009/10.

Patients Treated for Diving Decompression Illness 2003‐10

420 patients were treated in Scottish chambers for Decompression Illness (DCI) over the total period. Of these patients 121 patients were treated in Aberdeen, whilst 299 patients were treated in the other 3 Scottish chambers. This equates to approximately a 30%/70% split in activity.

In 2004 the number of patients treated within the Aberdeen unit fell substantially from 37 to 14, since that time the number of patients treated within the unit has remained fairly constant, with an average of 14 patients with the exception of 2006/07 when the number of patients treated fell to 9.

From the information gathered it was concluded there has been a decrease in the number of patients requiring treatment since 2003, falling from 84 to an average of 56 patients per annum over the next 6 years. From 1998 to 2003 the average number of patients treated within the hyperbaric chambers was 74. This is reflective of a similar decrease in patients across the UK.

Figures obtained from the BHA suggest that DCI activity within Scotland over 2008 is approximately 19% of the total UK activity. This is possibly related to greater recreational diving activity in Scottish waters, or due to the nature of diving in Scotland.

Whilst the economic downturn may be a factor in the declining number of DCI patients, it is of note that the decrease in the number of divers treated for DCI commenced prior to the economic downturn. It would seem to be likely that the Scottish level of activity has reached its lowest level, and therefore it is unlikely the number of patients requiring treatment for DCI will fall any further than the 47 patients treated last year. If the decrease in diving is economically driven, then should the economy recover there is the possibility the number of patients treated will return to around the previous average of 50 – 60 patients per year, with the maximum not exceeding the peak of 1998 – 2003 of average 73 patients per year.


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Table 3.3.1 ‐ Patients treated for DCI 2003 – 2010 by NHS Board Area of Residence

NHS Board Aberdeen Oban Millport Orkney Total

Ayrshire and Arran 1 0 4 1 6

Borders 0 1 0 0 1

Argyll and Clyde 2 4 7 0 13

Other UK (mainly England) 32 57 20 99 208

Fife 10 1 1 3 15

Greater Glasgow and Clyde 6 6 16 2 30

Highland 5 12 2 0 19

Lanarkshire 6 2 6 0 14

Grampian 24 2 0 2 28

Orkney 1 0 0 8 9

Lothian 20 9 0 6 35

Tayside 6 1 0 0 7

Forth Valley 6 1 1 0 8

Western Isles 0 5 0 0 5

Dumfries and Galloway 0 0 2 0 2

Shetland 1 0 0 0 1

Outwith UK 1 0 0 18 19

Missing 0 0 9 0 9

Total 121 101 68 139 429


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Table 3.3.1 indicates the largest user of hyperbaric treatment within Scotland for DCI for the reporting period was NHS Lothian with 35 patients, closely followed by NHS Greater Glasgow and Clyde on 30 and NHS Grampian on 28.

Table 3.3.1 shows that 28% of patients were treated in Aberdeen with the remaining 72% being treated within the other 3 independent chambers. (24% Oban, 16% Millport and 32% Stromness).

46% of Scottish patients were treated within Aberdeen from 2003‐10 with the remaining 54% treated within the other 3 independent chambers (23% Oban, 20% Millport and 11% Stromness).

53% of patients who were treated within Scotland from 2003 – 2010 were non‐residents of Scotland. These patients generate revenue for both the independent chambers and NHS Scotland. The NHS Chamber in Aberdeen currently applies a standard charge of £44k per patient to treat a patient from outwith Scotland. The independent chambers charge patients from outwith Scotland in a similar way to the charges they make to NHS Scotland.

The majority of the patients treated in Aberdeen were resident in Scotland. There is however a variance in the distribution of the Scottish residents NHS Boards. There were no treatments carried out by the Hyperbaric Medicine Unit for residents from the following Board areas within the report period.

Borders

Dumfries and Galloway or the

Western Isles

In addition, NHS Orkney, Ayrshire and Arran and Shetland only had 1 patient treated over the reporting period.

Patients who required Category 1 facility treatment

The annual reports provided by the service, indicate that from 2003 to 2010 there were 3 patients who required Category 1 level treatment in Aberdeen. These patients were not suitable to be treated in any of the other units. These 3 patients consist of 1 patient in 2004/2005 and 2 patients in 2009/2010. In addition, informal evidence from the service in Aberdeen indicates for the period 2003 to 2010 there were 18 patients in total who required Category 1 facility treatment.


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DCI Treated in Aberdeen by East and West split 2003‐10

The review team analysed the activity of divers’ resident within the NHS Boards for the East Coast (Borders, Fife, Grampian, Lothian, Tayside, Shetland and Orkney) and comparing it with those remaining who were resident in NHS Boards based on the West of Scotland, a split was identified.

Graph 3.3.2 – Analysis of East/West patients from data (2003‐10)

Percentage of East/West patients per chamber

3

32

86

30

97

68

14

70

0

10

20

30

40

50

60

70

80

90

100

Aberdeen (n=88) Millport (n=39) Oban (n=44) Stromness (n=22)

Name of Chamber

% o

f p

atie

nts

East

West

Within Aberdeen, 70% of patients were resident within the East and 30% were in the West.

With regards the 3 independent chambers: ‐ Within Oban 68% of the patients were resident within the west coast, with the remaining 32% resident within the East. Within Millport 97% of the patients were resident within the west coast, and only 3% were from the East. Within Stromness 86% of the patients who were treated were resident in the East coast with the remaining 14% being resident in the west.

The chart above shows the independent chambers in Millport and Oban are mainly facilitating divers’ resident within the west coast, whilst Aberdeen and Stromness are mainly dealing with divers who were resident within the East coast.

When looking at the percentages of patients treated within Scotland, there is an even split of treated divers being resident in the East and West coasts. This demonstrated to the Review Group that the national service as it stands, the NHS chamber in Aberdeen, is not truly national in terms of treatment and care of patients. Although affected divers were evenly split with regards to residence between the East and West coast the National Service in Aberdeen is dealing mainly with patients resident in the east coast of Scotland.

This is a major challenge for a national specialist service where, due to the emergency nature of the care that is required, time to treatment is seen as the most important factor. It is known that incidents occur across the whole of Scotland and whilst the low numbers of


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incidents annually clearly suggest that one facility should be able to manage the care required, the geography of Scotland makes this difficult to achieve in a safe and timely manner.

Chamber Hours in Aberdeen

The Hyperbaric Centre is available for operation 24 hours per day, 365 days per year. Therefore the unit is available for a total of 8,760 hours within the year. The total number of utilised chamber hours for diving related illness for the Hyperbaric Centre is shown below:‐

Graph 3.3.3 ‐ Total hours of treatment within Aberdeen 2003‐10

Total hours of treatment within Aberdeen

0

50

100

150

200

250

03/04 04/05 05/06 06/07 07/08 08/09 09/10

Year

Nu

mb

er o

f H

ou

rs

Total Chamber Hours

This graph shows the number of hours used dropped in 2003/2004 to 2004/2005 and has then varied year on year from 2004 until present.

Number of telephone calls received by the unit

In addition to this activity the unit within Aberdeen routinely receive calls from other agencies and from the other chambers for advice. These calls are audited and the number has varied year on year however remains between 150 and 250. The advice and guidance provided by the service in Aberdeen to the other chambers is greatly valued due the level of knowledge and expertise however the health impact of that input is not possible to quantify.

Diving Related Deaths

Information Services Division were contacted to ascertain if they had official statistics relating to the number of diving related deaths in Scotland. However, this information is not currently collected. Therefore the Review Group approached British Sub Aqua Club (BSAC) as they compile a report every year, in the interest of promoting diving safety, on diving incidents within the UK. The report contains details of UK sport diving incidents occurring to divers of all affiliations, plus incidents occurring worldwide involving BSAC’s 32,790 members.


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29

The report advises for the year October 2008 to September 2009 there were 111 reports of ‘DCI’ incidents in the year, some of which involved more than 1 casualty. When these multiple cases are counted the result is 117 cases of DCI.

Within the BSAC report there is a history of UK diving fatalities from 1965 to present. This shows the average number of diving fatalities per annum over this period was 13. When the average is taken over the last 10 years it has risen to 16. BSAC reports that there were 14 recorded diving fatalities within the UK from October 08 to September 09.

The Review Group accepted when taking into account the membership of BSAC, SCOTSAC and PADI it was reasonable to conclude the number of fatalities is small in relation to the number of divers.

Non DCI medical condition – (Elective) Procedures carried out in Aberdeen

NHS QIS completed a systematic review into the clinical and cost effectiveness of hyperbaric oxygen therapy (HBOT) in July 2008. The review looked at a number of uses for HBOT and concluded in the majority of cases there was insufficient evidence to support the routine use of HBOT as a treatment for non DCI medical conditions, however the report does advise there is some evidence to support the use of HBOT in relation to diabetic lower extremity ulcers and for radiation induced proctitis. These procedures are known as electives.

Patients are referred to the unit for elective procedures using the following route:‐ Consultant decides patient should receive oxygen treatment Discussed with hyperbaric consultant within Aberdeen Decide whether appropriate to continue.

The Hyperbaric chamber in Aberdeen currently carries out elective procedures; this is covered further within finance. Utilising the chamber for electives is currently available to all NHS Boards on a cost per case basis, however is not utilised well within some Boards. The number of elective procedures that have been carried out since 2003 by Health Boards area is shown on Table 3.3.4 on the following page:‐

Current Service

Table 3.3.4 ‐ Number of Electives carried out in Aberdeen 2003 – 2010

NHS Board

03/04

04/05

05/06

06/07

07/08

08/09

09/10

Ayrshire & Arran 1 4 3 3 1

Dumfries & Galloway 2 2 1 1

Grampian 17 14 19 20 11 14 11

Greater Glasgow 5 6 1 1 3 8 4

Highland 4 2 1 3 4 5 5

Lanarkshire 1 2 1

Lothian 1

Orkney 1

Shetland 1 1

Tayside 1

Eire 1

Total 30 23 32 29 23 28 23

As part of the review all NHS Boards were asked whether they had received or paid for elective treatment from any other hyperbaric chamber in the United Kingdom. Eight NHS Boards responded to advise they have not paid any other unit to carry out elective treatments. Including the approved elective treatments within the nationally designated service within Aberdeen with increased referral from across Scotland could improve the utility of the service for NHS Scotland.

=

=


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Current Service

PKQ=`çëíë==

PKQKN=^ÄÉêÇÉÉå=`çëíë=

The Unit within Aberdeen is funded via top‐slicing from all NHS Boards. The chart below shows the total budget and actual costs for the Hyperbaric and National Registration Service in Aberdeen since 2003/04. The costs for these services are combined. NHS Grampian advised the Review Group they were unable to disassociate the costs.

Graph 3.4.1.1 - Top Sliced Funding v Spend 2003 to 2010.

Top Sliced Funding v Spend

0

200000

400000

600000

800000

1000000

1200000

2003

/04

2004

/05

2005

/06

2006

/07

2007

/08

2008

/09

2009

/10

Year

Co

st Budget

Actual

The hyperbaric chamber within Aberdeen is situated within the grounds of Aberdeen Royal Infirmary in a building owned by the National Hyperbaric Centre (NHC) a private company. NHS Grampian pay for contract with NHC Ltd for the use of these premises and also for NHC staff to provide technical support to the NHS chamber. This payment comes form the budget provided by NSD. The cost paid to NHC has increased from £331,717 in 03/04 to £387,544 in 2009/10. The cost paid to NHC accounts for almost 40% of the total running cost of the service.


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Current Service

External Income (non NSD)

Income generated is mainly received from outwith Scotland (mainly English Primary Care Trusts (PCT)) for diving related incidents. The agreed charging structure for treating a patient from outwith Scotland is a standard charge of £44k per patient. Marginal gas costs of £35 for patients who are non‐diving related emergencies are also re‐charged to NHS Boards, total income received was received as follows:

06/07 ‐ £220,000

07/08 ‐ £236,000

08/09 ‐ £132,000

09/10 ‐ £134,000 Elective procedures have been carried out within the hyperbaric chamber, these procedures are not part of the funded agreement with the service and therefore NHS Boards should be charged for usage. At present Grampian is reviewing the cost of providing these procedures and working with NSD to ascertain an appropriate charging structure should this be required. The Review group agreed no patient should be accepted for elective treatment within the unit without prior agreement of funding from the respective NHS board. It should be noted though that if the approved elective treatments, as identified above, were included within the national specification and increased awareness of the referable conditions was raised with potential referring consultants across Scotland then improved cost effectiveness from the service within Aberdeen could be achieved. Although the distance to Aberdeen may be a deterrent for some referring clinicians/patients if many repeat procedures are required.


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The cost of providing hyperbaric treatment is substantial for each of the NHS Boards. The costs to each NHS Board since 2003/04 is shown in Table 3.4.1.2 below:‐

Table 3.4.1.2 – Indicative NRAC Cost per NHS Scotland Board for the Aberdeen Hyperbaric Unit (2003 – 2010)

NHS BOARD % Formula 2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10

Ayrshire and Arran 7.67 57,787 58,153 61,572 69,218 71,121 73,077 75,273

Borders 2.23 16,823 16,929 17,925 20,151 20,705 21,274 21,913

Dumfries and Galloway 3.20 24,149 24,302 25,731 28,926 29,721 30,539 31,456

Fife 6.76 50,966 51,289 54,304 61,047 62,726 64,451 66,388

Forth Valley 5.29 39,909 40,162 42,523 47,803 49,118 50,469 51,985

Grampian 9.12 68,761 69,197 73,265 82,363 84,628 86,955 89,568

Greater Glasgow and Clyde 25.16 189,648 190,850 202,070 227,163 233,410 239,828 247,036

Highland 6.46 48,705 49,013 51,895 58,339 59,943 61,592 63,443

Lanarkshire 10.73 80,910 81,423 86,210 96,916 99,581 102,319 105,394

Lothian 13.69 103,182 103,837 109,941 123,593 126,992 130,484 134,406

Orkney 0.42 3,173 3,193 3,381 3,801 3,905 4,013 4,133

Shetland 0.49 3,731 3,755 3,975 4,469 4,592 4,718 4,860

Tayside 7.97 60,086 60,467 64,021 71,971 73,951 75,984 78,268

Western Isles 0.78 5,879 5,916 6,264 7,042 7,235 7,434 7,658

100% 753,707 758,486 803,078 902,801 927,628 953,137 981,781


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Current Service

When the number of patients treated in the unit within Aberdeen is compared to the cost to the NHS Board for the same timeframe, Table 3.4.1.3 shows the following cost per patient.

Table 3.4.1.3 ‐ Cost per patient to NHS Board for the Aberdeen Hyperbaric Unit (2003–2010)

NHS Board

Number of patients

Cost to NHS Board

Cost per patient

NHS Ayrshire and Arran 1 466,201 466,201

NHS Borders 0 135,719 135,719

NHS Dumfries and Galloway 0 194,823 194,823

NHS Fife 10 411,171 41,117

NHS Forth Valley 6 321,969 53,661

NHS Grampian 24 554,735 23,114

NHS Greater Glasgow 7 1,530,005 218,572

NHS Highland 6 392,930 65,488

NHS Lanarkshire 6 652,754 108,792

NHS Lothian 20 832,437 41,622

NHS Orkney 1 25,599 25,599

NHS Shetland 1 30,099 30,099

NHS Tayside 6 484,747 80,791

NHS Western Isles 0 47,429 47,429

* Note patients for Argyll and Clyde have been incorporated into Highland and Glasgow


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Current Service

It is clear from Table 3.4.1.3 that, over the 7 year period, the cost per patient was substantial for all NHS Boards. In particular, NHS Ayrshire and Arran paid £466,201 and have had only 1 patient treated, Greater Glasgow and Clyde have paid £218,572 per patient and NHS Lanarkshire have paid £108,792 per patient. The 3 NHS Boards highlighted in red have paid their contribution to the National Hyperbaric Service however have not had any residents from their NHS Board treated within the Aberdeen unit for DCI.

PKQKO=fåÇÉéÉåÇÉåí=`Ü~ãÄÉê=`çëíë=As noted previously in addition to the cost for the National Service NHS Boards within Scotland are paying for hyperbaric services which are provided in the 3 independent chambers, these chambers were approved by the National Registration Service as suitable to treat NHS patients and are situated within Millport, Orkney and Oban. Information on the actual amounts paid have been collected from all NHS Boards and are detailed in Table 3.4.2.1 below.

Table 3.4.2.1 Cost of Independent Chambers to each NHS Board 2003 – 2010

Year

Health Board 03/04 04/05 05/06 06/07 07/08 08/09 09/10

Total cost to Board

Ayrshire and Arran 16,200 5,400 0 11,500 0 35,700 0 68,800

Borders 0

Dumfries and Galloway 0 0 0 0 0 0 0 0

Fife 39,605 900 0 0 0 13,500 0 54,005

Forth Valley 0 0 1,292 0 26,200 33,348 1,200 62,040

Grampian 0 0 0 17,000 38,000 0 0 55,000

Greater Glasgow and Clyde 58,270 88,695 21,400 154,137 0 48,500 16,492 387,494

Highland 45,900 0

7,617

37,560

26,548 49,583 74,889 242,097

Lanarkshire 28,800 19,800 9,900 107,633 2,000 0 14,300 182,433

Lothian 30,869 44,994 18,918 21,963 14,373 35,893 21,170 188,180

Orkney 115,000 115,000 115,000 115,000 115,000 115,000 115,000 805,000

Shetland 0

Tayside 1,058 0 0 38,608 0 0 1,350 41,016

Western Isles 26,966 0 48,136 22,471 97,573

Cost over and above funded agreement 362,668 274,789 222,263 525,871 222,121 331,524 244,401 2,183,637

Average cost per year is:- 311,948 Highland for 06/07 onwards includes Argyll and Bute

The financial information from NHS Boards shows the cost of the independent chambers service from 2003/04 to 2009/10 was £2,183,637; this was paid over and above the cost of the National Service.

The average cost per year to the NHS in Scotland for independent chamber services is £311,948. It is of note that the payments made by NHS Orkney take the form of a block contribution to the local independent chamber. NHS Orkney indicate that they have not made any additional payments for patients treated outwith this chamber, other than their contribution to the National Service.


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Current Service

From information provided by the NHS Boards it has become apparent that within the financial year ahead 2010/11 the independent hyperbaric chambers have increased the cost of service provision substantially with one board being charged £207,135 for 1 patient and another being charged £157,645 for 1 patient. The independent chamber concerned has advised this is due to the costs for the chamber, which was upgraded following recommendations made by the National Registration Service, being divided by the number of patients the chamber treated the previous year. It has been indicated that should overall activity increase the cost of provision will decrease.

Should independent charges remain high, with no capability of the NHS to reduce the cost burden, the Review Group recognised the cost of hyperbaric service provision would be of a greater burden to NHS Boards.


36

Current Service

PKQKP=`çãÄáåÉÇ=`çëíë=çÑ=eóéÉêÄ~êáÅ=mêçîáëáçå= In order to understand the full costs of hyperbaric provision, the costs of independent chambers to NHS Board in Scotland were added to the national cost of the hyperbaric service from 2003/04 to 2009/10. The combined costs were therefore identified as:‐ Table 3.4.3.1 Combined cost of both independent and national hyperbaric provision by each NHS board 2003 ‐ 2010

Health Board

Cost for National Service

Cost for private services

Total Cost

Ayrshire and Arran 466,201 68,800 535,001Borders 135,719 0 135,719Dumfries and Galloway 194,823 0 194,823Fife 411,171 54,005 465,176Forth Valley 321,969 62,040 384,009Grampian 554,735 55,000 609,735

Greater Glasgow and Clyde 1,530,005 387,494 1,917,499Highland 392,930 242,097 635,026Lanarkshire 652,754 182,433 835,187Lothian 832,437 188,180 1,020,617Orkney 25,599 805,000 830,599Shetland 30,099 0 30,099Tayside 484,747 41,016 525,763Western Isles 47,429 97,573 145,002

Total Hyperbaric Cost 6,080,618 2,183,637 8,264,255

The table above shows the total cost for hyperbaric provision in Scotland for the 7 years from 2003/04 to 2009/10 was £8,264,255. The costs of hyperbaric services to individual NHS Boards is dependent on a range of factors including the number of injuries sustained by residents of the Board and where they are treated. This in turn depends in part on the severity of their illness and whether this, or lack of capacity at a more local chamber necessitates a transfer to Aberdeen. The table on the following page shows the cost to NHS Boards for the National Service, the cost of the independent service and what the cost of these two services are combined, in addition the table also shows what percentage of the total cost the NHS Boards are paying, and what percentage they are expected to pay (Baseline %). In addition, the table also shows the activity for these NHS Boards with finally a cost per patient for each NHS Board area.


37

Current Service


38

Table 3.4.3.2 Combined Cost of Service, % Total Cost and Cost per Patient for each NHS Board 2003 – 2010

Health Board

Cost for National Service

Cost for private services

Total Cost

% of total cost

Baseline Share %

Total Activity

% of Total Activity

Cost per patient

Ayrshire and Arran 466,201 68,800 535,001 6.5 7.7 6 3.1 89,167Borders 135,719 0 135,719 1.6 2.2 1 0.5 135,719Dumfries and Galloway 194,823 0 194,823 2.4 3.2 2 1.0 97,412Fife 411,171 54,005 465,176 5.6 6.8 15 7.8 31,012Forth Valley 321,969 62,040 384,009 4.6 5.3 8 4.1 48,001Grampian 554,735 55,000 609,735 7.4 9.1 28 14.5 21,776

Greater Glasgow and Clyde 1,530,005 387,494 1,917,499 23.2 25.2 37 19.2 51,824Highland 392,930 242,097 635,026 7.7 6.5 25 13.0 25,401Lanarkshire 652,754 182,433 835,187 10.1 10.7 14 7.3 59,656Lothian 832,437 188,180 1,020,617 12.3 13.7 35 18.1 29,160Orkney 25,599 805,000 830,599 10.1 0.4 9 4.7 92,289Shetland 30,099 0 30,099 0.4 0.5 1 0.5 30,099Tayside 484,747 41,016 525,763 6.4 8.0 7 3.6 75,109Western Isles 47,429 97,573 145,002 1.8 0.8 5 2.6 29,000

Total Hyperbaric Cost 6,080,618 2,183,637 8,264,255 193

*Argyll and Clyde has been split between Greater Glasgow and Clyde and Highland NHS Boards.

The table shows that over the review period as a whole NHS Orkney, Highland and the Western Isles paid proportionally more for hyperbaric services than their “target” share. In the case of NHS Orkney, due to its funding agreement with the service provider on NHS Orkney this is substantially more than their NRAC ratio. The remaining NHS boards have paid less than their “target” share. In addition, the table indicates that there are some NHS Boards who, on a cost per case basis, pay more for the treatment of their DCI patients than others. This reflects the location of where the patient presents with symptoms of DCI and the severity of those symptoms. Whilst all Scottish NHS Boards have paid the invoices they have received, it is understandable that some NHS Boards are concerned that they are being double charged for a service they know they are already being top sliced for. This issue has been apparent during the last two reviews and the recommendation on both occasions was to find a method of funding the local chambers centrally for the work undertaken. This recommendation was not approved by SGHD in 2000, however, was approved in 2004 but no suitable mechanism for doing so was identified and the situation remains unchanged.

Current Service

PKR=`Ü~åÖÉë=páåÅÉ=i~ëí=oÉîáÉï== There have been three previous service reviews, in 1995, 2000 and 2004 respectively. On each occasion the recommendations of the review have led to some changes in service provision but not all recommendations were approved by NHS Boards and Scottish Executive Health Department (SEHD) / Scottish Government Health Department (SGHD). The most recent review in 2004 (Appendix 5) recommended:‐

The service continues to be a nationally designated service.

Communication between the Hyperbaric Service and the Coastguard and Ambulance Services was improved by developing clear lines of communication. This has happened and all parties are of the view there has been an improvement in treatment of hyperbaric patients. This review however highlights the lack of auditable information available from SAS on this service and therefore this review would recommend further work is completed in this area.

Both the review in 2004 and the review in 2000 recommended the Hyperbaric unit be relocated within the hospital setting. Serious consideration was given to this by NHS Grampian but there was no cost effective means of achieving a re‐provision of the chamber within the hospital, and the proposal had to be abandoned. It is unlikely the level of capital investment required to allow this move to progress could be achieved within the current financial position of the NHS in Scotland.

Greater liaison between the Independent chambers and the NHS Boards within which they were situated was to be encouraged. This was in place prior to the 2004 review in relation to NHS Orkney; and the arrangement which they have in place with their local chamber remains. This was not achieved by either of the other independent chambers.

A method of providing funding for the local chambers to offset their overhead costs should be developed. (This was also a recommendation of the 2000 review.) Revenue funding was expected to be released from moving the Aberdeen chamber onto the Foresterhill Hospital site – therefore avoiding the 40% overhead through National Hyperbaric Ltd. In the event, however, because the chamber could not be accommodated within the hospital, no revenue was released to form a pool of funding to meet the costs of access to the local independent chambers.

There were no recommendations relating to the National Registration Service, which was established following the review in 2000 to ensure patients were not treated in facilities which did not have the capability to treat the patient successfully.


39

Options for Service Provision

QK=léíáçåë=Ñçê=pÉêîáÅÉ=mêçîáëáçå=

QKN=léíáçåë=The Review Group and Support Teams met to discuss options for service provision. It was agreed the options for the hyperbaric service and the national registration service would be scored individually. There was recognition of a requirement to have no change as one of the options, although the group recognised the current service was not equitable and therefore did not meet this designation objective.

The group agreed the following options:‐

Hyperbaric Service

1. No Change 2. De‐designated Service 3. Direct all activity to Aberdeen Hyperbaric Unit. 4. Commission an additional unit on the West Coast. 5. Base‐line support for Independent chambers. 6. Extended designated service covering all NHS locations.

National Registration Service

1. No Change. 2. De‐designated. 3. Recommendation for creation of an NMCN.

A Strengths, Weaknesses, Opportunities, Threats (SWOT) analysis was carried out on each of the proposed options, the group agreed these covered the options appropriately. (Appendix 4). Prior to the scoring of the options the Review Group agreed they would not score option 4 for the hyperbaric area of the review as it was agreed this was not a viable option, within the current financial climate and considering the activity levels within Scotland.

The Review Group agreed to score the available options in line with the Scottish Governments commitment to the Quality Strategy, scoring according to the Institute of Medicine’s 6 Dimensions of Healthcare Quality:‐ Effective, Efficient, Equitable, Person Centred, Timely and Safe. (http://www.scotland.gov.uk/Resource/Doc/311667/0098354.pdf )

The Review Group agreed they would consider the evidence for each option against each criterion and score from 0 – 10, where 10 represented the best possible service from the point of view of the population of Scotland and 0 represented the worst. The Review Group were advised to ensure when scoring the options they remained impartial and scored with a view of the whole of Scotland.

The Review Group agreed they would ensure that scoring remained at a workable level and therefore they would follow previous review precedents to ensure the weight of all options


40



added up to 100. The Review Group therefore chose to weight the criterion as shown in Table 4.1.

Table 4.1 – Weighting of Options

Criteria Weighting

Effective 20

Equitable 20

Efficient 25

Person Centred 10

Timely 10

Safe 15

Total Weighting 100

The Review Group were advised following final scoring, sensitivity analysis would be applied to ensure consistency of view.


41



42

QKO=eóéÉêÄ~êáÅ=pÅçêáåÖ=The results of the scoring exercise for the Hyperbarics Service are shown in Table 4.2.1.

Table 4.2.1 – Hyperbarics Service: Outcome of Scoring

Option

1 Option

2 Option

3 Option

5 Option

6

ID1 4th 5th 1st 3rd 2nd

ID2 3rd 4th 1st 2nd= 2nd=

ID3 3rd 4th 5th 1st 2nd

ID4 1st 5th 2nd 4th 3rd

ID5 2nd 3rd 5th 4th 1st

ID6 3rd 4th 5th 1st 2nd

ID7 1st 5th 4th 3rd 2nd

ID8 4th 1st 2nd 3rd 5th

ID9 2nd 5th 4th 1st 3rd

ID11 3rd 1st 5th 2nd 4th

ID12 1st 5th 3rd 4th 2nd

ID13 5th 1st 4th 3rd 2nd

ID14 2nd 4th 5th 3rd 1st

ID15 3rd= 4th 1st 3rd= 2nd

ID16 4th 1st 2nd 3rd= 3rd=

ID17 3rd 1st 5th 2nd 4th

Totals 3rd 5th 4th 2nd 1st

Sensitivity analysis

Sensitivity Analysis was then conducted on the results.

Service scored Option 1 the highest closely followed by Option 6 with Option 2 being the least preferred option.

Management scored Option 3 highest, closely followed by Option 5 with Option 1 being the least preferred option.

Public/Patient representatives scored Option 2 the highest, closely followed by Option 1 with Option 3 scoring lowest.

Health and Safety/Emergency Service scored Option 6 the highest, with Option 5 second and Option 3 scoring the lowest.


QKP=k~íáçå~ä=oÉÖáëíê~íáçå=pÅçêáåÖ= The results of the scoring exercise for National Registration Service are shown in Table 4.3.1. Table 4 .3.1 – National Registration outcome of scoring

Option

1 Option

2 Option

3

ID1 2nd 1st= 1st=

ID2 2nd 1st 3rd

ID3 2nd 1st 3rd

ID4 1st 3rd 2nd

ID5 2nd 3rd 1st

ID6 1st 3rd 2nd

ID7 1st 3rd 2nd

ID8 2nd 1st 3rd

ID9 1st 3rd 2nd

ID11 2nd 3rd 1st

ID12 1st 3rd 2nd

ID13 3rd 2nd 1st

ID14 1st 3rd 2nd

ID15 2nd= 1st 2nd=

ID16 1st= 1st= 2nd

ID17 1st 3rd 2nd

Totals 1st 3rd 2nd

Sensitivity Analysis was then conducted on the results.

All groups except Management scored Option 1 the highest closely followed by Option 3 with Option 2 being the least preferred option.

Management scored Option 2 highest, closely followed by Option 1 with Option 3 being the least preferred option.


43

Discussion of Options Appraisal

RK==aáëÅìëëáçå=çÑ=léíáçåë=^ééê~áë~ä=lìíÅçãÉë==The Review Group met to discuss the outcome of the scoring exercise and ensure there was consensus with the recommended way forward.

The Group discussed the outcome of the scoring and the options available, and its conclusions are set out below.

RKN=eóéÉêÄ~êáÅë==RKNKN=J=léíáçå=N=Ó=kç=`Ü~åÖÉ=

The Review Group agreed that although this option was the preferred option of staff in the current service, there was evidence that the service, as it currently stands, does not provide an equitable level of service for all NHS Boards within Scotland and therefore does not meet this criterion for national designation.

RKNKO=J=léíáçå=O=Ó=aÉJÇÉëáÖå~íáçå=

The Review Group noted that de‐designation would involve withdrawal from NHS Grampian of the current funding (almost £1million) and, as a result, NHS Grampian was unlikely to be able to sustain the service. If the Aberdeen service had to be closed, this would remove category 1 facilities from Scotland. Patients who required Category 1 care would need to be transferred to one of the chambers in England (probably either Hull or Wirral). The cost of treating a patient within either of these chambers was regulated however there would be a considerable delay in patient time to treatment which may result in a poorer outcome for the patient. The Review Group also felt de‐designation of the service would result in an open market for the independent chambers. This would result in significant financial risk to the NHS Scotland, as there would be limited ability for the charges for hyperbaric provision to be regulated; therefore the Review Group concluded this may be of greater financial risk to NHS Boards.

RKNKP=J=léíáçå=P=Ó=`Éåíê~äáë~íáçå=ïáíÜáå=^ÄÉêÇÉÉå=

This option was discussed at length by the Review Group and was the preferred option for the management sub‐group. Centralisation of the service would meet the normal criteria for national designation. It would be demonstrably more equitable by providing the whole of the service for the whole of NHS Scotland.

However it was agreed there would be considerable increase in patient journey time which would increase the possibility of the patient not being treated within the clinically desired 6 hour window which may have a detrimental impact on quality of outcomes. The service providers, including the Aberdeen clinical representatives, and the diving representative strongly opposed this option and it was widely acknowledged that this was not the most person centred option. This option would also result in an increase in transport costs. It would be unlikely the additional transport costs through centralisation would be greater than the current combined cost of the whole service; however, this was a concern to the group.

In addition, the current chamber requires to be upgraded and it has been desirable for a number of years that the chamber is situated within a hospital setting, both of these require substantial capital investment which is not available at this time to NHS Scotland. =


44


RKNKQ=J=léíáçå=Q=Ó=kçí=ëÅçêÉÇ=

This option was not considered by the Review Group to be feasible.

RKNKR=J=léíáçå=R=Ó=_~ëÉäáåÉ=pìééçêí=Ñçê=fåÇÉéÉåÇÉåí=`Ü~ãÄÉêë=

This option scored highly and ranked 2nd in overall scoring. This option involved asking the NHS Boards to ‘top slice’ for the NHS aspect of provision and ‘bottom slice’ for the costs associated with the Independent chambers. The Review Group concluded this option would meet designation objectives as the service would be provided in more sites and would therefore be more equitable for the population of Scotland. This option also matched well against the scoring criterion however the Review Group concluded that although this option is desirable it would not be palatable to NHS Boards as it would continue the view that Boards were being charged twice for a national service, one from ‘top’ and the other from ‘bottom’.

RKNKS=J=léíáçå=S=Ó=bñíÉåÇÉÇ=ÇÉëáÖå~íÉÇ=ëÉêîáÅÉ=ÅçîÉêáåÖ=~ää=kep=içÅ~íáçåë=

This option was the preferred option for the group as a whole, and the Health and Safety/Emergency aspect of the group in particular. This option involved NHS Boards being asked for an increase in ‘top sliced’ funding, with the provision that this could not exceed the current total expenditure from NHS Scotland on hyperbaric provision. Option 6 would meet the criteria for national designation. Provision of the service would be more equitable as it would be available in more than one location, closer to the locations used by divers. A Category 1 facility would continue to be available in Aberdeen and it would enable the sustainability of the National Registration Service which relies on the skilled staff available in Aberdeen. The Review Group also agreed this would provide a level of financial security to the independent chambers which would reduce the financial risk to the NHS in Scotland. This option would also ensure there was a continued NHS provider in Scotland which was desirable to the group. However, the Review Group recognised in the current economic climate the configuration of services within the West Coast required clarification and therefore NSD should be asked to take this forward. Discussions would also be required with NHS Grampian regarding the management of the agreed elective work.

RKO=k~íáçå~ä=oÉÖáëíê~íáçå=pÉêîáÅÉ=RKOKN=Ó=kç=`Ü~åÖÉ=

This option scored highest and was the preferred option for the Review group as a whole and for all of the groups except Management, when sensitivity analysis was undertaken. The view from the Review Group was that the service which is provided by NRS is of a very high standard, ensuring the independent chambers are up to standard, providing advice and support, was cost effective and efficient and was viewed highly by those involved. The Review Group felt there was a continued need for the service as at present there were no other suitable agencies who could undertake the work of the National Registration Service. The Review Group acknowledged the establishment of Health Improvement Scotland from April 2011 and recognised there is the possibility of this organisation taking over some of the aspects of NRS work once they are more firmly established.

RKOKO=Ó=aÉJÇÉëáÖå~íáçå=


45



46

This option was scored highest by management when sensitivity analysis was undertaken, however did not score well in overall scoring coming in 3rd. This was not supported as this option involved a number of other organisations taking over the work which is currently undertaken by the NRS. The Review Group were not convinced this could be handled smoothly and were unsure whether there would be consistency of practice therefore felt this was not the best option for the NRS service.

It was acknowledged, however, that if wider designation of the service was implemented there would be a strong requirement to have independent quality assurance of the service providers. This could not be provided by the NRS and therefore discussion should be held with Healthcare Improvement Scotland about taking over some aspects of the NRS and that the NRS would require to be modified accordingly.

RKOKP=Ó=bëí~ÄäáëÜãÉåí=çÑ=~å=kj`k=

This option was scored 2nd overall and was 2nd for all groups except Management. However on discussion the Review Group accepted it would be unlikely a recommendation for an NMCN would be accepted by NSAG, in particular when this NMCN consisted of mainly independent non‐NHS organisations therefore this recommendation was not supported by the Review Group.

Conclusions and Recommendations

SK=`çåÅäìëáçåë=C=oÉÅçããÉåÇ~íáçåë=

SKN=eóéÉêÄ~êáÅ=pÉêîáÅÉ=hÉó=Ñ~ÅíçêëW=

Due to the low and unpredictable volume of diving decompression illness and the costly and complex nature of the Hyperbaric Oxygen Therapy required to treat this illness there is a requirement for a cost and effective solution involving concentration of clinical skills and activity in only a few sites.

The emergency nature of the care required, and the importance of time to treatment on the quality of outcomes, balanced against the geography of Scotland, and that patients present after incidents across Scotland, strongly suggest that one facility alone in Scotland is not a suitable option.

The level of clinical knowledge and expertise for HBOT for diving decompression illness is embedded within NHS Grampian and supports good provision of care within the independent chambers through advice and guidance.

Recommendations

1. The current configuration of service cannot be sustained as a designated national service because it does not meet the needs of the national caseload.

2. The configuration of the service within Scotland should be considered against activity levels, to ensure there is an appropriate level of service provision within Scotland for equitable access. It is proposed that this should be led by NSD working with the NHS Board Directors of Planning Group. Consideration should be given to the level of provision required for the West Coast of Scotland in particular, that is, whether one or two chambers would be required.

3. National Services Division should work with NHS Board Directors of Planning to explore the potential for wider national designation to achieve greater efficiency and equity in hyperbaric provision in Scotland.

4. National Designation should be extended to incorporate one or more of the local independent chambers to improve access, and ensure that the national service can meet the needs of the national caseload, as long as the cost of the service do not exceed the current cost of hyperbaric provision and efficiencies are pursued as a whole for NHS Scotland.

5. National Services Division should work with NHS Grampian to identify efficiencies from within the current Service Agreement between NHS Grampian


47

Conclusions and Recommendations


48

and National Services Division to identify resources to help widen the designated service.

6. If national designation is to continue then the limited number of elective treatments approved by NHS QIS should be included within the nationally designated service within Aberdeen. The level of geographical uptake would require to be monitored to assure of equity of access. Discussions would also be required with NHS Grampian regarding the management of the agreed elective work.

7. If wider designation within acceptable costs to NHS Scotland cannot be achieved, then the service should be de‐designated and NSD would need to work with NHS stakeholders and service providers to agree commissioning guidance for future hyperbaric care for NHS Scotland.

SKO=k~íáçå~ä=oÉÖáëíê~íáçå=pÉêîáÅÉ=It is acknowledged that the National Registration Service has achieved a great deal in improving the standard of care for diving decompression illness within NHS Scotland and there is great strength in the collaborative approach that has emerged within Scotland.

The benefits achieved through the inclusive clinical audit database and performance benchmarking between centres justifies retaining the service for NHS Scotland.

If the designated service is extended to include independent chambers, there is a strong requirement to have independent quality assurance of service provision therefore HIS would be the most appropriate organisation to undertake this.

Recommendations

1. The current National Registration Service retains its National Designation, whilst National Services Division has discussions with Healthcare Improvement Scotland about the potential of that organisation taking over the independent quality assurance of the hyperbaric service providers in Scotland. However, the costs of this service must be clarified and identified separately to NSD.

2. If this can be agreed with HIS and SGHD then a handover of quality assurance from NRS to NHSHIS should be planned with full involvement of the service providers to ensure that the high standards are maintained.

3. The Aberdeen service should continue to maintain an audit database to enable appropriate evaluation of the performance of the service provision across Scotland.

4. The Aberdeen service should continue to provide training and educational events. These should be provided on at least a cost neutral basis.

Bibliography

_áÄäáçÖê~éÜó=

British Sub Aqua Club “National Diving Committee Diving Incidents Report 2009” http://www.bsac.com/page.asp?section=1038

NHS Quality Improvement Scotland “The clinical and cost effectiveness of hyperbaric oxygen therapy”, July 2008, http://www.nhshealthquality.org/nhsqis/4208.html


49

http://www.bsac.com/page.asp?section=1038

http://www.nhshealthquality.org/nhsqis/4208.html

Acronyms Index

^Åêçåóãë=fåÇÉñ=

BHA British Hyperbaric Association BSAC British Sub Aqua Club DCI Decompression Illness HBOT Hyperbaric Oxygen Therapy MCA Maritime and Coastguard Agency NHC National Hyperbaric Centre NHS National Health Service NRS National Registration Service NSAG National Services Advisory Group NSD National Services Division PCT Primary Care Trusts SAS Scottish Ambulance Service SCOTSAC Scottish Sub Aqua Club SEHD Scottish Executive Health Department SGHD Scottish Government Health Department SHHD Scottish Home and Health Department SLA Service Level Agreement SMT Senior Management Team


50

NSSC 2013/44C

Addendum on Annex A of Hyperbaric Paper

Update on Potential for Income Generation for NHS Grampian

The NHS Grampian Hyperbaric unit has the potential to engage further with industry to generate income. To date the unit has been approached by a number of commercial ventures to offer diving medical support. The requests have ranged from the larger commercial diving company requesting inshore treatment support after saturation diving to small civilian inshore diving companies requesting medical advice for diving accidents and requests for equipment support. Unfortunately we have been unable to progress these requests any further due to the lack of certainty of the service. Notwithstanding, the unit has undertaken to support emergency medical hyperbaric treatment and advice for Police Scotland where required.

The unit has also supported commercial divers who have become critically ill when working

at depth in the North Sea and is ideally placed to do so as part of a tertiary referral hospital. There is ongoing work within NHS Grampian with the aim of setting up a telemedicine

decision making dashboard for offshore medical care which has the potential to include the treatment of injured divers. This venture has the potential to offer high quality care offshore with hyperbaric consultants as part of a multidisciplinary clinical team. Cost models would need to be explored. However, income from industry would be used to offset the current service costs to Boards contributing to service.

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-45 Proposed Extended Role

1. Background

The National Planning Forum considered the attached paper on 26 September which proposed a new role for the National Planning Forum and an associated extension of role for NSSC. 2. Issue for Discussion

Initial views of NSSC are invited on the proposed extended role. If NSSC considers such an extended remit appropriate, a fuller paper will be worked up for the March meeting. Mrs Deirdre Evans NSSC Secretariat 18 November 2013


NSSC

NSSC PAPER 2013/45

Proposed Extended Role for NSSC

NSSC 2013/45A

NATIONAL PLANNING FORUM Meeting date: 26 September 2013

Agenda item: 5

Purpose:

FOR DISCUSSION

Title: Integrated Approach to National Planning

Source & Rationale:

NPF will recall discussions on the future role of NPF at its meetings in December and February, where there has been recognition that discussions should not focus solely on NPF, but should consider the role of NPF within the wider planning and governance structures. In June, NPF agreed that a dedicated event should be held to continue to develop the vision for its future role.

Key Issues:

To support and ensure the most appropriate NPF structure and governance arrangements, in the context of where we are now, and where we need to get to, NPF considered the following questions on 3 September: 1. What do we need to do to ensure capacity to underpin delivery

of the 2020 vision and 12 improvement priorities? 2. What do we need to do to achieve joined-up, integrated

decision making across service, workforce, financial, capital and IT planning?

3. Do we need fewer groups and/or more effective thinking, advice and decision making across key areas? What might that look like?

Graeme Smith, Director of Modernisation, NHS Grampian, has produced the attached paper which summaries the outcomes of that discussion. Initial comments on Graeme’s paper from those who attended the 3 September, meeting are also attached.

Actions required:

The NPF is asked to consider the paper and discuss the next steps.

Date:

September 2013

NSSC 2013/45A

An Integrated Approach to National Planning - Discussion Paper Introduction

The National Planning Forum (NPF) was established in 2009 to provide a more consistent approach to national planning. The development of the national 2020 vision and the associated 2020 Route Map has prompted a review of the approach to planning at a national level with the aim of formulating more efficient and effective processes. The current NPF and other NHS stakeholders met on 3 September 2013 to consider the matter. This paper summarises the main issues discussed and outlines a proposed way forward. Key Issues

Much of the work of the NPF has been positive and productive. There are, however, a number of inter-related issues that need to be considered in the development of proposals for a way forward. The following is a summary of the main issues: 1. Anticipating the consequences of the 2020 approach: The 2020 vision provides a

good understanding of how the NHS in Scotland should change and a considerable amount of work is underway to develop the vision through the 12 Route Map priority areas. There is not, however, a shared understanding of how health services in Scotland should be configured in 2020 and beyond i.e. what will be the combined impact of government policy, population distribution, demographic change, and trends in clinical practice/technology on the configuration of local, regional and national services?

2. Proactive programme approach: There is a need to improve strategic planning and

anticipate the issues to be addressed over a three, five and ten year timescale. A more strategic forward look would provide time to manage issues effectively as part of a programme approach. Many issues on the NPF agenda have emerged from services, Boards or the Scottish Government and have been dealt with as specific issues and not necessarily within a wider context of national change.

3. Balanced decision making: A range of issues (e.g. TAVI, robotic surgery and major

trauma) require decisions on what should be provided and where. This inevitably raises questions about the critical mass of services in Board areas or regions and the impact that a national decision will have on the viability of a broader Board or regional service. The local/regional factors need to be more explicit and balanced against safety and sustainability. The bigger question in many respects is how we provide as full a range of services as possible in Scotland, consistent with public and political expectations , whilst ensuring equity of access, safety and sustainability.

4. Political/Public Acceptability: Related to the above, some decisions are not made

purely on the basis of evidence but also take account of other factors including political and public acceptability. In practical terms these factors are just as valid as the pure measurable evidence and are an essential element of a democratic system. There needs to be a better understanding of these factors and an attempt to include them more explicitly in the formal decision making process.

5. Communication: In addition to better understanding the public acceptability factors it is

important to shift public understanding of the how a transformed health system may be configured. Many of the difficult decisions at a local, regional and national level relate to closures of facilities and what is perceived as major service change. Such decisions are essential to permit the redesign of the resource – capital, workforce and IT – to support the modernisation of services to move towards the 2020 vision. They are often, however,

NSSC 2013/45A

seen in the context of the current configuration of services and not as part of a national programme of transformation.

6. Implementation of Decisions: The NPF has taken responsibility for many detailed

decisions on the implementation of services. There may be merit, however, in separating the development and agreement of strategy from the detailed decision making on implementation. Although the National Specialist Services Committee (NSSC) was only established in 2012 it has demonstrated success in the process of commissioning and reviewing national services. This approach could be adapted to deal with some issues that would have been on the NPF agenda in the past e.g. TAVI and Robotic Surgery.

7. Broad Agenda: The national planning agenda is not just about the determination of

what specialist services should be provided at national and regional level. Taking account of the principle of subsidiarity the agenda also includes the range of tasks that can and should only be done nationally. This requires debate but is likely to include the coordination and influence of all strategic health, healthcare and infrastructure factors that will deliver the 2020 vision e.g. public health, primary care, distribution of specialist services, workforce, eHealth, facilities etc.

8. Health and Social Care Integration: This agenda seeks to integrate services at a local

level around the needs of individuals. On the face of it this is clearly a local matter that will be the planning responsibility of local partnerships and their respective Boards. However, similar to item 7 above, there is a requirement for a supportive and “light touch” oversight at a national level as the coordination of national issues and resources will have an impact on the nature and pace of change locally. In addition, the acute service consequences of success in shifting care to communities needs to be anticipated.

9. Strategic Coordination: There are many groups and committees working on the 2020

Route map, primary care development, public health/health improvement, and the efficiency and productivity agenda. In the course of their work they have an impact on the development and implementation of strategy. There is a need to gather together the strategic element of their work, ensure that it is consistent and the maximise the combined strategic impact.

Summary

The above is a synopsis of some of the interlinked issues that influence the requirement for a national focus for strategic planning to support the delivery of the 2020 vision. The issues indicate a need for: The development of a practical 2020 vision for Scotland which identifies how health and

care will be tiered or configured in relation to the 2020 Route Map’s 12 priority areas, and how this configuration will be influenced by policy, demography and technology

The anticipation of change and its impact on specific services provided at national/regional level

Taking a strategic overview of the pan Scotland planning agenda and, wherever strategic planning is done, to ensure that there is an efficient, organised and consistent approach across service, workforce, capital and IT issues

A decision making process that balances all factors including evidence, acceptability and affordability

NSSC 2013/45A

The communication of a practical vision for the future to inform and support the public to participate in change

The above summary has been carried forward to a proposed remit for an Integrated Strategic Planning Group (ISPG) outlined. Integrated Strategic Planning Group Purpose

To provide an integrated national approach to the planning of health and healthcare in support of the delivery of the 2020 vision and ensure that strategy is organised in a rational way at national, regional and local level taking account of:

Government policy – 2020 vision, integration of health and social care etc.

Public expectations Population distribution

Demographic change

Changing clinical practice in relation to safety and effectiveness

Current and anticipated changes in technology

Current workforce and financial context In fulfilling its purpose a key task for an Integrated Strategic Planning Group (ISPG) will be to undertake a horizon scanning process based on the factors identified above. The aim will be to develop a practical and proactive consensus on how the NHS in Scotland will be configured in 2020 and beyond. This will provide a template for making planning decisions on specific services and issues and support the principle of subsidiarity. The specific remit of the ISPG will include:

Ensure strategic planning is joined-up across workforce, finance, health, services, IT and capital/ infrastructure to deliver the 2020 vision

Coordinate the strategic planning impact of all national groups e.g. quality portfolio groups and groups associated with the 12 priority Route Map, efficiency and productivity etc.

Advise the “Guiding Coalition” (see annex) on strategic planning priorities and support the management of strategic issues by the constituent parts of the coalition

Develop and maintain a communications strategy focused on the future configuration of the NHS in Scotland which demonstrates a coordinated approach;

Identify and oversee a proactive programme of national service reviews based on the horizon scanning to determine the detailed configuration at a national and regional level

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Work closely with the NSSC (and/or new group) and sponsor it to undertake the work to determine the detailed configuration and roll out of national services/national specialist services (note: the proposal here is that the ISPG would identify and agree, and have responsibility for, the broad service reviews with the NSSC (or new group) undertaking the detailed work in relation to implementation)

Support the development/strengthening of regional planning and provide the focus for the coordination and implementation of regional plans

Membership

Given the proposed remit the membership would require to be broadly based and include representatives from:

NHS Board Chief Executives Group

Directors of Planning Group

CMO Directorate

Primary Care

Directors of Planning Group

Workforce and Performance Finance

Capital and Facilities

eHealth

Quality Unit

Patient/Public organisations? For discussion. Organisational Relationships

The main function of the ISPG will be to advise the “guiding coalition” on matters of

strategic planning and service configuration.

The relationship with other national groups is of key importance and the ISPG will establish a network of contacts with groups working on the 12 Route Map priority areas, efficiency and productivity work streams etc. to ensure that strategy is communicated and that the work of the groups is coordinated to maximise strategic impact.

The national Directors of Planning Group will (could?) support the ISPG in horizon scanning and the development and maintenance of a 2020 service configuration for Scotland. The Directors of Planning Group will also support the process of national reviews and the maintenance of a programme approach to the management of specific issues.

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The ISPG will undertake and commission strategic reviews and work closely with the NSSC (or new group). NSSC will continue to commission national specialist services but its remit will be extended to include the decision making and implementation of the outcome of national reviews as appropriate. It may also be appropriate for NSSC to undertake strategic reviews for specific services.

G Smith 17.09.2013

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ANNEX A

Quality Alliance

Board

2020 Steering

Group

Guiding Coalition

Cabinet Secretary

SG Directors

NHS CEs NHS Chairs Quality

Portfolio

Groups

National Groups e.g.

Planning, MD, ND,

Finance

12 Priority Areas (Existing National Groups?)

Infrastructure Delivery Group

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ANNEX B

Comments received to date on the Discussion Paper From: Evans Deirdre (NATIONAL SERVICES SCOTLAND) Sent: 19 September 2013 07:27

Dear Chris, Thank you for the opportunity to comment - and well done Graeme - a great paper. It proposes a true strategic approach to planning health services which I believe is essential if NHS Scotland is to meet the challenges from the increasing health needs of an aging population across the geography of Scotland. It addresses the need to integrate workforce, financial, IT and service planning which is critical to service sustainability and achieving the 2020 vision. It is a most welcome contrast to the approach increasingly emerging from NHS England which is one of each specialty and subspecialty writing up their own plans and standards independently, with no evident strategic oversight or links to balance the aspirations of each separate strand. This approach risks an imbalance between investment in different services and an overall risk to affordability. It also is likely to drive unhelpful competition between specialties and uncoordinated development by some NHS Foundation Trusts. So I warmly welcome the proposal for a strategic approach to planning health services in Scotland, and agree with Catriona that we should not attempt, in one leap, to try to solve both the challenges of sustaining and planning health services, as well as social care services. I fear that if we bite off too much we will not make enough space to address the severe challenges facing health services in Scotland at present. I have the privilege of being able to attend all three Regional Planning Groups and there are clear and present workforce challenges which require structured, inter-regional service planning. The proposed remit of the Integrated Strategic Planning Group (whatever it is called) would provide a forum for this work - recognising the principles of subsidiarity and the important roles that the Directors of Planning Group and NSSC can play. I think that the role attributed to NSSC is appropriate and would allow it to continue to focus on the part of the spectrum of care which it was designed to address. I support the idea that NSSC service reviews are integrated with the wider planning context through the (Integrated) Strategic Planning Group. I look forward to discussion at the NPF next week. Deirdre Deirdre Evans Director National Services Division NHS National Services Scotland

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From: McMahon, Alex Sent: 18 September 2013 16:31

I left before the end. If that was the outcome then fine. We just take integration out.......but I think this is a missed longer term trick. By I will bow to collective peer views. From: Renfrew, Catriona Sent: Wednesday, September 18, 2013 04:25 PM

Graham, I think this is a really good write up, I would have issues with the wording of points 4 and 8 but happy to play these into the NPF debate and I think we need to consider the membership, we talked about a reference group(s) to enable the group itself to be tighter 9 is the most key issue we talked about the joining up in a cohesive way of the work being done across the strands into service plans is critical, I would not include any role in oversight outside health those joins and integration overview can be done in different processes. Alex, I thought we had reached a clear view that this group was about the planning of health services not about social care and not about the interface with community planning therefore need to think title, I suggest national health planning group signalling joint between SG and Board? Catriona Renfrew Director Corporate Planning and Policy NHS Greater Glasgow and Clyde

From: McMahon, Alex Sent: Wednesday, September 18, 2013 1:18 PM

Christopher Thanks for this and to Graeme for drafting it. I think the paper covers many of the points that were discussed at the session. That said if we are going to call the new body the integrated strategic planning group, it needs to have an eye to social care as well as just health care. Integration is synonymous with health and social care and to set a group and a process up that didn ’t build on the current political and policy drivers that look at national and local drivers for integration would be to miss a trick. So the terms of reference would need to be broadened or indeed made even more specific. Initially the work around the integration plans, strategic commissioning plans require ‘partnerships’ to consider how they will (we hope on behalf of Boards and Councils) to deliver not just community and primary care services but potentially (if not over time) acute care but certainly to identify how they will support better flow through systems, reduce delays and make the patient pathway more seamless. Whilst doing this we need to create efficiency and productivity gains and save millions of pounds .the latter of course is predicated on closing hospitals at a time when bed numbers are staying as they are and indeed in some Boards might need to increase! So the challenge for such a planning group is how to balance that whilst ensuring that we stop doing some of the lower clinical value work, so that we can re-invest money and also to ensure stability around acute and super acute/tertiary services that Boards host in behalf of NHS Scotland. Or we don’t call it an ‘integrated’ strategic planning group and have

NSSC 2013/45A

integration as a bullet point. Happy either way but I think we are missing a bit of trick if we don’t at least debate the former a bit more fully. If we are up for that I guess I would want us to think about how we relate to the community planning partnerships, which the Cabinet Secretary for Health and Well-being and the Finance Secretary see as key vehicles for driving change. How do they come in to our strategic thinking and ways of working? No easy answer but given that the LDP and the annual reviews have focused on how we develop and deliver these through the LDP we might need a discussion¦. These are just the views of one person. Happy to be shot down. But thanks for kicking off the debate which we can follow up on next week. Alex Professor Alex McMahon Director of Strategic Planning, Performance Reporting & Information NHS Lothian Dr Sara Davies Senior Medical Officer Scottish Government

Just a few comments to highlight the benefit of considering evidence assessments throughout the document. I wanted to know who looks at the evidence so any strategy passed onto the guiding coalition does not fall down due to lack of evidence, acceptability and affordability. Purpose section – 5th and 6th bullets:

Changing clinical practice in relation to safety, clinical and cost effectiveness

Current and anticipated changes in technology and its innovations and efficiencies Specific remit section – 5

th bullet:

Identify and oversee a proactive programme of national service reviews based on the

horizon scanning and evidence reports to determine the detailed configuration at a national and regional level

Membership – may wish to include:

Healthcare Improvement Scotland Medical Directors

Directors of Public Health Organisational Relationships section – 2nd bullet:

The relationship with other national groups is of key importance and the ISPG will establish a network of contacts with groups working on the 12 Route Map priority areas, efficiency and productivity work streams etc. to ensure that strategy follows a decision based approach that includes evidence, affordability and acceptability and is communicated and that the work of the groups is coordinated to maximise strategic impact.

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-46 Review of Risk Share

Background 1. National Services Division (NSD) manages a number of national financial risk share

arrangements on behalf of NHS Boards; these are listed in the table below. The arrangements are considered by NHS Board Chief Executives on an annual basis; the current arrangements were last formally reviewed in November 2012. There are currently 5 national financial risk share schemes being managed by NSD for Boards.

2011/12 outturn

2012/13 outturn

2013/14 budget

2013/14 forecast

Recombinant Drugs (Coagulation concentrates) for patients with haemophilia (Annex A)

£26.7m

£24.4m

£25.7m

£24.8m

Limited number of orphan drugs (Annex B) £4.8m £6.2m £4.6m £7.0m

Specialised services in England (Annex C)

£8.5m £8.9m £8.7m £8.8m

Forensic Medium Secure Services for Patients with Learning Disabilities (Annex D)

£3.4m

£3.2 m

£3.7m

£3.4m

Gender Reassignment Surgery (Annex E) - - 0.5m £0.3m

Total £43.4 m £42.7 m £43.2m £44.3 m

2. In January 2013, BCEs approved a recommendation that there should be a full review of the National Risk Share arrangements and a group was formed to undertake this task in line with work on medicines for rare diseases that was taking place within Scottish Government. The NSSC (National Specialist Services Committee) subgroup has a remit to provide a report on all the Financial Risk Share arrangements being managed by NSD on behalf of NHS Boards; and to make recommendation as to the future operation of these. The subgroup’s report is expected to be completed for the March 2014 meeting of NSSC.

3. There have been a series of relevant ministerial announcements. In January 2013 SGHSC announced the establishment of a Rare Diseases Medicines Fund; as well as two other external reviews; one into how SMC makes decisions, particularly in relation to orphan medicines; and the other into how NHS Boards make decisions using IPTR, again with a focus on access to orphan medicines that have not been recommended for use by SMC.

4. On 8 October 2013, SGHSC directed the SMC to apply different approaches in the evaluation of medicines used to treat very rare conditions or in end of life care, and directed SMC to undertake a rapid review of the wider aspects of value and QALYs in


NSSC

NSSC PAPER 2013/46

Review of Financial Risk Share Arrangements – update for information

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-46 Review of Risk Share

order to increase access to patients to these medicines. The SMC has already begun this work and will report their finding to the Cabinet Secretary before Christmas.

5. The outcomes of this work will have an impact on the recommendations from the subgroup in relation to the Orphan Drugs Risk Share scheme.

6. The purpose of the paper is to update NSSC on the reasons why the date for submission of the review group’s report is now postponed until March 2014.

Mrs Deirdre Evans NSSC Secretariat 18 November 2013

NSSC 2013/46 A Letter from Cabinet Secretary 8 October 2013 Dear Mr McNeil SCOTTISH GOVERNMENT RESPONSE TO THE HEALTH AND SPORT COMMITTEE 8TH REPORT 2013 – ACCESS TO NEW MEDICINES Thank you for the opportunity to consider the recommendations arising from its inquiry into access to new medicines published on 3 July 2013. We welcome the rigour and systematic methodology applied to the inquiry which is evident in the consensus achieved. The inquiry dealt with a number of complex and contentious issues and was helpful in addressing a number of fundamental questions about access to medicines. We believe that in responding to these and the issues raised in the independent reviews by Professors Routledge and Swainson, we should grasp the opportunity to elicit consensus across all political parties in Scotland. Our shared ambition is to improve access, within the NHS in Scotland, to newly licensed medicines that represent the best in therapeutic value and are cost-effective. I am pleased therefore to submit the Scottish Government's response which is attached. We have listened carefully to the concerns raised by the Committee and we have taken decisive action in a number of key areas which will increase access to new medicines within the NHS for patients in Scotland. The Scottish Medicines Consortium has been asked to apply different approaches in the evaluation of medicines to treat patients at end of life and to treat very rare diseases including, as a first step in a wider process to determine Scotland' requirement to a value-based approach in assessment, a rapid review of the wider aspects of value and QALYs to be considered. The SMC has been asked to report on their findings in this regard before Christmas. Other important improvements include the creation of a new Peer Approved Clinical System (PACS) to replace the Individual Patient Treatment Request (IPTR) process, improved patient support arrangements through a dedicated and centralised Patient Support Team, extension of the Rare Conditions Medicines Fund until 2016, and the creation of a dynamic Scottish Clinical Trials Register. I would like to thank the Committee for its work in this area and for producing a report which, through the actions which will be taken forward, help to ensure that NHS patients in Scotland are able to access medicines which will allow them to achieve improved health gain and to lead enriched lives. ALEX NEIL

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SSCNSSC 2013/46B RESPONSE TO THE HEALTH AND SPORT COMMITTEE INQUIRY INTO ACCESS TO NEW MEDICINES

Overview The Scottish Government welcomes the systematic, rigorous and consensual approach of the Health and Sport Committee in their inquiry into access to new medicines. We believe that in responding to the issues raised through the Committee, and through the independent expert reviews by Professors Routledge and Swainson, that there is an opportunity to build on the Committee’s consensus and to shape our access to new medicines for the future. Our shared ambition with the Committee is to improve access, within the NHS in Scotland, to newly licensed medicines that represent the best in therapeutic value and outcomes, allowing patients to achieve improved health gain and lead enriched lives. Scottish Government Consultation and Stakeholder Engagement The Scottish Government sought feedback on the Health and Sport Committee’s recommendations from those who provided evidence to the Committee and from other stakeholders who have expressed an interest in this area. Feedback was obtained through written responses; face to face meetings; and a stakeholder event involving industry, patient representative organisations and the Scottish Medicines Consortium (SMC). The face to face meetings included a meeting with clinicians and separate meetings with families who have had recent experience of the IPTR process. Whilst the timescale for the consultation was challenging, the Scottish Government received good engagement and a willingness to contribute constructively. Themes Emerging from the Consultation We identified the following key themes that stakeholders agreed they would wish to see running through the response to your Committee:

transparency to aid understanding;

equity of approach across Scotland;

person-centred approach;

additional tools for SMC to look at issues such as burden of illness and wider assessment of value;

sustainability;

timeliness;

a clear clinical focus in IPTRs with appropriate patient support and communication.

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The Scottish Government’s response to the Health and Sport Committee’s report reflects the feedback received. The Health and Sport Committee’s comments on recommendations from Professors Routledge and Swainson have been grouped together under the following broad headings:

Value-Based Assessment

Getting Different Outcomes from the SMC through a Broader Assessment of Value

Transparency and Public Engagement

Implementation of SMC “Accepted” Advice – NHS Board ADTCs and Formulary Management

Special Circumstances where a National Approach May be needed

Local NHS Board Consideration of SMC “Not Recommended” Advice for Individual Patients or Cohorts of Patients (Replacement of the Individual Patient

Treatment Request Process)

Research Opportunities within the NHS in Scotland

Value-Based Assessment Context The UK Government published “The Coalition: our programme for Government”1 on 20 May 2010 which set out the UK Government’s intention to reform arrangements of the pricing of branded medicines and to introduce a new system of value-based pricing when the current Pharmaceutical Price Regulation Scheme (PPRS) expires at the end of 2013. Medicines’ pricing is a matter currently reserved to the UK Government. The Department of Health’s published Impact Assessment for VBP at consultation stage2 describes the impact of change in price-negotiation roles as follows: “Under the current system, companies propose a price for their products and the government – through the authority devolved to commissioners – decides whether to accept or reject this offer. In VBP, the government will arrive at a “fair” price for a product, based on its value to patients, and it will be for companies to decide whether to accept this (and price at or below this level) or to decline to supply the product…” The UK Government’s publication “The Coalition: our programme for Government” also set out their proposals to introduce a Cancer Drugs Fund which was positioned as a “bridge” to VBP. Health and Sport Committee Recommendations The Committee heard evidence from the UK Government’s Department of Health lead official on Value Based Pricing (VBP), who alluded that VBP had been reshaped and would no longer relate to medicines’ pricing, but would instead be a reshaping of the Health Technology Assessment (HTA) model employed by the National Institute for Health and Clinical Excellence (NICE) in its appraisal of new medicines.

1

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/78977/coalition_programme_for_government.pdf 2 http://www.dhsspsni.gov.uk/value-based_pricing_impact_assessment.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/78977/coalition_programme_for_government.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/78977/coalition_programme_for_government.pdf

http://www.dhsspsni.gov.uk/value-based_pricing_impact_assessment.pdf

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While medicines pricing is reserved, medicines assessment is devolved. In the space of one short evidence session, it appeared that the common understanding of VBP had changed, and it now may be within the competence of the Scottish Government. The Committee consequently called for urgent clarity on the matter (Paragraph 100 of the Report). The Health and Sport Committee were of the view that, subject to confirmation that Scotland can undertake value- based assessments, Professor Routledge’s recommendation (Recommendation 8) that NHSScotland explore the ways in which the expertise available within the SMC could be used to support the process of value based pricing presented an unique opportunity to develop a Scottish solution which could provide greater flexibility than the current arrangements (Paragraph 104 of the Report). The Committee also indicated that a value-based assessment model could facilitate NHSScotland to gain access to innovative medicines at a more favourable cost than is currently the case and also secure related clinical trial and post-licensing data benefit (Paragraph 106 of the Report).

Scottish Government’s Response The Devolved Administrations asked for observer status at the Pharmaceutical Price Regulation Scheme (PPRS) negotiations between the UK Government and the Association of the British Pharmaceutical Industry (ABPI). This request was rejected by the UK Government and the Devolved Administrations were therefore put at a disadvantage. Scotland will, in response to the Committee’s recommendations, develop a value-based approach to SMC’s assessment, incorporating issues such as burden of illness and wider societal impact. This will be incorporated into the revised way of working by the SMC and, in response to the Committee’s recommendations elsewhere in the report the “pause” in the SMC process will be used where further discussion with the pharmaceutical company is needed on cost-effectiveness. Although the PPRS negotiations are ongoing, value based pricing will not be delivered, and we are firmly of the view that value-based assessment is wholly within the powers of the Scottish Government and the Scottish Parliament. We will now work to develop a Scottish model of value, and we will discuss with stakeholders how this new model of assessment will be evidenced and devised.

Getting Different Outcomes from the SMC through a Broader Assessment of Value Use of QALYs in SMC Appraisal - Context To conduct a comparison of health gains across a range of medicines and treatments, it is necessary to measure and quantify benefits from the new treatment relative to existing treatments. Many HTA systems, like the SMC, employ a model which centres on the establishment of a common unit of health benefits. The most prevalent unit of health benefit is the Quality Adjusted Life Year (QALY).

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In SMC, QALYs provide the basis for discussion about individual medicines by the Committee; the QALY alone does not determine the decision reached. A cost per QALY of under £20,000 is generally considered acceptable value. For a medicine with a cost per QALY between £20,000 and £30,000 SMC might accept this if the medicine gives significant benefits over existing treatments. In addition, SMC has a number of factors that can be applied to medicines with a cost per QALY above £30,000 to allow their approval in some cases. SMC calls these Modifiers. The Scottish Government introduced a £20 million Rare Conditions Medicines Fund (RCMF) for 2013/14 from 1 March 2013 on the basis of an interim recommendation from Professor Swainson. Health and Sport Committee Recommendations The Health and Sport Committee called on the SMC and the Scottish Government to review, as a matter of priority, how modifiers and thresholds are applied to take better account of orphan; ultra-orphan conditions; end of life and innovation; and to bring a higher degree of transparency (Paragraph 71 of the Report). Whilst there were no recommendations from Professor Routledge or Professor Swainson regarding cancer medicines, the Health and Sport Committee notes that its evidence found little support for the establishment of a Cancer Drugs Fund in Scotland. The Committee also notes that criticism of the Cancer Drugs Fund was to an extent its focus on one particular disease category, bypassing the cost effectiveness and regular NICE procedures (Paragraph 85 of the Report). The Health and Sport Committee welcomed Professor Routledge’s recommendation (Recommendation 5) for the SMC to develop a policy specifically related to ultra-orphan medicines to guide a process to consider all available evidence relevant to its advice on such medicines. The Committee recommended that the Scottish Government urgently address this with particular effort to review and consolidate the system of modifiers to take account of the factors specific to orphan and ultra-orphan medicines and to increase transparency and clarity in relation to their use (Paragraph 75 of the Report). The Committee welcomed the decision to establish a £20 million Rare Conditions Medicines Fund (RCMF) which provides increased access for some patients suffering from orphan and ultra-orphan conditions, to medicines not accepted for use by the SMC (Paragraph 77 of the Report). This was based on Professor Swainson’s interim recommendation and further recommendation (Recommendation 12) that the Rare Conditions Medicines Fund should focus on access to medicines for ultra-orphan diseases and that access should be supported where the SMC had published “not recommended” advice after a full submission and after a successful IPTR or GPTR had been agreed. The Committee further noted the time limited nature of the Fund for 13 months, and called on the Cabinet Secretary to update the Committee on how the Fund arrangements are expected to mesh with the development of Value-Based Pricing (Paragraph 80 of the Report).

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Scottish Government’s Response

The Committee recognised that existing cost-effectiveness thresholds are not always appropriate for end of life medicine or for medicines to treat very rare diseases. The Cabinet Secretary has therefore directed the SMC to apply different approaches in the evaluation of these medicines, including a rapid review of the wider aspects of value and QALYs in order to increase access to patients to these medicines. The SMC has already begun this work and will report their finding to the Cabinet Secretary before Christmas. This is the first step in a wider process to determine Scotland’s requirement to a Value-Based Approach to Assessment. The question of how innovation should, or could, be considered in the new medicines assessment system in Scotland will be taken forward in the Scottish Model of Value. Pending the introduction of Value-Based Assessment, the Scottish Government Will continue the Rare Conditions Medicines Fund to assist NHS Boards meet the high costs of the specified medicines until at least April 2016. This action will ensure the interim system (of medicines appraisal) is given time to establish itself and for the Scottish Model of Value to be developed.

Transparency and Public Engagement Transparency The Health and Sport Committee accepted the recommendation from Professor Routledge (Recommendation 1) that the SMC should meet in public (Paragraph 55 of the Report). Whilst the Health and Sport Committee, did not directly comment on recommendations 2 and 3 from Professor Routledge:

to invite the manufacturer of a new medicine to give evidence at the main SMC meeting (Recommendation 2); and

that the SMC should be able to appraise any new medicine which the NHS in Scotland considers potentially of major importance but for which the manufacturer has chosen not to submit clinical and cost-effectiveness evidence within 12 weeks of the medicine’s launch in the UK (Recommendation 3).

The Committee generally welcomed proposals to improve transparency but acknowledged that these would do little to change decision-making and identified the need to ensure the SMC process in the first instance better assesses the cost-effectiveness of medicines as a key challenge (Paragraph 56 of the Report).

Scottish Government’s Response The Scottish Government supports an approach whereby the SMC holds its meetings in public and will instruct the SMC to work on a transition to allow the first public meeting to take place in May 2014.

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The Scottish Government supports an approach whereby a representative from the manufacturer of a medicine being appraised, may attend the SMC meeting to answer any questions the Committee may have on the evidence submitted. The Scottish Government is also supportive of the SMC (working with ABPI) to meet with manufacturers prior to a submission for a newly licensed medicine. This would provide an opportunity to secure a high quality submission first time around.

The Scottish Government expects pharmaceutical companies who wish to have their medicines prescribed within the NHS in Scotland to comply with the submission arrangements as set out by the Scottish Medicines Consortium. However, if a submission is not received by the SMC for a medicine that they judge to be potentially of clinical importance to the NHS in Scotland, the Scottish Government is supportive of the SMC commissioning an independent evaluation of publicly available information about the medicine in question to use as a basis for an SMC appraisal. The significant increase in scope for the SMC will be underpinned by a further investment of £1 million per annum.

Engagement with Patients and the Public The Health and Sport Committee broadly accepted Professor Routledge’s recommendation (Recommendation 6) to establish a “Citizen’s Council” or “Citizen’s Jury” to explore views around societal issues of importance to the people of Scotland but noted the caveats mentioned by witnesses and recommended that this be approached cautiously (Paragraph 66 of the Report). The Committee called on the Scottish Government to consider plans for Citizen’s Juries and provide more detail on how it expects them to work in practice to ensure that they improve the process (Paragraph 67 of the Report). The Health and Sport Committee noted Professor Routledge’s recommendation (Recommendation 7) to explore other opportunities for the SMC to increase patient/public awareness of its role and the need for clear and concise documentation. The Committee’s view was that this recommendation was about relatively minor enhancements intended to improve transparency rather than radical changes to the systems themselves and therefore would do very little to improve access to new medicines in any meaningful way (Paragraph 45 of the Report). Nevertheless, the Committee welcomed the review proposal and identified the need to ensure the SMC process in the first instance better assesses cost-effectiveness of medicines as a key challenge (Paragraphs 55 and 56 of the Report).

Scottish Government’s Response During the Scottish Government’s consultation, it became clear that the proposed function of the “Citizen’s Councils” could be met by expanding and supporting the role of the SMC’s Patient and Public Involvement Group (PAPIG) to engage proactively with patient representative organisations and the public on SMC’s work generally rather than limiting this to the SMC.

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As part of the PAPIG’s extended role, they will assist in the development of “Plain English” Guides to describe the work of the SMC and NHS Board Area Drug and Therapeutics Committees. This will ensure patients are able to access improved information, particularly where a medicine which is not available for routine use is requested. PAPIG will also input to the development of a revamped SMC Annual Report to clearly articulate their work to the public and patients.

Engagement with Pharmaceutical Industry The Health and Sport Committee welcomed Professor Routledge’s recommendation (Recommendation 4) for the SMC to have a temporary “pause” in the appraisal process at any stage to permit further dialogue with the manufacturer on issues that could be central to subsequent decision-making. The Committee’s view was that it could create an opportunity for discussion on, for example, whether there was scope to develop a reimbursement rate which could take account of various factors such as supplying post-licensing data or assessed benefit post-approval (Paragraph 105 of the Report).

Scottish Government’s Response The Scottish Government supports the recommendation to introduce a temporary “pause” in the appraisal process which would represent a beneficial step to be instigated by the SMC where the clinical effectiveness of a medicine has been accepted by the SMC but the cost-effectiveness poses a stumbling block to allowing acceptance of the medicine. The “pause” would facilitate a confidential discussion with the manufacturer, through an external negotiator, about improving the medicine’s cost-effectiveness through a new or improved Patient Access Scheme.

Implementation of SMC “Accepted” Advice – NHS Board ADTCs and Formulary Management Context Feedback from stakeholders indicates a clear need for improved communication and transparency of local NHS Board consideration of SMC “accepted” advice and in particular, the need to communicate opportunities that exist for patient and public involvement.

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Health and Sport Recommendations The Health and Sport Committee noted Recommendations 3 and 5 from Professor Swainson:

14 NHS Board ADTCs should be retained to maintain alignment of patient and GP interests, safe prescribing and enable NHS Boards to manage their costs and that Regional Clinical Networks could have a role in agreeing equitable access to new medicines in relation to populations (Recommendation 5); and

The Health and Sport Committee noted Professor Swainson’s recommendation that NHS Board ADTCs should demonstrate engagement with the Patient and Public Forum (PPF) in their work and preferably include at least one member drawn from the PPF on the ADTC (Recommendation 3).

The Health and Sport Committee supported Recommendation 1 from Professor Swainson that NHS Board Area Drug and Therapeutics Committees (ADTCs) should publish their local response on the Board’s website within 30 days of SMC’s published advice on accepted medicines. The recommendation indicated that where further work is required, this should be made clear and final arrangements published within 90 days. The recommendation further indicated that formulary decisions should be easily accessed by the public and patients in “user friendly” language with established links to the Patients and Public Forum (Recommendation 1). The Committee’s view was that this recommendation would help to promote consistency and transparency. However, it considered that there may be a further case to be argued that all ADTCs should put new SMC accepted medicines on their formulary within three months whether or not prescribing and clinical guidelines had been fully completed by that time. Clinicians could therefore use their professional judgement on whether to use medicines on a national formulary or to await guidance locally (Paragraph 59 of the Report). The Health and Sport Committee supported Recommendations 2 and 11 from Professor Swainson that:

NHS Board ADTCs should publish their formulary decisions and the reason for these in relation to SMC advice to comply with the national guidance set out under SGHD/CMO (2012)1. Professor Swainson recommended that this should be done in a systematic way linking the formulary decision to the published SMC advice and access to this information should be signposted from the Board’s home page on their website and the information kept accurate and up to date (Recommendation 2); and

the Scottish Government and Boards should produce clear and concise documentation, available on national and local websites, that explains the role of ADTC and IPTR and how the public and patients can be involved, and provides links to ADTC and IPTR published information (Recommendation 11). However in response to these, the Committee indicated that there may also be arguments not yet explored in favour of a smaller number of ADTCs or even a single national body (Paragraph 62 of the Report).

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Special Circumstances where a National Approach May be Needed Context In certain circumstances, there may be a need to make decisions at a national level for implementation of SMC “accepted” medicines to reflect the key clinical importance of such medicines. Health and Sport Committee Recommendations The Health and Sport Committee noted Professor Swainson’s recommendation (Recommendation 4) that NHSScotland should consider a national meeting of all relevant specialists to explore and agree a national implementation for some new medicines accepted by the SMC that meet agreed criteria. These could include novel, first in class medicines where there is uncertainty of its place in therapy. Healthcare Improvement Scotland (HIS) should continue to audit access to new medicines compliance with national guidance set out under CEL 17 (2010) and SGHD/CMO(2012)1. However, the Committee indicated that there may also be arguments not yet explored in favour of a smaller number of ADTCs or even a single national body (Paragraph 62 of the Report). Scottish Government’s Response

The Scottish Government currently supports the retention of 14 NHS Board Area Drug and Therapeutics Committees (ADTCs) to maintain clinical engagement and education and training for clinicians to ensure safe and effective prescribing practices. Continued retention of the 14 ADTCs is, however, contingent on their demonstration that the new processes are working well to ensure clinical outcomes are optimised. The Scottish Government will introduce rigorous monitoring arrangements over the next three years in this regard. The Scottish Government supports the recommendation that NHS Board ADTCs should demonstrate engagement with the Patient and Public Forum (PPF) in their work and, indeed, our recommendation goes further to say that each ADTC should have two members of the PPF involved. The Scottish Government supports the NHS Board publication of their local response on the Board’s website within 30 days of SMC’s published advice where this is possible. Where further work is required, NHS Boards are expected to publish their response within 60 days of SMC’s published advice. The Scottish Government supports the recommendation that NHS Board ADTCs should publish formulary decisions and the reason for these in relation to SMC advice in a systematic way, linking the formulary decision to the published SMC advice. The Scottish Government supports open and transparent access to this information for patients and the public via clear signposting from the Board’s home page on their website with the information kept accurate and up to date.

10

The Scottish Government supports the recommendation that clear and concise information about local NHS Board consideration of SMC advice should be made available to patients and the public, including opportunities for patient/public involvement in such decision-making and providing links to published information. The Scottish Government supports decision-making at national level for the implementation of certain medicines of key clinical importance though discussion and agreement of the relevant specialists within NHSScotland to ensure clinical outcomes for patients in all parts of Scotland are optimised. The Scottish Government supports the Healthcare Improvement Scotland audit of NHS Board ADTC compliance with national guidance.

Local NHS Board Consideration of SMC “Not Recommended” Advice for Individual Patients or Cohorts of Patients (Replacement of the Individual Patient Treatment Request Process) Context The Scottish Government is supportive of introducing robust auditing of NHS Board decision-making about SMC “not recommended” medicines for individual patients or groups of patients through Healthcare Improvement Scotland, and for the results to be published in an anonymised way in line with data protection requirements. This audit process will begin following decisions taken under the new arrangements set out below. The Individual Patient Treatment Request (IPTR) process was established in April 2011 to recognise that not all patients will respond to medicines in the same way and to acknowledge that SMC “not recommended” advice, which was based on the results of a patient population, may not be appropriate for an individual patient because of their particular clinical circumstances. The IPTR arrangements were never intended to be an alternative route to accessing such medicines on a regular basis; rather it was an attempt to articulate that the SMC “not recommended” advice did not mean an absolute and final block on medicines where clinicians believed there was clinical evidence to suggest an individual patient might achieve a clinically significant benefit. Health and Sport Committee Recommendations Whilst the Health and Sport Committee did not make any specific comments on Recommendations 9 and 10 from Professor Routledge and Recommendations 6, 7, 8, 9, and 10 from Professor Swainson, they generally welcomed review proposals regarding improving transparency (Paragraph 55 of the Report):

Professor Swainson’s recommendation (Recommendation 6) that all NHS Boards should have the same IPTR paperwork and process based on examples by NHS Greater Glasgow & Clyde and NHS Lothian.

Professor Swainson’s recommendation (Recommendation 7) that NHS Board IPTR arrangements should be audited by Healthcare Improvement Scotland (HIS) to

11

assess compliance with guidance and consistency of application and to publish the results.

Professor Swainson’s recommendation (Recommendation 8) that NHS clinicians should be provided with basic training and guidance on the IPTR process locally. Clinicians who are uncertain or inexperienced should be able to access specialist advice and support.

Professor Swainson’s recommendation (Recommendation 9) that all NHS Boards should consider whether IPTR panels should include a member of the public drawn from the Board’s Patient and Public Forum (PPF). Members would require training and support.

Professor Swainson’s recommendation (Recommendation 10) that all doctors considering an IPTR must be able to access consistent, knowledgeable support for their patients. National Services Division should establish and maintain a register of approved specialists to support IPTR. One specialist may be sufficient for orphan and ultra-orphan diseases, but more than one specialist may need to be available for more common diseases or variants and on a regional basis. The model of cancer networks is an example.

Professor Routledge’s recommendation (Recommendation 9) that a register of IPTR decisions should be established (suitably anonymising patient details) and supporting information on IPTRs to be shared between NHS Boards.

Professor Routledge’s recommendation (Recommendation 10) that there should be regular sharing of expertise between IPTR panels across NHSScotland with opportunities to meet at least annually for induction; feedback and training.

The Committee remained concerned about the requirement that IPTRs for orphan and ultra-orphan conditions was proving the exceptionality of patients’ circumstances which is difficult in such small patient numbers. They indicated that this is believed to be a barrier for access to medicines that clinicians believe their patients need. The Committee called on the Scottish Government to outline the steps it plans to take to improve the process (Paragraph 57 of the Report). The Committee further recommended that the Scottish Government should review and analyse previous IPTR decisions and look to improve monitoring of applications and consistency of future decisions. The number of applications, negative and positive decisions, among other relevant details should be published regularly (Paragraph 58 of the report). The Committee noted that there may be arguments that have not, so far, been fully explored - particularly in relation to IPTRs such as a national treatment request body to ensure a both consistent application of IPTR and GPTR criteria as well as consistency in decision-making. This is particularly important in relation to IPTRs for orphan or ultra-orphan conditions where the clinical expertise of these is not available within particular localities or perhaps not in Scotland at all (Paragraph 62 of the Report). However, the Committee remained concerned about the criteria to be applied when considering IPTRs and believes that urgent consideration should be given to encouraging greater flexibility in the IPTR process to approve drugs where there is clear, clinical evidence

12

that a particular patient would derive material benefit from such a drug even if the existing IPTR criteria had not been met fully (Paragraph 89 of the Report).

Scottish Government’s Response

The Scottish Government believes that the introduction of value-based assessments of new medicines and the new interim arrangements (to be applied in the assessment of cost-effectiveness for newly licensed medicines to treat end of life situations and orphan/ultra-orphan medicines licensed to treat very rare conditions) will significantly reduce the current dependence on Individual Patient Treatment Requests (IPTRs).

The Scottish Government believes that the procedure for accessing drugs in exceptional prescribing circumstances, when all other treatments have been exhausted, should be clearly linked to clinical opinion. Therefore the Scottish Government is replacing the IPTR/GPTR system with a new system of “Peer Approved Clinical System” (PACS).

The new PACS guidance will be issued shortly and will clarify that there is a single, national system to be applied locally, and this will be clinically led. Variation in approach to such decision-making will be minimised through strict auditing arrangements.

The Scottish Goverment has listened to the concerns raised about the criteria associated with the IPTR process. In recogition of these, the new PACS system facilitates a peer review approach to access SMC "Not Recommended" medicines for individual patients based on the anticipated clinical outcome for an individual patient.

The new guidance will introduce, as a requirement, standardised application forms for NHSScotland.

It will set out clear parameters for expected deadlines for decisions in relation to requests.

The Scottish Government is supportive of establishing a centralised patient support team to act as adviser; support and advocate for patients and families involved in requests for SMC “not recommended” medicines, or those not yet appraised. The Scottish Government supports the establishment of a robust central collection of NHS Board data related to decisions about applications to prescribe SMC “not recommended” medicines. This will provide aggregated information only on an annual basis to ensure that patient confidentiality is maintained. The Scottish Government is supportive of introducing robust auditing of NHS Board decision-making about SMC “not recommended” medicines under the new PACS system for individual patients or groups of patients through Healthcare Improvement Scotland and the results to be published in an anonymised way. The Scottish Government supports the development of training materials for NHS clinicians and the introduction of training and guidance on the new “Peer Review” approach to local NHS Board consideration of SMC “not recommended” medicines

13

for individual patients or groups of patients. Improved information will be developed for patients, their families and carers in order that they know what to expect at each stage of the PACS. This will receive input from PAPIG and will replace the existing guidance available through the Health Rights Information Scotland website. The Scottish Government supports the availability of specialist clinical advice via a register of clinical specialists to assist local NHS Boards in consideration of SMC “not recommended” medicines for individual patients or groups of patients. The Scottish Government supports the regular sharing of expertise between NHS Boards across Scotland with opportunities to meet at least annually for induction; feedback and training. This will be facilitated by Healthcare Improvement Scotland as part of their Audit role.

Research Opportunities within NHSScotland Whilst there were no recommendations from Professor Routledge or Professor Swainson regarding the availability of research opportunities within NHSScotland, the Health and Sport Committee noted industry concerns that there had been a reduction in the research access and spend in Scotland by the pharmaceutical industry. The Committee called on the Scottish Government to urgently investigate and report back to the Committee on whether there is a decline in the number of Phase III trials placed in Scotland and consider any steps that may be needed to increase their number as well as maximising the overall number of clinical trials (Paragraph 96 of the Report). The Committee also recommended that NHS Boards take a more systematic approach to collating and updating data on clinical trials (both national and international) with a view to facilitating greater access to participation in such trials for patients in Scotland where appropriate (Paragraph 97 of the Report).

Scottish Government’s Response The Scottish Government has not been presented with any robust evidence to suggest a decline in Phase III commercial clinical trials being placed in Scotland. We will though explore the subject further to determine if there is a diminution in the number of Phase III trials for particular conditions. The Scottish Government believes that there may be scope to increase the number of trials conducted in Scotland and NHS Research Scotland (NRS) will be working closely with the pharmaceutical industry to improve the efficiency and effectiveness of the NHS clinical research offering. NRS has invested heavily in infrastructure to support both current and future research needs. The Scottish Government Chief Scientist Office will also explore the creation of a Scottish clinical trial register to raise patient and clinician awareness of ongoing

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clinical trials and allowing them to express an interest in participating. 8 October 2013

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-47 – Adult Renal Transplant Update

1


NSSC

NSSC PAPER 2013/47

Adult Renal Transplantation – NSSC Sub Group (Horizon scanning)

1. Introduction

Adult renal transplantation in Scotland is delivered by two distinct services for the adult population; at the Western Infirmary in NHS Greater Glasgow and Clyde, and the Royal Infirmary of Edinburgh in NHS Lothian. The Scottish Transplant Group (a group supported by the Scottish Government) considered the current Scottish commissioning arrangements of adult renal transplantation following recent changes to the commissioning of adult renal transplant services in England and Wales. In their discussion it became evident that clinical staff in the two Scottish renal transplant units had already had informal discussions about the possibility of national commissioning in Scotland. The Scottish Government (Blood, Organ Donation and Sexual Health Team) wrote to National Services Division in February 2013 to establish a short-life working group (SLWG) to:

formally explore the possibility of the national commissioning of renal transplantation in Scotland

explore the potential risks and benefits of national commissioning of renal transplantation in Scotland

provide advice to the Scottish Transplant Group on the future designation of adult renal transplant services in Scotland

As a result, a subgroup of NSSC was established to undertake this work. The subgroup discussed their conclusions and recommendations in their second and final meeting in October 2013. The subgroup’s report is currently being finalised.

2. Commissioning arrangements 2.1. Scotland

Whilst NSD commission all of the other solid organ transplant services, adult renal transplantation in Scotland is not commissioned by NSD, but is instead funded by local NHS Boards (Paediatric renal transplantation is however commissioned by NSD, and is provided at the Royal Hospital for Sick Children in Glasgow). 2.2. England

From 1st April 2013, NHS England (formerly NHS Commissioning Board) has had the responsibility for directly commissioning all prescribed specialised services for the English population, and commissions adult renal transplantation as a prescribed service. Prior to 1st April 2013, adult renal transplantation was commissioned by the regional Specialised Commissioning Teams.

The strategic planning of specialised services for the NHS Commissioning Board is informed by Clinical Reference Groups. A Clinical Reference Group for Renal Transplant has been established in NHS England, with a Chair and Clinical Director Co Chair.


2

2.3. Wales and Northern Ireland

In Wales and Northern Ireland, renal transplantation is commissioned by their respective Specialised Commissioners; by the Welsh Health Specialised Services Committee and the Health and Social Care Board in Northern Ireland.

3. Subgroup’s emerging findings and recommendations

The NSSC subgroup unanimously supported the principle of the national commissioning of a Scottish adult renal transplantation service provided by the two existing units.

The subgroup noted that the benefits of national commissioning significantly outweighed the risks of national commissioning.

The group found that national commissioning would enhance the strategic planning and performance management of the two services, and would ensure consistency in approach in the strategic planning for both services, in line with the strategic planning of the other Scottish solid-organ transplantation services which are commissioned by NSD. National commissioning would also promote equity of access to an equitable level of service, ensuring consistency for patients, referrers and NHS Scotland. The group also explored significant existing service risks and future issues, and indicated that the notable current service issue and future risk for the delivery of the service is capacity. Renal transplantation activity has increased by 113% over the past 10 years in Scotland from 108 in 2003/04 to 230 in 2012/13. The services have worked well to meet this increasing activity; however, this significant increase in activity has led to significant pressure and capacity issues in both sites. In line with the NHS Blood and Transplant and Scottish Government 2020 transplant strategies, renal transplant activity levels should further increase by 47-64% over the next 7 years, from 230 renal transplants in 2012/13 to 307-342 in 2019/20. In meeting these levels of demand, the services will also need to support the associated higher future levels of new and follow-up outpatient activity. In light of the ambitious strategies set forward by the Scottish Government

1 and NHS Blood

and Transplant2, paper NSSC 2013/51 proposes the establishment of an NSSC subgroup to work with all nationally commissioned transplantation services to plan the transplantation services to 2020 in order to meet the forecast future activity levels for each transplant service, to agree on appropriate future service specifications, and to manage risks and issues. It has been recommended that it would also be pragmatic for the adult renal transplant service to be commissioned as a national service, and to be included as a peer in this process.

4. Next steps

The subgroup’s final report will be discussed at in the December 2013 meeting of the Scottish Transplant Group, where the formal written endorsement of the subgroup’s conclusions and recommendations will be sought from the Scottish transplant community. The support of the two host NHS Boards of the services (NHS Greater Glasgow and Clyde and NHS Lothian) will also be sought. Should the two host Boards support the application, they will be invited to submit a stage 2 application to the NSSC. This stage 2 application could potentially accompany the NSSC subgroup’s report for consideration by the NPPPRG and NSSC in their February and March 2014 meetings.

1 Scottish Government (2013). A Donation and Transplantation Plan for Scotlan d 2013-2020.

2 NHS Blood and Transplant (2013). Taking Organ Transplantation to 2020.


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5. Action required

The NSSC are asked to note the emerging findings and recommendations of the NSSC Adult Renal Transplantation subgroup, and to expect the subgroup’s final report in their March 2014 meeting.

The NSSC are asked to be aware that the subgroup’s report may also accompany a stage 2 application, should the two NHS Boards support an application for national designation.


Stereotactic Radiotherapy for Benign Conditions

Review Initiation Document

1 06/11/2014

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-48 Stereotactic Radiotherapy for

Benign Conditions PID

NSSC PAPER 2013/48

DOCUMENTATION

SHORT-LIFE NATIONAL SPECIALIST SERVICES COMMITTEE SUB-

GROUP

INITIATION DOCUMENT

Access to Stereotactic Radiotherapy for benign conditions

Release: Draft v0.1 Date: October 2013

PRINCE 2

Authors:

Janice Birrell Carol Colquhoun

Owner:

Deirdre Evans

Client: National Services Division



K:\07 Health Support Ser\Specialist & Screening\Spec\Stereotactic Radiotherapy for Benign Conditions \Review

2

Document control

Key personnel

Title: Review of Access to Stereotactic Radiotherapy for benign

conditions

Authors: Janice Birrell, Project Manager and Senior Programme Manager National Services Division

Approver: Carol Colquhoun, Project Executive

Owner: Deirdre Evans, Director, National Services Division

Version history

Version Date of revision Summary of changes Changes

marked

0.1 14/10/2013 First draft JB

Distribution

Name Role Organisation

Mrs Deirdre Evans Project Sponsor National Services Division

Dr Mike Winter Medical Adviser & Project Executive


Mrs Janice Birrell Project Manager &

Senior Programme Manager


Ms Karen Roberts Project Support

Officer





3

Review Initiation Document

2 Purpose of Document

This Initiation Document outlines the direction and scope of the Review of

access to Stereotactic Radiotherapy for benign conditions. This document will form the basis of the methodology that will be applied to conduct this review:

the aims and objectives of the review;

the need for this review;

how the review will be delivered;

the communication plan and strategy;

the timescale for the completion of this review.

The purpose of this document is to begin a controlled start to the Review of the Stereotactic Radiotherapy Services for benign conditions in Scotland, by ensuring:

reporting and decision-making arrangements for the review are clear;

Terms of Reference are formalised;

Individuals are appointed and authorised to undertake review work.

This is a dynamic document, which will form the ‘baseline’ for this review, to enable the NSSC Sub-group and NSD to assess progress towards the review

aims and issues.

3 Background

The National Specialist and Screening Services Directorate (NSD) is a Directorate of the Procurement, Commissioning & Facilities (PCF) Strategic Business Unit (SBU) of NHS National Services Scotland.

Each year NSD receives top-sliced ring-fenced funding from the Scottish Government and NHS Boards to commission and performance manage

National Screening Programmes, Specialist Clinical Services and National Managed Clinical Networks and National Risk Share Schemes on behalf of NHS Scotland.

Individual referrals are made throughout the year to access specialist advice, second opinion and/or treatment not available in Scotland. These referrals

are dealt with on a case by case basis via the Cross-border referral/Access to Specialist Services provided by NHS England Process established between National Services Division and NHS Boards.1These referrals also include

access to stereotactic radiotherapy for some benign conditions from some areas of Scotland.

1 NHS National Services Scotland – National Services Division –

NationalSpecialist Service Committee – Policy Statement; Criteria for Designation as National Specialist Service and Principles of Operation.




4

Standard radiation therapy uses high energy X-rays to destroy DNA in cancer cells. It is provided over a number of weeks. Stereotactic radiation therapy

involves the delivery of radiation therapy and includes stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT). SRS refers to radiation treatment that is provided in one session (a single dose treatment),

whereas SRT occurs over multiple sessions or days (fractionated dose treatment). It is technically possible for Gamma knife surgery to provide SRT,

however, the LINAC based systems are more suited to providing fractionated radiotherapy. SRS and SRT provides a strong and focussed dose of radiation and this modality enables the treatment to be targeted to the

abnormal tissues whilst sparing the surrounding healthy tissue. It was initially used to treat tumours and other abnormalities of the brain however, now it is

also used to treat tumours in other parts of the body. This is called Stereotactic Body Radiotherapy (SBRT).2

SRS is used to treat benign conditions included arteriovenous malformations, other vascular malformations (benign and malignant) e.g. acoustic neuromas

(sometimes referred to as a vestibular schwannoma or neurilemoma), and other neurological conditions, including trigeminal neuralgia. A large number of Scottish referrals for these benign conditions, mainly from the North East

and West of Scotland NHS Boards, are directed to the Sheffield Teaching Hospital with a few being directed to Leeds.

The Service

Radiotherapy is a key component of modern cancer treatment and is likely to

remain so for the foreseeable future.3 Around half of patients being treated for cancer will receive radiotherapy as part of their treatment plan. 4 In Scotland

there are 25 modern linear accelerators(LINACs) distributed between the five cancer centres (Glasgow – 11, Edinburgh 6, Dundee – 3, Aberdeen – 3 and Inverness – 2) that equates to 4.98 LINAC per million of the population.

Scottish cancer centres are therefore able to deliver high quality radiotherapy to the Scottish population.

The Scottish Government National Planning Forum recently supported a proposal from the Radiotherapy Programme Board that there was a need to

consider national planning models for some clinical oncology service provision in Scotland. This proposal had Cabinet Secretary for Health and Wellbeing

support as well as support from the clinical oncology community. A sub -set of this work will be a review of the patient flows from Scotland to England to access stereotactic radiotherapy for benign tumours. It is proposed therefore

that a sub-group of the National Specialist Services Committee be established to take this workstream forward and report to the NSSC and Scottish

Government.

2 Evidence Adoption Centre (East of England) – Stereotactic Radiosurgery, Stereotatic

Radiotherapy and Stereotactic Body Radiation Therapy – A rapid Literature Review – May 2011. 3Scottish Executive Health Department (2006) Radiotherapy Activity Planning for Scotland

2011 – 2015 available at http://www.scotland.gov.uk/Resource/Doc/90297/0021749.pdf 4 Cancer Research UK (2009) Achieving a World-class Radiotherapy Service Across the UK





5

4 Review Definition

4.1 Objectives

The remit of the NSCC Sub-group will be:

Map out the current stereotactic radiotherapy provision for benign conditions.

Identify patient flows

Identify and detail any issues to include

o capacity:demand o technical expertise

o technical capability The key drivers can be summarised as follows:

Recent Scottish Government investment in LINAC to enable the delivery

of stereotactic radiotherapy

The Scottish Government and NHS Scotland Quality Strategy and 20:20

vision.

Equitable access to stereotactic radiotherapy across Scotland for patients with benign conditions.

Provide best value through the further development of Scottish patient pathways

This will involve collecting the relevant information; generating feasible options for consideration and implementation by regional cancer networks and

Cancer Centres in the North, South East and West of Scotland. . Activity

Stereotactic Radiotherapy Referrals outwith Scotland and costs

2011/2012 and 2012/2013.

Financial Year

Health

Board

Number of

patients Costs

1/4/11 - 31/03/12 A & A 5 £44,856

Borders 2 £442

D & G 1 £221

Fife 3 £13,241

Fvalley 3 £14,453

Glasgow 20 £92,102

Grampian 20 £91,093

Highland 6 £22,290

Lanarkshire 8 £50,231

Lothian 5 £16,655

Shetland 1 £221

Tayside 1 £20,044

Total 75 £365,849




6

Financial Year

1/4/12 to 31/3/13

Health

Boards

Number of

patients Total Cost

A & A 9 £66,608

Borders 0

D & G 2 £16,939

Fife 1 £6,672

Fvalley 5 £23,751

Glasgow 16 £108,480

Grampian 14 £68,903

Highland 10 £64,635

Lanarkshire 13 £68,982

Lothian 5 £25,861

Orkney 0

Shetland 0

Tayside 2 £8,923

Total 77 £459,754

4.2 Defined Method of Approach

The Senior Programme Manager NSD will be responsible for the

project management of this review, reporting to a Sub-group of the

NSSC) and maintaining regular communication with Scottish Government, Regional Cancer Networks, NHS Boards etc.

The NSSC sub-group will ensure that all users of this service are

suitably represented and can participate in the development of the

recommendation. The views of users, their carers and families need to form part of considerations.

All available activity data and technical specification data will be

used.

4.3 Review Scope

The scope of this review will include:

Remit and accountabilities;

Data;

Clinical Governance responsibilities;

Assessment against the Healthcare Quality Strategy for NHS

Scotland; The Scottish Government’s 20:20 vision;, standards and health technology assessments ; operational policies;

patient-centred care; national audit; clinical trials etc.

recruit members to the NSSC sub-group; comprising of the key stakeholders of the service - to advise on clinical and regional

issues.




7

4.4 NSSC Sub-group

The remit of the NSSC Sub-group is

to examine the patient-referrals and flows from Scotland to access

stereotactic radiotherapy for benign conditions against the o NHS Scotland Healthcare Quality strategy quality ambitions

Person-centred Safe Effective

and o to make recommendations to the newly established National

Specialist Service Committee and to NHS Scotland Board Chief Executives that will help ensure access to a stereotactic radiotherapy for benign conditions addressing current and future

needs over the next 3 – 5 years.

It is proposed that the following participants are invited to the NSSC Sub-group:

Policy Lead - Cancer, Head of Long-Term Conditions and Cancer

Team Scottish Government Health and Social Care Directorates (SGHSC) (tbc)

Regional Cancer Network Manager, Regional Cancer Network –

Scotland (tbc)

Regional Planning nominee

NHS Board Planning nominee

Neurosurgical Managed Service Network nominee

Patient/Public/Carer input

Clinical expert from outwith Scotland tbc

Consultant Clinical Oncology representation from each of the five

Cancer Centres in Scotland.

Cancer Centre General Manager

NHS Board Director of Finance (tbc)

NSD Representation

Dr. Mike Winter (Medical Director, National Services Division)

Mr Gordon Kirkpatrick (Finance, National Services Division)

Mrs Janice Birrell(Senior Programme Manager, National Services

Division)




8

Miss Karen Roberts (Programme Support Officer, National Services Division)

4.4 Exclusions

There are no exclusions identified

4.5 Review Deliverables and/or Desired Outcomes

The desired outcome is to provide a recommendation to the National

Specialist Services Committee, NHS Board Chief Executives and the Scottish Government on patient referral pathways to access stereotactic radiotherapy

for Scottish patients with benign conditions. 4.6 Constraints

Resources

There will be other projects within NSD competing for staff resources, which may impact on the timescale that this review can be conducted.

Budget

Where reviews require external facilitators and/or patient involvement a budget for such costs is allocated. In this case an allowance of £5,000 has

been made to facilitate nationwide representation and patient involvement. 4.7 Interfaces

This review requires to interface with a number of stakeholders; in particular

there needs to be strong lines of communication with patients and carers, the voluntary sector, multidisciplinary teams, Managed Neurosurgical Service

Network, NHS Boards, Regional Planning, Scottish Government Health and Social Care Directorates.

4.8 Reporting and Decision Making

The following assumptions have been made:

The NSSC sub-group will include personnel with sufficient experience

and knowledge to provide credible and reliable advice to decision makers (NSSC,NHS Board Chief Executives, and SGHSC).

The recommendations will be disseminated to decision makers who will have the authority to accept the recommendations.

The NSSC sub-group will represent the range of users of the service, who can influence the decision makers at local level.

The NSSC sub-group will make recommendations to NSSC, NHS

Board Chief Executives and Scottish Government Health and Social Care Directorates




9

Milestone Schedule

The schedule below details the key project milestones.

ID Task name Start date End date

1 2

3 4

5 6

7

8 9

10 11

12 13

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07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-49 - Co-location of Congenital Cardiac Services

1


NSSC

NSSC PAPER 2013/49

Co-location of congenital cardiac services

1. Background

The following two specialist congenital cardiac services are commissioned for patients with congenital heart disease by National Services Division on behalf of NHS Scotland:

The national Paediatric Cardiac Service - For patients up to and including 16 years of age. This service is hosted by NHS Greater Glasgow and Clyde, delivered at the Royal Hospital for Sick Children (Yorkhill).

The Scottish Adult Congenital Cardiac Service – For adults. This service is hosted by NHS National Waiting Times Centre Board at the Golden Jubilee National Hospital.

Both services include specialist multidisciplinary assessment and inpatient services from admission for specialist congenital heart surgery/interventional cardiology up to discharge or transfer from the ward post-operatively, and include all specialist congenital heart surgery, interventional cardiology and intensive therapy. Cardiology, diagnostic and imaging activities such as angiography and cardiac catheterisation, normally carried out prior to the definitive admission are also part of these national services. The same consultant surgeons perform the surgery for both the adult and paediatric services. 1.1. Safe and Sustainable standards of care

In 2011, clinicians and managers in the national Paediatric Cardiac Service at the Royal Hospital for Sick Children at Yorkhill undertook a self-assessment against NHS in England’s ‘Safe and Sustainable’ standards of care. NSD then invited an independent expert panel, chaired by Sir Ian Kennedy, to review the self-assessment documentation and the service delivered at Yorkhill. The Kennedy panel visited Yorkhill in November 2011, and their report was published in May 2012. The report highlighted a number of areas for improvement, which NHS Greater Glasgow and Clyde and NSD have worked to address. 1.2. Healthcare Improvement Scotland Review of the Paediatric Cardiac Services Healthcare Improvement Scotland was asked to conduct a follow-up review of paediatric cardiac services to seek an assurance that the identified improvements had taken place. In June 2013, Healthcare Improvement Scotland published their independent review report of the paediatric cardiac services at the Royal Hospital for Sick Children Glasgow. This report noted that a number of improvements had been made in the delivery of paediatric cardiac services, and noted a number of recommendations, which are being taken forward by NHS Greater Glasgow and Clyde, NSD, and the Scottish Congenital Cardiac Network. The report also made one recommendation out with the scope of the review, which was that:

“the Scottish Government consider combining the national paediatric and adult congenital cardiac services, with the potential that the service be co-located at the new South Glasgow Hospitals Campus in 2015.”


2

2. Scottish Government response

As noted in the attached letter, Mr Alex Neil, Cabinet Secretary for Health and Wellbeing has considered the recommendations of the Healthcare Improvement Scotland review and accepted the recommendations insofar as they relate to the current service. Mr Neil has also requested that a subgroup be established by the NSSC to consider whether the Scottish Adult Congenital Cardiac Service should be transferred from the Golden Jubilee National Hospital (National Waiting Times Centre Board) to the Southern General Hospital campus by 2015, so as to provide greater resilience and sit alongside the national paediatric cardiac service. The Scottish Government has suggested that this subgroup complete their work by Spring 2014, and to report back to the Scottish Government once their work is complete.

3. Potential outline approach of an NSSC subgroup

Should this workstream have the support of the NSSC, a full Project Initiation Document will be developed, and a formal Options Appraisal will be undertaken. At this time, the steer of the NSSC is sought on the following specific areas of approach: 3.1. Options appraisal

To respond to Mr Neil’s request, it is proposed that a subgroup of NSSC be established to undertake a formal options appraisal to consider the following two options set out by the Scottish Government/Healthcare Improvement Scotland report:

1. The status quo, i.e. that the two services continue to be provided in the same locations 2. The future relocation of the Scottish Adult Congenital Cardiac Service to the Southern

General Hospital

The subgroup will also be encouraged to suggest further options, which will be considered as part of the Options Appraisal process. 3.2. Timescales

It is acknowledged that the potential relocation of the Scottish Adult Congenital Cardiac Service would require major service change, and in order to ensure that an appropriate robust process is followed; that this group conclude their work and report to the NPPPRG, NSSC and the Scottish Government in early Autumn, for the August 2014 meeting of the NSSC. 3.3. Subgroup membership

It is proposed that the subgroup who would undertake the options appraisal include the following representation:

NHS National Waiting Times Centre Board o Senior Operational, Medical, and Nursing Management

NHS Greater Glasgow and Clyde o Senior Operational, Medical, and Nursing Management

Scottish Congenital Cardiac Network o Paediatric and Adult Clinical Leads

The Voluntary Sector o The Somerville Foundation o The Scottish Association for Children with Heart Disorders

British Congenital Cardiac Association

English Clinical Professional Expert

NSSC representative (independent of the two services)

3 Regional Cardiac Planning representatives

Scottish Government o Clinical Cardiac Lead o Policy (National Planning Team)

NSD


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4. Issues for discussion

The NSSC are asked to consider: 1. Whether an NSSC subgroup should be established to consider the co-location of the

specialist congenital cardiac services at the Southern General Hospital campus 2. The potential approach of the NSSC subgroup and timescales


St Andrew’s House, Regent Road, Edinburgh EH1 3DG www.scotland.gov.uk αβχδε αβχ α

The Quality Unit Planning and Quality Division T: 0131-2443308 E: [email protected]

αβχδεφγηιϕMrs Deirdre Evans Director National Services Division PCF Strategic Business Unit NHS National Services Scotland

___ 1 October 2013 Dear Deirdre HEALTHCARE IMPROVEMENT SCOTLAND - INDEPENDENT REVIEW REPORT – PAEDIATRIC CARDIAC SERVICES AT YORKHILL, GLASGOW As you are aware the above report was published on 24 June 2013, the recommendations of which were accepted insofar as they relate to the current service, NSD’s role as commissioner and that of NHS Greater Glasgow & Clyde as provider. I must apologise to all concerned for not formally seeking submission to NSSC before now. You are aware that there was a further recommendation, which was described in the report as “out of scope”, i.e.that consideration should be given to transferring the Scottish Adult Congenital Cardiac service from the Golden Jubilee National Hospital (National Waiting Times Centre Board) to the Southern General Hospital campus by 2015 so as to provide greater resilience and sit alongside the national paediatric cardiac surgery service. In considering this recommendation Mr Alex Neil, Cabinet Secretary for Health and Wellbeing has agreed that as both SACCS and the paediatric cardiac surgery service are nationally designated and commissioned by NSD working with the respective providers, this is a matter that should be looked at by the National Specialist Services Committee. I am therefore writing to as that you put this matter on the agenda for the next NSSC meeting with a view to setting up a small sub-group to look at this recommendation, in particular with regard tothe implications for both services, the organisations involved and including for staff and patients. It would be a matter for the NSSC to consider how long such a short life sub-group might need to assess all of the aspects and report back, however, it would seem reasonable to suggest this might be completed by spring 2014, however, I would be glad of further advice as appropriate once NSSC has had a chance to look at this.The subsequent report and any recommendation(s) from NSSC would, as is normally the case, be submitted to SGHSC, via myself, for consideration by the Cabinet Secretary.

St Andrew’s House, Regent Road, Edinburgh EH1 3DG www.scotland.gov.uk αβχδε αβχ α

If you have any queries, please just let me know. I am copying this letter to Robert Calderwood and Dr Jennifer Armstrong (NHS GGC) and to Jill Young and Dr Mike Higgins (Golden Jubilee Hospital/National Waiting Times Centre Board) and to Margaret Duncan, here in SGHSC who is the sponsor for NWTCB). Yours sincerely ELIZABETH PORTERFIELD Head, Planning Team

07 HSS\Cttees & Grps\Policy Grps\NSSC\Papers\2013-11-26\NSSC 2013-50 Horizon Scanning

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NSSC

NSSC PAPER 2013/50

Horizon Scanning

Previously notified / Updates

Tuberous Sclerosis Clinic

NSD has given advice to the clinical team in NHS GGC regarding national designation of this very rare condition. Stage 2 documentation has been provided to the applicant who is in continuing dialogue with NSD. It should be noted that a new medicine is to be launched in 2014 and it is likely the application will make reference to offering specialist advice on its use in selected cases. Application expected Jan 2014 Selective Dorsal Rhizotomy

Following submission of a proposed national clinical care pathway which will guide access to SDR for all patients in Scotland the clinicians in the group indicated that NHS Scotland should offer the surgical element of the service within Scotland rather than, as at present, through a third party provider – in NHS England or in USA. The Cabinet secretary for health has now accepted the recommendations from the report and the SDR care pathway is shortly to be published. It should be noted that the provision of specialist intensive physiotherapy prior to surgery and post operation is essential. The clinical advisors have continued to meet and have indicated an intention to submit a proposal to designate the surgical component of SDR as a national specialist service for consideration by NPPPRG and NSSC. Application expected Jan 2014

Epidermolysis Bullosa (EB)

NSD has been in discussion with DEBRA and dermatologists around Scotland about the need for a national service for this devastating condition. At present, the small numbers of paediatric and adult patients are seen in several centres around Scotland with input from services in England. DEBRA are heavily involved with patients and until recently were providing direct care. National designation and likely future service models still require to be discussed within the dermatological community and with possible host boards before an application can be made.

Child and adolescent mental health services for people who are deaf

NSD has been approached by the National Deaf Children’s Society about the establishment of a child and adolescent community mental health service for young people who are deaf. NDCS report that there is a significant difference between the delivery of an adult mental health service and a child & adolescent one. The National Deaf Children’s Society have still to establish links with an NHS Board who would be prepared to host this national service but hope to be able to provide an application to the October NPPPRG.

Vasculitis NMCN

Colleagues from the renal department in NHS Lothian have approached National Services Division (NSD) to discuss the designation of an NMCN for severe vasculitis.


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NSSC

NSSC PAPER 2013/51

Planning Transplantation to 2020

1. Introduction

Two complimentary strategies were published in summer 2013 by the Scottish Government

1and NHS Blood and Transplant

2, which set out the requirement to increase

deceased donor transplantation levels from 17.9 to 26 per million population over the next 7 years. There is also expected to be an increase in the number of paediatric and adult living donor kidney transplants over the next years3. Adult renal transplantation is not currently commissioned by NSD (further information is available in NSSC paper 2013/47). Within the Scottish Government’s strategy, there is an aspiration for “Scotland to be amongst the best performing countries in the world for donation and transplantation.” The NHS Blood and Transplant UK strategy for Living Donor Kidney Transplant also sets out the requirement to increase living donor kidney transplantation levels. An initial impact assessment undertaken by NSD has suggested that this is likely to increase solid-organ transplantation levels in Scotland (including adult renal) by 48% from 344 in 2012/13 to around 510 transplants in 2019/20, with increases in the number of transplants using organs from both deceased and living donors. In order to meet this significant growth in levels of transplantation activity, the capacity and of the Scottish solid-organ transplantation services will need to be considered. Increased transplantation levels may also bring the benefit of reducing pressures in other associated areas of treatment including dialysis, insulin therapy, hospital admissions, medical management (which include some high cost drugs), and surgery.

The Scottish Government has also requested that NSD implement action 15 of their strategy, namely to “continue to monitor aftercare requirements across Scotland, as well as relevant developments in evidence and research, to ensure transplant recipients receive the support that they need. Consideration should be given to working with primary care and other parts of the NHS to raise awareness on longer-term post-transplant management.”

2. NSSC subgroup

To consider the potential impact of a significant increase in the availability of donor organs and plan services, NSD recommends the establishment of an expert subgroup of the NSSC to act in an advisory capacity to the NSSC.

1 Scottish Government (2013). A Donation and Transplantation Plan for Scotland 2013 -2020.

2 NHS Blood and Transplant (2013). Taking Organ Transplantation to 2020.

3 NHS Blood and Transplant (2013). Forecast renal transplant activity levels 2013-2020 (paper provided to

NSSC adult renal transplant short-li fe working group)

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2.1. Proposed objective and aims of subgroup

The proposed objective of the subgroup would be to consider the growing future needs for solid organ transplantation, and make recommendations on the specifications and capacity required for each of the solid organ transplantation services in Scotland.

The proposed aims of the subgroup would be:

A. To forecast the future demand and availability/capacity required leading up to 2020 for

each of the services in scope: Transplantation capacity required to meet need for each service per year

o Associated outpatient capacity required o Live donor coordination capacity o Required workforce requirements o Input from supporting services, e.g. Histocompatability and Immunogenetics,

Pathology, Independent Assessors, Skin Surveillance o Physical hospital capacity required

Developments which may impact on the demand, availability/capacity of the transplant services

B. To ensure that the transplant service specifications are appropriate for 2020, including:

Service definitions

Quality Indicators

Approaches to machine organ reperfusion,

Approached to the care of patients, including critical care, ECMO and VADs Follow-up and shared care arrangements post-transplant (i.e. aftercare)

C. To explore the required future relationships/ requirements of other key stakeholders in

transplantation including the Scottish Government (inc. STG), NHS Blood and Transplant, NHS England, the Welsh Health Specialised Services Committee and the Health and Social Care Board in Northern Ireland

D. To undertake a Healthcare Economics analysis costing report, looking at the resource impact (benefits/costs/saving) of implementing the group’s recommendations

2.2. Proposed approach of subgroup

It is suggested that the NSSC subgroup include representation from the NSSC, the transplantation services, the associated supporting services, referrers, the donor/recipient community, the Scottish Government, NHS Blood and Transplant, Regional Planners, NSD and other key stakeholders. The Scottish Government’s Scottish Transplant Group will monitor progress against the Scottish Government’s strategy. The NHS Blood and Transplant Implementation Oversight Group will monitor progress against its strategy across the UK. Both of these groups will oversee all areas including awareness, registration on the Organ Donor Register, referrals to the Specialist Nurses in Organ Donation, family authorisation rates, organ retrieval, organ utilisation and transplant. It is proposed that the subgroup also provide reports to these two groups on progress.

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2.3. Proposed scope of subgroup

It is proposed that the group undertake planning for the following transplant programmes:

Liver Heart

Simultaneous Pancreas/Kidney

Islet

Paediatric kidney

Adult kidney (should the service be nationally commissioned in the future)

Face (should the service be nationally commissioned in the future)

Lung (provided in England) Heart/lung (provided in England)

Small bowel (provided in England)

Paediatric liver (provided in England)

Paediatric heart (provided in England) The Paediatric and Adult Bone Marrow Transplantation services have recently concluded their NSD 3-5 year major reviews and so would remain out of scope of the Planning Transplantation to 2020 workstream.

3. Action required by NSSC

NSSC is asked to consider:

Whether an NSSC subgroup should be established to plan transplantation to 2020

Whether they are broadly content with the subgroup’s proposed objective and aims, approach and scope

Chris Myers NSSC Secretariat 18 November 2013