BLOOD AND MARROW TRANSPLANTATION IN NORTH WALES

Transcription

1 BLOOD AND MARROW TRANSPLANTATION IN NORTH WALES 1. Betsi Cadwaladr University Health Board (BCUHB) suspended the BMT programme in Autumn 2012 due to difficulties in consultant staffing. Autograft transplants have been undertaken at The Christie NHS Foundation Trust in Manchester since then. 2. Dr Matt Makin, Chief of Staff, who is responsible for the Cancer, Palliative Medicine and Clinical Haematology Clinical Programme Group (CPG) in BCUHB has been in regular communication concerning the question of whether to restore the transplant programme in Bangor. He invited me to consider the clinical arrangements for the transplant programme including clinical and laboratory support. It was agreed that a joint meeting with the transplant team should examine the action plan developed by the Cancer Clinical Programme Group. 3. We (Phil Webb and myself), met with the full transplant team on Friday, 17 May 2013 at the Alaw Unit, Ysbyty Gwynedd. 4. The clinical and laboratory facilities including key staff were visited including the day unit where stem cells are harvested, the inpatient ward where two new transplant rooms are being constructed and the haematological laboratory including the cell manipulation and storage sections. 5. The main meeting focused on joint assessment to be clear whether the transplant service, if reinstated, would meet the standards for a safe and sustainable programme. 6. We systematically examined the stem cell programme workplan: This had been authored by Mr Damian Heron (Director of the Cancer Network and Associate Chief of Staff) and Dr Melinda Hamilton (Clinical Director of Clinical Haematology), Mr Heron was not able to be present at the meeting but Dr Matt Makin provided the Health Board Executive perspective and the clinical team response was led by Dr Melinda Hamilton and Dr David Edwards (Stem Cell Programme Lead). 7. Clinical guidelines are essential for compliance with JACIE standards: The Joint Accreditation Committee of the International

2 Society for Cellular Therapy (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT). The clinical guidelines have been extensively revised to ensure that all necessary protocols are updated, stored and accessible. Some further work is required including an audit trail/method and a quality manual. 8. Patient selection: there is now a single BMT MDT for North Wales. The operational policy for the MDT including chair (currently Dr David Edwards), including methods of operation and recording as well as referral of patients to other transplant centres was not available / completed. Extensive discussion included description of the typical patients considered for transplantation as candidates for autografts (lymphomas and patients with multiple myeloma). Because patients are currently still referred from Wrexham to The Christie for autografts, it is clear that the MDT is not yet providing a comprehensive capture of all North Wales patients who are transplant candidates. A small number of transplants were undertaken in 2012/13 in Liverpool and there was a discussion about whether any further referrals to Liverpool are necessary if The Christie provides the expert transplant centre support for all indications. Note that Dr Edwards referred to the historical referral pathway for patients with aplastic anaemia to the transplant service at Bristol. 9. Harvesting preparation: most significant conclusion from the discussion was that the decision to use Plerixafor if the day 1 harvest was limited requires an explicit revision to the existing protocol to relate to the draft service specification. Note that it was recognised that the consent form does not make the timing of the use of Plerixafor clear to patients and that amendment will be required. 10. Harvesting: takes place at the Alaw Unit for all autograft patients, including patients under the care of YGC. Recent changes have resulted in dedicated nurse staffing for harvesting. Structural changes to the day unit will, when completed, provide separate and private rooms for harvesting. Note, new rapid harvesting machines are ready for use. 11. Cell storage: The organisation of cell storage and processing is excellent and has been the subject of a site visit inspection report by the Human Tissue Authority (HTA).

3 The HTA found that YG Bangor met the majority of the HTA standards with five specific shortfalls related to governance and quality systems as well as premises, facilities and equipment. The laboratory lead and the transplant service director, confirmed that all the HTA requirements are being addressed, including extensive strengthening of quality assurance and reprovision of laboratory space following upgrade. 12. Cell transportation: the discussion on the transport of harvested stem cells for reinfusion at Glan Clwyd was described. The joint meeting discussed the fact that by transporting the stem cells and reinfusing at YGC, there is in effect a second transplant unit in operation. We considered that the clinical staff from Bangor do not attend YGC to manage the patients after reinfusion and the nature of the clinical support from the haematology team at YGC. 13. Medical responsibility and cover: Dr Edwards and Dr Jim Seale provide the principal support for the transplant programme but Dr Hamilton and the fourth haematologist Dr Sally Evans provide full cover as the attending physician and when on call. In effect all four consultants are involved in the transplant programme participation in the MDT as well as provision of clinical care. 14. Conditioning chemotherapy: protocols have been revised. 15. Stem cell reinfusion: As in paragraph 13 above, there was detailed discussion concerning the organisation, governance and consequences of re-infusing on the YGC site with clinical support from the YGC haematology team. The extent to which this is dilution of the strength of the transplant programme in Bangor including the benefits of rebuilding the day unit for harvesting and reconstruction of the ward to support transplant cubicles was heavily debated. 16. Post infusion care guidelines: alignment of protocols for use at Bangor and Glan Clwyd still raises the fact that two separate clinical teams are managing transplant patients in small numbers over the two sites. The CPG has given a commitment to work with the Consultant Haematologists across BCUHB to consider a single site for re-infusion. 17. Environment: Additional rooms with en-suite facilities at Bangor are a considerable improvement. 18. Relatives: Facilities available (not specific to the BMT service). 19. Information: Common information pack for patients but Wrexham patients are not currently included in the transplant programme and would require additional specific information.

4 20. JACIE Accreditation: There is a clear understanding on the part of the transplant team that JACIE accreditation is essential and there is a mandatory requirement for accreditation if The Christie transplant service agree to share post allograft care. 21. The Christie Hospital: Dr Adrian Bloor joined the meeting and reported the willingness of The Christie to network on a regional basis with a strong commitment to sustained support for the transplant MDT, selection of patients for transplantation and as above consideration of shared care after allografts. However, Dr Bloor discussed the referral of some patients to other centres including Liverpool and Bristol and proposed that The Christie should have first refusal, in effect, because the transplant programme is fully comprehensive and manages all disease sub types and related transplants. Dr Edwards repeated the historical referral pattern to Bristol for aplastic anaemia. The solution to stop referrals to Liverpool requires a full commitment to a North Wales haemato-oncology / transplant MDT with full links to The Christie. 22. Conclusions: a. The service provided data and clinical assurance that the HSCT outcomes produced by the service before suspension (i.e. survival) were statistically similar those expected of other UK centres providing an autograft service. Therefore, with respect to survival there were no clinical governance concerns relating to the outcomes of the service. With respect to other end points such as morbidity, adverse events and quality of life, no data were provided (nor are these data routinely provided by other HSCT centres). The service is in the process of capturing patient experience data which would be shared with the Medical Directorate when available. b. The lack of JACIE accreditation for both the laboratory and clinical service is a major derogation from the English service specification extant 1 April This places the autograft service at Ysybty Gwynedd as one of only 9 HSCT centres in the UK without JACIE accreditation which represents a significant concern. However, the action plan submitted addresses the process by which JACIE accreditation could take place and BCUHB have committed investment in 2013/14 ( 40, 000) to ensure that JACIE accreditation is worked towards and obtained.

5 It is also clear from the meeting that JACIE accreditation would be more easily obtained in the context of an existing and operational service providing care to patients so due clinical consideration should be given to re-instating the service while the JACIE process is being undertaken. c. A single centre for autograft transplant is a better option than the existing two-site centre for reasons of clinical governance, protocol compliance and consistent clinical management of patients by all levels of staff involved in the care of patients. A single transplant site would also support the consistent collection of data required for the BMT registry and data required to support populating the quality and outcomes dashboard. d. Collaboration with The Christie Hospital and the development of this clinical relationship is essential to improve the clinical processes of patient identification, treatment and wider pathway management issues for more complex cases. A considered view would need to be taken about future referral patterns for more complex cases (i.e. consolidation at The Christie or continued referral to Liverpool and Bristol for a small number of cases). e. The Christie clearly would be able to provide a comprehensive service for all complex cases (e.g. all disease subtypes for allogenic transplants). This single tertiary provider option would facilitate shared care in the future following JACIE accreditation for allogenic transplants which is an aspirational objective for the service. f. An improved focus on patient pathways across BCUHB is critical and the service acknowledged that more work would need to be done in this area. g. A future meeting is required on an All Wales basis to agree the finalised version of the Clinical Access Policy, Service Specification and Quality Dashboard which will be lead by the Medical Directorate, WHSSC. DR GEOFFREY CARROLL Medical Director DR PHILIP WEBB Specialised Commissioner 21 May 2013

6 APPENDIX 1 CLINICAL ACCESS POLICY WELSH HEALTH SPECILAISED SERVICES Clinical Access Policy: Haematopoetic Stem Cell Transplantation - Adults First published:

7 1. Policy Statement WHSSC will commission haematopoetic stem cell transplantation (HSCT) for the clinical conditions outlined in this document. In creating this policy, WHSSC has considered the evidence base for clinical and cost effectiveness for the clinical conditions and options for treatment. This document outlines the arrangements for clinical access and funding for treatments for the population of Wales. WHSSC will provide funding for the following clinical conditions based on the British Society of Blood and Bone Marrow Transplantation (BSBMT): All Standard (S) indications are routinely funded. Clinicians should refer appropriate patients to Designated Providers for treatment (see Service Specification); Indications listed as Clinical Option (CO) are not routinely funded. Clinicians should refer all patients for consideration to the WHSSC prior approvals Panel before any discussion with patients has commenced (see Clinical Option Appendix A for method of consideration and clinical context); Indications listed as Developmental (D) and/or Generally Not Recommended - (GNR) are considered as experimental and are not funded. Patients should be recruited into an appropriate clinical trial. 2. Definitions Autologous stem cell transplantation uses the patients own stem cells which are harvested prior to high dose therapy. It is performed as part of dose escalation therapy as a Standard indication for the following conditions: Myeloma for patients suitable for intensive treatment; Acute Myeloid Leukemia (APL CR2) Lymphoma (CR>1 and relapse, primary refractory, chemosensitive) Mantle Cell Lymphoma (CR1/PR1; CR/PR>1)

8 Follicular Lymphoma (CR/PR>1) Diffuse Large B-Cell Lymphoma (CR/PR>1) Peripheral T-Cell Lymphoma (CR/PR>1) Neuroblastoma (poor risk disease) Germ Cell (PR>1)

9 Allogenic haematopoetic stem cell transplant (HSCT) involves replacing the bone marrow stem cells following high-dose therapy with stem cells from a tissue-type matched or mis-matched unrelated donor (MUD). This approach is a Standard therapy in for the following conditions Chronic Myeloid Leukemia (Chronic phase: TKI refractory, intolerant or T351I mutation sibling allograft or unrelated donor; Accelerated phase: after initial therapy with TKI - sibling allograft or unrelated donor; 2 nd Chronic Phase: sibling allograft or unrelated donor) Myeloma (First line sibling transplant; Plasma Cell Leukemia: if chemoresponsive disease in young patients <56 years) Acute Myeoid Leukemia (APL CR2: sibling or MUD; good risk CR2: sibling or MUD; standard risk: CR1/CR2 sibling or MUD; poor risk: CR1/CR2 sibling or MUD) Acute Lymphoid Leukemia (CR1 standard or poor risk: sibling or MUD; CR2: sibling or MUD; Philadelphia positive: sibling or MUD) Chronic Lymphoid Leukemia (Very High Risk CR1: Reduced Intensity Conditioning Sibling or VUD; High Risk CR2: Reduced Intensity Conditioning Sibling or VUD; Richters Transformation CR1: Reduced Intensity Conditioning Sibling or VUD; T-PLL: Reduced Intensity Conditioning Sibling or VUD) Aplastic Anaemia (Severe Aplastic Anaemia: Sibling or MUD; Constitutional Aplastic Anaemia: Sibling or MUD) Myelodysplatic Syndromes (Int-2, High: Sibling or VUD; Therapy Related MDS: Sibling or VUD) 3. Patient Pathway The procedure for transplantation can be divided into several phases: Pre-transplant work up: This includes assessment of transplant eligibility, tissue typing of donors if applicable and basic investigations of the fitness of the donor and recipient. Pre-transplant work up is the funding responsibility of Health Boards.

10 Mobilisation: Mobilisation involves the collection of stem cells from either the donor or the patient and processing the cells in the laboratory. Mobilisation and mobilisation regimens are the funding responsibility of Health Boards. Conditioning: Conditioning prepares the marrow for transplantation by either myeloablative or immunosuppression therapies. Conditioning regimens are the funding responsibility of Health Boards. Transplantation and engraftment: Cells are transplanted in the form of an intravenuous infusion and then inpatient care is delivered until the patient has recovered enough to reduce the risk of infection. This process is termed engraftment. Transplantation and engraftment are the funding responsibility of WHSSC. Post-transplant follow up and complications management: This varies according to the nature of the transplant and can take up to one year. Complications are managed by the transplant team. Serious complications such as the development of graft versus host disease (GVHD) are the funding responsibility of WHSSC. 4. Exclusions Specifically, this policy is for adults requiring a BMT. All patients 19 years of age and over are covered by this policy which outlines the indications that will be funded ( Standard ), those that will require prior approval ( Clinical Option ) and those that will not be funded ( Developmental and Generally Not Recommended ). Patients 18 years and under are covered by the Paediatric BMT Clinical Access Policy and Service Specification. The classification of indications may change following review and evaluation of evidence. Any revisions will be agreed by the WHSSC Joint Committee and any revision will be notified to BMT Units treating Welsh patients and will be reflected in changes to SLAs and contractual conditions with Providers.

11 It is expected that patients eligible for BSBMT clinical trials will only be treated by Providers formally participating in the trial. Patient funding for inclusion into clinical trials will need to be agreed with WHSSC at least 3 months in advance of patient recruitment and consent into the clinical trial. In addition: Repeat autologous or allogenic transplantation for relapsed disease will not be routinely commissioned. Repeat transplants will be considered under the category of Clinical Option and will require Prior Approval; Antifungals 100 days post-transplant are the funding responsibility of Health Boards; Should patients die before transplant infusion, incomplete transplants will not be funded. 5. Review This policy will be reviewed on XXXXXXXXXX or following the publication of material evidence to change the classification of the indications funded.

12 APPENDIX 2 SERVICE SPECIFICATION WELSH HEALTH SPECILAISED SERVICES Service Specification: Haematopoetic Stem Cell Transplantation - Adults First published: 6. Aims and Objectives The objective of the service specification is to identify and describe the minimum standards required for any stem cell transplantation unit provide services to Welsh residents. Delivering high quality care and improving outcomes will consistent with the NICE Guidelines on Improving Haematological Cancers and JACIE Standards (version 5.0 Appendix 1). This includes meeting the standards for: Treating patients in-line with the Clinical Access Policy (Appendix 2); Optimising patients outcomes after transplantation (reference policy on Extra-Corporeal Photophoresis Appendix 3);

13 Reduction of transplant related mortality and morbidity; Development and production of appropriate patient and carer information Clinical audits on patient consent, outcomes and satisfaction as indicated in this service specification reported to WHSSC for all Welsh patients; Entry of patients into clinical trials and collection of national clinical trials data 7. Applicable Service Standards Standards All transplants should take place in JACIE accredited centres and BMT Units should be compliant with JACIE version 5; - As such a minimum of five (5) new allogenic patients during the twelve (12) months period prior to accreditation and a minimum average of five (5) new autologous patients shall be transplanted per year within the accreditation. Centres will require a catchment population of million patients; - In addition all centres should adhere to the key IOG recommendation that all patients should be managed by a multi-disciplinary haematooncology team - Transplant units must meet the standards for specialised centres by undertaking transplants in accordance with the extant guidance as recommended by JACIE. WHSSC will monitor against these standards and will expect Providers to provide evidence in support; - Centres should meet the requirements defined as level 3 and/or 4 in accordance with previous BCSH Guidelines (level 4 if MUD are undertaken);

14 - Each transplant centre must have a named designated person acing as a unit co-ordinator; - There should be a full range of support staff including social workers, psychological support, physiotherapy, pharmacy and radiological support; - There should be close support with the Palliative Care Service; - The transplant centre should have a full range of back-up services on a 24-hour basis including ITU, specialist respiratory, renal, cardiac, gastroenterological and microbiologial expertise on site; - Strategies for prevention, control and treatment of infections and complications should be defined and up to date; - Clinical nurse specialists should be available to provide support. Clinical nurse specialist should have specific training in communication, counselling and ethics and should be members of the multi-disciplinary team; Days/Hours of Operation Transplant centres must be staffed on a 24-hour basis. There should be appropriately trained specialised nursing staff. The nurse to patient ratio must be 1:2 or better. Each BMT unit must provide 24 hour inpatient care and appropriate access to day care and outpatient services; WHSSC will monitor length of stay and early transfer back to secondary care, including cost implications for shared care centres; BMT consultants must report back to referring consultants on the progress of patients. The quality of the communications between the BMT consultant

15 and the referring consultant will be monitored as appropriate to the treatment plan; The should be written arrangements in place for direct 24-hour emergency access post-discharge; Referral criteria and Providers WHSSC will expect consultants to refer to Provider Units with which WHSSC has contracted with; WHSSC reserves the right to re-designate Providers for certain services with 6-months notice. Designation will apply equally to all Providers but the outcome may differentiate between Providers where there are differences in quality, service, value, sub-speciality or patient experience; Consultants should refer patients already registered in BSBMT/NCRN clinical trials to the contracted Provider Units already participating in the trial; Providers are required to meet the National Minimum Dataset Discharge Process and Aftercare Discharge documentation should be sent to the relevant healthcare professionals on the day of patient discharge in accordance with national guidelines. Discharge meetings with other care providers must be arranged as appropriate; A written, clearly defined after care plan should be developed between the patient and the Provider Unit. Communication with general practioners and staff in primary care should be timey, consistent, efficient and continuous; The general practioner should be informed at all stages of the patients treatment and should be informed as to how to access advice; The follow-up period must run for the time agreed with the referring clinicians and in-line with this service specification. A clinical review is expected 3-months after transplant between referring and providing clinicians to enhance communication, to plan further treatment and to agree on transfer arrangements;

16 Delays in planned or agreed transfers are required to be audited. The clinical quality, timing and effect in terms of cost of transfer arrangements will be monitored; Response Times and Prioritisation Providers will respond to the referral and initiate the admission process or initiate any other clinical actions (including completing requests for prior approval in line with the Clinical Access Policy); If providers do not have the capacity to accept patients the service must liase immediately with WHSSC to arrange alternative plans for patients; Tissue typing turnaround times are as follows: 96 hours for extremely urgent patients; 5 10 days for other patients according to clinical need. Informed Participation The Transplant Unit must enable the patients, donors, carers and advocates informed participation and to be able to demonstrate this. Provision must be made for patients with communication difficulties and those whose first language is not English or Welsh; Patients and carers must be given the names and responsibilities of the multidisciplinary team; A dedicated counselling service should be available to the patient at all stages of treatment from point of referral onward. Counselling should be available, at least during working hours, either personally or via telephone. Uptake and patient satisfaction of the counselling service will be monitored by WHSSC; Good quality patient information (which has been evaluated by patients) should be available to patients at the point of referral and should be used to re-enforce clinical communication and to inform patients about all aspects of the condition and treatment and its effects on daily living. This should include accurate and balanced information based on unit clinical outcomes and risk of complications and adverse events. A review of patient information should be carried out annually. Patient satisfaction, experience and quality of life are expected to be carried out including views on the information they were given and it s sufficiency in

17 enabling them to make informed consent about each intervention, quality of care and pain control; The patients contact with the unit in terms of day care and local shared care should be planned in consultation with the patient. The care plan should include the likely timescale for treatment; The existence of a patient run support group is desirable. Facilities The Transplant Centre should have a designated transplant unit with four or more designated beds. This could be part of a larger facility for the treatment of patients with haematological and or other malignancies. The unit should have facilities that minimise airborne microbial contamination; All patients receiving induction therapy should be in single rooms; There should be a designated outpatient area that reasonable protects patients from the transmission of infective agents; The Transplant Centre should be able to perform on site all procedures connected to harvesting and manipulation of storage of bone marrow and/or PBSC or confirm to WHSSC that alternative appropriate arrangements have been made with another designated Transplant Centre of Blood Authority; The centre should have facilities for the reverse barrier nursing of patients; Adequate access to CT and MRI is required. PET/CT is available consistent with the Clinical Access Policy for PET/CT. There should be appropriate access Radiotherapy Services with at least two radiotherapists with a special interest in haematological malignancy and expertise in appropriate specialised techniques; 8. Key Service Outcomes

18 Expected Outcomes Mortality rates will be recorded at one and five years Autologous 100 day mortality should be less than 5%; Allogenic 100 day mortality should be less than 30% WHSSC will monitor with each Provider separately:100 days post-transplant survival and overall survival rates The service should demonstrate progression free survival and other end points equivalent to reported trial data. This includes complication rates such as Graft versus Host Disease. All mortality events should be reported formally to WHSSC The service should provide quality of life monitoring using an appropriately validated instrument (generic and disease specific) and allogenic services should aim to provide a late effects service. Transplant Centres should prospectively inform WHSSC of patient being entered into clinical trials. All Providers will agree with WHSSC on how the outcomes of service will be assessed. There will be an agreed process for clinical surveillance involving regular and documented clinical audit. This information will be considered by the WHSSC Patient Quality and Safety Panel. All transplants should be registered with the BSBMT and the European Bone Marrow Transplant Register via the BSBMT Data Office. Data completeness will be reviewed by WHSSC and corrective action will be taken by WHSSC for centres with repeated data incompleteness issues. Providers will be expected to provide full and complete data to populate the National BMT Dashboard either directly or via the BSBMT registry as greed with WHSSC. Additional relevant information may be required by WHSSC.

19 Mr Geoffrey Carroll Medical Director WHSCC Grwp Rhaglen Glinigol Canser, Meddygaeth Liniarol a Haematoleg Glinigol, Ysbyty Maelor Wrecsam Cancer, Palliative Medicine and Clinical Haematology Clinical Programme Group, Wrexham Maelor Hospital Ein cyf / Our ref: MKM/jad : E-bost / matthew.makin@wales.nhs.uk Dyddiad / Date: 27 th May 2013 Dear Dr Carroll Stem Cell Transplant Service Ysbyty Gwynedd Thank you for the report following your visit to the Bone Marrow Transplant (BMT) Unit at Ysbyty Gwynedd. We have now had the opportunity to consider the content of the report and Dr Melinda Hamilton (Clinical Director) has discussed it with our clinical teams across the three sites of the Health Board. We have taken note of the recommendations within the report, and I can confirm we have agreed the following: That the service will move from offering reinfusion at two sites (Ysbyty Gwynedd and Ysbyty Glan Clwyd) to reinfusion at one site (Ysbyty Gwynedd) That the patients from Ysbyty Maelor that are currently referred to the Christie NHS Foundation Trust for autograft will be referred to the Bone Marrow Transplant Unit at Ysbyty Gwynedd That a more formal network arrangement will be established in general, with a commitment to develop a Bone Marrow Transplant MDT with the BMT Team at Betsi Cadwaladr University Health Board (BCUHB) and the Christie NHS Foundation Trust Cyfeiriad Gohebiaeth ar gyfer y Cadeirydd a'r Prif Weithredwr / Correspondence address for Chairman and Chief Executive: Swyddfa'r Gweithredwyr / Executives Office, Ysbyty Gwynedd, Penrhosgarnedd Bangor, Gwynedd LL57 2PW Gwefan: / Web:

20 We are committed to gaining JACIE accreditation; an outline plan has been developed, and the Cancer Clinical Programme Group (CPG) has committed 40K to ensure the necessary staffing is in place to support the process. I have discussed the above with our acting Chief Executive Geoff Lang, and we have agreed to inform the chair of the BCUHB Quality and Safety Committee that we intend to restart the BMT auto graft service at Ysbyty Gwynedd on the 10 th June. Your inspection visit with your colleague Phil Webb and Dr Adrian Bloor from the Christie NHS Foundation Trust was extremely helpful in ensuring that the service will be restarted on a safe and sustainable footing. Yours sincerely Matthew K Makin MA MD FRCP (Edin) Chief of Staff: Cancer Clinical Programme Group Visiting Professor and Consultant in Palliative Medicine Cc Martin Duerden Acting Medical Director BCUHB Geoff Lang Acting Chief Executive BCUHB Damian Heron Director North Wales Cancer Network Neil Bradshaw Executive Director of Planning BCUHB Dr Melinda Hamilton Clinical Director: Clinical Haematology BCUHB Dr David Edwards Stem Cell Transplant Lead BCUHB Dr David Fletcher Associate Chief of Staff (Operations) Pathology CPG BCUHB.