DRAFT
Commissioning Guidance for Blood and
Bone Marrow Transplants in Wales
October 2007.
1
Contents
Page
1)
Introduction
3
2)
Context
3
3)
Definitions and Clinical Pathways
3
4)
Current Provision in Wales
4
5)
Service specification
5
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11
5.12
JACIE Accreditation
Activity
Facilities
Programme Management
MDT Structures and Personnel
Support Staff and Facilities
Transfusion and Laboratory services
Pharmacy service
Clinical Policies
Follow Up
Information
Clinical Research
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5
6
6
7
8
8
9
9
10
10
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6)
Performance and Clinical Information
11
7)
Referral Mechanisms
11
8)
Patient Selection
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8.1
8.2
Procedures Supported
Clinical Options Panel
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Appendix 1
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2
1)
Introduction
The purpose of this document is to build upon the current commissioning policy issued
by Health Commission Wales (HCW) in October 2006 and in doing so provide more
informed guidance on the governance and performance aspects of a blood and bone
marrow transplant (BMT) service.
In addition, and in light of developments within what is a rapidly changing field of
oncology/haematology recommendations are also made for a more refined process for
identifying patients that may be suitable for a blood or bone marrow transplant.
2)
Context
BMT activity is rising significantly with data from the European Group for Blood and
Marrow Transplantation (EBMT) showing that there has been a significant increase in
the number of transplants performed in Europe over the past 30 years rising from 14 in
1975 to over 30,000 in 2005 (Gratwohl et al, BMT 2001;27:899-916;Gratwohl et al, BMT
2006; EBMT Annual Surveys 2000 – 2005) This growth is in part due to an increase in
the number of diseases found to be improved through BMT, the development of reduced
intensity transplants, improvements in tissue typing and the expansion of the donor pool.
The majority of transplants (60%) are autologous but allogeneic transplants are
increasing significantly, rising in the UK and Eire by 17% between 2004 and 2005;
unrelated donor BMTs accounted for 49% of allogeneic activity in 2005.
The HCNA indicates an estimated requirement of at least 40 transplants per million
population leading to a suggested annual figure for Wales of approximately 120
procedures per annum.
Despite the increased activity sufficient evidence for the efficacy of BMT for certain
diseases remains open to interpretation, (Carroll, BMT briefing paper, unpublished,
2007).
3)
Definitions and clinical pathways
For the purpose of this document BMT is defined as the transplantation of blood stem
cells derived from bone marrow or blood in order to repopulate the bone marrow and
produce new healthy blood cells.
Where appropriate a distinction will be made between a procedure where the source is
the patient themselves, an autologous transplant or from a donor, an allogeneic
procedure.
3.1)
Clinical Pathways
Clinical pathways will differ by primary disease, type of transplant and location. However
understanding some core elements of the clinical pathway is essential to the
commissioning process as elements of the pathway can be delivered by different
organisations with different levels of service and different commissioning arrangements.
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As a consequence each pathway should be identified for each part of Wales – see table
1.
Table 1.
Common elements of a BMT pathway
Pathway element
Potential location
Initial remission induction Unit level
chemotherapy
Decision to transplant
Unit/ centre level
Donor selection
Harvesting
Unit/ centre level
Centre
Storage
Centre
Conditioning
Re-infusion
Centre
Centre/unit level
Post infusion recovery
Centre/unit level
Follow up
Centre/unit level
Notes
Depends on primary disease
MDT discussion that should be joint
with BMT centre
Dependent on procedure identified
May include donor and procedure.
Blood stem cell harvesting may
include multiple visits
A percentage of stored blood and
bone marrow may not be used and
may be stored for future use
Chemotherapy work up
Optimum location is at centre to
reduce risks.
Dependent on time post infusion, well
being post infusion, type of
transplant, psychological status and
facilities
Can be performed in either subject to
protocols
Providers of BMT services should identify to commissioners annually the clinical
pathways for BMT in their locality naming the organisations involved and their
role within the pathway.
4)
Current Provision in Wales
Adults
Allogeneic transplants for the South, Mid and West Wales are performed at University
Hospital Wales (UHW) within a purpose built 6-bedded unit. Autologous transplants for
the same population are also performed within UHW. Approximately 50 BMT are
performed within UHW per annum.
Swansea NHS Trust do not perform allogeneic transplants but do provide an autologous
BMT service for a specified population from West Wales exceeding the required 10
procedures per annum.
North West Wales NHS Trust also perform in excess of 10 autologous BMT per annum
within their oncology/haematology unit and also provide harvesting and storage facilities
4
for patients to later have their cells re-infused at Conwy & Denbighshire NHS Trust
within the confines of the North Wales Cancer Treatment Centre.
Access to allogeneic transplant for the North Wales population is via the Christie Hospital
in Manchester using their 18 bedded BMT unit. Occasional referral is also made to Bristol
for specific cases.
North East Wales NHS Trust currently refer all their BMT patients to Manchester though
plans have been agreed to use North West Wales Trust for autologous transplantation in
the future.
Children
There is currently no childrens BMT service in Wales with the services at Bristol,
Manchester, Newcastle and Great Ormond St providing access.
This commissioning guidance does not apply to BMT for children.
Other providers
It is believed that other providers used in the past for specific adult cases have been
Liverpool, Birmingham and Bristol although none have been subject to a commissioning
policy.
5)
Service specification
In order to be commissioned as a provider of a BMT service the following elements of
the service must be in place and maintained. Where indicated evidence must be
provided on annual basis.
Key factors identified below directly relate to the ‘ International Standards for Cellular
Therapy Product Collection, Processing and Administration’ FACT –JACIE (3RD Edition –
Feb 2007) and are also in line with NICE IOG and the Welsh Cancer Standards.
5.1)
JACIE Accreditation
It is a key requirement that units providing BMT services should work towards JACIE
accreditation (see 5.8).
The requirements below are identified as key requirements of a BMT service
that assure basic safety and quality and though key elements of JACIE are
considered to be elements of a service specification that should be in
evidence before final JACIE accreditation is achieved.
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5.2)
Activity
A service providing allogeneic transplantation should perform a minimum of 10 new
patient procedures per annum with no minimum number for autologous transplants
being required if performed within the same unit.
A service providing solely an autologous BMT service should perform a minimum of 5
new patient procedures per annum.
A breakdown of activity must be provided monthly and a summary provided
annually
5.3)
Facilities
Inpatients
Inpatient facilities must be of a nature to minimise airborne microbial contamination with
a minimum requirement being single bedded, private accommodation with en suite
sanitary facilities. Such facilities must be provided for the remission induction, bone
marrow re-infusion and marrow recovery phases of the pathway.
Laminar flow, HEPA filtration facilities are desirable for allogeneic BMT services but are
not required for an autologous BMT service.
All facilities must be supported by a protocol for environmental hygiene e.g. room
cleaning, filter cleaning/replacement schedule. Adherence to this protocol should be
audited annually.
Facilities supporting an allogeneic programme should ideally be able to support mobile
renal dialysis facilities.
Day case/outpatients
Dedicated outpatient and day case facilities should exist that are designed to,
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
minimise infection risk
facilitate IV drug and blood product administration
- Facilities should be described annually and confirmed year on year.
- Audit of environmental hygiene measures should be provided annually.
5.4)
Programme Management
The Clinical Transplantation Programme must be under the leadership of a single
Programme Director with an agreed deputy both of whom are deemed to have adequate
experience for the role, as agreed by the relevant Cancer Network.
The Clinical Programme Director will
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Be responsible for the administrative and clinical functions of the service
Have oversight of all elements of the clinical programme including quality
management, selection and care of patients and donors, cell collection and
processing (internal or contracted out)
Have oversight of all medical care and the proficiency of those delivering that
care
Have oversight of the clinical care delivery by the transplant team (MDT)
Programme Director confirmed annually
5.5)
MDT structures and personnel
The BMT service must be supported by a sustainable BMT related multi disciplinary team
(MDT) who function both in a virtual and physical manner to identify and deliver the
optimum care for the patient.
The MDT must identify the following members and the cross cover/deputisation
arrangements,
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Lead clinician and deputy who have adequate clinical experience of BMT ( as
indicated by JACIE)
Junior and senior clinicians providing 24hr on-call
Lead nurse for in and out patient /day case setting
Microbiologist
Virologist
Radiologist
Pharmacist
Dietician
Social worker
Psychologist
The MDT must ensure that appropriate MDT members convene daily to assess those
patients currently under going BMT.
The full MDT should meeting regularly to discuss, if appropriate, patients undergoing
BMT, patients being worked up for BMT and patients post BMT under follow up. If
patients are being followed up at unit level, where appropriate, these patients should be
discussed at the request of the unit level team.
Patient discussion at the MDT should be supported by a protocol that as a minimum
confirms the decision making process and communication of that decision to the patient
and clinical team
If not meeting to discuss patients the full MDT must meet to discuss outcomes, service
issues, audit and the ongoing delivery of the service. The frequency of these review
meetings will be at the discretion of the programme lead but must be frequent enough
to ensure adequate clinical governance is achieved.
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Annual confirmation of MDT membership and MDT meeting
timetable/attendance
5.6)
Support Staff and Facilities
A requirement of a service providing allogeneic transplantation must be immediate
access to,
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designated renal expertise and dialysis facilities on site, preferably within the
BMT unit
accessible HDU/ICU care if not integrated within the BMT unit
Mechanical ventilation facilities should be accessible on site and supported by a protocol
for the management of patients ventilated off site and away from the BMT setting. For
units providing an autologous transplantation service only the above is desirable but not
essential.
Evidence of access to renal/HDU/ICU facilities and expertise - annually
Nursing and Allied Health Professions
The nursing team should,
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Be of a size adequate to ensure that staffing levels are safe and appropriate at
all times.
Have a greater nurse to patient ratio in allogeneic BMT units
Have enough flexibility to ensure 1:1 nursing where patients are severely ill
Demonstrate core skills pertaining to IV administration of chemotherapy and
other drugs via central lines and management of blood disorders
Be proficient in cardio-vascular monitoring
Have an adequate skill mix to ensure that experienced, post graduate qualified
nurses are in place on each shift
Have in place a rolling programme of post graduate education relevant to BMT
Those Allied Health Professions involved in the care of BMT patients should as a
minimum be designated staff. Post graduate education should be provided for those
staff designated to the MDT.
Annual self assessment of nursing profile
5.7)
Transfusion and laboratory services
The service should have the ability to access CMV appropriate blood products as well as
irradiated blood products, where indicated, at all times. In the eventuality that such
products are not available alternative blood products should only be used according to a
previously agreed protocol.
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In the case of an allogeneic BMT service access should also be made available to HLA
DNA – based typing.
A protocol must be in place to support the transfusion of patients who, undergoing
allogeneic BMT, experience, as a result a change in blood group.
- Description of access to transfusion services and details of access to
CMV/irradiated blood products and annual confirmation.
- Submission of transfusion protocols.
5.8)
Pharmacy services
Access must be available to pharmacy services at all times.
Pharmacy input into the MDT should come from a designated member of staff who is
able to respond in an informed way to the themes pertaining to pharmaceutical
management of BMT patients.
Description of access to pharmacy
5.9)
Clinical policies
The Programme Director together with key MDT members must ensure that the BMT
service is supported by evidence based clinical management and administrative
protocols/policies.
In addition the Programme Director should ensure that these protocols/policies are
audited frequently and re-visited at least every 3 years.
As a minimum there must be policies and protocols regarding,
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Chemotherapy administration and spillage
Environmental management of the immuno compromised patient
Clinical and laboratory monitoring of the patient
Clinical use and management of blood products
Use of prophylactic anti infection measures and growth factors
Clinical management of neutropaenic sepsis
Post discharge precautions
It is noted that a prerequisite of JACIE accreditation is evidence of protocols/policies
covering a wide range of issues and the list identified above should not be considered
exhaustive.
All BMT units should be seeking to obtain JACIE accreditation by 2010.
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Evidence of progress towards JACIE accreditation provided annually.
5.10) Follow up
Immediate follow-up (day 0 – 100) should be conducted at the transplant centre in
facilities co-terminus with the BMT unit itself.
Where follow up is delivered prior to day 100 at a local unit it should only be done so
through agreement between the programme director and the local unit level clinician. If
this follow up arrangement exists it then should be supported by a suitable protocol.
Part of the agreed protocol must ensure that,
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The unit level clinician is ‘integrated’ into the BMT MDT
Immediate access to the BMT services is ensured
The unit level facilities are adequate for the management of the patient
Long term follow up over and beyond day 100 can be performed at unit level but should
be supported by a suitable protocol.
Communication between the BMT centre and the unit should be considered of a
standard adequate for the unit to
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Provide follow up in an appropriate, safe and integrated manner
Provide emergency interventions as required
Provision of protocols for emergency care, immediate and long term follow up
Provision of a standard for communication between the BMT centre and units
5.11) Information
Data collection must be an integrated part of the BMT service and all MDT personnel
should recognise their individual role in collecting adequate data. Data on BMT should
equate to the requirements of EBMT FMedA form.
The Programme Director should work with colleagues across Wales to ensure common
data items are collected. Key items of data that must be collected and reported on
annually include,
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Primary diseases, and phases of diseases transplanted
Types of transplants performed
Donor selection
Length of disease free survival
All complications in first 100 days (including episodes of infection)
All deaths within first 100 days
Long term/delayed side effects
Patient support including information for patients from units
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Information summary should be provided quarterly and a summary annually
5.12) Clinical Research
As many patients as possible should be offered the opportunity to be submitted into
recognised clinical trials
6)
Performance and Clinical Information
Commissioners require three sets of performance information,
a)
A response to the measures identified within this commissioning guidance
document - Annual.
b)
Completion of the annual audit of activity against the Wales Cancer Standards.
c)
Numbers of patients waiting for BMT identifying primary disease, disease status,
time waiting, predicted BMT date, point on clinical pathway ( donor search, bed
awaited) - Quarterly.
Clinical information should be submitted to the BSBMT data register annually.
7)
Referral mechanisms
Referral for BMT should be to the BMT Programme Director in those BMT units
recognised by the commissioner. Referrals should only be received from recognised
Haematology MDT members identified by their local Cancer Network.
Table 2.
Commissioned Providers of BMT services Oct 2007.North Wales
Region
S E Cancer Network
S W Cancer Network
N W Cancer Network
8)
Allogeneic BMT
UHW
UHW
Christie/Bristol
Autologous BMT
UHW
UHW/Swansea
Christie/NWWT
Patient selection process
All BMT procedures must be verified by the commissioner in the first instance and
submissions for approval must be submitted to the commissioner via the established
route by the clinician who first deems the requirement for BMT (this may
follow advice from the BMT Programme Director).
8.1)
Procedures supported
Procedures supported should conform with the standard indication for transplantation as
described by EBMT (2005) and be in the category ‘Standard of Care’. See Appendix 1.
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Additional procedures supported include,

Lymphomas – chemosensitive disease using reduced intensity conditioning (RIC)
prior to sibling allograft or well matched MUDs.
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AML high risk and young AML , both in CR1 – allograft sibling or MUD
Relapsed AML – allograft or MUD
Refractory AML- chronic low disease burden - MUD
8.2)
Clinical Options panel
The EBMT classification of BMT by disease status (2005) identifies in a number of cases
the procedures as a ‘clinical option’ which translates operationally to individual patient
assessment, risk and value assessment.
In these cases, where an individual clinicians feel BMT is a ‘clinical option’ the
commissioner should convene a ‘Clinical Options’ panel the purpose of which will be to
assess the appropriateness of BMT through an informed assessment of,
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Clinical appropriateness
Clinical safety and risk
Assessment of outcome
Value
The process is for consideration by the panel is as follows,
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the referring clinician will complete the referral pro forma which serves to
provide clinical information and signify to the commissioner the need to convene
the Clinical Options Panel.
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the commissioner will convene the Clinical Options panel within 10 working days.
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the Clinical Options Panel will consist, as a minimum, of the following,
- referring clinician
- national chair for haematology oncology (or nominated deputy)
- 1of the 2, or both haematology clinical leads from each of the remaining
Networks
- medical commissioning lead
- finance commissioning lead
- relevant Network Director or nominee (optional)

the Clinical Options Panel will deliver one of three options
- agree to support
- agree not to support
- request additional information
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
In the case of agreement to or not to support the commissioner will issue the
advice within 5 working days and that advice will be agreed by the panel and be
binding

When further information is required this will be made available within 5
working days and the panel reconvened. The outcome from this second
discussion will then follow the process above i.e. agree to support or not
support with appropriate rationale.
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Appendix 1
EBMT Transplant Indication (2005)
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