CHAPTER 4: IMPLEMENTATION AND SERVICE
DELIVERY THROUGH THE NHS
Introduction
4.1. Advances in genomic science have already
led to some new developments in clinical practice (see Chapter
2). Further changes to patient care are likely to include:
- advances in diagnostics and treatments both for
rare genetic diseases and for single-gene subtypes of more common
diseases;
- improved efficacy of treatments through stratification
of patient groups;
- improved safety of treatments, with a reduction
in adverse reactions;
- more effective screening for an increasing number
of diseases; and, eventually,
- preventative healthcare through predictive tests
for common diseases.
4.2. Although these advances will lead to improvements
in the delivery of healthcare services in the NHS, they will also
present significant challenges. As genomic medicine develops,
commissioning systems for genetic tests, the structure of laboratory
services for the provision of genetic (and other) tests and patient
care pathways will need to adapt in order to ensure that appropriate
additional steps are integrated into the healthcare service (for
example, carrying out a genetic test as part of a patient's care,
interpreting and communicating the results appropriately and adjusting
treatments accordingly). This has significant cost implications
for the NHS and will require careful planning for the provision
of such services in the future. We have therefore—where
possible—considered changes to the current service configurations
with a view to cost savings in the long run.
4.3. We are aware that, at present, some genetic
tests which are available now have not been integrated properly
into the healthcare service—for example, diagnostic tests
to identify and personalise treatments for single-gene subtypes
of common diseases (such as diabetes (see paragraphs 2.18-2.19))
and pharmacogenetic tests to stratify the use of medicines and
personalise treatments to certain subgroups of the population
(see paragraphs 3.42-3.50). According to Professor William
McKenna, Professor of Cardiology, University College London,
"we have not taken advantage of the knowledge that we have
to implement gene testing" even for single-gene disorders"
(Q 537). Professor McKenna gave an example:
"The disease causing genes for … sudden
death [disorders], have been identified going back more than 20 years
and being able to perform gene testing in the family would have,
and does have when it is available to us, a major impact on being
able to make an early diagnosis in the family … Recently
NICE have recommended in their guidance that there should be gene
… testing for the monogenic disorders that cause sudden death
in the young, and yet on a clinical level that is not readily
available" (Q 531, 537).
4.4. We are also aware that advances in genomic
science will lead to a need for education and training of the
healthcare workforce (see Chapter 7). The Wellcome Trust Sanger
Institute told us that the efficient use of diagnostics for single-gene
disorders would require "further development of clinical
diagnostic laboratories and specialised training of clinicians
and health care providers" and that developments enabling
"predictive testing for susceptibility to late onset common
diseases" would lead to a "substantial" demand
for "adequate education, training and counselling of healthcare
providers, test providers and the public" (p 333). Professor Finbarr
Cotter, Professor of Experimental Haematology, Barts and
the London School of Medicine, also referred to the need for "educated
clinicians who know how to use the tests, what is appropriate
to order and how to apply [them]" (Q 125).
4.5. Professor Donnelly foresaw that the
availability of direct to consumer tests (DCTs) would also have
implications for the NHS: "people will be arriving at the
door of their GPs or their health professionals saying, 'I've
had this test and I've got these SNPs; I've learned that my risk
of prostate cancer is increased by 30 per cent; what should I
do?'" (Q 134). Dr Imran Rafi of the Royal
College of General Practitioners thought that it would be "a
time-consuming affair" and that there were "going to
have to be service models set up to look at what is the most effective
way of being able to provide patients with the necessary support
that they need" (Q 196).
4.6. The Minister for Public Health, Ms Primarolo MP,
told us that, in her view, her role as Minister was "to make
sure that we have the framework and the necessary levers to deliver
the strategic objective" and this involved ensuring "that
… scientific developments … can be delivered into real
patient benefits" (Q 855). We welcome this statement.
But the Minister's belief that the real benefit for patients was
at least ten years away (Q 855) contrasts with other evidence
which we received (see Chapter 2). It also fails to acknowledge
both the developments in genomic science that have taken place
(particularly those identifying single-gene subtypes of common
diseases) and the rate at which new developments are likely to
occur in the future. We recommend that the Government should
reconsider how they will prepare NHS commissioners and providers
for the uptake of genomic medicine in the NHS. We also recommend
that the National Institute for Health Research, as part of its
remit, regularly monitors developments in genomic medicine and
their implications for the NHS now and in the future.
THE 2003 GENETICS WHITE PAPER
4.7. In the 2003 Genetics White Paper, the Government
set out a plan of action for "taking advantage … of
the new genetic knowledge and technologies" and made a commitment
to invest £50 million to achieve that aim through activities
to strengthen the existing healthcare service, to mainstream genetics
into clinical practice and to educate the workforce (see Chapter
3). The Government also sought to ensure that genetics permeated
all branches of medicine by supporting new initiatives in genetics-based
care in key disease areas, in secondary and primary care and in
national screening programmes. The initiatives included several
pilot projects for genetic disorders and additional screening
for genetic conditions.
4.8. In addition, the White Paper included a
commitment to invest in strengthening existing hubs of NHS expertise.
Measures included: earmarking substantial capital investment (over
£18 million capital in 2003-06) for a major programme of
modernisation of genetics laboratories; expanding the workforce
within specialised genetics services; and investing in genetics
training and information and communications technology budgets.
It also included commitments with regard to developing NHS informatics,
start-up funding for building genetics into mainstream practice,
training and education of the workforce, and setting out strategies
for communication and engagement with the public on the ethical
and social issues surrounding genomic medicine.
THE 2008 REVIEW
4.9. In April 2008, the Government published
a review of the 2003 White Paper which set out progress since
2003. It also reported the views of key stakeholders on what has
been achieved and the opportunities and challenges they anticipated.
Integration of genetics into
mainstream practice
4.10. The Government has developed a number of
models to integrate genetics expertise into mainstream practice.
These include:
- pilots to test new patient pathways designed
to give easier access to genetics services (including Teesside
Cancer Family History Service and Poole Familial Cancer project);
- ten service development pilots to bring specialist
genetics advice into mainstream NHS services (such as Oxford Ophthalmic
Genetics Service); and
- a project to implement and evaluate cascade testing
in families with familial hypercholesterolaemia (London IDEAS
knowledge park).
Significant progress has also been made on the screening
commitments, including Down's syndrome screening (available to
almost all maternity units to women of all ages) and the roll-out
of newborn hearing screening and sickle cell and cystic fibrosis
screening (now offered to all babies).
4.11. These pilots demonstrated that non-specialist
NHS staff, with appropriate training and support, are able to
develop sufficient expertise to provide genetics services within
mainstream practice; and, as a result, recommendations have been
made within the Department of Health (DoH) for extending such
services in the future. Diana Paine of the DoH NHS Genetics Team
told us that the evaluation reports from these projects, along
with an external evaluation by Nottingham University looking at
the operational issues of embedding new technologies and services
in the NHS, would be reporting later in the year and that they
would be looking at how they could share some of the lessons learnt
from the pilots within the NHS (Q 72).
4.12. In Chapter 3 we have recommended a new
White Paper on genomic medicine. We envisage that the proposed
White Paper will address the operational changes needed as a result
of bringing genetic aspects of treatments for common disorders
into mainstream clinical specialities (including changes to commissioning
arrangements, processes for providing genetic tests within the
NHS and arrangements for NHS laboratories to conduct such tests).
Infrastructure investment
4.13. Both the 2008 Review and the evidence that
we received highlighted a need for continued capital investment
to ensure that advances in genomic medicine are brought into clinical
practice. The Joint Committee on Medical Genetics (JCMG) suggested
that, although the Review confirmed that the Government were "committed
to bringing new genetic advances to bear wherever they can be
used to benefit patients"—"matching these aspirations
with a long-term commitment to infrastructure, funding and support,
remains one of the greatest challenges facing the delivery of
genomic medicine and technology via the NHS" (p 549).
Similarly, the British Society for Human Genetics (BSHG) said
that "the Genetics White Paper helped modernise and network
specialised genetic services but a new and resourced plan is needed
if genomic medicine is to be successfully exploited in the NHS"
(p 130). And Dr Elles, Chairman of the BSHG, stressed
that "if we are to realise the benefits that have rolled
on since then from our knowledge of the human genome sequence
then we need to continue that investment stream. Genetics is not
a box that has been ticked" (Q 284).
4.14. Although the 2008 Review outlines a number
of significant achievements since 2003, it gives no indication
of the Government's plans for future funding of activities or
for the next steps in taking forward the lessons learnt either
from the pilots or from the Nottingham University review. If the
NHS is "to lead the world in taking maximum advantage of
… new genetic knowledge and technologies as soon as they
become available" (the 2003 Genetics White paper), the Government
will have to strengthen their commitment to investing in this
area of medicine.
Provision of genetic services
in the NHS
INTEGRATING GENOMIC MEDICINE INTO MAINSTREAM PRACTICE
4.15. At present genetics services in the NHS
focus on the specialised provision of clinical genetics services
to families and individuals at risk of single-gene disorders.
In the future, genetic tests to target treatment and prescription
for both single-gene disorders and single-gene subtypes of common
diseases are likely to become more routine. Dr Frances Flinter,
a Member of the Human Genetics Commission (HGC), described how
"more and more genetic tests are being requested by physicians
outside genetic centres". Clinical geneticists, she said,
were few in number and worked in a very specialised area, concentrating
on the management of single-gene disorders. In the face of this
increase in demand for genetic tests, she suggested that clinical
geneticists worked with colleagues in other specialities "to
help them develop clear guidelines, or protocols, which identify
the subgroup of their patients for whom genetic testing may be
indicated" (Q 336).
4.16. The UK Genetic Testing Network (UKGTN)
warned about the implications of this increase in demand: "as
the number of appropriate genetic tests increases, the current
role of the specialised genetic services in 'gate-keeping' will
need to be reconsidered. Some colleagues in other specialties
increasingly will want to use genetic testing. Funding will need
to take account of test costs within these specialties and there
will also be a need for education and information" to allow
for the effective commissioning and interpretation of such tests
(p 215). The Foundation for Genomics and Population Health
("the PHG Foundation") suggested that "as genomics
is increasingly applied in mainstream medicine, new service models
are needed in which appropriately trained health professionals
from other clinical specialties take responsibility for routine
genetic aspects of care, with access to specialist genetics referral
where necessary" (p 135).
4.17. Following a request from the JCMG, the
PHG Foundation established an expert group to review the use of
genetic testing as a means of non-invasive prenatal diagnosis
to inform a strategy for the implementation of diagnostics within
clinical services. Their report was published in January 2009.[17]
The PHG Foundation and JCMG told us that the technology provided
"an exemplar of the development, evaluation and implementation
of new genetic technologies into healthcare" (p 155).
The report identified a number of significant challenges associated
with the need to adapt current prenatal and antenatal healthcare
pathways, specifically of screening and testing, to accommodate
such developments. Recommendations of the report included "development
and implementation of appropriate clinical pathways, laboratory
standardisation and infrastructure development, continuing professional
oversight, and formal evaluation and long-term monitoring of prenatal
testing".[18] The
report also highlighted an urgent need for professional education
(p 158).
4.18. Lord Darzi of Denham's final report (see
paragraph 3.13 above) outlines plans to develop the NHS and its
workforce in the coming years with a move towards more local control
and provision of services. Whilst the report includes proposals
to encourage innovation in the NHS (including efforts to streamline
the pathways for diagnostics), it does not acknowledge the challenges
that application of new developments in genomic medicine will
present to the NHS. The evidence we received has caused us to
question whether these challenges would in fact be better met
by centralised, rather than local, assessment of the impacts of
genomic medicine on clinical practice, in order to address some
of the broader issues affecting healthcare service delivery.
4.19. Although specialised genetic services are
important for the diagnosis and treatment of single-gene disorders,
we share the view of UKGTN that their role as "gatekeepers"
for the increasing application of genomic medicine within mainstream
medicine needs to be reconsidered. We recommend that, on the
basis of the monitoring activity of the National Institute for
Health Research recommended in paragraph 4.6 above, the Secretary
of State for Health should ensure that any necessary NHS operational
changes, as a result of a shift in the provision of genomic services
to mainstream medicine in the NHS, are implemented in the NHS.
In order to facilitate the process the Secretary of State should
identify whether the NHS is fit to handle such changes and also
what new service models are needed if health professionals from
other clinical specialties are to take routine responsibility
for genomic aspects of healthcare (with referral to specialist
genetics services only where necessary).
Commissioning of genetic services
4.20. The need to revise the framework for the
assessment and evaluation of clinical validity and utility for
all types of genetic tests (see Chapter 3) coupled with mainstreaming
the use of genetic tests and stratified prescribing in the NHS
have implications for the commissioners of genetic tests. Inevitably,
they will need to change their commissioning practices to meet
changes in arrangements for the assessment, evaluation and provision
of specialised diagnostics. The commissioning structure will need
to be reviewed as genetics spreads further into the mainstream
NHS. We agree with the UKGTN that "it is important that the
commissioning and funding of genetic testing and genetic services
are explicitly considered when national policies are developed
that affect all aspects of health care" (p 211).
SINGLE-GENE DISORDERS
4.21. Genetic services are currently commissioned
by specialised commissioning groups (SCGs). The UKGTN was set
up to co-ordinate the evaluation of genetic tests for single-gene
disorders and to provide advice to commissioners about such tests
with the objective of promoting delivery of a consistent service.
There is a consensus that the current system for single-gene disorders
and the service that UKGTN provides in assessing the tests work
well (although, we note that the UKGTN is not responsible for
monitoring the uptake or use of genetic tests, or the extent to
which funding is available for their use in the NHS.)
GENETICALLY COMPLEX DISEASES AND SINGLE-GENE SUBTYPES
4.22. Genetic tests that are used to quantify
risks of common disorders, to treat single-gene subtypes of common
diseases, and pharmacogenetic and other tests used to stratify
therapeutics are not included in the same commissioning category
as single-gene disorder tests. They are outside the SCGs' remit.
Dr Mark Bale, Deputy Director of Scientific Development and
Bioethics at the DoH, made reference to this gap in the system:
"we have acknowledged in the review [of the White Paper]
recently that there is an issue around how to ensure that commissioners
and commissioning can cater for the new tests, which may have
different approaches from the way you have managed certain sub-sets
of the population" (Q 64).
4.23. We recommend that the Department of
Health should conduct a review with the aim of establishing appropriate
commissioning structures for pharmacogenetic tests, tests for
management of genetically complex diseases and tests for diagnosing
single-gene subtypes of common diseases, as the use of such tests
spreads further into the mainstream NHS.
Commissioning across the NHS
4.24. A second commissioning issue which has
been drawn to our attention is that it appears that genetic services
are not provided consistently across the NHS—as regards
both tests for single-gene disorders and for single-gene subtypes
of common diseases. We are particularly concerned about the latter
because they are poorly represented at present and a positive
diagnosis has important implications for family assessment and
individual treatment.
4.25. Jacqui Westwood, Director of Specialised
Services for South East London, Bexley Primary Care Trust (PCT),
told us that "at the moment there is no proper understanding
of the way that genetic services are commissioned nationally.
They are all dealt with differently in the different areas and
there is no structure to that and therefore the tariffs are inconsistent
because everybody is doing it differently" (Q 401).
Dr Crolla of the JCMG noted the "very patchy uptake
by PCTs" of genetic tests and highlighted a number of reasons
for this, including the low priority given to such tests by Health
Service Managers compared to other interventions. Dr Crolla
suggested that PCTs were at the wrong level to commission genetic
services because of the complexities of evaluating the benefit
of genetic tests, and also because of the "enormous pressure"
that commissioners were under to assess other interventions (Q 208).
4.26. For this reason, the JCMG recommended that
"this specialist commissioning should go back to a national
level so that when agreed nationally there should be provision
for the rolling out of these tests" (Q 208). Dr Crolla
suggested that "this would be the ideal" and likened
the present system to "a postcode lottery". He went
on: "I think it needs to be ring-fenced and national"
(Q 209).
4.27. Professor O'Rahilly gave an example
of inequity in the current system:
"Jenny Taylor ... was involved in Oxford
in the development of a service whereby people who died young
and suddenly of sudden cardiac death, of which there are a number
of genetic causes, would have their post-mortem DNA analysed and
family members would be screened and then those individuals who
carried the risk factors were given implantable defibrillators,
et cetera, to prevent sudden cardiac death. That was accepted
pretty much everywhere in the UK apart from the Oxford region
and it could not be implemented there because of financial pressures
on the PCT, so there you had an example of the very place that
was developing and leading internationally in the area of development
was unable to find funding. There are numerous such anomalies
within the Health Service" (Q 209).
Professor McKenna supported this point:
"It is very much … down to the postcode.
If you happen to live in one area you can access gene testing,
but in general it is a real struggle to access mutation analysis
for your patients. We have about 4,000 patients a year with inherited
forms of sudden death and heart failure and we do not have routine
gene testing, we have to do this through research grants and international
collaborations" (Q 537).
4.28. We recommend that the Department of
Health should conduct a review of current genetic test service
provision within the NHS both for single-gene disorders and for
single-gene subtypes of common disorders. This should aim to eliminate
what are serious inconsistencies in the provision of genetic services
across the NHS.
Uptake of pharmacogenetic tests
in the NHS
4.29. There are differences not only in the provision
of pharmacogenetic tests across the NHS, but also in the way in
which they are applied by different practitioners. There are two
main reasons for this: first, a lack of clarity of appropriate
funding streams (or tariffs) for the use of such tests as part
of treatments within non-genetic specialties; and, secondly, inconsistencies
in the actual prescribing of such tests by healthcare workers
during patient consultations.
FUNDING STREAMS
4.30. We have already noted that an increasing
number of genetic tests are now ordered by specialties other than
genetics. This can cause problems as there are no specific funding
mechanisms within the non-genetic specialty for the use of such
tests as part of a patient's treatment. For example, Professor Peter
Farndon, Director of the UKGTN, told us that:
"The tension we have got is if an ophthalmologist
wants to send a test in, they have no funding stream in ophthalmology
to pay for it unless they pay for it out of their budget. The
funding stream for the majority of these tests is through the
genetics services; that is another policy tension. If we try to
roll out equity of genetic testing into other specialties, we
have to come to some re-think about how that might occur"
(Q 396).
4.31. As new tests develop, national tariffs
or local prices will need to adjust for these costs. We are aware
that the UKGTN is working to develop tariffs for genetic tests
that are separate from clinical service provision (UKGTN). In
December 2008, the report of the second phase of the Independent
Review of NHS Pathology Services in England, chaired by Lord
Carter of Coles (the second Carter Report), was published. The
report noted that the DoH was considering the feasibility of a
tariff for pathology and recommended that further work should
be undertaken to develop tariff commissioning guidance for community-based
and specialist (for example, genetics) pathology.[19]
4.32. We recommend that the Department of
Health should develop a national set of standards and tariff guidance
for the commissioning of genetic tests, taking into account the
recommendations from the second phase of the Carter Review of
NHS Pathology Services that there should be tariff guidance for
community-based and specialist pathology, particularly relating
to DNA and RNA-based genetic tests.
PRESCRIBING PRACTICES
4.33. Professor Pirmohamed gave an example
of inconsistent use of pharmacogenetic tests within the NHS by
practitioners during the patient consultation process which involved
genetic testing to assess whether patients might be susceptible
to certain risks associated with the use of the drug azathioprine.
"If you look at the different physicians who actually use
this drug in this country, you find that there is a great deal
of variability in terms of uptake" (Q 726). An extension
of the current "red flag system" could alert healthcare
workers to the need to use pharmacogenetic tests as part of the
prescribing process where appropriate.[20]
Professor Pirmohamed commented that, "as the new NHS
IT system develops, then it may be possible to build [testing]
into the prescribing process" (Q 728). Dr Hilary
Harris, a GP and former member of the HGC, supported this:
"It is perfectly possible to flag up prescribing
so that some of the warnings will come up, as they do now, or
the instruction to have a test allied to a particular pharmaceutical
preparation" (Q 834).
4.34. We recommend that the Department of
Health should commission the National Institute for Health and
Clinical Excellence to issue guidance on the use of genetic tests
by non-genetic specialties; and that the NHS should consider the
expansion of the "red flag system" to alert healthcare
workers to the need to conduct a specific test, in some cases
a pharmacogenetic test, before deciding on treatment or prescription.
Provision of laboratory services
4.35. It appears that a further cause of inconsistent
provision of genetic services across the NHS has been the control
of laboratory services at the level of the NHS Trust. This is
partly due to the rapid advances in the field and developments
in technology—many laboratories now need to replace equipment
and replacement has varied across NHS Trusts—and partly
because of variations in the availability of tests across laboratories.
This is compounded by challenges in recruitment and retention
of highly trained staff to run the service.
RE-CAPITALISING OF LABORATORIES
4.36. As a result of the speed of technological
developments in genomic sequencing and informatics, according
to the BSHG, "[laboratory] services will be faced with a
need to re-capitalise in the next three to five years". They
advised that "the Government should consider recurrent mechanisms
to ensure that the NHS maintains cost effective access to appropriate
technology platforms" (p 130). Oxford Nanopore made
a similar point:
"At the time of the 2003 Genetics White
Paper, the funding structure for new technology assumed that it
should be considered for replacement after five years. The existing
technology pipeline indicates that a two-year cycle would be more
appropriate for one technology to be replaced by the subsequent
generation. Planning of the infrastructure and funding of genomic
medicine would need to take this into account" (p 345).
4.37. The provision of laboratory services varies
across the UK because of commissioning arrangements and also because
of differences in the investment decisions of PCTs. Professor Furness
told us that:
"it was anticipated that when the [Genetics]
White Paper introduced new developments and new equipment that
commissioners would have arrangements to replace that equipment
in due course. My understanding is that in some areas a lifetime
of five years has been agreed in the budgets over which such equipment
will be written off, and that is probably too long, but there
are certainly other areas where commissioners have made no provision
whatsoever for writing off and replacing the equipment, so we
are getting differences of funding in different parts of the country
which I think is regrettable" (Q 229).
4.38. Other witnesses, including Sir Alex
Markham, Professor Sir John Bell, Professor Martin
Bobrow and Professor Furness, suggested that the combination
of molecular pathology (that is, DNA or RNA-based tests, in the
context of mainstream specialities) and clinical genetics services
should be combined within a single clinical service structure.
This would help to address these variations and to ensure a more
coherent and streamlined approach to genetic testing within the
NHS. Professor Sir John Bell suggested that:
"Pathology and laboratory services in NHS
hospitals are severely fragmented and there is a serious risk
that introduction of a range of new technology platforms will
lead to further duplication in multiple different laboratory settings.
Many of the technologies necessary for moving pathology into a
new era are the same as those that would be used in clinical genetics
laboratories and will also have applicability to both microbiology
and haematology. There is an urgent need therefore to rationalise
the management of these, either at an NHS Trust level or through
large regional laboratories. These tools need careful technical
support, bioinformatics and quality control and it seems unlikely
that these can be developed in multiple sites within a hospital
without undue costs. I think the coalescence of these platforms
within a single clinical service structure is imperative to ensure
that there is a coherent approach to these methodologies within
the NHS. We have achieved this in Oxford using the Clinical Research
agenda to drive integration of laboratory services. It should
be replicated elsewhere" (p 226).
4.39. Professor Sir John Bell, citing
developments in Oxford, referred to Figure 5 below.
FIGURE 5
Laboratory Structures
Current laboratory structure (a) in which pathology
services are funded and delivered separately; and suggested new
arrangements (b) with the coalescence of molecular diagnostics
into a centralised 'hub' with more locally positioned 'spokes'
of specialised services
4.40. The view expressed by Professor Sir John
Bell was supported by Professor Martin Bobrow, former Head
of the Department of Medical Genetics, Cambridge University, who
stressed the need to "consider a much greater degree of integration
of the laboratory disciplines and [to] break down this now century
old division into haematology and histopathology and so forth
and start bringing the processes together" (Q 285).
"HUB AND SPOKE" ARRANGEMENT
4.41. Reconsideration of pathology services is
already underway. The second Carter Report, endorsing a Healthcare
Commission report on pathology services published in 2007, argued
that there was
"… a strong case for consolidation
of pathology to improve quality, patient safety and efficiency.
Driving up standards, quality and patient care at the same time
as reducing costs by between £250 and £500 million a
year for reinvestment in the service which is necessary to deliver
and assure service quality and to support the rapid adoption of
innovative new technology and new approaches to the delivery of
pathology services".[21]
4.42. We envisage that for genomic medicine the
"hub and spoke" system would mean that rapid specialised
services would remain in local laboratories and highly technical
DNA and RNA tests with expensive equipment would be in a hub.
Professor Furness, for example, said that:
"There are aspects of providing molecular
biology systems that are very expensive and nowadays rely on very
large expensive machines where you only have [to] look at the
economics and it is absolutely obvious that it is more efficiently
done with a small number of those machines analysing samples from
all over the country … However, on the other hand, the people
who actually interact with patients … have to be where the
patients are. To that extent you are potentially talking about
a hub and spoke arrangements to make it most efficient. How many
hubs you have around the country is a difficult question and will
probably depend on the tests that you are talking about"
(Q 219).
4.43. Although Professor Furness anticipated
savings from such a reorganisation, he thought that funding would
be a problem:
"The barrier to [the hub and spoke arrangement]
is, first of all, the need for capital investment to do it and,
secondly, the current structure of NHS funding. We have 'silo'
funding where this amount of money goes to this service to keep
doing what it has been doing year in, year out, irrespective largely
of new demands and new developments, and it is very difficult
to get agreement to change that pattern. The expense of that sort
of reorganisation …, I personally suspect it would not be
enormous and I think the savings could be greater than the expense
if it is done logically; but we have this hump, this barrier of
organisational inertia to get over to make it happen" (Q 219).
4.44. The 2008 second Carter Report followed
this model and recommended that specialist services should be
consolidated through referral to specialist testing centres. It
also recommended that pathology networks should be developed with
a single, integrated management structure, with only urgent testing
carried out on-site. It suggested that Strategic Health Authorities
(SHAs) should draw up implementation plans for consolidating services
in their regions, requiring the PCTs to take the lead with local
providers in drawing up cost-effective plans for implementation.[22]
4.45. The Minister for Public Health, Ms Primarolo MP,
said that the Government was working with some SHAs to explore
how the second phase of the Carter Review could be taken forward
(Q 875)—although she also said that it was "for
the NHS to make the decisions on the spend and their equipment
in the light of circumstances" (Q 871). Following this
work, the DoH intend to publish an impact assessment of possible
changes to the provision of laboratory services in the early summer
2009.
4.46. The first Carter Report, Report of the
Review of NHS Pathology Services in England, published in
2006, made a range of recommendations about pilot projects to
evaluate how to integrate pathology services. Two years and a
second report later, a further recommendation about pilot projects
was made and the impact of potential change to the service is
still being assessed. The pace of change towards consolidation—a
key recommendation of the first and second phase of the Carter
Review—has been disappointingly slow. Consolidation of pathology
services is essential to the cost-effective spread of genomic
medicine across the NHS.
4.47. We recommend that the Government centralise
laboratory services for molecular pathology, including genetic
testing, in line with the recommendations of the second phase
of the Carter Review of NHS Pathology Services. The aim should
be to organise effective laboratory services for molecular pathology
and genetics by bringing together the whole range of DNA and RNA-based
tests for pathology and medical specialties to ensure that services
are cost effective. This would have the potential to free up funds,
for example, for the highly specialised technical equipment that
is needed.
17 Wright, C., Cell-free fetal nucleic acids for non-invasive
prenatal diagnosis, Report of the UK expert working group, PHG
Foundation, 2009. Back
18
Ibid, p 53. Back
19
The second Carter Report, p 24. Back
20
The red flag system is an electronic prescribing system that alerts
the practitioner to the need to take a certain treatment option
during a consultation process by flashing up a red flag on the
practitioner's computer screen. Back
21
The second Carter Report, pp 5-7. Back
22
Ibid, p 23. Back
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