1. This event has been initiated and funded by Roche Diagnostics
REALISING THE VALUE OF DIAGNOSTICS: TRANSLATING NATIONAL POLICY TO LOCAL
ACTION
Report of a parliamentary roundtable held on Wednesday 11th March 2015, chaired
by Lord Warner
SUMMARY:
National policy has long recognised the value of a strategically developed
pathology service, where diagnostics are considered as an intrinsic part of the
pathway rather than an afterthought. Despite strong support for the role of
diagnostics at a national level, this does not tend to feed through into local
approaches where, more often than not, the value of diagnostics fails to be realised.
In competition with other services, pathology struggles to get prioritised by local
commissioners.
A roundtable discussion, chaired by Lord Warner, was convened in Parliament to
consider how this situation might be addressed. Representatives were drawn from
NHS England, Royal College of Pathologists (RCPath), Public Health England (PHE),
an Academic Health Science Network (AHSN), Commissioning Support Unit (CSU)
and local commissioning groups. A full list of participants is attached as an
appendix.
There are some pockets of good practice, as set out by attendees, and these need
to be understood and implemented more widely. By strengthening the national
vision for pathology, it should also be possible to raise awareness and mobilise
champions to encourage commissioners to take a more proactive approach to
pathology.
RECOMMENDATIONS:
This report seeks to reflect the roundtable discussion, which focused on some of the
challenges facing diagnostics and the wider NHS and identified practical
recommendations to be taken forward by relevant stakeholders.
Recommendation Responsible organisations
1. Early conversations should be held with NHS
England’s lead, Sam Jones, to ensure pathology is
explicitly incorporated in suitable new care model
vanguard sites and Greater Manchester.
NHS England, CCGs, NHS
providers
2. A succinct, national vision for pathology should be
developed and rolled out through national and
local pathology champions.
NHS England, Public Health
England, RCPath, CCGs, local
authorities, NHS providers
3. Key national resources such as the National
Laboratory Medicine Catalogue (NLMC) and
Standards for Microbiology Investigations (SMI)
should be promulgated as the basis for all CCG
contracts and extended to all tests.
NHS England, PHE, AHSNs, CSUs,
CCGs

2. This event has been initiated and funded by Roche Diagnostics
4. Pathology should be a discrete item in service
specifications or tenders.
NHS England, CCGs, local
authorities
5. The Innovative Medicines and Medical Technologies
Review should consider the particular challenges of
rolling out innovation in diagnostics.
Department of Health,
contributing organisations
NOTE OF THE ROUNDTABLE:
National policy
Summary
 Taking a national approach provides the opportunity to standardise
approaches to pathology and improve quality
 Some national initiatives are in place but appear to lack a coherent narrative
that will resonate among local commissioners
 The health reforms have led to some recent reforms in relation to pathology
being reversed due to the upheaval and changes in personnel
 Moves to devolve further commissioning responsibility and explore different
care models may compound these issues, unless efforts are made to increase
commissioner understanding of pathology
Discussions about national policy and local action on pathology should be
considered in the context of ongoing moves to devolve more responsibility to local
commissioners – whether this be plans to integrate health and social care across
Greater Manchester, or the implementation of the care models within the Five Year
Forward View.
There are significant national initiatives on diagnostics and pathology. For example,
PHE’s microbiology service has two national centres at Colindale and Porton and
has eight regional laboratories. PHE plays a significant role in helping regions to
deliver microbiology services that the NHS can’t do through its total microbiological
service, which provides end to end diagnostic services with specialist consultant
clinical advice. It has been involved in finding a test for swine flu and is providing
Ebola outbreak support. Alongside NHS microbiologists, PHE has also developed
Standards for Microbiology Investigations (SMI) to link clinical information to
laboratory processes. This national leadership should be able to support quality
services with tests being delivered faster, cheaper and with a rapid response.
One challenge with these services is that there have been a number of
organisational changes, most recently the move from the Health Protection Agency
to PHE, which has had an impact on the awareness and profile of these services.
The local NHS is struggling to understand what PHE does in this area, something that
PHE regional teams are starting to address more actively.
Following the pathology quality assurance review, efforts have been made to try to
standardise approaches to pathology. RCPath and NHS England are leading the

3. This event has been initiated and funded by Roche Diagnostics
development of the National Laboratory Medicines Catalogue (NLMC) to
standardise the requesting, reporting and analysing of pathology tests to help
ensure the right patient gets the right test at the right time. NLMC will also provide a
basis for test optimisation/demand management and interpretive information on
results. Progress in developing the NLMC has been slowed by the health reforms.
The challenge at the moment is that treatment decisions may be based on a World
Health Organization (WHO) standard test but the local NHS is using different testing
methods which can lead to high variation between laboratories in numerical results.
The potential impact on clinical decision making because of this variation could be
profound. For example, enzyme test results for the use of carboplatin for ovarian
cancer could result in a 26% increase in dosage which could impact on patient
outcomes. Ensuring uniform quality in testing was therefore vital.
Where NICE guidance has been developed for diagnostic tests, it was observed that
local implementation is patchy and that clinical interpretation can vary significantly
between individual clinicians, regardless of national guidance. The voluntary nature
of guidance on diagnostics was considered a contributing factor, compared with
technology appraisals where implementation is mandatory. At present, the roll out
of innovative tests such as BNP for heart failure has been haphazard, despite the
existence of NICE guidance. For example, GPs may not be commissioning the test
at all, maintaining demand for the more expensive, hospital-based echocardiogram
or may be requesting both the BNP and echocardiogram.
Where national policy hasn’t been properly implemented, it was suggested that if
NHS England, PHE and NICE think that a policy is good, a more robust approach
should be taken to support local implementation. All agreed that CCG awareness
of national guidance and the potential benefits of implementing it would help them
to be better informed about decisions relating to pathology than is currently the
case.
The example of liquid based cytology shows that it is possible to implement a
standardised test across the NHS but this required a robust, national approach
based on health economics. National screening programmes are also delivered
across one health system. These processes did, however, require massive system
change. Professional agreement is essential to delivering such changes and the
devolution of commissioning responsibility may make these things harder to
manage.
Even though there is national recognition that pathology should be prioritised, the
mechanisms to deliver this are lacking. The challenge is significant in pathology
because it is not necessarily clearly defined within any given pathway. It was
observed that prior to the reforms, some diagnostics featured specifically within the
Specialised Services National Definition Set but that a decision had been made to
reference all pathology within specific service specifications. In reality, this has led
to diagnostics being ignored within the majority of service specifications.
Concerns were raised that the potential to deliver the ‘bigger picture’ for pathology
was being eroded by the decision to deliver pathways in different ways. This

4. This event has been initiated and funded by Roche Diagnostics
provided scope for huge variation, as demonstrated by the atlas of variation in
diagnostics which showed a 67 fold variation in many tests.
Local approaches
Summary
 Too often, pathology is the hidden science within commissioning and is
subsumed within wider service specifications
 Commissioners do not appear to have sufficient knowledge or motivation to
hold local pathology service providers to account or to consider wider system
reform
 Decisions to consider pathology tend to form part of wider programmes such
as moving care into the community or closer to home. Commissioners may
not be seeing these reviews as an opportunity to raise standards in testing and
reporting more generally
 Where a proactive approach to pathology is taken, it appears to be led by
individuals within a locality
Participants described pathology as ‘invisible’ within commissioning processes for
secondary and tertiary care. Pathology falls into wider service specifications or
tenders and may only be briefly considered or excluded from official commissioning
policies. For example, even though pathology is a critical element of any long term
condition or cancer service, specifications may not mention pathology or are
unlikely to set out requirements of tests within a particular service. There has been
some commissioning of pathology services for primary care but in many cases the
main driver for this was cost saving rather than quality improvement. Some
remarked that even well-researched, well-intentioned reviews or tenders might fail
to consider pathology because its profile is so low.
The reasons for this are complex but it is likely that commissioners simply do not
consider the potential benefits of taking a more proactive approach due to a lack
of awareness. It was suggested that this low awareness may go beyond the NHS
and that professional bodies which might provide suggested guidelines for inclusion
within service specifications may not set out pathology considerations.
A failure by commissioners to engage in pathology services not only impacts on
quality but has a financial impact. For example, expensive genetic testing had
been undertaken by a lab every six months, despite the fact that the results would,
by definition, be the same. Silo budgets have had an impact on opportunities to
take a more proactive approach to pathology in some areas. For example, where
a cheap test could be delivered easily within a GP practice, rather than a hospital
visit, there was reluctance for anyone to pay for the test because the lines of
responsibility were unclear. A hospital would be keen to keep the service and
maintain its income while a GP practice may not be willing to cover the cost of a
particular test, as the savings would be felt elsewhere in the system.1
1 In theory, GPs’ role within CCGs could provide a potential solution to this problem.

5. This event has been initiated and funded by Roche Diagnostics
Concerns were raised about commissioner awareness of pathology and their ability
to drive improvements. It was believed that information is available to support a
more proactive approach to pathology but that commissioners may be choosing
not to tap into it or are simply not aware of it. Furthermore, the sector is not static
and there are continuing developments in technology to be considered. Adopting
such developments might require a review of pathways and payment mechanisms.
Horizon scanning for new developments in pathology might allow commissioners to
prepare for changes and CSUs may be well placed to support this process, with de-
commissioning being particularly important in pathology.
Commissioning has tended to concentrate on ‘tests’ rather than services and
pathways. Laboratories can, however, help to relieve pressures and costs of primary
care by developing direct services with primary care and patients for the monitoring
of long term conditions. This has been introduced for hypothyroidism in Leicester for
the monitoring of lithium therapy and thyroxine replacement.
There are other examples of good practice. Devon and the South East have
programmes, run by experts in pathology to streamline processes and commission
high quality, efficient pathology services.
 In Devon, the appointment of a Director of Pathology has led to quality
improvements and significant savings through review of pathways and local
approaches to pathology
 In the South East, a service specification-led approach has been used since
2010, coordinated first by Kent and Medway Pathology Network, then Kent and
Medway Commissioning Support and finally, South East CSU. Despite the many
changes in support, the consistent involvement of committed individuals and the
streamlined approach has helped to maintain the programme, which is
implemented by eight CCGs in the South East
Some commissioners had been considering new approaches to pathology as part
of wider discussions around moving towards community-based care or care closer
to home. This would not necessarily be linked in to a wider consideration of
pathology services within a particular locality. For national experts, maintaining
quality of testing and reporting of results was a priority. There are also challenges in
relation to how a patient-focused approach to pathology can be rolled out, while
maintaining acute pathology services. Many commented on the reluctance of
local providers to support reform, which was holding back change.
If a local system is led by clinical expertise, it is likely that the clinicians are seeking to
maintain the status quo, further reducing the chance of commissioners seeking
reform.
Securing local action on pathology
Summary
 Education is essential to ensuring a coherent approach to pathology across
the country

6. This event has been initiated and funded by Roche Diagnostics
 Encouraging commissioners to consider pathology is dependent on their
being clear messages on why it is important
 There may be opportunities for NHS England and PHE to take a stronger
approach in relation to pathology
 Vanguard care model sites provide an opportunity to embed pathology into
new systems
 The Medicines and Medical Technology Review provides a further opportunity
to raise the profile of diagnostics and to encourage a more proactive
approach to innovation
Attendees were unanimous that the key to unlocking the potential of diagnostics
within the NHS was education. By raising awareness of the value of diagnostics
among commissioners, the national initiatives on offer, such as NLMC, would be
realised. In order to achieve this, clear messages on the value of diagnostics should
be developed and rolled out through national and local champions. Although
diagnostics is a complex area, these messages should be simple in order to achieve
cut through. Agreed messages could then by rolled out to pathologists through
existing training programmes run by RCPath.
Despite the increasing devolution of responsibility, Simon Stevens remains the
accountable officer for the NHS and it is in his interest to secure the cost benefits that
could be delivered by more efficient approaches to pathology. Clear, national
leadership from Simon Stevens and PHE on this issue could deliver significant
efficiencies within the system. This might include a consideration of tariff
arrangements for diagnostics which could potentially be linked to the NLMC.
The recently announced vanguard sites for the care models as set out in the Five
Year Forward View provide a timely opportunity to raise the profile of pathology. By
incorporating pathology in the early planning stages for this process, it may be
possible to develop pathology systems that could be rolled out to other areas as
and when the care models are rolled out more widely. The devolution of health
budgets to Greater Manchester provided a parallel opportunity at scale.
The Innovative Medicines and Medical Technology Review was also highly relevant
to the profile of innovation in diagnostics. The review’s terms of reference clearly
state that technologies should be considered on an equal basis as medicines which
is encouraging. As there is an increasing move towards personalised medicines, a
streamlined system will be essential to ensure the adoption of new developments.
JMC Partners’ work on diagnostics is funded by Roche Diagnostics.
JMC Partners had full editorial control over the materials produced to support this
roundtable. Representatives from Roche Diagnostics were present at the roundtable
as observers.

7. This event has been initiated and funded by Roche Diagnostics
APPENDIX: ATTENDEES:
Name Role Organisation
Dr Gifford Batstone Fellow Royal College of
Pathologists (RCPath)
Jatinder Garcha Planned Care Programme
Manager (Diabetes, MSK
and Ophthalmology)
NHS Central London Clinical
Commissioning Group
Julie Hart Associate Director of
Networking
Oxford Academic Health
Science Network
Prof Jo Martin National Clinical Director for
pathology
NHS England
Dr Christine McCartney Director of Microbiology Public Health England
Dr Joe McGilligan Health and Wellbeing
Champion
Former Chair
Local Government
Association
NHS East Surrey CCG
Teresa Moss Director of Transforming
Cancer Services for London
Hosted by South East CSU
Dr Jeff Seneviratne Former Clinical Lead Greater Manchester
Pathology Network
Prof Keith Stone Senior Partner, Clinical
Services
South East CSU
Peter Taylor Commissioning Lead, Sexual
and Reproductive Health;
and London Sexual Health
Strategic Commissioning
Coordinator
Royal Borough of Kingston
and Kingston CCG
Lord Warner Chair House of Lords