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WELCOME
London, 08TH November 2018
Conference Chair
Introduction
Doris – Ann Williams MBE, Chief Executive, BIVDA
Keynote Address – UK AMR
Diagnostics Collaborative
Fiona Carragher, Deputy Chief Scientific Officer, NHS England
Fiona Carragher FRCPath @DepCSOFiona
Deputy Chief Scientific Officer for England
england.amrdiagnostics@nhs.net
UK AMR Diagnostics Collaborative:
Maximising the use of diagnostic technology
to
tackle AMR
November 2018
•
•
•
•
•
•
The UK AMR Strategy: a tripartite approach
Diagnostics – the current view of the system
Complexity
of system
Levers &
Incentives
ExternalAssurance
Adoption
Routes
to use
Standards Inappropriate
use
(diagnostics)
Models of
provision
Service
quality
Data
InfrastrucureCommissioning
arrangements
UK AMRDC- Providing a single point of
focus for the system
System
Leadership
Strategic
Direction
UK
Oversight
Local
connectivity
& good
practice
System
Alignment
Nat’l Policy,
Levers,
Incentives,
UKAMRDC
UK AMR Diagnostic Collaborative Programme
Value
proposition
Diagnostic
Stewardship
One Health Innovation
Policy and
Communication
aligned to
current policy
and regulatory
environment
System partners
Public Health England
Health Education England
DEFRA
Key areas of focus
Devolved Administrations
Diagnostic stewardship- definition
• Coordinated professional guidance and interventions to
improve patient understanding, care and management
through the appropriate use of clinical assessment and
clinical scoring algorithms, biomarker tests and/or
microbiological diagnostics to guide therapeutic decisions
or screening strategies.
• It should promote appropriate, timely diagnostic testing,
including specimen collection, and pathogen identification
and accurate, timely and audited reporting of results to
guide care. It should discourage unnecessary diagnostic
testing and the use of tests that yield misleading results.
• Diagnostic Stewardship should utilize microbiological
data, including accurate and representative AMR
surveillance data to inform local treatment guidelines, and
AMR control strategies, and should be an integral
component of measures to improve antimicrobial
stewardship and infection prevention and control
• WHO 2016: Diagnostic stewardship
A guide to implementation in antimicrobial resistance
surveillance sites
UK AMR DC 18/19 areas of focus
-Diagnostic Stewardship
• Use of biomarkers eg CRP/Procalcitonin in acute settings or
as POCT in the community
• Quality improvement approach to diagnostics within the blood
culture pathway enabling timely review of antibiotic therapy
• Urinary infections: Tackling inappropriate use of urinary
diagnostics and focus on the urine culture pathway
UK wide building on good practise, driving quality
improvement and addressing variation
•
Innovation: challenging ourselves
to go further, faster
Handheld
‘lab on a chip’
High throughput
genomic technologies
Point of
care testing
Evolving technologies
Disruptive approaches –
What else can we learn from:
Big data,
analytics & AI
Developing
world
approaches
Animal
Health
Other
scientific
specialisms
UK AMR Diagnostic Collaborative
- next steps
•
• The government will shortly be setting out a
refreshed UK strategy for AMR, this is likely
to set out a longer term vision accompanied
by a shorter term 5 year National Action Plan
•
• The new plan will take a coordinated approach,
setting out challenging ambitions for the next
five years and commitments across humans,
animals, food and the environment.
•
Key milestones to come in 18/19:
November: UK wide survey of blood culture. To gain a
system wide understanding of current laboratory
practice in relation to quality and unwarranted variation
and enable the UK ADC with partners to develop
mechanisms to improve services.
5th December: Engagement event to gain an
understanding from industry and innovators
• The current challenges when accelerating usage of
solutions developed by industry
• The challenges and potential solutions to feed into
national policy
• Highlight opportunities for test bed working
31st January: With all system partners to understand
how health regulation, policy innovation, funding,
quality, safety and research can support the
government’s ambition to embed rapid diagnostics.
• The Health and Social Care Select Committee released the report from
their inquiry into AMR 22nd October 2018
• Within this there are specific recommendations relating to diagnostics
•
•
Continued Focus on AMR Diagnostics
The system must be responsive
System
response
Define the capabilities
Prioritise technologies
Supportive regulatory
structure
Systematic approach to
rapid adoption
Streamline & develop
evidence base
Connected data across
care pathways
The work of the UK AMR diagnostic collaborative is crucial in ensuring that all the
right groups and agencies are working together to address these challenges.
The UKAMRDC
Working in partnership
UKAMRDC
HOW DIAGNOSTICS CAN DRIVE
EFFICIENCY WITHIN THE NHS
Event: UK DIAGNOSTICS SUMMIT
Presenters: Professor Adrian Newland, Chair, National
Pathology Optimisation Board
Date: 8th November 2018
Dunn et al, Deficits in the NHS, King’s Fund 2016
‘..factors such as the growing
and ageing population, patients’
rising expectations and an
increased prevalence of long-
term conditions have increased
demand for NHS services but
without an equivalent growth in
spending to pay for it….’
Lafond S et al: Hospital finances & productivity: in a critical condition?
Health Foundation 2015
Unwarranted Variation: final report summary, January
2016
The Weighted Activity Unit (WAU)
• The type of treatments provided by acute trusts differ substantially (casemix).
• This makes it difficult to make robust comparisons between trusts using simple measures of output.
• Both in the UK and elsewhere (e.g. US, Australia), this issue is tackled by using a measure of cost-weighted output.
• Cost-weighting is used to adjust for differences in casemix between trusts.
• Lord Carter has pioneered the use of the Weighted Activity Unit (WAU).
• One WAU is the equivalent of an elective inpatient admission, based on the cost of providing that treatment (≈£3,500).
•
•
Main Presentation UK Diagnostic Summit 2018
Results : The Carter review
• Report saw £5bn
of value
opportunity
2020-21, if
unwarranted
variation
removed.
• New Operational
Productivity
Directorate in
NHSI to deliver
report’s
recommendatio
ns09.16)
•
The opportunity
Why does diagnostics need to change?
• Over the last 5 years demand for diagnostic tests
has increased by 26.8%
• The total waiting list has increased by 36%
• The diagnostic standard of 6 weeks has not been
met since November 2013
• Everyone accessing diagnostic services should
receive where possible a diagnosis at first point of
contact
• This would support earlier diagnosis, earlier
intervention with less costly treatments and a
potential change in disease burden
Diagnostics and the clinical pathway
• 80% of pathways start with diagnostic services
Primary and Secondary care
• Services deliver over1bn tests yearly at a cost of ~£9.0bn
(10% of NHS spend)
• Effective diagnostics fundamental to optimising
healthcare provision, improving outcomes and driving
efficiencies
• Maximising value from the £17.5bn medicines spend
Diagnostics and the Long Term Plan
Priority areas within the LTP
• Cancer – Rapid diagnostic centres
• Cardiovascular and Respiratory – Early diagnosis and intervention
• Paediatric and Maternal Health – appropriate use of diagnostics
• Research and Innovation – support the systematic uptake of new
technologies
• Genomics – accessibility to other diagnostics to provide integrated
reporting
• Primary and Community care – joined up service
•
Why does pathology need to change?
• Wide variations in in quality and service provision
Atlas of Variation of Diagnostic Services
Accreditation of services to ISO standards
Quality Assurance
Access and control of Point of care
• Insufficient data and digital infrastructure
Interoperability impacts on resource utilisation
Over testing and duplicate testing
• Insufficient equipment
• Demand and capacity issues
• Complex and variable commissioning arrangements
Specialised and CCG
Little incentive for efficiency and financial sustainability
Background; 2016/17 data
collection
• Case for change
identified through
successive Carter
reports
• Operational Productivity
Directorate
commissioned large
scale data collection
• This data has allowed
for the identification
and quantification of
sources of
unwarranted
variation
• Modelling of the data
has identified
opportunities for
efficiency savings
2017/18 Data insights – Changes
2017/8 information
122 Providers
30m fewer tests
£33.6m cost-savings
31 |
• Imaging is an essential part of the vast
majority of patient pathways
• Imaging is critical for screening and assisting
with diagnosis and treatment of patient
pathways
• There is under provision of imaging
capacity within the NHS, exacerbated
by high vacancy rates and the age
demographics requiring both
outsourcing and insourcing to meet
demand
• Lack of detailed benchmarking data to date
has prevented opportunities to identify
unwarranted variation
• High levels of variation in radiographer
reporting of plain films (77% to 0%) and
in skill mix
• Variation in the costs per report (Complexity
not accounted for currently)
• High level of clinical service engagement
with 22 Expressions of interest to work
with NHS Improvement to be an ‘Early
Adopter’ Imaging Network
Transforming Imaging Services –
Improving Efficiency & Sustainability
£2 Billion Spent
onDelivering
Imaging
Services
Non Medical
Workforce 23,500
(vacancy rates of
15%)
3,000 Medical
Consultants
(vacancy rates 12.5% &
ageing demographic)
£134 Million spent on
Outsourcing &
Insourcing
(to manage demand)*
39 Million
reports
Upper quartile: £69 / Report
Median: £55 / Report
Lower Quartile: £46 / Report
Cost per report
NHS Improvement currently working with
4 Early Adopter Imaging Networks to identify
the benefits of Imaging networks
* Data Collection for 2016/17
(Figure likely to be much higher for 2017/18)
All Staff Update 11/7/18
Diagnostic Services - Imaging
Equipment sales and after-market
32
• Aged asset base
According to the industry, 12% of CT and 29% of MRI scanners are
>10 years old
•
• Lack of capital resources
Replacement of imaging equipment competing with multiple other
priorities
•
• Managed Equipment Services
Shortage of clear case studies demonstrating value for money
•
• Third-party maintenance and service contracts
Little evidence of strong competition in the Imaging equipment market
to challenge OEM dominance
34 |
In 2017/18, Clinical & Workforce Productivity delivered a range of significant
achievements, supporting NHS Trusts to improve Productivity.
30
£78m
£571m
1200+
£327m
Workforce “Deep Dives” completed in Wave 1
across Nursing, Doctors, AHPs and Pharmacy.
Case studies published as part of our Tier 1
offer
Metrics developed for Imaging Services in the
newly published Model Hospital Compartment
Capital funding secured for investment in
Pharmacy infrastructure IT systems and E-
Prescribing systems to improve medication
safety, efficiency and interoperability
Clinical & Workforce Productivity – Highlights
29
saved through the “Top 10 Medicines”,
switching to cheaper generic and biosimilar
medicines, improving patient access
Pathology Networks modelled and mapped and
communicated to the NHS in England
£33.6m of diagnostic services-related cost
improvements delivered by Trusts
of workforce-related cost improvements
delivered by Trusts
£26m
Capital funding secured for investment in e-
Rostering and e-Job Planning systems to
ensure comprehensive coverage (all staff, all
sectors)
All Staff Update 11/7/18
Questions?
NHSI Operational Productivity
Pathology Consolidation – The State of the Nation
Presenters: David Wells, Head of Pathology Consolidation
Date: Autumn / Winter 2018
Pathology Networks
“Consolidating pathology services allows for most consistent, clinically appropriate turnaround
times ensuring the right test is available at the right time. It makes better use of our highly
skilled workforce to deliver improved, earlier diagnostic services supporting better patient
outcomes. Taking a hub and spoke approach to this consolidation can ensure an appropriate
critical mass to support specialist diagnostics, so that patients have equal access to key tests
and services are sustainable.”
Overview of the final report: £5bn savings
15 recommendations involving:
• Optimising application of
clinical resources
• Optimising use of non-clinical
resources
• Quality & efficiency
throughout care pathway
• Implementation &
engagement with trusts
Unwarranted Variation: final report summary, January
2016
Improving the quality and value of NHS pathology
services
39
Data shows +£200m
efficiency saving
NHS Improvement is working with trusts to
move towards 29 pathology networks across
England
122 Pathology
providers
Workforce of 25
thousand
Processing 1.1 billion
tests per year
£2.1 billion delivery
cost
• Pathology is essential in over 70% of patient pathways.
• High quality services, delivering timely results for
patients, will also support national priorities in
genomics, cancer care and integrated healthcare
•
• Currently there is national excess capacity in
equipment, yet we are seeing local workforce
shortages
•
• Variation of non-pay costs in routine testing from 2p to
£1.26 per test
•
• Networking at scale allows for better value, better
utilisation of capital equipment, faster turn around
times where required and more opportunities for
the workforce to undertake extended roles.
•
• NHS Improvement is engaging with the sector, with
strong support for the hub and spoke model
By next year, the networks need to be operational and starting to deliver these quality and efficiency improvements.
Pathology
• Clinically lead service. Every result
issued has been monitored,
reviewed or commented upon by a
medical clinician or state registered
(via HCPC) Biomedical or Clinical
Scientist.
• Integrated access to sub-specialty
expertise available for community,
primary, secondary and tertiary at a
single touch point. Scientists all have
a sub-speciality training, and have
an active role in many specialist
MDT meetings.
• Accreditation and quality assurance
integral to service delivery.
Pathology in the UK has lead the
way in clinical accreditation for
more than 20 years. UK system is
the basis of the current
international accreditation
standard.
• Keen technology adopters. Moving
academic and novel technologies
into routine, safe, clinical practice.
Covers all healthcare across prevention, screening, monitoring and diagnosis from before conception until post
mortem. All with appropriate clinical and scientific support for local clinical teams.
Networks & Consolidation with engagement
41
The benefits are:
• Driving up clinical quality, better for patient outcomes
• Faster turnaround times
• Right testing available at the right time.
• Better access to sub-specialty expertise
• Access to new technology
•
• Improving service resilience
•
• Efficient use of highly skilled staff. Right role, right person.
•
• Economies of scale and purchasing – linking into the current NHS Improvement
Procurement teams and Category Tower provider using the NPODG to set the
clinical standard and requirements for national purchasing
•
• National excess equipment capacity, yet workforce shortages
• Networking across wider geographies provides a solution to localised
recruitment challenges and development of advance scientific
roles.
•
NPODG
Regulators
- UKAS
- CMA
- BIVDA
Clinical community
- RCPATH
- IBMS
Providers
- Trusts
- Private sector
providers
Suppliers
- Equipment
- Private sector
operators
Commissioners
- NHSE
- CCGs
Workforce
- Unions such as
UNITE
- Health Education
England
The programme is working in true partnership with the clinical and scientific community to deliver the right test, with the right advice at the
right time – utilising the right approach and technology via the National Pathology Delivery group (NPODG)
We are working with other colleagues in legal, procurement, finance. In addition with are also aligned and contributing to national
programmes for example Genomics, AMR, sepsis and digital / AI with NHS England, Public Health, and Office of Life Science
Outputs
Described and enabling 29 Pathology networks: To set out the direction and ambition.
Publication of clinical and operational advice in the form of toolkits: To share learning and provide consistent advice with
agreement of the professional bodies and other ALBs
Development of specialist testing networks: To ensure highly complex clinical services are sustainable and efficient, supporting
faster access to sub-specialist clinical expertise
Facilitating network workshops involving clinical and operational teams: To drive the pace of change to ensure local
empowerment and ownership of networks.
Development and launch of the National Pathology Quality Assurance Dashboard: To monitor and measure quality of
pathology services clinically and operationally. To ensure good practice in adoption of national guidance, accreditation, training and education
and also to ensure corporate good practice in monitoring supplier performance, quality of industry service delivery and provider interactions for
new models of care (e.g Point of care testing in primary care).
Identifying national funding and innovations: A Working with Office of Life Science to ensure innovation pipelines to digitise and
adopt AI where clinical appropriate at pace and scale. Working with industry to identify disruptive technologies – for example drone delivery for
blood samples, or point of care diagnostics to improve bed utilisation
Collecting system wide data….
Data insights - Validation
Pay Cost Validation
Non-Pay Cost Validation
Data insights – Total costs
Data insights – Agency costs
Data insights – Bank costs
Model Hospital – Cost per test
Spring 2018: NHS Improvement pathology networks
State of the Nation
State of the Nation
State of the Nation
“In September 2017 we signalled to all acute hospital trusts in England that they would need to
change how they work and collaborate to drive out unwarranted variation in pathology services.
The first tranche of pathology networks is fully operational, and we expect a third of all the
networks to be fully operational by the end of this financial year, with the rest to follow by
2021.”
“To meet this deadline, there is much to do. We need to scale up from the one in five pathology
networks that are operational today, to at least a third by the end of 2018/19. The formation of
pathology networks is a core part of implementing national policy on improving quality and
productivity. NHS Improvement will continue to support and guide the development of these
networks, ensuring that services are safe, effective, caring, and responsive. We will work with
trusts in networks yet to become operational to jointly agree milestones, establish what extra
support they need and ensure local leadership (across trusts and commissioners) is in place to
complete or network becoming operational.”
Next steps for the sector
• It is important that networks are progressed at pace.
• Actions to support realisation of efficiencies, available immediately, should be taken now.
• Centres that have been identified as Essential Services Laboratories should begin to model
the transition to delivering this service model.
• Centres identified as hubs should be supporting the preparatory work to consolidate any
testing activity that can be moved in advance of further networking.
• It is vital that staff and subject matter experts are engaged at all stages of the process,
executive commitment is also essential in the next phase of developing networks.
• Review service contracts – Level of
cover versus clinical requirement.
• Review provision of complex testing
against savings of retiring equipment
and out sourcing
• Consolidation of consumables provider,
with Trust and across aspirant
network
• Consolidate referral activity to a single
diagnostic provider.
• Review service contracts – Level of
cover versus clinical requirement.
• Review provision of complex testing
against savings of retiring equipment
and out sourcing
• Consolidation of consumables provider,
with Trust and across aspirant
network
• Consolidate referral activity to a single
diagnostic provider.
Grip & Control: Action now
Inventory
management
Inventory
management
Non-
recurrent
actions
Non-
recurrent
actions
Cash
management
Cash
management
ProcurementProcurement
5
6
7
8
Governance
& Comms
Governance
& Comms
Pay cost
actions
Pay cost
actions
Non-pay / all
cost actions
Non-pay / all
cost actions
Rapid
actions
Rapid
actions
1
2
3
4
• Consolidate referral activity to a single
diagnostic provider.
• Review service contracts – Level of
cover versus clinical requirement.
• Review logistics - operational delivery
and contracting arrangements.
• Business cases and Capex review.
• Demand management of testing –
RCPath/IBMS/ACB guidance
• Consolidate referral activity to a single
diagnostic provider.
• Review service contracts – Level of
cover versus clinical requirement.
• Review logistics - operational delivery
and contracting arrangements.
• Business cases and Capex review.
• Demand management of testing –
RCPath/IBMS/ACB guidance
• Reduce reliance on agency / locums;
• Review Out of hours arrangements
where the are outside of AfC
• Review sample delivery time to reduce
out of hour staffing requirements
• Review Consultant Job plans
• Increase staff availability – remote and
flexible working
• Improve staff retention –Training &
Development
• Reduce reliance on agency / locums;
• Review Out of hours arrangements
where the are outside of AfC
• Review sample delivery time to reduce
out of hour staffing requirements
• Review Consultant Job plans
• Increase staff availability – remote and
flexible working
• Improve staff retention –Training &
Development• Ensure all R&D activities are funded
and appropriately priced.
• Consolidate referral activity to a single
diagnostic provider.
• Demand management of testing –
RCPath guidance
• Ensure all R&D activities are funded
and appropriately priced.
• Consolidate referral activity to a single
diagnostic provider.
• Demand management of testing –
RCPath guidance
• Adopt just in time stock management
• Introduction of automated stock
management systems to meet
accreditation requirements and
reduce staff time.
• Remove ad-hoc deliveries via improved
stock management.
• Adopt just in time stock management
• Introduction of automated stock
management systems to meet
accreditation requirements and
reduce staff time.
• Remove ad-hoc deliveries via improved
stock management.
• Ensure all R&D activities are funded and
appropriately priced.
• Sale of old equipment
• Asset review. Consolidation on
technology type across disciplines
•
• Ensure all R&D activities are funded and
appropriately priced.
• Sale of old equipment
• Asset review. Consolidation on
technology type across disciplines
•
• Governance and cash management –
PO or approved testing request
route only.
• Capital and assets opportunities;
• Governance and cash management –
PO or approved testing request
route only.
• Capital and assets opportunities;
• Clear delivery plan on and around
consolidation
• Engage staff and key stakeholders.
Particularly Clinical users.
• Clinical need rather than clinical want
• Clear delivery plan on and around
consolidation
• Engage staff and key stakeholders.
Particularly Clinical users.
• Clinical need rather than clinical want
Essential Services Laboratory – Action now
Principles
The ESL
The provision of laboratory services for the acute setting is vital to ensure safe patient care. We have developed
a tool kit that describes the minimum service that should be available. ESL that vary from this toolkit should be
justified using clinical evidence, or robust data to demonstrate efficient use of resources.
●What does good look like
●
Clinical Governance • Clear leadership
• Clear escalation points for
local issues
●LIMS • Integration and full
interoperability
●Logistics • Harmonised with Hub
• Timely
●
Quality • Provided by Hub
• ISO 15189
• MHRA
●
Training • Supported by the Hub,
delivered across the
network
• Full rotation of staff
●Business continuity • Clear robust, tested plans.
• POC and emergency
procedures.
●Implementation • Step change implementation,
involving quality
assessments and
review
• Only the services needed to provide acute pathology
provision, including appropriate blood
transfusion services, should be commission in an
ESL. All other work should be performed in the
hub laboratory.
• Meet all regulatory and accreditation standards (BSQR
(MRHA), UKAS, HSE).
• Have a clear clinical and operational governance link
to the Hub.
• Have a clear management structure.
• True interoperability with the Hub, with a single LIMS
or full IT integration, common platforms and
procedures.
• Full 24/7 rota, multidisciplinary assistant grades,
aspiration towards multidisciplinary Biomedical
Scientists.
• Have clear training strategy that is harmonised with
the Hub laboratory, provided by staff
supernumerary to the ESL.
• Have agreed performance metrics, service
specification. Variation only where it is
warranted.
•
improvement.nhs.uk/resources/pathology-networks-
toolkit/
Next steps for NHS Improvement
• NHS Improvement will continue to support and guide the development of these networks,
ensuring that services are safe, effective, caring, and responsive.
• We will work with trusts in networks yet to become operational to jointly agree milestones,
establish what extra support they need and ensure local leadership (across trusts and
commissioners) is in place to complete or network becoming operational.
• Support progress at pace.
• Continue data collection and providing insight support to providers and commissioners.
• Release Pathology Quality Assurance Dashboard
What Good Looks Like
Clinical Leadership: Clinical team must take responsibility for delivering a high
quality, appropriate but cost effective service and manage the relationship between
pathology and other clinical disciplines.
Partnership Model: Informal networks are unable to agree and deliver change fast
enough, and have under-developed management structures for effective clinical
governance.
Executive Participation: Board support, coupled with strong, experienced leadership
is critical to the success of any consolidation project.
Customer Service: The need for a strong customer focus, supported by the
appropriate clinical staff and infrastructure, is essential within any large organisation,
including pathology, whether public or private.
Procurement: Procurement continue to deliver cost savings through better contracting
and a more competitive market place. However, standardising the procurement process
and building on best practices will save significant time and effort and improve the
comparability and management of contracts.
IT: A standard LIMS (Laboratory Information Management System) is a key enabler for
pathology consolidation. Of equal importance is a dedicated IT team that can manage and
optimise the various systems.
Demand optimisation aims to deliver additional
value in two ways:
1. By ensuring that only appropriate tests are
requested
2. By recommending different analysis that
will provide additional insight and
Impact on the quality and cost of patient care
Working with GIRFT:
Pathology Quality Assurance Dashboard
56
• This is a tool for individual Trusts to assess and manage the benefit Pathology
services can deliver. It is not a contractual tool to manage the service.
• Timely collection of appropriate data. To give Trust Board visibility of system wide
metrics that Pathology has an impact on. The aim is to support national
initiatives.
•
• Collecting data in one place, once. Benchmarking performance to continuously
drive improvement.
•
• Looking to include metrics for Innovation and Training to support long term
sustainability of workforce and adopting advance and innovative roles.
•
• Potential to propose KPIs initially where national targets do not exist.
Specialist Testing
57
• Specialist Trusts have been mapped into networks, however, we are aware of the
supra-regional and national impact some of services have.
• Formation of a board sub-committee to investigate the opportunity and approach.
•
• Defining attributes of specialist services to support: -
• Training / Succession
• Clinical Pathways - Providing greater access to more patients
• Innovation and translational development
• Development of accepted standards, protocols, and national leadership
• Diagnostic pathway optimisation
•
National Funding Opportunities
UK Life Science strategy
- NHS Improvement inputting into the delivery of this national strategy.
- NHS Improvement influencing competition success criteria to ensure funding to aligned to
organisations that can deliver adoption at scale to benefit patients and the wider UK PLC
National Funding
Forty NHS hospitals and community services will get £760 million to
modernise and transform their buildings and services in the year of
the NHS’s 70th birthday. Included in this are a number of pathology
programmes supporting the national configuration of pathology
services into 29 Networks across England.
- Up to £31.2 Million for Lancashire and South Cumbria Pathology
Collaboration.
- Up to £2 million for West Yorkshire National Pathology Exchange.
- Up to £9 million for Black Country Pathology.
- Up to £19.3 million for Sussex and East Surrey pathology hub and
laboratory information management system.
-
This funding recognises the progress made by these organisations
towards implementation of their pathology network and underlines
the importance for pathology services to consolidate at pace to
realise the efficiency for greater patient benefit.
Carter Efficiency
Capital
- Awaiting on HMT for
agreement on £40m
funding for
Diagnostics.
STP Capital
- Supporting Networks to
submit bids against
latest wave of capital
funds
Cancer Boards
- NHSI Teams building an
understanding to
support networks in
accessing funds
associated with
regional cancer
boards.
- Supporting business
cases and benefit
models
Questions?
A partnered development of a
circulating tumour ESR1 Mutation
Test for the detection of metastatic
breast cancer mutations indicative of
resistance to endocrine hormone
therapy
08 November 2018
Head of Diagnostics
Ciaran Fulton
Who are LifeArc?
A UK registered charity
Translating academic research
Life Science specialist
Founded in mid 1980s
25+ years in the ‘technology transfer’ business
Key Client: UK Medical Research Council
Collaborating widely - UK, Europe, USA, China
What LifeArc Does
Technology Transfer
Identification, protection, management and licensing IP
Centre for Therapeutics Discovery
Small molecule drug discovery team
Antibody engineering team
Centre for Diagnostics Development
Molecular Dx assay development
Pre-clinical & clinical validation
Business Development - scouting for great science
Scouting activities on 3 continents
Due diligence team
Our Organisation Today
Our ambitions driven by our Charitable ‘Objects’
‘To promote the public benefit by improving human
health and medical research…
‘Accelerate the progress of these discoveries and
technologies to the stage at which they are (i) capable of
being made generally available to the medical profession
and the public for practical application for the improvement
of health and/or (ii) are transferred or licensed to a third
party to progress development of such discoveries or
technologies towards such goals’
Over 180+ Staff, spread over our three sites including…
30 in Technology Transfer (London)
80 Drug Discovery scientists (Stevenage)
10 Diagnostics scientists (Edinburgh)
We are financially self sufficient -
Revenue (2017/18) £25.85m
Expenditure (2017/18) £26.54m
With our R&D spending, we have invested over (2017/18)-
Drug Discovery £16.2m
Diagnostics Development £2.2m
We have also invested over £19m in a new Drug
Discovery Complex & Diagnostics Development Centre in
Stevenage and Edinburgh.
Products on the Market
LifeArc’s Centre for Diagnostic Development, Edinburgh
Set-up in 2014
We help translate early stage diagnostic opportunities
We work collaboratively with academics & industry partners
We do this at our own risk – providing the resources, expertise
& investment to effect this development
Our focus is in developing molecular diagnostics
Work across wide ranging disease areas
We’re interested in novel ways, new or enabling technologies
Look to find the best path to bring new & novel tools to the clinic
Our focus in diagnostics
Commercial Collaboration – Biocartis
co-development of a liquid biopsy
assayBiocartis is a molecular diagnostics company based in Mechelen, Belgium.
The Company’s proprietary Idylla platform is a fully automated, real time qPCR
system offering accurate, highly-reliable molecular information from any clinical
sample.
The Idylla system covers the entire process from sample to result in about 35 to 150
minutes with less than 2 minutes hands-on time.
Biocartis developed assays in oncology (KRAS, NRAS, EGFR & BRAF, RUO & CE-IVD)
and infectious diseases (IFV-RSV, FDA cleared); the platform is FDA waived & CE-IVD
marked.
Fully automated molecular testing with
Idylla™
Instrument
Console
Cartridge
(consumable)
Scan
sample
Scan
cartridge
Load
sample
Insert
cartridge
Clinically-
actionable
results
Superior sensitivity and ease-of-use, combined
with sample to result turnaround time of
90 to 150* minutes
* Based on turnaround times of current on-market oncology tests
Breast Cancer and ESR1 Mutations
First-line treatment of estrogen receptor (ER+) metastatic Breast Cancer
(MBC) is endocrine hormonal therapy: hormone treatments lower the levels of
estrogen in the body, or block their effects.
70% of Breast Cancers (BC) express estrogen receptors which makes them
sensitive to hormonal blockage.
Endocrine hormone treatments include selective estrogen receptor
modulators/down-regulators (SERMs/SERDs) or by estrogen
agonists/antagonists, and aromatase inhibitors (AIs).
The ESR1 gene codes for the estrogen receptor. Mutations in this gene have
been associated with acquired endocrine resistance in patients with ER-
positive metastatic breast cancer (MBC) previously treated with endocrine
therapy.
ESR1 mutations are rare in primary breast cancers at the time of diagnosis
(<2%).
ctESR1 Mutation
AssayThe Biocartis Idylla ctESR1 Mutation Test will be
developed for the detection of 10 point mutations within
the ligand-binding domain (LBD) of the ESR1 (estrogen
receptor 1) gene.
The assay will target patients with ER-positive
metastatic breast cancer who may be at risk of acquiring
resistance to endocrine hormone therapy.
●Mutation ●SNP ●Sequence
●E380Q [n1138] ●G -> C ●CTTCTACAATGTGCC
●S463P [n1387] ●T -> C ●TTTCTGCCCAGCACC
●L536H [n1607] ●T -> A ●GTGCCCCACTATGAC
●L536R [n1607] ●T -> G ●GTGCCCCGCTATGAC
●L536P [n1607] ●T -> C ●GTGCCCCCCTATGAC
●L536Q [n1607_1608] ●TC -> AG ●GTGCCCCAGTATGAC
●Y537N [n1609] ●T -> A ●GTGCCCCTCAATGAC
●Y537S [n1610] ●A -> C ●GTGCCCCTCTCTGAC
●Y537C [n1610] ●A -> G ●GTGCCCCTCTGTGAC
●D538G [n1613] ●A -> G ●GTGCCCCTCTATGGC
E380Q S463P
AF-1 DBD Hinge LBD
L536H
L536R
L536P
L536Q
Y537N
Y537S
Y537C
D538G
5
Initiated breast cancer menu development with
partners
Resistance
monitoring test
Therapy selection
test
1.On 15 June 2017 MRC Technology changed its name in LifeArc. LifeArc has been involved in helping deliver a number of therapies including Keytruda (pembrolizumab, marketed by MSD) which is an important immunotherapy treatment for various cancers
2.Partnership is with ETPL, the commercialization arm of A*STAR
• Liquid biopsy test
• Monitoring of metastatic breast cancer
patients for resistance to hormone
therapy
UK based medical research charity1
Description Partner
• Solid biopsy test
• Supporting optimal therapy selection
decisions for breast cancer patients
Singapore’s Agency for Science, Technology and
Research2
Partnership structure
• Development multiple Idylla™ tests
• LifeArc acts as development contractor
• Biocartis responsible for commercialization under
own label
• Parties will co-invest in development of selected
Idylla™ tests
• A*STAR acts as development partner
• Biocartis responsible for commercialization under
own label
Oncotype Dx Breast
Recurrence Score®
test US based provider of genomic-based diagnostic tests in
cancer
• Solid biopsy test
• Tailoring treatment of breast cancer
patients based on the biology of their
individual disease
• Genomic Health to develop Idylla™ versions of
proprietary Genomic Health tests
• Genomic Health responsible for
commercialization under own label
• Biocartis acts as supplier of tests
Detecting, analysing and interpreting diagnostic
devices for use outside clinical laboratories
§ Most value provided to diagnostic tests taken in remote
locations (in-field) or at the point of patient care (at
home)
§
§ Support patient care within chronic/autoimmune disease
monitoring, or to diagnose and track infectious disease
§
§ Can be applied to almost any visually read tests including:
lateral flow, colorimetric, ELISA and agglutination
§
§ CE-Marked medical products for IBD in Europe & Canada.
First FDA 510 (K) approval in the US expected Dec 2018
§
§ Patent protected in the US, Europe (includes UK), China,
Japan, Russia.
§
§ Use cases in human clinical, animal health, food safety and
environmental
§
§ ISO 13485:2016 and EIC 62304 compliant
About Novarum DX
Read and share the results of point of care tests using
smartphone reader technology.
§ Healthcare institutions overburdened
§ Waiting lists - increasing time to result
§ Geographic barriers to healthcare provision
§ Resource poor settings and infrastructure
§ Inconvenience of recurring appointments
§ Patients too sick to travel
Decentralised Healthcare
Mobile Ecosystem
Multi-frame analysis
technique provides highly
accurate results, whilst
removing human subjectivity.
Test results shared securely
to an end-user portal online.
Image-capture technology transforms a mobile phone into a diagnostic test reader
the results of which are shared to an end-user portal.
§ Step-by-step instruction carousels
§ In-app Videos and voice
instruction
§ Incubation timers and alarms
Correct sample preparation is achieved using
Test Choreography which ensures incubation
periods are adhered to - preventing false
results.
How can errors be prevented?
§ Patients can monitor chronic conditions with regular self-testing
§ Bedside testing an option for patients who are too sick to visit their GP
§ Overcomes geographic constraints for patients too remote from healthcare provision
§ Maintains confidentiality and removes the stigma of attending sexual health clinics
§ Enables lay users to have confidence in performing tests
§ Enables clinicians to trust self-tests
Point of Care Testing – At Home
Crohn’s Disease & Ulcerative Colitis
The first CE-Marked smartphone-
based calprotectin home test
measuring the inflammatory marker for
faecal calprotectin at home.
§ Mobile App (CalApp®)
§ Desktop Portal (IBDoc®)
Data recorded from the portal is shared
with trusted end-users, which can
include Electronic Healthcare providers
to shape the future of healthcare.
§ Help to reduce the spread of blood-borne disease with an early diagnosis
§ Support technician fieldwork with quick and accurate test results outside a laboratory
§ Tag test results with a geo-location to track infectious disease outbreaks
§ Enable connected, monitored testing in remote locations
Point of Care Testing – In Field
§ Rapid diagnosis to distinguish between bacterial and viral infectious
§ Robust traceability for prescriptions to human and food-producing animals
§ Track and trace infectious disease outbreaks to limit its spread
Antibiotic Stewardship
Overestimate the expectations of patients to get a prescription
§ Patients want to feel better
§ Patients don’t want to wait for an appointment if they don’t improve
§ Patients find it easier to accept if there is a test result
§
Prof Klepser @ Ferris State University – extensive research on the role of Community Pharmacists in reducing antibiotic overprescribing
Potential for Pharmacists?
§ Unlikely to happen without a government driven agenda
§ Requires a joined up ecosystem to manage diagnosis, prescription,
care and follow up of antibiotic use
§ Putting patients at centre could transform the approach – and mobile
may enable that
Viability?
T: +44(0)131 290 2 290
npolwart@novarumdx.com
enquiries@novarumdx.com
www.novarumdx.com
LT-41_2018_10_22
Panel Debate – How do we
create a diagnostic pathway for
the UK
Chair: Daniel Berman, Longitude Prize, Challenge Prize Centre, Nesta
Panellist: Doris-Ann Williams, Chief Executive, BIVDA
Panellist: Fiona Carragher, Deputy Chief Scientific Officer, NHS England
Panellist: Professor Adrian Newland CBE, Professor of Haematology, Barts and
the London School of Medicine and Dentistry
Panellist: David Wells, Head of Pathology Services Consolidation, NHS Improvements
Refreshments &
Expo
London, 08TH November 2018
Workshop
Breakout
London, 08TH November 2018
Point of care blood testing (POCbT) for patients >65 years
presenting with acute frailty syndromes.
Using diagnostics to improve clinician confidence in
discharge of patients presenting with acute frailty
syndromes.
Introduction
Ronald’s Story
Fall 1:
• Ambulance
• Non Injury
• Non urgent
falls
referral
Fall 2:
• 111 - GP
• Non Injury
• Not seen
Fall 3:
• Ambulance
• Non Injury
• No referral
made
Fall 4:
• Neck of Femur #
• Loss of independence
• Complaint from hospital
Hb 75 g/L
Biochemical and Haematological
contributors to falls
§ WHO epidemiology of falls
§ Cognitive deficit
§ hypercalcaemia,
§ hyponatraemia,
§ hypo/ hyperglycaemia
§ Renal failure
§ hypoxia from respiratory failure,
§ Muscle weakness
§ Anaemia,
§ Hypocalcaemia
§ Hypokalaemia/ hyperkalaemia
§
The Project
§1 x iSTAT alinity
§CRG4+ and CHEM8 Cartridges
§4 Specialist Paramedics + 4 Frailty
Paramedics
§Patients >65 years presenting with acute
frailty syndromes
Rationale
Acute frailty
syndromes
Falls
Confusion
Immobility
Increased side effect
to medications
Incontinence
Underlying illness
that needs
identification and
correction
Aims
Inform safe hospital
avoidance
Earlier disease
management
Increased clinician
confidence
Increased knowledge
of POCbT use
The evidence
iSTAT ALinity
Deployment and referrals
Device used on specialist Paramedic car
plus falls and frailty response vehicle
Deployment
§ Self deployment
§ Specialist Paramedic Hub
Referrals
§ Crew referrals
Safety nets
• Standard Operating
procedures
• Team training
• Access to previous
results
• GP telephone triage
and advice
• Multiple PDSA cycles
•
Results
§ 78 patients involved
§
§ Improvement in
reported clinician
confidence
§ Improved discharge on
scene and recontact
rates (when compared
with frailty specific
project)
§ Case studies support
earlier disease
management.
CASE EXAMPLES
Brenda – 84 yEArs, Fall and confusion
Ken – 94 yEArs, Fall with ?Long lie
Dot – 86 Years, reduced mobility
Bob – 92 years, Recurrent falls
Key Learnings●Learning
●Cost vs benefit ●Patient demographic selection is vital
●Targeted use of device on selected resources
Access to
previous results
●Recognition of the normally abnormal
●ICE (Integrated Clinical Access) access
Appropriate
training of the
team
●Initial group training run by qualified ACP
●Monthly 1-2-1 sessions with team
●Senior support – GP or Medical team
Use in
prognosticating
infection
●Lactate alone is not sufficient to identify early sepsis
Logistics ●Temperature management
●Cartridge management
Thanks
Conclusion
Whilst formal research is required
to validate its use, this
QIP showed POCbT to have a
positive impact on all stated
aims.The projects results,
whilst taken from a small sample
size and of limited transferability,
show promise for POCbT
in both the pre-hospital environment
and in the field of frailty.
Questions
BiomArker-guided Duration of Antibiotic treatment in hospitalised
PaTients with Sepsis
ADAPT-Sepsis Trial Investigators
Biomarkers: Serum Procalcitonin (PCT) & C-reactive protein (CRP)
Sage, Gateshead
Investigator team
• Critical Care: Paul Dark ( Manchester); Gavin Perkins (Warwick); Danny McAuley (Belfast); Tony
Gordon (Imperial); Mervyn Singer (UCL); Tim Walsh (Edinburgh); Gordon Carlson (Salford)
• Microbiologists/antibiotic stewardship: Ronan McMullan (Belfast); Peter Wilson (UCL)
• Statisticians/trial methodologists: Ranjit Lall; Simon Gates (Warwick)
• Health economics: Matt Stephenson (Sheffield)
• Patients/relatives: Keith Young (Intensive Care Society/Salford Citizen Scientists)
• Laboratory clinical biochemistry: Jonathan Clayton (Salford)
• Outcome data linkage: Paul Mouncey (ICNARC); Naz Lone (Edinburgh)
• Pharmacology/pharmacy: Tim Felton; Kay Marshall (Manchester)
• Trial managers and coordinators: Scott Regan, Nicola McGowan, Johnny Gluck, Maddie
Flawn (Warwick Clinical Trials Unit).
Independent Trial Steering Committee: Chair Julian Bion (Birmingham)
Independent Data Monitoring Committee: Chair Ly-Mee Yu (Oxford)
Intended learning outcomes
• Identify sepsisas a severe life-threatening infection syndrome
•
• Describe NICEDiagnostic Guidance in sepsis
•
• Outline a NIHR HTA commissioned diagnostic trial
•
• Discuss opportunities for trial adoption at your centre
•
• Discuss knowledge mobilisation from trial into NHS
•
Sepsis
• Body’s overwhelming response to infection (= organ failure, death)
• Time-critical medical emergency
•
Sage, Gateshead
Background
NICE Diagnostic Guidance DG18 (Oct. 2015):
“Procalcitonin testing for diagnosing and monitoring sepsis”
• Systematic review of clinical and cost effectiveness
• 8 RCTs (critically ill adults with sepsis) = daily PCT for antibiotic
discontinuation
•
• All ‘uncertain quality’ with some ‘at significant risk of bias’
•
Sage, Gateshead
Background
NICE Diagnostic Guidance DG18 (Oct. 2015)
• Promising results from international trials
• Concerns about risk of performance bias from evidence base
• Lack of a systematic evidence from the UK
• Uncertainty of results in current standard NHS clinical practice
•
Further research is recommended in UK
Is there a role for CRP monitoring?
•
•
Sage, Gateshead
Research question
•
•
•
•
•
•
•
•
•
•
Research Question:
Does a treatment protocol based on serial monitoring of CRP or PCT
safely allow reduction in duration of antibiotic therapy in hospitalised
patients with sepsis?
Specifies: definitive 3-arm RCT
Sage, Gateshead
•
•
•
•
•
•
•
•
•
•
Population: Hospitalised adults receiving intravenous
antibiotics for suspected sepsis
Intervention: Antibiotic discontinuation protocol based on
monitoring daily CRP or PCT
Comparator: Standard NHS care for patients with sepsis
Outcomes: Antibiotic duration (effectiveness)
28-day all-cause mortality (safety)
Sage, Gateshead
Pilot data
1. Antibiotic duration for sepsis in the UK?
• No readily available high quality reliable data from UK
-
• International recommendations: 7-10 days (Surviving Sepsis Guidelines)
•
• PHE antibiotic stewardship guidance: 7 days
-
• Best estimate from Evelien de Jong (SAPS trial 2016)
•
• Netherlands (documented low antibiotic burden country)
• Median duration 7 (IQR 4-11) days standard care arm
Sage, Gateshead
Pilot data
2. Is there equipoise in UK for PCT and CRP monitoring in sepsis?
Survey of healthcare professionals managing patients with sepsis
• 380 contributors over 4 weeks
•
• CRP frequently used non-systematically with no defined stop rules
•
• PCT used infrequently with stop rules consistent with NICE DG 18
•
• High desire to take part in a large scale pragmatic RCT (76%)
50 NHS service laboratories surveyed separately with concordant
Results and important assay platform information for trial feasibility
Sage, Gateshead
Study design
Multi-centre 3-arm randomised controlled trial
Internal pilot (completed Oct 2018)
Random group allocation
• computer-generated randomisation sequence with the minimisation
method using random blocks
• randomised in a ratio of 1:1:1 to PCT:CRP: usual care
Stratification by:
• centre
• severity of sepsis
• surgery within 72 hours or not
•
Sage, Gateshead
Study design
Inclusion criteria
• Age at least 18 years
• Hospital inpatient
• Commenced on iv antibiotics for sepsis (within 24 hours)
• Likely to be receiving intravenous antibiotics at 72 hours
• Requires Critical Care
Main exclusion criteria
• Prolonged antimicrobial therapy mandated (e.g. for tuberculosis,
osteomyelitis)
• Severely immunocompromised (e.g. neutropenia, less than 500
neutrophils/microliter)
Sage, Gateshead
Study interventions
•
●PCT protocol
●
●Standard care + daily serum
PCT measurement until
antibiotic discontinuation
●CRP protocol
●
●Standard care + daily serum
CRP measurement until
antibiotic discontinuation
●
●
● Advice for both PCT and CRP
groups delivered daily to
treating clinician
●
●
●PCT < 0.25µg/l
●
●
●
●CRP < 25mg/l
●
●“Protocol STRONGLY
supports stopping antibiotics”
●
●
●PCT fall by >80% from
baseline or PCT > 0.25 & <
0.50 µg/l
●
●
●CRP fall by 50% from
baseline
●
●“Protocol suggests stopping
antibiotics”
●
●PCT does not meet above
criteria
●
●
●CRP does not meet above
criteria
●
●“Protocol supports usual care”
Sage, Gateshead
Study interventions
•
●PCT protocol
●
●Standard care + daily serum
PCT measurement until
antibiotic discontinuation
●CRP protocol
●
●Standard care + daily serum
CRP measurement until
antibiotic discontinuation
●
●
● Advice for both PCT and CRP
groups delivered daily to
treating clinician
●
●
●Control group advice
●delivered daily to treating
clinician
●
●
●PCT < 0.25µg/l
●
●
●
●CRP < 25mg/l
●
●“Protocol STRONGLY
supports stopping antibiotics”
“Protocol supports usual
care”
●
●PCT fall by >80% from
baseline or PCT > 0.25 & <
0.50 µg/l
●
●
●CRP fall by 50% from
baseline
●
●“Protocol suggests stopping
antibiotics”
“Protocol supports usual
care”
●
●PCT does not meet above
criteria
●
●
●CRP does not meet above
criteria
●
●“Protocol supports usual care” “Protocol supports usual
care”
Sage, Gateshead
Study flow diagram
•
Sage, Gateshead
Study design
•
Sage, Gateshead
Study design
•
Sage, Gateshead
Study design
•
Sage, Gateshead
Study design
•
Sage, Gateshead
Study design
Primary outcome measures:
1. Effectiveness
• Total duration of antibiotic treatment to 28 days following
randomisation (superiority) measured in days (24-hour time
periods from randomisation)
2. Safety
• 28-day all-cause mortality (non-inferiority) following
randomisation as primary safety outcome
Sage, Gateshead
Study design
Secondary effectiveness & safety outcome measures to 28 days:
• Antibiotic dose (measured as Defined Daily Dose)
• Unscheduled care escalation/re-admission
• Infection relapse/recurrence requiring further antibiotic treatment
• Super-infection defined as new infection at a different anatomical site
All-cause mortality rates at 90 days will be collected via linked records
Health care system benefit measures:
• Assessment of in-trial cost effectiveness
• Critical care unit length and level of stay
• Hospital length of stay
Process evaluation of trial:
Sage, Gateshead
Study design
A total sample size of 2760 (912 patients per group)
To detect both:
• a mean of 1-day reduction in antibiotic duration
(using a mean antibiotic duration of 7 days, a pooled standard deviation
of 6 days, 90% power, a significance level of 5%, with a 5% withdrawals
rate)
• a non-inferiority safety margin of 5%
•
(using a 1-sided significance level of 2.5%, 90% power and 5% withdrawal
rate) assuming 28-day mortality is 15%.
Sage, Gateshead
Study progress
Intended learning outcomes
• Identify sepsis as a severe life-threatening infection syndrome
•
• Describe NICE Diagnostic Guidance in sepsis
•
• Outline an NIHR HTA commissioned diagnostic trial (ADAPT-Sepsis)
•
•
•
• Discuss opportunities for NIHR trial adoption at your centre
•
• Discuss knowledge mobilisation from trial into NHS care
•
Sage, Gateshead
adaptsepsistrial@warwick.ac.uk
Lunch & Expo
London, 08TH November 2018
Belgium | China | France | Germany | Italy | Luxembourg | Netherlands | UK | US (Silicon Valley) | fieldfisher.com
In vitro Diagnostic Medical Devices
Challenges and opportunities in a post-Brexit UK
8 November 2018
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com137
Unknowns
• Will the EU Withdrawal Bill be enacted essentially in current
form?
• Will there be mutual recognition with the EU?
• Will the Transition Agreement be agreed, or will the UK “crash
out of the EU”: the ultimate hard Brexit?
• Will the UK Government introduce laws bringing MDR/ IVDR
into UK law?
• ……or will there be something different?!
•
•
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com138
Withdrawal Bill as Written Today: Future Two separate Bodies of Law
UK LAW from 30 March 2019
EU law enacted as UK law (Directives):
Become “stand-alone” UK law:
MDD/ AIMD/ IVDMDD
EU law with direct effect (Regulations):
Become part of “stand-alone” UK law ONLY if
both in force AND “applicable” at 29 March
2019:
Most provisions of MDR and IVDR will not be
part of UK Law on 30 March 2019
EU LAW
Gradual applicability of MDR and IVDR:
26 May 2020: MDR fully applicable
26 May 2022: IVDR fully applicable
Transition
EU law will apply in UK until 31 December 2020
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com
MDR no
longer
applicable
in UK
MDR no
longer
applicable
in UK
139
Current Flow of Legislation in UK: Per Current Documents
29 March
2019
UK Sovereign Law Applies per EU Withdrawal ActUK Sovereign Law Applies per EU Withdrawal Act
31 December
202026 May 2020
EU law: MDD/ AIMD and
IVDMDD plus limited
provisions of MDR/ IVDR
EU law: MDD/ AIMD and
IVDMDD plus limited
provisions of MDR/ IVDR
EU law: MDR fully
applicable
EU law: MDR fully
applicable
EU
Law?
Transition
Agreement
EU
Withdrawal
Act: UK
Law
EU law applies in the UK
per Transition Agreement
EU law applies in the UK
per Transition Agreement
26 May
2022
In EU (not UK) :
IVDR fully applicable
In EU (not UK) :
IVDR fully applicable
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com140
Will UK Government enact MDR and IVDR?
“The UK will comply with all key elements of the Medical Devices Regulation (MDR)
and the in vitro diagnostic Regulations (IVDR), which will apply in the UE from May
2020 and 2022 respectively”
How medicines, medical devices and clinical trials would be regulated if there’s no
Brexit deal (updated 14 September 2018)
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com141
Medical Device Manufacturers: What to do, and when?
Action!!!
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com142
Regulations: Making Sales in EU after 31 December 2020
Current UK notified bodyCurrent UK notified body
UK Legal ManufacturerUK Legal Manufacturer
29 March 2019
UK: EU27:
UK Authorised RepresentativeUK Authorised Representative
EU27 notified bodyEU27 notified body
EU27 Legal Manufacturer
OR appoint AR in EU27
EU27 Legal Manufacturer
OR appoint AR in EU27
EU27 Authorised
Representative
EU27 Authorised
Representative
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com143
Interesting NB Dilemma: What about the UK?
So, now I
don’t have a
notified body
in the UK??
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com144
Interesting NB Dilemma: What about the UK?
23 August Technical Note from MHRA:
“UK will recognise medical devices approved for the EU market
and CE-marked”
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com145
R&D/ manufacturing/ regulatory functions/ HQ in UK?
• EU law does not prevent these being outside the EU27
• Just need other another entity inside EU to be holder of the
regulatory functions: legal manufacturer/ holder of CE
certificates for EU27 OR Authorised Representative
• MDR, Article 15: “Person responsible for regulatory
compliance”: no requirement to be in the EU27
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com146
UK Opportunities
• MHRA: Focus on influencing international platforms and standards
• Potential to “mutually (or non-mutually) recognise” a number of laws - eg
US as well as EU?
• Is lighter regulation an opportunity?
• Lead the way in developing guidelines and standards in certain sectors?
•
•
•
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com147
Any Questions?
Alison Dennis
Partner
Co-head of Life Sciences Sector
ABHI Legal and Compliance Committee Vice-Chair
T: +44(0)207 861 4637
M: +44 (0)7525 902 361
E: alison.dennis@fieldfisher.com
Michael Wakeman BSc, MSc MRPharmS
Case Study
CRP in Community Pharmacy
The protein is made up of five sub-units arranged in a ring with beta sheets and alpha helices connected by
linking regions. CRP is a blood plasma protein produced by the liver. It is an acute phase protein, whose
levels rise in response to inflammation. It assists the binding of complement proteins to foreign or damaged
cells, an immunological response that destroys the target cells.
C-reactive Protein (CRP)
Main Presentation UK Diagnostic Summit 2018
6037
4530
50
Adults
Children/adolescents
Age unknown
more than 40% of study participants were children as from the age of 1 year
439
426
1852
820
200
608
Tonsillopharyngitis (children)
Acute sinusitis (adults)
Acute bronchitis (adults)
Acute bronchitis (children)
Chronic bronchitis
Common Cold
4345 patients in placebo-controlled clinical trials
Kaloba-Extensively Clinically
Investigated
16 151
Aims of Study
O Evaluate a CRP test in community pharmacy
O Assess the acceptability of point of care CRP testing in
community pharmacy
O Investigate any reduction in GP appointments for non- LRTIs
O Assess impacts upon a subsequent antibiotic prescribing.
Supporting Materials
O A brief introduction to CRP
O Cough/Chest Infection Poster A3
O Dear Doctor letter
O Dear patient letter
O FAQs
O PATIENT QUESTIONNAIRE
O Point of Care CRP testing Service Level Agreement
O Symptoms of a cold
O V4 TYI leaflet for community pharmacy
https://www.northstaffslpc.co.uk/point-of-care-testing-for-rti/
Creating Consumer Awareness
Patient pathway
Main Presentation UK Diagnostic Summit 2018
Day 3 Follow-up
O Day 3 questions only:
O Were you expecting the test? (yes/no)
O Did the test help your understanding? (yes/no)
O Was it painful? (yes/no)
O Were the results easy to understand? (yes/no)
O Would you have otherwise have visited the GP? (yes/no)
O Would you have otherwise have visited another healthcare
professional? (yes/no)
O Would you have expected antibiotics? (yes/no)
O Can I call back in 4 days? (yes/no)
O
Day 3 and 7 follow-up
O Day 3 and 7 questions:
O On a scale of 1–5 how would you assess the following symptoms:
O Shortness of breath (likert scale 1–5)
O Wheezing (likert scale 1–5)
O Chest pain (likert scale 1–5)
O Breathing abnormalities (likert scale 1–5)
O Perspiring (likert scale 1–5)
O Headache (likert scale 1–5)
O Myalgia (likert scale 1–5)
O Feeling generally unwell (likert scale 1–5)
O Others (please state)
O Do you have a fever (>38°C)? (yes/no)
O Have you subsequently needed to visit a GP or another healthcare professional as a
result of these symptoms? (yes/no)
O If yes, did you receive an antibiotic prescription? (yes/no)
O
Reports
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Outcomes
Conclusions
https://www.pharmaceutical-journal.com/research/research-article/point-of-care-c-reactive-
protein-testing-in-community-pharmacy-to-deliver-appropriate-interventions-in-respiratory-tract-
infections/20204635.article
Supporting UK pharmacist study
O Evaluating a point-of-care C-reactive protein test to support
antibiotic prescribing decisions in a general practice
O
O
O
O pharmaceutical-journal.com/research/research-article/evaluating-a-point-of-care-c-reactive-protein-test-to-support-
antibioticprescribing-decisions-in-a-general-practice/20201688.article
Main Presentation UK Diagnostic Summit 2018
Main Presentation UK Diagnostic Summit 2018
Moving Forwards
O Extension of pilot study to embrace the whole town of Cheadle
O 9 more community pharmacies commissioned by NHS England
to deliver POC CRP in Staffordshire/Shropshire
O 2 community pharmacies delivering the service in South and
North of England
O Detailed impact of the intervention on antibiotic prescribing
Thank You
Dr Anita Sharma
GPwSI Gynaecology
Clinical Lead Oldham GP Federation
Educational Lead North West FDA
NICE QSAC GP Member
Caring, Compassionate Committed
Reducing Antimicrobial
Prescribing
OLDHAM CRP PROJECT
Caring, Compassionate Committed
177
TODAY’S SESSION
§ Health in Oldham
§ Triple Aim Strategic Objectives
§ Oldham AMR strategy in line with UK’s
§ TARGET Workshop
§ CRP Project
§ Where are we now in Oldham

Caring, Compassionate Committed
178
HEALTH IN OLDHAM
• Registered population 242,970 (1/1/16)
• 21% of households in fuel poverty
• 20% BME population
• Marked regional variation in health/mortality
• High smoking prevalence ---24% as compared to 22%
North West, 19% England
• High levels of obesity---25%
• Low levels of physical exercise—47% as compared to 53% NW, 56% England

Caring, Compassionate Committed
179
FUTURE CHALLENGES
§ Ageing population: 65 yrs (19%), 75 yrs (26%),
85 yrs (27%) in next 10 yrs
§ Ethnic Population
§ Increasing obesity, smoking, alcohol and drug abuse

§ Multiple vascular pathology - Increasing complexity
§
§ Financial constraints

§
 Caring, Compassionate Committed
180
TRIPLE AIM OBJECTIVES
• To improve the health of the people of Oldham

• To improve the care they receive

• To deliver best value for money

Caring, Compassionate Committed
181
Oldham Antimicrobial Strategy
• To develop Primary Care Antimicrobial Policy
•
• To guide professionals regarding appropriate prescribing for
the treatment of commonly encountered infections
•
• To make the right decision when to prescribe

Caring, Compassionate Committed
182
Oldham’s Antimicrobial Prescribing
Challenges
• Oldham prescribed large numbers of antibiotics
• QIPP indicator showed Oldham in the bottom national quartile
• 22 practices within the bottom national quartile
• 16 practices within the top national quartile

Caring, Compassionate Committed
183
Oldham Antimicrobial Policy
• Developed in April 2013 in collaboration with NE sector Drugs
and Therapeutics
• Guidance on management of RTI, UTI, ENT ,Acne, sexually
transmitted infections, GI ,Eye, Viral and skin and soft tissue
infections
• Focus was on appropriate prescribing: Outcomes

Caring, Compassionate Committed
184
Main Presentation UK Diagnostic Summit 2018
This toolkit is here to help clinicians and commissioners to
use antibiotics responsibility and meet CQC requirements
Caring, Compassionate Committed
186
TARGET PROJECT OLDHAM
PROJECT AIM
To determine whether the provision of one hour workshop
using the TARGET presentation explaining the HOW? And
WHY? of AB prescribing results in fewer prescribing
compared to controls who only have the website material.

Caring, Compassionate Committed
187
METHODOLOGY
• Designed by TARGET Team: Dr Cliodna McNulty, Meredith
Hawking, Dr Donna Lecky
• To evaluate the toolkit material RCT with a modified –Zelan
design was undertaken
• 28 practices stratified
• 15 surgeries in the Intervention group
• 1 hr workshop on TARGET materials. PACT data

Caring, Compassionate Committed
188
METHODOLOGY
§ CCG approval taken on 1.8.2013
§ Train the Trainer’s workshop organised 15.8.2013
§ Presentations, AB guidance, workshop delivery, GP commonly
asked questions
§ Practices invited to take part
§ Workshop delivered in their practice +CPD
§ Prescribing data shown to the practices (one year before and
after the workshop)
§ Practices were not informed that they were part of the study

Caring, Compassionate Committed
189
Total items prescribed per 1000
population per practice (2012/13
Caring, Compassionate Committed
190
Main Presentation UK Diagnostic Summit 2018
FEEDBACK
Caring, Compassionate Committed
192
§ 80% of patients attended their GP because they expected
Antibiotics

§ 30-50% of patients wanted a referral to hospital

§ If not given antibiotics they attended Out of Hours or A&E

§ Some joined the next door practice

FEEDBACK
Caring, Compassionate Committed
193
When asked specifically if they had access to PoC CRP
test would that help to reassure patient?
NICE pathway (POC) CRP Test
Caring, Compassionate Committed
194
 NICE guideline CG191 recommends that GPs should consider carrying out a
point of care (POC) C-reactive protein (CRP) test for people presenting in
primary care with symptoms of lower respiratory tract infection.

Pneumonia not diagnosed or not
clear if antibiotic should be
prescribed
CRP rapid test
< 20mg/L
Do not routinely offer
antibiotic therapy
20-100
mg/L
Consider a delayed
antibiotic prescription
>100 mg/L
Offer antibiotic
therapy
Current Prescribing in
Primary care
Caring, Compassionate Committed
195
• 78.5% of antibiotic prescribing is in Primary Care.
• Antibiotic prescribing by GPs increased by 4% between
2010 and 2013.
• Over half of antibiotics prescribed in Primary Care are for
respiratory tract infections (RTI).
• However, systematic reviews have shown that most of
these infections are viral and patients derive little
benefit from antibiotic treatment.

PROJECT PLAN
Caring, Compassionate Committed
196
PROJECT PLAN
Caring, Compassionate Committed
197
Caring, Compassionate Committed
198
PRACTICE SELECTION
Caring, Compassionate Committed
199
§ Oldham CCG consisting of 45 GP practices.
§ 8 highest prescribing practices were randomly selected from
the top 12 prescribers (by total antibiotic prescription).
§ GP practices approached by letter and telephone
§ Appropriate Governance and Ethical approval was taken
§
Alere—now Abbott PoC CRP was chosen

Oldham CRP Project
Caring, Compassionate Committed
200
§ Started in Jan 2016
§ 800 CRP tests were available to be used by 8 practices
§ Usage per practice:
Practice A 97
Practice B 11
Practice C 11
Practice D 75

Oldham CRP Project
Caring, Compassionate Committed
201
§ Practice E 43
§ Practice F 18
§ Practice G 100
§ Practice H 0

§ Total number of CRP tests completed: 359
§ 59 were excluded
§ Final included sample: 300
§ 43% were Male, 57% Female

Patient presenting condition
Caring, Compassionate Committed
202
CRP results
Caring, Compassionate Committed
203
Were antibiotics prescribed after
the CRP Test ?
Caring, Compassionate Committed
204
Re-consultation (within 4 weeks)
per CRP Test Score
Caring, Compassionate Committed
205
Hospitalisation and complication
rates
Caring, Compassionate Committed
206
Big Question

Is C-Reactive Protein PoC testing feasible
in routine General Practice,
improving diagnostics certainty and AB use ?
FEASIBILITY
208
C-reactive protein point-of-care testing in Oldham CCG
• 45% (359) CRP tests used over 6 months
• 78% of CRP results were <20mg/L
•
88% in line with NICE guidance: Self care advice only
21% in line with NICE guidance: Delayed
antibiotic
100% in line with NICE guidance: Immediate antibiotic
Post CRP test patient questionnaires
209
C-reactive protein point-of-care testing in Oldham CCG
• 50% completion
• Patients were positive about CRP, no dislikes reported
• 88% comfortable; 84% convenient; 92% useful; 85% explained very well
• Patients believed POC CRP: aids clinical diagnosis;
provides quick results;
reduces unnecessary antibiotic use
• 78% would be happy to have CRP at a local pharmacy
• framework
•
“Helps diagnosis and
treatment”
“Quick, simple, easy and gave
instant results”
“Saves issuing antibiotics when
not needed”
GP staff interviews
210
C-reactive protein point-of-care testing in Oldham CCG
• The GP staff interview findings are published in the BMJ Open, Oct 2018
GP staff interviews (26 staff, 12 practices)
211
C-reactive protein point-of-care testing in Oldham CCG
• Staff viewed CRP POCT as a “tool in your
armoury” to support clinical decision
and educate patients.
•
• Barriers; cost, time, easy access to the
machine, and the effects on clinical
workflow.
•
• Only fully utilised in practices with single
staff member who saw most acute
cases
•
• Further machine development is needed to
simplify process and increases access
by reducing cost and size
•
Capability
•Clear local guidance
•Training: to perform
•Knowledge: of value to reduce antibiotics
when to use
•Skills: to take, perform & interpret test
Opportunity
•Funding to support
•Easy access in surgery
•Time to use in consultation
•Adaptable clinical workflow
•Patient awareness
Motivation
•Confidence in the test
•Belief in benefits of CRP
•Belief supports clinical decisions and diagnostic
certainty
•Feel patients will accept the result
•Intent to use test appropriately
•
FUNDING
This work was supported by Public Health England £4,200
More funding has come from PHE £4,500
Alere (ABBOTT): Provided machines (free of charge) and reduced rate PoC £2/
Publications: BMJ article and other magazines
My Presentations

212
C-reactive protein point-of-care testing in Oldham CCG
WHAT NEXT FOR OLDHAM
Caring, Compassionate Committed
213
PoC CRP testing well received by GP practice staff as an additional
diagnostic tool to support clinical decision

NICE guidelines CG191 recommends PoC CRP testing

Used in Norway, Sweden, Netherlands, Germany, Estonia, Czech
Republic

QUALITY PREMIUMS
Caring, Compassionate Committed
214
• In April 2015, NHS England included antibiotic prescribing in the
2015/16 Quality Premium guidance for Clinical
Commissioning Groups (CCG).
• Of the total £5 per patient available to CCGs, 10% is attributed
to improving antibiotic prescribing,an average of £127,000.*

Questions
Caring, Compassionate Committed
215
Closing Keynote – How
Diagnostics make economic
sense for the NHS
Lord Jim O’Neill of Gatley
http://prezi.com/-qtgxvia6wry/?utm_campaign=share&utm_medium=copy&rc=ex0share
Chairs Closing
Remarks
Dorris – Ann Williams MBE, Chief Executive, BIVDA
Conference Close

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Main Presentation UK Diagnostic Summit 2018

  • 2. Conference Chair Introduction Doris – Ann Williams MBE, Chief Executive, BIVDA
  • 3. Keynote Address – UK AMR Diagnostics Collaborative Fiona Carragher, Deputy Chief Scientific Officer, NHS England
  • 4. Fiona Carragher FRCPath @DepCSOFiona Deputy Chief Scientific Officer for England england.amrdiagnostics@nhs.net UK AMR Diagnostics Collaborative: Maximising the use of diagnostic technology to tackle AMR November 2018
  • 5. • • • • • • The UK AMR Strategy: a tripartite approach
  • 6. Diagnostics – the current view of the system Complexity of system Levers & Incentives ExternalAssurance Adoption Routes to use Standards Inappropriate use (diagnostics) Models of provision Service quality Data InfrastrucureCommissioning arrangements
  • 7. UK AMRDC- Providing a single point of focus for the system System Leadership Strategic Direction UK Oversight Local connectivity & good practice System Alignment Nat’l Policy, Levers, Incentives, UKAMRDC
  • 8. UK AMR Diagnostic Collaborative Programme Value proposition Diagnostic Stewardship One Health Innovation Policy and Communication aligned to current policy and regulatory environment System partners Public Health England Health Education England DEFRA Key areas of focus Devolved Administrations
  • 9. Diagnostic stewardship- definition • Coordinated professional guidance and interventions to improve patient understanding, care and management through the appropriate use of clinical assessment and clinical scoring algorithms, biomarker tests and/or microbiological diagnostics to guide therapeutic decisions or screening strategies. • It should promote appropriate, timely diagnostic testing, including specimen collection, and pathogen identification and accurate, timely and audited reporting of results to guide care. It should discourage unnecessary diagnostic testing and the use of tests that yield misleading results. • Diagnostic Stewardship should utilize microbiological data, including accurate and representative AMR surveillance data to inform local treatment guidelines, and AMR control strategies, and should be an integral component of measures to improve antimicrobial stewardship and infection prevention and control • WHO 2016: Diagnostic stewardship A guide to implementation in antimicrobial resistance surveillance sites
  • 10. UK AMR DC 18/19 areas of focus -Diagnostic Stewardship • Use of biomarkers eg CRP/Procalcitonin in acute settings or as POCT in the community • Quality improvement approach to diagnostics within the blood culture pathway enabling timely review of antibiotic therapy • Urinary infections: Tackling inappropriate use of urinary diagnostics and focus on the urine culture pathway UK wide building on good practise, driving quality improvement and addressing variation •
  • 11. Innovation: challenging ourselves to go further, faster Handheld ‘lab on a chip’ High throughput genomic technologies Point of care testing Evolving technologies Disruptive approaches – What else can we learn from: Big data, analytics & AI Developing world approaches Animal Health Other scientific specialisms
  • 12. UK AMR Diagnostic Collaborative - next steps • • The government will shortly be setting out a refreshed UK strategy for AMR, this is likely to set out a longer term vision accompanied by a shorter term 5 year National Action Plan • • The new plan will take a coordinated approach, setting out challenging ambitions for the next five years and commitments across humans, animals, food and the environment. • Key milestones to come in 18/19: November: UK wide survey of blood culture. To gain a system wide understanding of current laboratory practice in relation to quality and unwarranted variation and enable the UK ADC with partners to develop mechanisms to improve services. 5th December: Engagement event to gain an understanding from industry and innovators • The current challenges when accelerating usage of solutions developed by industry • The challenges and potential solutions to feed into national policy • Highlight opportunities for test bed working 31st January: With all system partners to understand how health regulation, policy innovation, funding, quality, safety and research can support the government’s ambition to embed rapid diagnostics.
  • 13. • The Health and Social Care Select Committee released the report from their inquiry into AMR 22nd October 2018 • Within this there are specific recommendations relating to diagnostics • • Continued Focus on AMR Diagnostics
  • 14. The system must be responsive System response Define the capabilities Prioritise technologies Supportive regulatory structure Systematic approach to rapid adoption Streamline & develop evidence base Connected data across care pathways The work of the UK AMR diagnostic collaborative is crucial in ensuring that all the right groups and agencies are working together to address these challenges.
  • 15. The UKAMRDC Working in partnership UKAMRDC
  • 16. HOW DIAGNOSTICS CAN DRIVE EFFICIENCY WITHIN THE NHS Event: UK DIAGNOSTICS SUMMIT Presenters: Professor Adrian Newland, Chair, National Pathology Optimisation Board Date: 8th November 2018
  • 17. Dunn et al, Deficits in the NHS, King’s Fund 2016 ‘..factors such as the growing and ageing population, patients’ rising expectations and an increased prevalence of long- term conditions have increased demand for NHS services but without an equivalent growth in spending to pay for it….’
  • 18. Lafond S et al: Hospital finances & productivity: in a critical condition? Health Foundation 2015
  • 19. Unwarranted Variation: final report summary, January 2016
  • 20. The Weighted Activity Unit (WAU) • The type of treatments provided by acute trusts differ substantially (casemix). • This makes it difficult to make robust comparisons between trusts using simple measures of output. • Both in the UK and elsewhere (e.g. US, Australia), this issue is tackled by using a measure of cost-weighted output. • Cost-weighting is used to adjust for differences in casemix between trusts. • Lord Carter has pioneered the use of the Weighted Activity Unit (WAU). • One WAU is the equivalent of an elective inpatient admission, based on the cost of providing that treatment (≈£3,500). • •
  • 22. Results : The Carter review • Report saw £5bn of value opportunity 2020-21, if unwarranted variation removed. • New Operational Productivity Directorate in NHSI to deliver report’s recommendatio ns09.16) • The opportunity
  • 23. Why does diagnostics need to change? • Over the last 5 years demand for diagnostic tests has increased by 26.8% • The total waiting list has increased by 36% • The diagnostic standard of 6 weeks has not been met since November 2013 • Everyone accessing diagnostic services should receive where possible a diagnosis at first point of contact • This would support earlier diagnosis, earlier intervention with less costly treatments and a potential change in disease burden
  • 24. Diagnostics and the clinical pathway • 80% of pathways start with diagnostic services Primary and Secondary care • Services deliver over1bn tests yearly at a cost of ~£9.0bn (10% of NHS spend) • Effective diagnostics fundamental to optimising healthcare provision, improving outcomes and driving efficiencies • Maximising value from the £17.5bn medicines spend
  • 25. Diagnostics and the Long Term Plan Priority areas within the LTP • Cancer – Rapid diagnostic centres • Cardiovascular and Respiratory – Early diagnosis and intervention • Paediatric and Maternal Health – appropriate use of diagnostics • Research and Innovation – support the systematic uptake of new technologies • Genomics – accessibility to other diagnostics to provide integrated reporting • Primary and Community care – joined up service •
  • 26. Why does pathology need to change? • Wide variations in in quality and service provision Atlas of Variation of Diagnostic Services Accreditation of services to ISO standards Quality Assurance Access and control of Point of care • Insufficient data and digital infrastructure Interoperability impacts on resource utilisation Over testing and duplicate testing • Insufficient equipment • Demand and capacity issues • Complex and variable commissioning arrangements Specialised and CCG Little incentive for efficiency and financial sustainability
  • 27. Background; 2016/17 data collection • Case for change identified through successive Carter reports • Operational Productivity Directorate commissioned large scale data collection • This data has allowed for the identification and quantification of sources of unwarranted variation • Modelling of the data has identified opportunities for efficiency savings
  • 28. 2017/18 Data insights – Changes 2017/8 information 122 Providers 30m fewer tests £33.6m cost-savings
  • 29. 31 | • Imaging is an essential part of the vast majority of patient pathways • Imaging is critical for screening and assisting with diagnosis and treatment of patient pathways • There is under provision of imaging capacity within the NHS, exacerbated by high vacancy rates and the age demographics requiring both outsourcing and insourcing to meet demand • Lack of detailed benchmarking data to date has prevented opportunities to identify unwarranted variation • High levels of variation in radiographer reporting of plain films (77% to 0%) and in skill mix • Variation in the costs per report (Complexity not accounted for currently) • High level of clinical service engagement with 22 Expressions of interest to work with NHS Improvement to be an ‘Early Adopter’ Imaging Network Transforming Imaging Services – Improving Efficiency & Sustainability £2 Billion Spent onDelivering Imaging Services Non Medical Workforce 23,500 (vacancy rates of 15%) 3,000 Medical Consultants (vacancy rates 12.5% & ageing demographic) £134 Million spent on Outsourcing & Insourcing (to manage demand)* 39 Million reports Upper quartile: £69 / Report Median: £55 / Report Lower Quartile: £46 / Report Cost per report NHS Improvement currently working with 4 Early Adopter Imaging Networks to identify the benefits of Imaging networks * Data Collection for 2016/17 (Figure likely to be much higher for 2017/18) All Staff Update 11/7/18 Diagnostic Services - Imaging
  • 30. Equipment sales and after-market 32 • Aged asset base According to the industry, 12% of CT and 29% of MRI scanners are >10 years old • • Lack of capital resources Replacement of imaging equipment competing with multiple other priorities • • Managed Equipment Services Shortage of clear case studies demonstrating value for money • • Third-party maintenance and service contracts Little evidence of strong competition in the Imaging equipment market to challenge OEM dominance
  • 31. 34 | In 2017/18, Clinical & Workforce Productivity delivered a range of significant achievements, supporting NHS Trusts to improve Productivity. 30 £78m £571m 1200+ £327m Workforce “Deep Dives” completed in Wave 1 across Nursing, Doctors, AHPs and Pharmacy. Case studies published as part of our Tier 1 offer Metrics developed for Imaging Services in the newly published Model Hospital Compartment Capital funding secured for investment in Pharmacy infrastructure IT systems and E- Prescribing systems to improve medication safety, efficiency and interoperability Clinical & Workforce Productivity – Highlights 29 saved through the “Top 10 Medicines”, switching to cheaper generic and biosimilar medicines, improving patient access Pathology Networks modelled and mapped and communicated to the NHS in England £33.6m of diagnostic services-related cost improvements delivered by Trusts of workforce-related cost improvements delivered by Trusts £26m Capital funding secured for investment in e- Rostering and e-Job Planning systems to ensure comprehensive coverage (all staff, all sectors) All Staff Update 11/7/18
  • 33. NHSI Operational Productivity Pathology Consolidation – The State of the Nation Presenters: David Wells, Head of Pathology Consolidation Date: Autumn / Winter 2018
  • 34. Pathology Networks “Consolidating pathology services allows for most consistent, clinically appropriate turnaround times ensuring the right test is available at the right time. It makes better use of our highly skilled workforce to deliver improved, earlier diagnostic services supporting better patient outcomes. Taking a hub and spoke approach to this consolidation can ensure an appropriate critical mass to support specialist diagnostics, so that patients have equal access to key tests and services are sustainable.”
  • 35. Overview of the final report: £5bn savings 15 recommendations involving: • Optimising application of clinical resources • Optimising use of non-clinical resources • Quality & efficiency throughout care pathway • Implementation & engagement with trusts Unwarranted Variation: final report summary, January 2016
  • 36. Improving the quality and value of NHS pathology services 39 Data shows +£200m efficiency saving NHS Improvement is working with trusts to move towards 29 pathology networks across England 122 Pathology providers Workforce of 25 thousand Processing 1.1 billion tests per year £2.1 billion delivery cost • Pathology is essential in over 70% of patient pathways. • High quality services, delivering timely results for patients, will also support national priorities in genomics, cancer care and integrated healthcare • • Currently there is national excess capacity in equipment, yet we are seeing local workforce shortages • • Variation of non-pay costs in routine testing from 2p to £1.26 per test • • Networking at scale allows for better value, better utilisation of capital equipment, faster turn around times where required and more opportunities for the workforce to undertake extended roles. • • NHS Improvement is engaging with the sector, with strong support for the hub and spoke model By next year, the networks need to be operational and starting to deliver these quality and efficiency improvements.
  • 37. Pathology • Clinically lead service. Every result issued has been monitored, reviewed or commented upon by a medical clinician or state registered (via HCPC) Biomedical or Clinical Scientist. • Integrated access to sub-specialty expertise available for community, primary, secondary and tertiary at a single touch point. Scientists all have a sub-speciality training, and have an active role in many specialist MDT meetings. • Accreditation and quality assurance integral to service delivery. Pathology in the UK has lead the way in clinical accreditation for more than 20 years. UK system is the basis of the current international accreditation standard. • Keen technology adopters. Moving academic and novel technologies into routine, safe, clinical practice. Covers all healthcare across prevention, screening, monitoring and diagnosis from before conception until post mortem. All with appropriate clinical and scientific support for local clinical teams.
  • 38. Networks & Consolidation with engagement 41 The benefits are: • Driving up clinical quality, better for patient outcomes • Faster turnaround times • Right testing available at the right time. • Better access to sub-specialty expertise • Access to new technology • • Improving service resilience • • Efficient use of highly skilled staff. Right role, right person. • • Economies of scale and purchasing – linking into the current NHS Improvement Procurement teams and Category Tower provider using the NPODG to set the clinical standard and requirements for national purchasing • • National excess equipment capacity, yet workforce shortages • Networking across wider geographies provides a solution to localised recruitment challenges and development of advance scientific roles. • NPODG Regulators - UKAS - CMA - BIVDA Clinical community - RCPATH - IBMS Providers - Trusts - Private sector providers Suppliers - Equipment - Private sector operators Commissioners - NHSE - CCGs Workforce - Unions such as UNITE - Health Education England The programme is working in true partnership with the clinical and scientific community to deliver the right test, with the right advice at the right time – utilising the right approach and technology via the National Pathology Delivery group (NPODG) We are working with other colleagues in legal, procurement, finance. In addition with are also aligned and contributing to national programmes for example Genomics, AMR, sepsis and digital / AI with NHS England, Public Health, and Office of Life Science
  • 39. Outputs Described and enabling 29 Pathology networks: To set out the direction and ambition. Publication of clinical and operational advice in the form of toolkits: To share learning and provide consistent advice with agreement of the professional bodies and other ALBs Development of specialist testing networks: To ensure highly complex clinical services are sustainable and efficient, supporting faster access to sub-specialist clinical expertise Facilitating network workshops involving clinical and operational teams: To drive the pace of change to ensure local empowerment and ownership of networks. Development and launch of the National Pathology Quality Assurance Dashboard: To monitor and measure quality of pathology services clinically and operationally. To ensure good practice in adoption of national guidance, accreditation, training and education and also to ensure corporate good practice in monitoring supplier performance, quality of industry service delivery and provider interactions for new models of care (e.g Point of care testing in primary care). Identifying national funding and innovations: A Working with Office of Life Science to ensure innovation pipelines to digitise and adopt AI where clinical appropriate at pace and scale. Working with industry to identify disruptive technologies – for example drone delivery for blood samples, or point of care diagnostics to improve bed utilisation Collecting system wide data….
  • 40. Data insights - Validation Pay Cost Validation Non-Pay Cost Validation
  • 41. Data insights – Total costs
  • 42. Data insights – Agency costs
  • 43. Data insights – Bank costs
  • 44. Model Hospital – Cost per test Spring 2018: NHS Improvement pathology networks
  • 45. State of the Nation
  • 46. State of the Nation
  • 47. State of the Nation “In September 2017 we signalled to all acute hospital trusts in England that they would need to change how they work and collaborate to drive out unwarranted variation in pathology services. The first tranche of pathology networks is fully operational, and we expect a third of all the networks to be fully operational by the end of this financial year, with the rest to follow by 2021.” “To meet this deadline, there is much to do. We need to scale up from the one in five pathology networks that are operational today, to at least a third by the end of 2018/19. The formation of pathology networks is a core part of implementing national policy on improving quality and productivity. NHS Improvement will continue to support and guide the development of these networks, ensuring that services are safe, effective, caring, and responsive. We will work with trusts in networks yet to become operational to jointly agree milestones, establish what extra support they need and ensure local leadership (across trusts and commissioners) is in place to complete or network becoming operational.”
  • 48. Next steps for the sector • It is important that networks are progressed at pace. • Actions to support realisation of efficiencies, available immediately, should be taken now. • Centres that have been identified as Essential Services Laboratories should begin to model the transition to delivering this service model. • Centres identified as hubs should be supporting the preparatory work to consolidate any testing activity that can be moved in advance of further networking. • It is vital that staff and subject matter experts are engaged at all stages of the process, executive commitment is also essential in the next phase of developing networks.
  • 49. • Review service contracts – Level of cover versus clinical requirement. • Review provision of complex testing against savings of retiring equipment and out sourcing • Consolidation of consumables provider, with Trust and across aspirant network • Consolidate referral activity to a single diagnostic provider. • Review service contracts – Level of cover versus clinical requirement. • Review provision of complex testing against savings of retiring equipment and out sourcing • Consolidation of consumables provider, with Trust and across aspirant network • Consolidate referral activity to a single diagnostic provider. Grip & Control: Action now Inventory management Inventory management Non- recurrent actions Non- recurrent actions Cash management Cash management ProcurementProcurement 5 6 7 8 Governance & Comms Governance & Comms Pay cost actions Pay cost actions Non-pay / all cost actions Non-pay / all cost actions Rapid actions Rapid actions 1 2 3 4 • Consolidate referral activity to a single diagnostic provider. • Review service contracts – Level of cover versus clinical requirement. • Review logistics - operational delivery and contracting arrangements. • Business cases and Capex review. • Demand management of testing – RCPath/IBMS/ACB guidance • Consolidate referral activity to a single diagnostic provider. • Review service contracts – Level of cover versus clinical requirement. • Review logistics - operational delivery and contracting arrangements. • Business cases and Capex review. • Demand management of testing – RCPath/IBMS/ACB guidance • Reduce reliance on agency / locums; • Review Out of hours arrangements where the are outside of AfC • Review sample delivery time to reduce out of hour staffing requirements • Review Consultant Job plans • Increase staff availability – remote and flexible working • Improve staff retention –Training & Development • Reduce reliance on agency / locums; • Review Out of hours arrangements where the are outside of AfC • Review sample delivery time to reduce out of hour staffing requirements • Review Consultant Job plans • Increase staff availability – remote and flexible working • Improve staff retention –Training & Development• Ensure all R&D activities are funded and appropriately priced. • Consolidate referral activity to a single diagnostic provider. • Demand management of testing – RCPath guidance • Ensure all R&D activities are funded and appropriately priced. • Consolidate referral activity to a single diagnostic provider. • Demand management of testing – RCPath guidance • Adopt just in time stock management • Introduction of automated stock management systems to meet accreditation requirements and reduce staff time. • Remove ad-hoc deliveries via improved stock management. • Adopt just in time stock management • Introduction of automated stock management systems to meet accreditation requirements and reduce staff time. • Remove ad-hoc deliveries via improved stock management. • Ensure all R&D activities are funded and appropriately priced. • Sale of old equipment • Asset review. Consolidation on technology type across disciplines • • Ensure all R&D activities are funded and appropriately priced. • Sale of old equipment • Asset review. Consolidation on technology type across disciplines • • Governance and cash management – PO or approved testing request route only. • Capital and assets opportunities; • Governance and cash management – PO or approved testing request route only. • Capital and assets opportunities; • Clear delivery plan on and around consolidation • Engage staff and key stakeholders. Particularly Clinical users. • Clinical need rather than clinical want • Clear delivery plan on and around consolidation • Engage staff and key stakeholders. Particularly Clinical users. • Clinical need rather than clinical want
  • 50. Essential Services Laboratory – Action now Principles The ESL The provision of laboratory services for the acute setting is vital to ensure safe patient care. We have developed a tool kit that describes the minimum service that should be available. ESL that vary from this toolkit should be justified using clinical evidence, or robust data to demonstrate efficient use of resources. ●What does good look like ● Clinical Governance • Clear leadership • Clear escalation points for local issues ●LIMS • Integration and full interoperability ●Logistics • Harmonised with Hub • Timely ● Quality • Provided by Hub • ISO 15189 • MHRA ● Training • Supported by the Hub, delivered across the network • Full rotation of staff ●Business continuity • Clear robust, tested plans. • POC and emergency procedures. ●Implementation • Step change implementation, involving quality assessments and review • Only the services needed to provide acute pathology provision, including appropriate blood transfusion services, should be commission in an ESL. All other work should be performed in the hub laboratory. • Meet all regulatory and accreditation standards (BSQR (MRHA), UKAS, HSE). • Have a clear clinical and operational governance link to the Hub. • Have a clear management structure. • True interoperability with the Hub, with a single LIMS or full IT integration, common platforms and procedures. • Full 24/7 rota, multidisciplinary assistant grades, aspiration towards multidisciplinary Biomedical Scientists. • Have clear training strategy that is harmonised with the Hub laboratory, provided by staff supernumerary to the ESL. • Have agreed performance metrics, service specification. Variation only where it is warranted. • improvement.nhs.uk/resources/pathology-networks- toolkit/
  • 51. Next steps for NHS Improvement • NHS Improvement will continue to support and guide the development of these networks, ensuring that services are safe, effective, caring, and responsive. • We will work with trusts in networks yet to become operational to jointly agree milestones, establish what extra support they need and ensure local leadership (across trusts and commissioners) is in place to complete or network becoming operational. • Support progress at pace. • Continue data collection and providing insight support to providers and commissioners. • Release Pathology Quality Assurance Dashboard
  • 52. What Good Looks Like Clinical Leadership: Clinical team must take responsibility for delivering a high quality, appropriate but cost effective service and manage the relationship between pathology and other clinical disciplines. Partnership Model: Informal networks are unable to agree and deliver change fast enough, and have under-developed management structures for effective clinical governance. Executive Participation: Board support, coupled with strong, experienced leadership is critical to the success of any consolidation project. Customer Service: The need for a strong customer focus, supported by the appropriate clinical staff and infrastructure, is essential within any large organisation, including pathology, whether public or private. Procurement: Procurement continue to deliver cost savings through better contracting and a more competitive market place. However, standardising the procurement process and building on best practices will save significant time and effort and improve the comparability and management of contracts. IT: A standard LIMS (Laboratory Information Management System) is a key enabler for pathology consolidation. Of equal importance is a dedicated IT team that can manage and optimise the various systems. Demand optimisation aims to deliver additional value in two ways: 1. By ensuring that only appropriate tests are requested 2. By recommending different analysis that will provide additional insight and Impact on the quality and cost of patient care Working with GIRFT:
  • 53. Pathology Quality Assurance Dashboard 56 • This is a tool for individual Trusts to assess and manage the benefit Pathology services can deliver. It is not a contractual tool to manage the service. • Timely collection of appropriate data. To give Trust Board visibility of system wide metrics that Pathology has an impact on. The aim is to support national initiatives. • • Collecting data in one place, once. Benchmarking performance to continuously drive improvement. • • Looking to include metrics for Innovation and Training to support long term sustainability of workforce and adopting advance and innovative roles. • • Potential to propose KPIs initially where national targets do not exist.
  • 54. Specialist Testing 57 • Specialist Trusts have been mapped into networks, however, we are aware of the supra-regional and national impact some of services have. • Formation of a board sub-committee to investigate the opportunity and approach. • • Defining attributes of specialist services to support: - • Training / Succession • Clinical Pathways - Providing greater access to more patients • Innovation and translational development • Development of accepted standards, protocols, and national leadership • Diagnostic pathway optimisation •
  • 55. National Funding Opportunities UK Life Science strategy - NHS Improvement inputting into the delivery of this national strategy. - NHS Improvement influencing competition success criteria to ensure funding to aligned to organisations that can deliver adoption at scale to benefit patients and the wider UK PLC National Funding Forty NHS hospitals and community services will get £760 million to modernise and transform their buildings and services in the year of the NHS’s 70th birthday. Included in this are a number of pathology programmes supporting the national configuration of pathology services into 29 Networks across England. - Up to £31.2 Million for Lancashire and South Cumbria Pathology Collaboration. - Up to £2 million for West Yorkshire National Pathology Exchange. - Up to £9 million for Black Country Pathology. - Up to £19.3 million for Sussex and East Surrey pathology hub and laboratory information management system. - This funding recognises the progress made by these organisations towards implementation of their pathology network and underlines the importance for pathology services to consolidate at pace to realise the efficiency for greater patient benefit. Carter Efficiency Capital - Awaiting on HMT for agreement on £40m funding for Diagnostics. STP Capital - Supporting Networks to submit bids against latest wave of capital funds Cancer Boards - NHSI Teams building an understanding to support networks in accessing funds associated with regional cancer boards. - Supporting business cases and benefit models
  • 57. A partnered development of a circulating tumour ESR1 Mutation Test for the detection of metastatic breast cancer mutations indicative of resistance to endocrine hormone therapy 08 November 2018 Head of Diagnostics Ciaran Fulton
  • 58. Who are LifeArc? A UK registered charity Translating academic research Life Science specialist Founded in mid 1980s 25+ years in the ‘technology transfer’ business Key Client: UK Medical Research Council Collaborating widely - UK, Europe, USA, China
  • 59. What LifeArc Does Technology Transfer Identification, protection, management and licensing IP Centre for Therapeutics Discovery Small molecule drug discovery team Antibody engineering team Centre for Diagnostics Development Molecular Dx assay development Pre-clinical & clinical validation Business Development - scouting for great science Scouting activities on 3 continents Due diligence team
  • 60. Our Organisation Today Our ambitions driven by our Charitable ‘Objects’ ‘To promote the public benefit by improving human health and medical research… ‘Accelerate the progress of these discoveries and technologies to the stage at which they are (i) capable of being made generally available to the medical profession and the public for practical application for the improvement of health and/or (ii) are transferred or licensed to a third party to progress development of such discoveries or technologies towards such goals’ Over 180+ Staff, spread over our three sites including… 30 in Technology Transfer (London) 80 Drug Discovery scientists (Stevenage) 10 Diagnostics scientists (Edinburgh) We are financially self sufficient - Revenue (2017/18) £25.85m Expenditure (2017/18) £26.54m With our R&D spending, we have invested over (2017/18)- Drug Discovery £16.2m Diagnostics Development £2.2m We have also invested over £19m in a new Drug Discovery Complex & Diagnostics Development Centre in Stevenage and Edinburgh.
  • 61. Products on the Market
  • 62. LifeArc’s Centre for Diagnostic Development, Edinburgh Set-up in 2014 We help translate early stage diagnostic opportunities We work collaboratively with academics & industry partners We do this at our own risk – providing the resources, expertise & investment to effect this development Our focus is in developing molecular diagnostics Work across wide ranging disease areas We’re interested in novel ways, new or enabling technologies Look to find the best path to bring new & novel tools to the clinic Our focus in diagnostics
  • 63. Commercial Collaboration – Biocartis co-development of a liquid biopsy assayBiocartis is a molecular diagnostics company based in Mechelen, Belgium. The Company’s proprietary Idylla platform is a fully automated, real time qPCR system offering accurate, highly-reliable molecular information from any clinical sample. The Idylla system covers the entire process from sample to result in about 35 to 150 minutes with less than 2 minutes hands-on time. Biocartis developed assays in oncology (KRAS, NRAS, EGFR & BRAF, RUO & CE-IVD) and infectious diseases (IFV-RSV, FDA cleared); the platform is FDA waived & CE-IVD marked.
  • 64. Fully automated molecular testing with Idylla™ Instrument Console Cartridge (consumable) Scan sample Scan cartridge Load sample Insert cartridge Clinically- actionable results Superior sensitivity and ease-of-use, combined with sample to result turnaround time of 90 to 150* minutes * Based on turnaround times of current on-market oncology tests
  • 65. Breast Cancer and ESR1 Mutations First-line treatment of estrogen receptor (ER+) metastatic Breast Cancer (MBC) is endocrine hormonal therapy: hormone treatments lower the levels of estrogen in the body, or block their effects. 70% of Breast Cancers (BC) express estrogen receptors which makes them sensitive to hormonal blockage. Endocrine hormone treatments include selective estrogen receptor modulators/down-regulators (SERMs/SERDs) or by estrogen agonists/antagonists, and aromatase inhibitors (AIs). The ESR1 gene codes for the estrogen receptor. Mutations in this gene have been associated with acquired endocrine resistance in patients with ER- positive metastatic breast cancer (MBC) previously treated with endocrine therapy. ESR1 mutations are rare in primary breast cancers at the time of diagnosis (<2%).
  • 66. ctESR1 Mutation AssayThe Biocartis Idylla ctESR1 Mutation Test will be developed for the detection of 10 point mutations within the ligand-binding domain (LBD) of the ESR1 (estrogen receptor 1) gene. The assay will target patients with ER-positive metastatic breast cancer who may be at risk of acquiring resistance to endocrine hormone therapy. ●Mutation ●SNP ●Sequence ●E380Q [n1138] ●G -> C ●CTTCTACAATGTGCC ●S463P [n1387] ●T -> C ●TTTCTGCCCAGCACC ●L536H [n1607] ●T -> A ●GTGCCCCACTATGAC ●L536R [n1607] ●T -> G ●GTGCCCCGCTATGAC ●L536P [n1607] ●T -> C ●GTGCCCCCCTATGAC ●L536Q [n1607_1608] ●TC -> AG ●GTGCCCCAGTATGAC ●Y537N [n1609] ●T -> A ●GTGCCCCTCAATGAC ●Y537S [n1610] ●A -> C ●GTGCCCCTCTCTGAC ●Y537C [n1610] ●A -> G ●GTGCCCCTCTGTGAC ●D538G [n1613] ●A -> G ●GTGCCCCTCTATGGC E380Q S463P AF-1 DBD Hinge LBD L536H L536R L536P L536Q Y537N Y537S Y537C D538G 5
  • 67. Initiated breast cancer menu development with partners Resistance monitoring test Therapy selection test 1.On 15 June 2017 MRC Technology changed its name in LifeArc. LifeArc has been involved in helping deliver a number of therapies including Keytruda (pembrolizumab, marketed by MSD) which is an important immunotherapy treatment for various cancers 2.Partnership is with ETPL, the commercialization arm of A*STAR • Liquid biopsy test • Monitoring of metastatic breast cancer patients for resistance to hormone therapy UK based medical research charity1 Description Partner • Solid biopsy test • Supporting optimal therapy selection decisions for breast cancer patients Singapore’s Agency for Science, Technology and Research2 Partnership structure • Development multiple Idylla™ tests • LifeArc acts as development contractor • Biocartis responsible for commercialization under own label • Parties will co-invest in development of selected Idylla™ tests • A*STAR acts as development partner • Biocartis responsible for commercialization under own label Oncotype Dx Breast Recurrence Score® test US based provider of genomic-based diagnostic tests in cancer • Solid biopsy test • Tailoring treatment of breast cancer patients based on the biology of their individual disease • Genomic Health to develop Idylla™ versions of proprietary Genomic Health tests • Genomic Health responsible for commercialization under own label • Biocartis acts as supplier of tests
  • 68. Detecting, analysing and interpreting diagnostic devices for use outside clinical laboratories
  • 69. § Most value provided to diagnostic tests taken in remote locations (in-field) or at the point of patient care (at home) § § Support patient care within chronic/autoimmune disease monitoring, or to diagnose and track infectious disease § § Can be applied to almost any visually read tests including: lateral flow, colorimetric, ELISA and agglutination § § CE-Marked medical products for IBD in Europe & Canada. First FDA 510 (K) approval in the US expected Dec 2018 § § Patent protected in the US, Europe (includes UK), China, Japan, Russia. § § Use cases in human clinical, animal health, food safety and environmental § § ISO 13485:2016 and EIC 62304 compliant About Novarum DX Read and share the results of point of care tests using smartphone reader technology.
  • 70. § Healthcare institutions overburdened § Waiting lists - increasing time to result § Geographic barriers to healthcare provision § Resource poor settings and infrastructure § Inconvenience of recurring appointments § Patients too sick to travel Decentralised Healthcare
  • 71. Mobile Ecosystem Multi-frame analysis technique provides highly accurate results, whilst removing human subjectivity. Test results shared securely to an end-user portal online. Image-capture technology transforms a mobile phone into a diagnostic test reader the results of which are shared to an end-user portal.
  • 72. § Step-by-step instruction carousels § In-app Videos and voice instruction § Incubation timers and alarms Correct sample preparation is achieved using Test Choreography which ensures incubation periods are adhered to - preventing false results. How can errors be prevented?
  • 73. § Patients can monitor chronic conditions with regular self-testing § Bedside testing an option for patients who are too sick to visit their GP § Overcomes geographic constraints for patients too remote from healthcare provision § Maintains confidentiality and removes the stigma of attending sexual health clinics § Enables lay users to have confidence in performing tests § Enables clinicians to trust self-tests Point of Care Testing – At Home
  • 74. Crohn’s Disease & Ulcerative Colitis The first CE-Marked smartphone- based calprotectin home test measuring the inflammatory marker for faecal calprotectin at home. § Mobile App (CalApp®) § Desktop Portal (IBDoc®) Data recorded from the portal is shared with trusted end-users, which can include Electronic Healthcare providers to shape the future of healthcare.
  • 75. § Help to reduce the spread of blood-borne disease with an early diagnosis § Support technician fieldwork with quick and accurate test results outside a laboratory § Tag test results with a geo-location to track infectious disease outbreaks § Enable connected, monitored testing in remote locations Point of Care Testing – In Field
  • 76. § Rapid diagnosis to distinguish between bacterial and viral infectious § Robust traceability for prescriptions to human and food-producing animals § Track and trace infectious disease outbreaks to limit its spread Antibiotic Stewardship
  • 77. Overestimate the expectations of patients to get a prescription § Patients want to feel better § Patients don’t want to wait for an appointment if they don’t improve § Patients find it easier to accept if there is a test result § Prof Klepser @ Ferris State University – extensive research on the role of Community Pharmacists in reducing antibiotic overprescribing Potential for Pharmacists?
  • 78. § Unlikely to happen without a government driven agenda § Requires a joined up ecosystem to manage diagnosis, prescription, care and follow up of antibiotic use § Putting patients at centre could transform the approach – and mobile may enable that Viability?
  • 79. T: +44(0)131 290 2 290 npolwart@novarumdx.com enquiries@novarumdx.com www.novarumdx.com LT-41_2018_10_22
  • 80. Panel Debate – How do we create a diagnostic pathway for the UK Chair: Daniel Berman, Longitude Prize, Challenge Prize Centre, Nesta Panellist: Doris-Ann Williams, Chief Executive, BIVDA Panellist: Fiona Carragher, Deputy Chief Scientific Officer, NHS England Panellist: Professor Adrian Newland CBE, Professor of Haematology, Barts and the London School of Medicine and Dentistry Panellist: David Wells, Head of Pathology Services Consolidation, NHS Improvements
  • 83. Point of care blood testing (POCbT) for patients >65 years presenting with acute frailty syndromes. Using diagnostics to improve clinician confidence in discharge of patients presenting with acute frailty syndromes.
  • 85. Ronald’s Story Fall 1: • Ambulance • Non Injury • Non urgent falls referral Fall 2: • 111 - GP • Non Injury • Not seen Fall 3: • Ambulance • Non Injury • No referral made Fall 4: • Neck of Femur # • Loss of independence • Complaint from hospital Hb 75 g/L
  • 86. Biochemical and Haematological contributors to falls § WHO epidemiology of falls § Cognitive deficit § hypercalcaemia, § hyponatraemia, § hypo/ hyperglycaemia § Renal failure § hypoxia from respiratory failure, § Muscle weakness § Anaemia, § Hypocalcaemia § Hypokalaemia/ hyperkalaemia §
  • 87. The Project §1 x iSTAT alinity §CRG4+ and CHEM8 Cartridges §4 Specialist Paramedics + 4 Frailty Paramedics §Patients >65 years presenting with acute frailty syndromes
  • 89. Acute frailty syndromes Falls Confusion Immobility Increased side effect to medications Incontinence Underlying illness that needs identification and correction
  • 90. Aims Inform safe hospital avoidance Earlier disease management Increased clinician confidence Increased knowledge of POCbT use
  • 93. Deployment and referrals Device used on specialist Paramedic car plus falls and frailty response vehicle Deployment § Self deployment § Specialist Paramedic Hub Referrals § Crew referrals
  • 94. Safety nets • Standard Operating procedures • Team training • Access to previous results • GP telephone triage and advice • Multiple PDSA cycles •
  • 95. Results § 78 patients involved § § Improvement in reported clinician confidence § Improved discharge on scene and recontact rates (when compared with frailty specific project) § Case studies support earlier disease management.
  • 97. Brenda – 84 yEArs, Fall and confusion
  • 98. Ken – 94 yEArs, Fall with ?Long lie
  • 99. Dot – 86 Years, reduced mobility
  • 100. Bob – 92 years, Recurrent falls
  • 101. Key Learnings●Learning ●Cost vs benefit ●Patient demographic selection is vital ●Targeted use of device on selected resources Access to previous results ●Recognition of the normally abnormal ●ICE (Integrated Clinical Access) access Appropriate training of the team ●Initial group training run by qualified ACP ●Monthly 1-2-1 sessions with team ●Senior support – GP or Medical team Use in prognosticating infection ●Lactate alone is not sufficient to identify early sepsis Logistics ●Temperature management ●Cartridge management
  • 102. Thanks
  • 103. Conclusion Whilst formal research is required to validate its use, this QIP showed POCbT to have a positive impact on all stated aims.The projects results, whilst taken from a small sample size and of limited transferability, show promise for POCbT in both the pre-hospital environment and in the field of frailty.
  • 105. BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with Sepsis ADAPT-Sepsis Trial Investigators Biomarkers: Serum Procalcitonin (PCT) & C-reactive protein (CRP)
  • 106. Sage, Gateshead Investigator team • Critical Care: Paul Dark ( Manchester); Gavin Perkins (Warwick); Danny McAuley (Belfast); Tony Gordon (Imperial); Mervyn Singer (UCL); Tim Walsh (Edinburgh); Gordon Carlson (Salford) • Microbiologists/antibiotic stewardship: Ronan McMullan (Belfast); Peter Wilson (UCL) • Statisticians/trial methodologists: Ranjit Lall; Simon Gates (Warwick) • Health economics: Matt Stephenson (Sheffield) • Patients/relatives: Keith Young (Intensive Care Society/Salford Citizen Scientists) • Laboratory clinical biochemistry: Jonathan Clayton (Salford) • Outcome data linkage: Paul Mouncey (ICNARC); Naz Lone (Edinburgh) • Pharmacology/pharmacy: Tim Felton; Kay Marshall (Manchester) • Trial managers and coordinators: Scott Regan, Nicola McGowan, Johnny Gluck, Maddie Flawn (Warwick Clinical Trials Unit). Independent Trial Steering Committee: Chair Julian Bion (Birmingham) Independent Data Monitoring Committee: Chair Ly-Mee Yu (Oxford)
  • 107. Intended learning outcomes • Identify sepsisas a severe life-threatening infection syndrome • • Describe NICEDiagnostic Guidance in sepsis • • Outline a NIHR HTA commissioned diagnostic trial • • Discuss opportunities for trial adoption at your centre • • Discuss knowledge mobilisation from trial into NHS •
  • 108. Sepsis • Body’s overwhelming response to infection (= organ failure, death) • Time-critical medical emergency •
  • 109. Sage, Gateshead Background NICE Diagnostic Guidance DG18 (Oct. 2015): “Procalcitonin testing for diagnosing and monitoring sepsis” • Systematic review of clinical and cost effectiveness • 8 RCTs (critically ill adults with sepsis) = daily PCT for antibiotic discontinuation • • All ‘uncertain quality’ with some ‘at significant risk of bias’ •
  • 110. Sage, Gateshead Background NICE Diagnostic Guidance DG18 (Oct. 2015) • Promising results from international trials • Concerns about risk of performance bias from evidence base • Lack of a systematic evidence from the UK • Uncertainty of results in current standard NHS clinical practice • Further research is recommended in UK Is there a role for CRP monitoring? • •
  • 111. Sage, Gateshead Research question • • • • • • • • • • Research Question: Does a treatment protocol based on serial monitoring of CRP or PCT safely allow reduction in duration of antibiotic therapy in hospitalised patients with sepsis? Specifies: definitive 3-arm RCT
  • 112. Sage, Gateshead • • • • • • • • • • Population: Hospitalised adults receiving intravenous antibiotics for suspected sepsis Intervention: Antibiotic discontinuation protocol based on monitoring daily CRP or PCT Comparator: Standard NHS care for patients with sepsis Outcomes: Antibiotic duration (effectiveness) 28-day all-cause mortality (safety)
  • 113. Sage, Gateshead Pilot data 1. Antibiotic duration for sepsis in the UK? • No readily available high quality reliable data from UK - • International recommendations: 7-10 days (Surviving Sepsis Guidelines) • • PHE antibiotic stewardship guidance: 7 days - • Best estimate from Evelien de Jong (SAPS trial 2016) • • Netherlands (documented low antibiotic burden country) • Median duration 7 (IQR 4-11) days standard care arm
  • 114. Sage, Gateshead Pilot data 2. Is there equipoise in UK for PCT and CRP monitoring in sepsis? Survey of healthcare professionals managing patients with sepsis • 380 contributors over 4 weeks • • CRP frequently used non-systematically with no defined stop rules • • PCT used infrequently with stop rules consistent with NICE DG 18 • • High desire to take part in a large scale pragmatic RCT (76%) 50 NHS service laboratories surveyed separately with concordant Results and important assay platform information for trial feasibility
  • 115. Sage, Gateshead Study design Multi-centre 3-arm randomised controlled trial Internal pilot (completed Oct 2018) Random group allocation • computer-generated randomisation sequence with the minimisation method using random blocks • randomised in a ratio of 1:1:1 to PCT:CRP: usual care Stratification by: • centre • severity of sepsis • surgery within 72 hours or not •
  • 116. Sage, Gateshead Study design Inclusion criteria • Age at least 18 years • Hospital inpatient • Commenced on iv antibiotics for sepsis (within 24 hours) • Likely to be receiving intravenous antibiotics at 72 hours • Requires Critical Care Main exclusion criteria • Prolonged antimicrobial therapy mandated (e.g. for tuberculosis, osteomyelitis) • Severely immunocompromised (e.g. neutropenia, less than 500 neutrophils/microliter)
  • 117. Sage, Gateshead Study interventions • ●PCT protocol ● ●Standard care + daily serum PCT measurement until antibiotic discontinuation ●CRP protocol ● ●Standard care + daily serum CRP measurement until antibiotic discontinuation ● ● ● Advice for both PCT and CRP groups delivered daily to treating clinician ● ● ●PCT < 0.25µg/l ● ● ● ●CRP < 25mg/l ● ●“Protocol STRONGLY supports stopping antibiotics” ● ● ●PCT fall by >80% from baseline or PCT > 0.25 & < 0.50 µg/l ● ● ●CRP fall by 50% from baseline ● ●“Protocol suggests stopping antibiotics” ● ●PCT does not meet above criteria ● ● ●CRP does not meet above criteria ● ●“Protocol supports usual care”
  • 118. Sage, Gateshead Study interventions • ●PCT protocol ● ●Standard care + daily serum PCT measurement until antibiotic discontinuation ●CRP protocol ● ●Standard care + daily serum CRP measurement until antibiotic discontinuation ● ● ● Advice for both PCT and CRP groups delivered daily to treating clinician ● ● ●Control group advice ●delivered daily to treating clinician ● ● ●PCT < 0.25µg/l ● ● ● ●CRP < 25mg/l ● ●“Protocol STRONGLY supports stopping antibiotics” “Protocol supports usual care” ● ●PCT fall by >80% from baseline or PCT > 0.25 & < 0.50 µg/l ● ● ●CRP fall by 50% from baseline ● ●“Protocol suggests stopping antibiotics” “Protocol supports usual care” ● ●PCT does not meet above criteria ● ● ●CRP does not meet above criteria ● ●“Protocol supports usual care” “Protocol supports usual care”
  • 124. Sage, Gateshead Study design Primary outcome measures: 1. Effectiveness • Total duration of antibiotic treatment to 28 days following randomisation (superiority) measured in days (24-hour time periods from randomisation) 2. Safety • 28-day all-cause mortality (non-inferiority) following randomisation as primary safety outcome
  • 125. Sage, Gateshead Study design Secondary effectiveness & safety outcome measures to 28 days: • Antibiotic dose (measured as Defined Daily Dose) • Unscheduled care escalation/re-admission • Infection relapse/recurrence requiring further antibiotic treatment • Super-infection defined as new infection at a different anatomical site All-cause mortality rates at 90 days will be collected via linked records Health care system benefit measures: • Assessment of in-trial cost effectiveness • Critical care unit length and level of stay • Hospital length of stay Process evaluation of trial:
  • 126. Sage, Gateshead Study design A total sample size of 2760 (912 patients per group) To detect both: • a mean of 1-day reduction in antibiotic duration (using a mean antibiotic duration of 7 days, a pooled standard deviation of 6 days, 90% power, a significance level of 5%, with a 5% withdrawals rate) • a non-inferiority safety margin of 5% • (using a 1-sided significance level of 2.5%, 90% power and 5% withdrawal rate) assuming 28-day mortality is 15%.
  • 128. Intended learning outcomes • Identify sepsis as a severe life-threatening infection syndrome • • Describe NICE Diagnostic Guidance in sepsis • • Outline an NIHR HTA commissioned diagnostic trial (ADAPT-Sepsis) • • • • Discuss opportunities for NIHR trial adoption at your centre • • Discuss knowledge mobilisation from trial into NHS care •
  • 130. Lunch & Expo London, 08TH November 2018
  • 131. Belgium | China | France | Germany | Italy | Luxembourg | Netherlands | UK | US (Silicon Valley) | fieldfisher.com In vitro Diagnostic Medical Devices Challenges and opportunities in a post-Brexit UK 8 November 2018
  • 132. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com137 Unknowns • Will the EU Withdrawal Bill be enacted essentially in current form? • Will there be mutual recognition with the EU? • Will the Transition Agreement be agreed, or will the UK “crash out of the EU”: the ultimate hard Brexit? • Will the UK Government introduce laws bringing MDR/ IVDR into UK law? • ……or will there be something different?! • •
  • 133. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com138 Withdrawal Bill as Written Today: Future Two separate Bodies of Law UK LAW from 30 March 2019 EU law enacted as UK law (Directives): Become “stand-alone” UK law: MDD/ AIMD/ IVDMDD EU law with direct effect (Regulations): Become part of “stand-alone” UK law ONLY if both in force AND “applicable” at 29 March 2019: Most provisions of MDR and IVDR will not be part of UK Law on 30 March 2019 EU LAW Gradual applicability of MDR and IVDR: 26 May 2020: MDR fully applicable 26 May 2022: IVDR fully applicable Transition EU law will apply in UK until 31 December 2020
  • 134. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com MDR no longer applicable in UK MDR no longer applicable in UK 139 Current Flow of Legislation in UK: Per Current Documents 29 March 2019 UK Sovereign Law Applies per EU Withdrawal ActUK Sovereign Law Applies per EU Withdrawal Act 31 December 202026 May 2020 EU law: MDD/ AIMD and IVDMDD plus limited provisions of MDR/ IVDR EU law: MDD/ AIMD and IVDMDD plus limited provisions of MDR/ IVDR EU law: MDR fully applicable EU law: MDR fully applicable EU Law? Transition Agreement EU Withdrawal Act: UK Law EU law applies in the UK per Transition Agreement EU law applies in the UK per Transition Agreement 26 May 2022 In EU (not UK) : IVDR fully applicable In EU (not UK) : IVDR fully applicable
  • 135. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com140 Will UK Government enact MDR and IVDR? “The UK will comply with all key elements of the Medical Devices Regulation (MDR) and the in vitro diagnostic Regulations (IVDR), which will apply in the UE from May 2020 and 2022 respectively” How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal (updated 14 September 2018)
  • 136. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com141 Medical Device Manufacturers: What to do, and when? Action!!!
  • 137. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com142 Regulations: Making Sales in EU after 31 December 2020 Current UK notified bodyCurrent UK notified body UK Legal ManufacturerUK Legal Manufacturer 29 March 2019 UK: EU27: UK Authorised RepresentativeUK Authorised Representative EU27 notified bodyEU27 notified body EU27 Legal Manufacturer OR appoint AR in EU27 EU27 Legal Manufacturer OR appoint AR in EU27 EU27 Authorised Representative EU27 Authorised Representative
  • 138. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com143 Interesting NB Dilemma: What about the UK? So, now I don’t have a notified body in the UK??
  • 139. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com144 Interesting NB Dilemma: What about the UK? 23 August Technical Note from MHRA: “UK will recognise medical devices approved for the EU market and CE-marked”
  • 140. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com145 R&D/ manufacturing/ regulatory functions/ HQ in UK? • EU law does not prevent these being outside the EU27 • Just need other another entity inside EU to be holder of the regulatory functions: legal manufacturer/ holder of CE certificates for EU27 OR Authorised Representative • MDR, Article 15: “Person responsible for regulatory compliance”: no requirement to be in the EU27
  • 141. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com146 UK Opportunities • MHRA: Focus on influencing international platforms and standards • Potential to “mutually (or non-mutually) recognise” a number of laws - eg US as well as EU? • Is lighter regulation an opportunity? • Lead the way in developing guidelines and standards in certain sectors? • • •
  • 142. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com147 Any Questions? Alison Dennis Partner Co-head of Life Sciences Sector ABHI Legal and Compliance Committee Vice-Chair T: +44(0)207 861 4637 M: +44 (0)7525 902 361 E: alison.dennis@fieldfisher.com
  • 143. Michael Wakeman BSc, MSc MRPharmS Case Study CRP in Community Pharmacy
  • 144. The protein is made up of five sub-units arranged in a ring with beta sheets and alpha helices connected by linking regions. CRP is a blood plasma protein produced by the liver. It is an acute phase protein, whose levels rise in response to inflammation. It assists the binding of complement proteins to foreign or damaged cells, an immunological response that destroys the target cells. C-reactive Protein (CRP)
  • 146. 6037 4530 50 Adults Children/adolescents Age unknown more than 40% of study participants were children as from the age of 1 year 439 426 1852 820 200 608 Tonsillopharyngitis (children) Acute sinusitis (adults) Acute bronchitis (adults) Acute bronchitis (children) Chronic bronchitis Common Cold 4345 patients in placebo-controlled clinical trials Kaloba-Extensively Clinically Investigated 16 151
  • 147. Aims of Study O Evaluate a CRP test in community pharmacy O Assess the acceptability of point of care CRP testing in community pharmacy O Investigate any reduction in GP appointments for non- LRTIs O Assess impacts upon a subsequent antibiotic prescribing.
  • 148. Supporting Materials O A brief introduction to CRP O Cough/Chest Infection Poster A3 O Dear Doctor letter O Dear patient letter O FAQs O PATIENT QUESTIONNAIRE O Point of Care CRP testing Service Level Agreement O Symptoms of a cold O V4 TYI leaflet for community pharmacy https://www.northstaffslpc.co.uk/point-of-care-testing-for-rti/
  • 152. Day 3 Follow-up O Day 3 questions only: O Were you expecting the test? (yes/no) O Did the test help your understanding? (yes/no) O Was it painful? (yes/no) O Were the results easy to understand? (yes/no) O Would you have otherwise have visited the GP? (yes/no) O Would you have otherwise have visited another healthcare professional? (yes/no) O Would you have expected antibiotics? (yes/no) O Can I call back in 4 days? (yes/no) O
  • 153. Day 3 and 7 follow-up O Day 3 and 7 questions: O On a scale of 1–5 how would you assess the following symptoms: O Shortness of breath (likert scale 1–5) O Wheezing (likert scale 1–5) O Chest pain (likert scale 1–5) O Breathing abnormalities (likert scale 1–5) O Perspiring (likert scale 1–5) O Headache (likert scale 1–5) O Myalgia (likert scale 1–5) O Feeling generally unwell (likert scale 1–5) O Others (please state) O Do you have a fever (>38°C)? (yes/no) O Have you subsequently needed to visit a GP or another healthcare professional as a result of these symptoms? (yes/no) O If yes, did you receive an antibiotic prescription? (yes/no) O
  • 166. Supporting UK pharmacist study O Evaluating a point-of-care C-reactive protein test to support antibiotic prescribing decisions in a general practice O O O O pharmaceutical-journal.com/research/research-article/evaluating-a-point-of-care-c-reactive-protein-test-to-support- antibioticprescribing-decisions-in-a-general-practice/20201688.article
  • 169. Moving Forwards O Extension of pilot study to embrace the whole town of Cheadle O 9 more community pharmacies commissioned by NHS England to deliver POC CRP in Staffordshire/Shropshire O 2 community pharmacies delivering the service in South and North of England O Detailed impact of the intervention on antibiotic prescribing
  • 171. Dr Anita Sharma GPwSI Gynaecology Clinical Lead Oldham GP Federation Educational Lead North West FDA NICE QSAC GP Member Caring, Compassionate Committed
  • 172. Reducing Antimicrobial Prescribing OLDHAM CRP PROJECT Caring, Compassionate Committed 177
  • 173. TODAY’S SESSION § Health in Oldham § Triple Aim Strategic Objectives § Oldham AMR strategy in line with UK’s § TARGET Workshop § CRP Project § Where are we now in Oldham  Caring, Compassionate Committed 178
  • 174. HEALTH IN OLDHAM • Registered population 242,970 (1/1/16) • 21% of households in fuel poverty • 20% BME population • Marked regional variation in health/mortality • High smoking prevalence ---24% as compared to 22% North West, 19% England • High levels of obesity---25% • Low levels of physical exercise—47% as compared to 53% NW, 56% England  Caring, Compassionate Committed 179
  • 175. FUTURE CHALLENGES § Ageing population: 65 yrs (19%), 75 yrs (26%), 85 yrs (27%) in next 10 yrs § Ethnic Population § Increasing obesity, smoking, alcohol and drug abuse  § Multiple vascular pathology - Increasing complexity § § Financial constraints  §  Caring, Compassionate Committed 180
  • 176. TRIPLE AIM OBJECTIVES • To improve the health of the people of Oldham  • To improve the care they receive  • To deliver best value for money  Caring, Compassionate Committed 181
  • 177. Oldham Antimicrobial Strategy • To develop Primary Care Antimicrobial Policy • • To guide professionals regarding appropriate prescribing for the treatment of commonly encountered infections • • To make the right decision when to prescribe  Caring, Compassionate Committed 182
  • 178. Oldham’s Antimicrobial Prescribing Challenges • Oldham prescribed large numbers of antibiotics • QIPP indicator showed Oldham in the bottom national quartile • 22 practices within the bottom national quartile • 16 practices within the top national quartile  Caring, Compassionate Committed 183
  • 179. Oldham Antimicrobial Policy • Developed in April 2013 in collaboration with NE sector Drugs and Therapeutics • Guidance on management of RTI, UTI, ENT ,Acne, sexually transmitted infections, GI ,Eye, Viral and skin and soft tissue infections • Focus was on appropriate prescribing: Outcomes  Caring, Compassionate Committed 184
  • 181. This toolkit is here to help clinicians and commissioners to use antibiotics responsibility and meet CQC requirements Caring, Compassionate Committed 186
  • 182. TARGET PROJECT OLDHAM PROJECT AIM To determine whether the provision of one hour workshop using the TARGET presentation explaining the HOW? And WHY? of AB prescribing results in fewer prescribing compared to controls who only have the website material.  Caring, Compassionate Committed 187
  • 183. METHODOLOGY • Designed by TARGET Team: Dr Cliodna McNulty, Meredith Hawking, Dr Donna Lecky • To evaluate the toolkit material RCT with a modified –Zelan design was undertaken • 28 practices stratified • 15 surgeries in the Intervention group • 1 hr workshop on TARGET materials. PACT data  Caring, Compassionate Committed 188
  • 184. METHODOLOGY § CCG approval taken on 1.8.2013 § Train the Trainer’s workshop organised 15.8.2013 § Presentations, AB guidance, workshop delivery, GP commonly asked questions § Practices invited to take part § Workshop delivered in their practice +CPD § Prescribing data shown to the practices (one year before and after the workshop) § Practices were not informed that they were part of the study  Caring, Compassionate Committed 189
  • 185. Total items prescribed per 1000 population per practice (2012/13 Caring, Compassionate Committed 190
  • 187. FEEDBACK Caring, Compassionate Committed 192 § 80% of patients attended their GP because they expected Antibiotics  § 30-50% of patients wanted a referral to hospital  § If not given antibiotics they attended Out of Hours or A&E  § Some joined the next door practice 
  • 188. FEEDBACK Caring, Compassionate Committed 193 When asked specifically if they had access to PoC CRP test would that help to reassure patient?
  • 189. NICE pathway (POC) CRP Test Caring, Compassionate Committed 194  NICE guideline CG191 recommends that GPs should consider carrying out a point of care (POC) C-reactive protein (CRP) test for people presenting in primary care with symptoms of lower respiratory tract infection.  Pneumonia not diagnosed or not clear if antibiotic should be prescribed CRP rapid test < 20mg/L Do not routinely offer antibiotic therapy 20-100 mg/L Consider a delayed antibiotic prescription >100 mg/L Offer antibiotic therapy
  • 190. Current Prescribing in Primary care Caring, Compassionate Committed 195 • 78.5% of antibiotic prescribing is in Primary Care. • Antibiotic prescribing by GPs increased by 4% between 2010 and 2013. • Over half of antibiotics prescribed in Primary Care are for respiratory tract infections (RTI). • However, systematic reviews have shown that most of these infections are viral and patients derive little benefit from antibiotic treatment. 
  • 194. PRACTICE SELECTION Caring, Compassionate Committed 199 § Oldham CCG consisting of 45 GP practices. § 8 highest prescribing practices were randomly selected from the top 12 prescribers (by total antibiotic prescription). § GP practices approached by letter and telephone § Appropriate Governance and Ethical approval was taken § Alere—now Abbott PoC CRP was chosen 
  • 195. Oldham CRP Project Caring, Compassionate Committed 200 § Started in Jan 2016 § 800 CRP tests were available to be used by 8 practices § Usage per practice: Practice A 97 Practice B 11 Practice C 11 Practice D 75 
  • 196. Oldham CRP Project Caring, Compassionate Committed 201 § Practice E 43 § Practice F 18 § Practice G 100 § Practice H 0  § Total number of CRP tests completed: 359 § 59 were excluded § Final included sample: 300 § 43% were Male, 57% Female 
  • 197. Patient presenting condition Caring, Compassionate Committed 202
  • 199. Were antibiotics prescribed after the CRP Test ? Caring, Compassionate Committed 204
  • 200. Re-consultation (within 4 weeks) per CRP Test Score Caring, Compassionate Committed 205
  • 201. Hospitalisation and complication rates Caring, Compassionate Committed 206
  • 202. Big Question  Is C-Reactive Protein PoC testing feasible in routine General Practice, improving diagnostics certainty and AB use ?
  • 203. FEASIBILITY 208 C-reactive protein point-of-care testing in Oldham CCG • 45% (359) CRP tests used over 6 months • 78% of CRP results were <20mg/L • 88% in line with NICE guidance: Self care advice only 21% in line with NICE guidance: Delayed antibiotic 100% in line with NICE guidance: Immediate antibiotic
  • 204. Post CRP test patient questionnaires 209 C-reactive protein point-of-care testing in Oldham CCG • 50% completion • Patients were positive about CRP, no dislikes reported • 88% comfortable; 84% convenient; 92% useful; 85% explained very well • Patients believed POC CRP: aids clinical diagnosis; provides quick results; reduces unnecessary antibiotic use • 78% would be happy to have CRP at a local pharmacy • framework • “Helps diagnosis and treatment” “Quick, simple, easy and gave instant results” “Saves issuing antibiotics when not needed”
  • 205. GP staff interviews 210 C-reactive protein point-of-care testing in Oldham CCG • The GP staff interview findings are published in the BMJ Open, Oct 2018
  • 206. GP staff interviews (26 staff, 12 practices) 211 C-reactive protein point-of-care testing in Oldham CCG • Staff viewed CRP POCT as a “tool in your armoury” to support clinical decision and educate patients. • • Barriers; cost, time, easy access to the machine, and the effects on clinical workflow. • • Only fully utilised in practices with single staff member who saw most acute cases • • Further machine development is needed to simplify process and increases access by reducing cost and size • Capability •Clear local guidance •Training: to perform •Knowledge: of value to reduce antibiotics when to use •Skills: to take, perform & interpret test Opportunity •Funding to support •Easy access in surgery •Time to use in consultation •Adaptable clinical workflow •Patient awareness Motivation •Confidence in the test •Belief in benefits of CRP •Belief supports clinical decisions and diagnostic certainty •Feel patients will accept the result •Intent to use test appropriately •
  • 207. FUNDING This work was supported by Public Health England £4,200 More funding has come from PHE £4,500 Alere (ABBOTT): Provided machines (free of charge) and reduced rate PoC £2/ Publications: BMJ article and other magazines My Presentations  212 C-reactive protein point-of-care testing in Oldham CCG
  • 208. WHAT NEXT FOR OLDHAM Caring, Compassionate Committed 213 PoC CRP testing well received by GP practice staff as an additional diagnostic tool to support clinical decision  NICE guidelines CG191 recommends PoC CRP testing  Used in Norway, Sweden, Netherlands, Germany, Estonia, Czech Republic 
  • 209. QUALITY PREMIUMS Caring, Compassionate Committed 214 • In April 2015, NHS England included antibiotic prescribing in the 2015/16 Quality Premium guidance for Clinical Commissioning Groups (CCG). • Of the total £5 per patient available to CCGs, 10% is attributed to improving antibiotic prescribing,an average of £127,000.* 
  • 211. Closing Keynote – How Diagnostics make economic sense for the NHS Lord Jim O’Neill of Gatley http://prezi.com/-qtgxvia6wry/?utm_campaign=share&utm_medium=copy&rc=ex0share
  • 212. Chairs Closing Remarks Dorris – Ann Williams MBE, Chief Executive, BIVDA

Editor's Notes

  1. 1
  2. Antimicrobial resistance arises when the organisms that cause infection evolve ways to survive treatment. Once standard treatments are ineffective, it is easier for infections to persist and spread. The inappropriate use of anti-infectivesand antimicrobials in both human and animal medicine, and unintentional exposure, for example through environmental contamination and food, is rapidly accelerating the pace at which it develops and spreads. By 2030, the global human consumption of antibiotics is forecast to rise by more than 30% and animal antimicrobial use is also expected to increase, especially in low- and middle-income countries. The rise and spread of antimicrobial resistance is creating a new generation of ‘superbugs’ that cannot be treated with existing medicines. Already, antimicrobial resistance is estimated to cause 700,000 deaths around the world each year. That figure is predicted to rise to 10 million, alongside a cumulative cost of $100 trillion, by 2050 if no action is taken. The 2013–2018 strategy and UK Government ambitions on antimicrobial resistance have helped reduce antibiotic use in both humans and food-producing animals The UK programmeis currentlyfocused on delivery of those ambitions through 4 core programmes (infection, prescribing, diagnostics, animal use) and 3 supporting work-streams (surveillance and behaviour, education and training, global and domestic research and drug pipeline activity). 2
  3. 3
  4. 4
  5. 5
  6. Diagnostics as part of the multi-professional approach ‘a seamless partnership between laboratories, pharmacists and clinicians’ 6
  7. 7
  8. Biomarkers, immunology, genomics 8
  9. 9
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  11. Define the capabilitiesthat new technologies should deliver in different settings Prioritise technologieswhich have the potential to both assess the pathogen as well as resistance that can inform and reduce antibiotic prescribing Encourage industry to focus on thedevelopment of multiplex systemsreflecting the clinical presentations that are often affected by multiple organisms Ensure thatregulationsin relation to licencing facilitate rapid adoption of priority technologies, Streamline the development of theevidence basefor many tests and fast track clinical trial data to aid implementation into clinical use Ensure theavailability of test resultsboth to support clinical decision making and epidemiology. 11
  12. 12
  13. Titleslide with embedded images 1
  14. Titleslide with embedded images 1
  15. Remind why we this programme is needed 3
  16. The 2015/16 data collection is the largest collection of pathology data ever undertaken to ratify and model the Lord Carter proposed Hub and Spoke model 75-80% of All Trusts have agreed with both our approach and modelling, the remaining Trusts agree with the hub and spoke model, just not the network choice, some of these we are able to support in moving them. 4
  17. Cover the range of services we are expecting the system to cover, primary to tertiary 5
  18. Slide to note that we are collecting data consistently year on year will low variation between returns. 8
  19. An example of an area labs can make a change now by bringing in a bank system 10
  20. Savings for moving from Agency to bank can be Circa £20m. Agency average £75k per FTE per year, Bank £35k per year 11
  21. 12
  22. Mention advanced roles 16
  23. Support - Regional teams, support in speeding up the business case process, delivering PQAD, specialist testing, advice on advance roles. Working on identifying funding sources.Requirement for UKAS 19
  24. Whilst the programme is not dependent on central capital investment, this will significantly accelerate implementation Targeting a range of opportunities to secure capital investment 23
  25. 1
  26. 3
  27. 2
  28. 1
  29. Introduction to the project My background is as a specialist paramedic with south central ambulance and I am currently training as an advanced clinical practitioner at the University hospital Southampton. Last year I was fortunate enough to be on a HEETV funded program for trainee ACPs which gave me the opportunity to develop a quality improvement plan aimed at improving diagnostics for the frail older person. 2
  30. About 10% of people with a hip fracture die within 1 month and about 30% within 12 months – NICE 3
  31. http://www.who.int/ageing/projects/1.Epidemiology%20of%20falls%20in%20older%20age.pdf 4
  32. In sept 2017 – March 2018 I trained 4Spsand 4 frailty paramedics in the use of the iSTAT Alinity device with CRG4+ and CHEM8 Cartridges. Specialist Paramedics are Paramedics who have gone on to do masters modules to specialise in critical or urgent care and frailty paramedics are Paramedics who work on the falls and frailty car and have a special interest in frailty. We targeted Patients &amp;gt;65 years old presenting to the ambulance service with acute frailty syndromes and in whom their disposition is unclear – Just to explain that – In the ambulance service once assessing a patient we must make a decision about their best treatment location – For some it is very clear that definitive care should be provided in hospital, for others it is abundantly clear that either primary care management (or no management at all) is required. However often patients sit in an area of uncertainty between the two which can cause a great deal of anxiety among a paramedic who is often working without senior support. In particular, the frail older person – through no fault of their own, commonly falls into this group of unclear disposition. 5
  33. Rationale Specialist Paramedics are currently used within the south central ambulance service to make advanced decisions regarding hospital admission, treatment and referral. They do this utilising a range of advanced assessment skills and treatment skills however have no additional diagnostic tools. It stood to reason that a workforce trained in advanced diagnostics could utilisePoCTbloods to assist their decision making and perhaps enable more appropriate treatment and referral thus preventing deterioration of illness and or avoidable hospital admissions. Observation from practice identified that patients with frailty in the emergency department are commonly investigated with basic blood tests, ECGs, observations and physical examination. In the absence of blood tests in the pre hospital environment staff may be susceptible to over sensitive triage of the frail older person which in turn can contribute to inappropriate admission21. Admission to hospital results in poor functional outcomes for patients living with frailty4thus increasing the need to avoid unnecessary admission from the pre-hospital environment. This knowledge provided the basis for formulation of this quality improvement project. 6
  34. Acute frailty syndromes Acute frailty syndromes, like the proverbial tip of the iceberg, are seemingly benign symptoms that can mask serious underlying injury. It is vital we go looking for the cause. 7
  35. Aims When I started out with this project I had three main aims. These were: Safer discharges - measured by recontact rates and results affecting decision making Earlier disease management - measured by onward referrals and hospital length of stay Increased clinician confidence - measured by self report in response to qualitative questions However as I began to do background research and even more so as the project commenced another aim developed and this was to increase the knowledge of Point-of -care-blood-testing in the pre hospital environment. The reason for this final aim was that despite a fairly robust literature search there seemed to be a significant lack of published evidence in its use. 8
  36. Evidence The most notable use of pre-hospital point of care testing I found was theLabkit® Near Patient Diagnostics service tested with Surry pathology services and South East Coast ambulance service. This project involved a three phase trial that researched effective functionality, pre-hospital suitability and impact on patient management20, the outcomes of which are unclear. Whilst promotional material for the study reported positive outcomes I was unable to find a full peer reviewed publication of the study. There were two pre-hospital studies carried out in Germany, the first looking at using thei-STAT troponin I to facilitate the early identification of Non ST Segment Elevation Myocardial Infarction and the second to monitor critical care patients during Helicopter Emergency Medical Services (HEMS) transfer to hospital. The troponin study found the POCT results to be accurate but not diagnostic due to the common requirement for serial troponin monitoring in hospital9. The second study into use of POCT on HEMS inter hospital transfers identified a need for transfer of real time results to achieve patient benefit. Whist interesting, both studies lack transferability to the UK pre-hospital see and treat model due to their focus on critically ill patients whose trajectory of care is pre-determined by their potential or realised illness. It seemed to me that I was hearing of many NHS services ranging from OOH primary care to emergency services and secondary care using POCbT but that no-one seemed to be sharing their learning. So, In addition to trying to use this diagnostic tool to facilitate the assessment and management of acute frailty syndromes I hoped to generate knowledge that could be disseminated on pre-hospital POCbT. 9
  37. Project - iSTAT So how did the project actually work? Firstly we used the iSTAT alinity device – this is an example of it here and I also have one that I will pass around the room for you to look at. The iSTAT device is a handheld device that uses only a small sample of blood inserted into single use cartridges producing a result within minutes. This met the requirements of the pre-hospital environment for a number of reasons. Firstly it was small enough to carry around (has anyone seen the amount of kit a paramedic carries into any job – trust me a small lightweight device was essential), secondly it was quick (when we are asked to make a transport decision with 30 minutes on scene it is vital that results return quickly) and finally it was simple to use. (Vital because it was me using it!!) We chose the CRG4+ and CHEM8 cartridges as they most closely resembled routine bloods carried out in the hospital environment and could identify common causes of acute frailty syndromes such as anaemia, electrolyte disturbances and altered respiratory or metabolic function. The device was placed on the Reading specialist paramedic car during the week and the falls and frailty response car Saturday – Monday. 10
  38. Project – Patient selection and referrals Patient were identified through a number of means – the most common was specialist paramedic selection once with the patient or via the CAD system as jobs came in. We also used the specialist paramedic hub to notify of us of any jobs in the area presenting with acute frailty syndromes And we also received crew referrals from other paramedics and technicians who were with a patient and were unsure of their disposition. Once with the patient, informed consent was obtained and the patient outcome later followed up through the ambulance CAD system or hospital notes. 11
  39. Safety netting Of course the introduction of a new diagnostic tool is not without its risks so it was important to put some safety nets in place. Standard Operating procedures were written up and reviewed by specialist paramedic managers and staff were given training in both the use of the iSTAT and the interpretation of blood results. I was able to establish access to the Integrated Clinical Environment (ICE) which gave us access to our patients most recent blood results – this was done in recognition of the fact that this patient group often has normally abnormal blood results and we needed to know when to act on abnormal results. As paramedics we have access to GP telephone triage (which if there are any GPs in the room we are eternally grateful for!!). All staff trained on the iSTAT were encouraged to discuss abnormal results with the patients GP or OOH GP if there was any difficulty interpreting these. And finally the project was subject to multiple PDSA cycles with changes being made to improve safety throughout as learning increased. 12
  40. Results: The quality improvement project recruited 78 patients aged 65 years to 97 years There was an even split between male and female The majority of presenting complaints were falls – I think this is for two reasons – firstly the use of the falls and frailty response car pre-disposed clinicians to this presenting complaint but secondly falls are a very common presenting complaint to the ambulance service and would be more common and easier to identify that other acute frailty syndromes. Results outside of reference ranges were found in 55.1% of the cases with only half of these requiring clinical action or referral. Only 14 of the 73 patients required transport to the emergency department as a result of abnormal blood results and all of these were subsequently admitted under specialty into hospital. Patients who returned abnormal blood results but that were not transported to hospital received an outpatient frailty specific referral such as falls clinic, Parkinson’s specialist team or a rapid access clinic for the older person Clinicians reported improved decision making and confidence in &amp;gt;75% of the cases however in some circumstances clinicians felt that blood results actually confused them further. And finally the project showed to have improved discharge on scene rates and reduced recontact rates when compared with a similar frailty specific project the previous year. It is important to note when hearing these results that further formal research is required to validate these results but it does show promise for the use of POCbT both pre-hospital and in the field of frailty. 13
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  42. Case examples Case 1: Brenda was an 84 year old female with learning difficulties, HTN and osteoporosis presenting with an explained fall in the early hours of the morning. On initial assessment the patient was uninjured, fully mobile, alert and orientated with a slightly raised respiratory rate and SP02 of 88% in the presence of sever kyphosis. The clinician was unsure if this respiratory rate and oxygen saturations were normal for her due to her severe kyphosis and Initial thought was given to providing oral antibiotics and discharging on scene. When POCbT results returned and were compared with results taken 10 days earlier she was found to have a new severe hyponatraemia and respiratory acidosis. With these new findings it was deemed necessary to admit the patient to the emergency department to investigate the underlying cause of these acute findings. The patient was subsequently admitted to the medical team with a diagnosis of pneumonia and hyponatraemia from ED and the receiving medical doctor provided positive feedback regarding its use on this job. 15
  43. Case 2: 94 year old male who had fallen but due to advanced dementia could not remember how. He had last been seen by his carers late the evening before and was found first thing on the morning beside his bed. Clinical examination was able to rule out significant head injury or acute illness but in these patients a creatine kinase is usually required to exclude acute kidney injury. However due to the availability of urea and creatinine through the iSTAT and access to recent results we could apply the RIFLE and AKIN criteria for acute kidney injury and refer the patient to GP for follow up bloods to ensure no further progression. 16
  44. Case 3: Dot was an 86 year old lady who had been recently discharged from hospital on furosemide for fluid overload secondary to heart failure. She had been doing well at home up until the last couple of days when her mobility started to progressively worsen. Family had called 999 because they were due to go home and were concerned about her ability to safely mobilise around the flat. The patient was observed to mobilise safely however fatigued easily and complained of muscle cramps. One member of the ambulance crew felt the patient was safe to discharge on scene whilst the other remained unsure. POCbT revealed a furosemide induced metabolic alkalosis with a hypokalaemia of 2.3. This knowledge when combined with the patients significant cardiac history made the decision to admit the patient to hospital the safest option and possibly avoided a significant adverse event. 17
  45. Case 4: 92 year old Bob presented to the ambulance service after a non-injury fall however was noted to have been experiencing increased falls over the last month. In addition to interventions put in place by the falls and frailty team, POCbT discovered a new Hb of 84. The patient was reporting some fatigue but no heart failure symptoms and had not had a full blood count since 2015. A referral was made back to her GP who booked a review of her anaemia with her own GP. This patients regularity of falls decreased once her anaemia was addressed and it is hoped that an injury and or admission was avoided. 18
  46. Learnings: As I mentioned earlier, an initially unintended aim of the project was to develop learnings in the practical implementation of pre-hospital point of care blood testing. So I just wanted to talk through some of these. Cost vs benefit: When considering point of care diagnostics for any environment it is important to consider the cost vs benefit ratio. I felt that in order to justify the cost of POCbT it needed to have the ability to alter decision making and determine the trajectory of the patient journey. To my mind it is pointless doing a test that will only be repeated in a patient that is already destined for hospital. It was also vital to target the device to selected resources not only to optimise training and safety but also to be able to target a patient demographic. Access to previous results and staff training: As mentioned earlier – this patient group often has normally abnormal results so it was incredibly important to have access to old results and the appropriate training of staff is vital to the success of the project. I found that due to the lack of WCC or CRP the device was least useful in the assessment of infection for the purposes of hospital avoidance. Whilst lactate is available, a raised lactate indicates hypoperfusion in the presence of sepsis which can typically be identified by SIRS criteria without this. For this reason staff were encouraged not to use the device to assist decision making if the patient had been recently diagnosed with infection of gave a history of infective symptoms. Logistics: As you might imagine the ambulance service isn’t the most controlled environment with most of our kit being exposed to the elements and the occasional clumsy hand. The iSTAT device didn’t work under 16 degrees which during the winter months proved tricky but It did warm up quickly when in a warm house or warmed against the body so it didn’t prevent us using it. The cartridges also have a strict storage temperature and once warmed had an accelerated expiry date so a fridge on the ambulance station was required. 19
  47. Thanks I do need to take this time to thank some of the participating trusts and companies who provided time, money or support to the project. These things are never achieved by a single person! 20
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  50. Feasibility additional figures 300 used in analysis; 82% CRP tests were administered on patients who met study criteria Practices varied in CRP uptake 3 x &amp;lt;10 CRP test 2 x 10-60 CRP tests 3 x &amp;gt;60 CRP tests Most CRP results were &amp;lt;20mg/L (78%) The following CRP results were managed in line with NICE guidance: 88% of patients with a CRP result of &amp;lt;20mg/L 21% of patients with a CRP result of 20-100mg/L 100% of patients with a CRP results of &amp;gt;100mg/L 12% of patients who had a CRP test re-consulted with the same presenting conditions within 4 weeks. Patient’s with CRP results &amp;lt;20mg/L re-consulted less (10%) than patients with CRP results 20-100mg/L (20%) or &amp;gt;100mg/L (40%). 33 11/6/2018
  51. Questionnaire given to patients after receiving a CRP POCT to assess patient views on CRP testing in general practice Patients were positive about CRP: 88% comfortable; 84% convenient; 92% useful; 85% explained very well CRP tests were conducted by a Prescribing Pharmacist (38%), GP (33%) or Nurse (22%) Most patients said CRP took 5 (62%) or 10 mins (22%). Patients believed CRP: aids clinical diagnosis; provides quick results; reduces unnecessary antibiotic use Overall patients did not report any dislikes about the CRP test Nearly three quarters of patients stated they would be happy for a CRP test to be done at a local pharmacy (73%). 34 11/6/2018
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  53. Results Seven intervention and five control practices consented to participate. Participants compromised of 26 general practice staff; fifteen General Practitioner’s, five Practice Managers, three Practice Nurses, and one Prescribing Pharmacist, Community Matron and Healthcare Assistant. Qualitative data fromeleven interviews, three focus-groups and one hand written response was collected. Participants believed that CRP POCT can increase diagnostic certainty, help target appropriate treatments, help manage patient expectations and patient demand for antibiotics, support patient education, and improve appropriate antibiotic prescribing. Barriers to implementing CRP POCT include; financial support, time, access to the CRP POCT machine, and the effects on clinical workflow. Conclusions CRP POCT was well received by many general practice staff as an additional diagnostic“tool in your armoury”to support clinical decision making in the management of LRTI. To see an increase in the implementation of CRP POCT, further research into machine development is required, to overcome time, cost and access barriers. Further evidence of the impact of CRP POCT on appropriate antimicrobial prescribing is required to inform future guidance which will be the initial facilitator for behaviour change. 36 11/6/2018
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