REPLACEMENT OF LABORATORY
INFORMATION MANAGEMENT SYSTEM
WITHIN NHS HIGHLAND
Business Case
Version: 1.1
21st DECEMBER 2012
Contents
1.
EXECUTIVE SUMMARY
4
2.
INTRODUCTION
5
2.1
Purpose
5
2.2
Background
5
3.
STRATEGIC CONTEXT
7
4.
THE OPTIONS
9
5.
INDICATIVE COSTS
10
6.
PROJECT MANAGEMENT
11
7.
EQUALITY AND DIVERSITY IMPACT
11
8.
BENEFITS ASSESSMENT
11
9.
CONCLUSION
13
APPENDICES
Appendix A – Options Appraisal
Appendix B – Benefits Analysis
Appendix C – Risk Analysis
Appendix D – Implementation Plan
Appendix E – Primary Care Reponses
Replacement LIMS Business Case v1.1
2
Version and Configuration Management
Configuration History Sheet
Version
No.
Date
Details of Changes included in Update
1.1
21.12.12
Section 5 updated to include revenue savings
The issue of this document requires the approval of the signatories below on
behalf of the Project Board.
Name
Title
Signature
Distribution
Version No.
Date
Replacement LIMS Business Case v1.1
3
Date
1.
Executive Summary
Introduction
The Laboratory Services within NHS Highland consist of a number of specialised laboratories
encompassing the disciplines of Blood Sciences, Blood Transfusion, Microbiology and
Pathology and operate from three locations; Raigmore, Belford and Caithness General
Hospitals. The existing Laboratory Information Management System (LIMS) within these
three sites comprises of:


LRS Medipath (Blood Sciences Laboratory and Microbiology)
GE Ultra Centricity Laboratory (Pathology)
Background
The Medipath system was procured nearly twenty years ago, is supported by an Australian
based company (LRS) and the Western Isles Health Board is its only other Northern
Hemisphere customer. There is no formal development programme for the version installed
within NHSH, meaning that requirements of users have to be met by individual customised
alterations to the software. This limits the extension of functionality to that required of a
modern LIMS, and management information tools are limited in range and function – data
extraction is cumbersome, time-consuming and not sufficient to support the requirements of
audit, workload analysis, quality management and demand management/control. Critically,
Medipath does not support electronic ordering, which is a key requirement of requestors and
laboratories, as well as being central to the benefits associated with the upcoming Patient
Management System. Electronic resulting from Medipath is of a form that does not fully
meet users’ needs.
The GE Ultra Centricity system was implemented in February 2009, but in July 2010, GE
announced that it would be undertaking no further development work on the Ultra product,
and that its customers must withdraw the system from operational use by July 23 2013.
However, because NHSH signed a 7 year support contract then support for NHSH only
would be extended to February 2016 with the rest of the World no longer being supported
from July 2013. Without a supported LIMS in place the Pathology service of NHS Highland
would no longer be able to function and service would cease.
Recommendation
This business case provides the rationale and benefits for replacing the current LIMS with
the preferred option of a unified system for all NHS Highland laboratory disciplines, being
one of the pillars of the eHealth strategy alongside replacement of the Patient Management
and Radiology Information Systems in delivering an end to end IT solution for laboratory
diagnostics. Cost savings related to reduction in WTE associated with booking in samples
and delivering paper reports, equating to £257K over the three year implementation
timescale. The extensive product sourcing and procurement lead-in times coupled with the
obsolescence of GE Ultra from 2016 necessitates the approval of this business case within
FY 12/13.
Action Required
NHS Highland is requested to accept the above recommendation which will enable progress
towards commencing the replacement of the LIMS before the expiry of the GE Ultra
Centricity system and associated loss of service provision for Pathology.
Replacement LIMS Business Case v1.1
4
2.
Introduction
2.1 PURPOSE
The purpose of this Business Case is to set out the need, implications, risks, benefits and
indicative costs of implementing the Laboratory Information Management Systems (LIMS)
replacement programme in NHS Highland.
The Business Case also seeks to achieve the following:



2.2
Endorse the provision of a replacement LIMS which complements and supports
ongoing eHealth developments in Order Comms and Patient Management Systems
Enabling of management information arising from LIMS to drive performance
improvements with ensuing financial benefit
Endorse the provision of a replacement LIMS which reduces non value adding steps
in sample flow (such as manual data entry and authorisation)
BACKGROUND
Laboratory diagnostics is the science at the heart of modern medicine and is vital to the
diagnosis and clinical management of disease, determining the cause of diseases and
revealing the targets for their treatment. Laboratory tests reveal the success or failure of
both the progress and the final outcome of that treatment and the laboratory service is
therefore integral to the patient pathway.
Royal College of Pathologists figures show that laboratory investigations are critical in
determining over 75% of patients’ treatment pathways and are therefore LIMS are crucial to
enabling the results of these investigations to be communicated accurately and swiftly to aid
rapid clinical decision-making as an output of a 24/7 diagnostic service. The LIMS must be
resilient, in terms of hardware, software and support, to avoid downtime which would impact
on the ability of the laboratories to deliver the required level of service to its stakeholders –
principally GPs and hospital clinicians who act as the proxy for the patients.
The Laboratory Services within NHS Highland consist of a number of specialised laboratories
encompassing the disciplines of Blood Sciences (Biochemistry and Haematology), Blood
Transfusion, Microbiology (culture, molecular, serology [including the Scottish Toxoplasma
Reference Laboratory and Specialist Service for Lyme borreliosis])
and Pathology
(Histology, Mortuary, Cytology and Cytogenetics). NHS Highland has, owing to its
geography, a larger number of laboratories than would be normal in a more densely
populated area. Accordingly, there are four physical locations, all of which are vital
components of the organisation in which these laboratories are sited – Raigmore, Belford,
Caithness General and Lorn and Islands Hospitals in Inverness, Fort William, Wick and Oban
respectively. Blood transfusion is the responsibility of the respective laboratories on each of
these sites with the exception of Raigmore Hospital and is therefore within the specification
of the current and future LIMS.
This business case considers the LIMS requirements of the first three sites, though is
designed to accommodate the needs of the Lorn and Islands Hospital within Argyll and Bute,
should that become a requirement.
Replacement LIMS Business Case v1.1
5
The LIMS operated within the Raigmore, Belford and Caithness General Hospitals receive
and handle nearly 1 million requests and process over 11 million results per annum, and this
figure rises incrementally due to workload increases and case complexity. The systems
provide:






Accurate registration and management of samples and requests
Interfacing with, and control of, a wide range of analysers, automated platforms and
printers used in the performing and tracking of tests and subsequent delivery of
results
The processing and quality control associated with the sample and reagent utilisation
Production and authorisation of results, with flagging of abnormal results
Production of a printed report as required, along with the electronic transfer of results
into SCI Store with onward transmission into other clinical systems (such as EDT for
GPs)
Storage of all data associated with the above in line with regulatory requirements and
future utilisation
The existing LIMS within the three sites are:


LRS Medipath (Blood Sciences Laboratory and Microbiology)
GE Ultra Centricity Laboratory (Pathology)
The Medipath system was procured nearly twenty years ago. The support provider, Last
Resort Support (LRS), is based in Australia, where the majority of its users are also based –
Western Isles Health Board is its only other Northern Hemisphere customer. There is no
formal development programme for the version installed within NHSH, meaning that the
requirements of users have to be met by individual customised alterations to the software.
Medipath does not support electronic ordering (order comms) by primary or secondary care,
and transmits results to requestors as an image rather than discrete values, requiring
resource to be used in transcribing results into systems such as National Sexual Health
System (NaSH) and Scottish Cervical Cytology Recall System (SCRS). The above issues
limit the extension of functionality to that required of a modern LIMS, and management
information tools are limited in range and function – data extraction is cumbersome, timeconsuming and not sufficient to support the requirements of audit, workload analysis, quality
management and demand management/control.
The GE Ultra Centricity system was procured in 2008 and fully implemented in 2009, as a
replacement for the foremost Apex Pinnacle system which had reached the end of its
projected lifespan. Only 17 months into its operational life GE announced that it would not
be selling the Ultra product anymore, and that all customers must withdraw the system from
operational use by 23 July 2013. An extension of timescale to February 2016 for NHSH
customers was granted, but the system must be removed from use by that time, as must onsite service provision unless a replacement is procured.
Replacement LIMS Business Case v1.1
6
3.
Strategic Context
Key to any organisation is the ability to communicate between systems both internal (EPR,
PMS, Renal) and external (GP systems). This is identified as one of the five strategic aims
from the NHSS eHealth Strategy 2011-2017, as endorsed by the Scottish Government:
‘Improve the availability of appropriate information for healthcare workers and the tools to
use and communicate that information effectively to improve quality.’
The current process of test requesting and reporting in NHS Highland sees specimens arrive
at the laboratories with generally no advance notice or tracking facility, accompanied by
manually-filled out paper request forms, leading to the possibility of lost or delayed
specimens, or association of the specimen with the incorrect patient due to transcription error
or incomplete demographics and/or test requirements. Each specimen is manually booked
in by the laboratories staff, a laborious task which introduces delay, and transferred to the
requisite laboratory for testing. Once testing is completed and verified, the current LIMS are
able to relay results electronically to Primary Care from SCI store via the Electronic Data
Transfer (EDT) but, due to discrete data values not being transmitted, these discrete values
have then to be manually transcribed to the patients individual records, a rather time
consuming exercise that, as with manual booking in, has the inherent potential for data input
error. Results to Secondary Care are provided via SCI Store.
For Secondary Care, along with external NHS Highland customers such as NHS Western
Isles, paper results are required to be printed and despatched since accessing the results via
SCI Store does not provide adequate assurance that the results have been acknowledged by
the treating clinician. This requires 0.5 WTE staff resource in addition to stationery costs
incurred.
It is therefore imperative that Laboratories have an IT system that is able to track the
specimen from source, associate sample with request and relay results electronically direct
to Primary and Secondary Care without the need for manual transcription. Use of such a
facility would also allow audit of the time taken between specimen collection to receipt in the
laboratory which would facilitate identifying issues with specimen transportation to the
laboratory. The capability to send discrete values to associated interfaced system is
essential. Any and all of the LIMS systems being considered must meet relevant national
standards and protocols as well as being flexible enough to respond to any future initiatives
and requirements. The current LIMS are unable to fully support the functions needed to
administer and monitor the remote requesting as would be required to support any initiatives
pursued by the Board to provide Laboratory services to outside institutions. A modern LIMS
system will fit with a number of other national and organisational strategies:







Enable electronic requesting from, and resulting to, Primary and Secondary Care
Allow for the Laboratories to function in a paper-free environment
Allow for integration of laboratory diagnostics with recognised technologies such as
digital voice recognition, synoptic reporting and image capture
Allow connectivity and compliance with the national systems such as SCI Store and
GP systems such as Vision, such that diagnostic results are delivered in the required
format to the requestor
Support Point of Care (near patient) testing and disseminated laboratory services
allowing Laboratories to monitor and audit results produced from these devices
Support comprehensive demand management
Support the bringing together of systems and information to support Cancer Networks
and the development of other networks
Replacement LIMS Business Case v1.1
7













Support national targets such as 62 day and 31 day wait-to-treatment for Cancer and
Cardiology, 18 week referral to treatment (RTT), 4 hour A&E by allowing flagging and
prioritisation of cases
Support utilisation of the National Pathology Catalogue, comprised of a list of
standardised tests and associated reference ranges which are identified by their
associated Systematized Nomenclature of Medicine (SNOMED) concepts
Support the Primary Care Pathology Requesting and Reporting Project which will
implement a full requesting and reporting service between primary care and
laboratories using these national standards, leading to end-to-end IT infrastructure for
all the laboratory disciplines
Allow the option of remote hosting of system
Facilitate Laboratories’ ability to easily, cost effectively and efficiently provide
diagnostic services to other Boards and external organisations, supportive of
partnership and income generation approaches
Will be fully compliant with and be developed by suppliers to implement any current
and future regulatory standards, (such as required by Clinical Pathology Accreditation
(CPA), Medicines and Healthcare Regulatory Authority (MHRA) and associated
bodies), statutory developments being part of the yearly support costs
Support data export to external systems for surveillance of communicable diseases
(ECOSS), infection prevention and control (ICNet) and other systems as required
Support measurement and monitoring of key performance indicators (KPIs),
contributing to management dashboard and departmental scorecards
Enable ad hoc and scheduled reporting of KPIs using customisable queries at a
patient-based level
Allow for extraction of information associated with each and every data object (e.g.
patient flags, all standard demographics, test component(s), SNOMED codes,
requesting and reporting clinician etc)
Support activity based costing budgetary approach by allowing a cost per test to be
attributed to individual tests and components of tests
Support the extraction of data for statistical returns for Keele benchmarking and
Scottish Pathology Network (SPAN)
Allow for recurrent revenue savings by reducing the manual elements of data
transcription and report delivery
Replacement LIMS Business Case v1.1
8
4.
The Options
The following options were in scope for consideration:
1. Do nothing (maintain status quo)
2. Replace GE Ultra Centricity Laboratory
3. Replace both GE Ultra Centricity Laboratory and LRS Medipath with product(s) from
a single provider (PREFERRED OPTION)
4. Replace both GE Ultra Centricity Laboratory and LRS Medipath with products from
separate providers
5. Purchase Pathology module of LRS Medipath
6. Outsource the LIMS function and support to another Health Board
Given the fundamental requirement to have correctly functioning and externally-supported
LIMS option 1 is deemed too great a risk to consider as it would leave the Board with no
Pathology service. Option 2 leaves Microbiology and Blood Sciences with an aged system
that is unable to accommodate electronic ordering or true electronic resulting, with limited
vendor support delivered from the southern hemisphere. Option 3 would enable Blood
Sciences and Microbiology to upgrade to a system which meets the requirements outlined in
section 2, and provides Pathology with a system supported beyond 2016 – this is the
preferred option in terms of procurement, implementation and support as it brings significant
operational benefits both to the laboratories and also to the eHealth team who will support
and develop its integration into the existing and future organisation-wide systems.
Option 4 has many of the benefits of option 3 but procurement, implementation and
associated support costs would be more complex. Option 5 would only be feasible if
Medipath were upgraded to the latest version, one that is supportive of order comms and
multiple interfaces with modern platforms and systems, along with the level of support
provided being increased too. Option 6 would require as much training of staff as options 3
and 4, without the control of future direction of service.
The options appraisal identified that replacing the current dual LIMS with a unified
LIMS from a single provider was the preferred and best practice option. This will allow
for the maintenance of service delivery across all laboratory disciplines, facilitate the
switch to electronic ordering that would allow requestors to reduce reliance on
manual transcription and thereby enhance quality, effectiveness and efficiency of
service throughout the spectrum from request to diagnosis to treatment.
Replacement LIMS Business Case v1.1
9
5.
Indicative Costs
Indicative costs are shown below, based NHS Lanarkshire’s proposal. Although broadly
equivalent in terms of laboratory services and multi-site delivery to a mix of primary and
secondary care, it is not representative of the geography or specific operational requirements
of NHS Highland and the costs are therefore provided for illustrative purposes only. Entering
a joint procurement exercise with NHS Western Isles would reduce the capital and revenue
commitment required from NHSH by approximately 10%, in line with the Partnership
Agreement between the two organisations.
Revenue savings associated with the implementation are shown below. These are
predominantly comprised of reduction in headcount of Medical Laboratory Assistants (MLAs)
and A&C staff, both in the laboratory and wider hospital setting (the latter involved in
delivering paper reports to requesting clinicians), the exact amounts being dependent on
which laboratories ‘go live’ first; Blood Sciences has a current establishment of 8.5WTE
MLAs, Microbiology 10.29WTE, Pathology 2.6WTE therefore greater revenue savings will
accrue if Medipath were to be replaced before Ultra. Non-pay savings associated with
reduced printing costs are also included.
Costs
Capital (excluding VAT)
Purchase and interfacing of
multi-lab system
Interfacing to eHealth
systems
Hardware costs
Capital charges
Total Capital
Procure new
LIMS System
for all
Laboratories
2013/14
2014/15
2015/16
2016/17
commitment commitment commitment commitment
£500K
£250K
£50K
£250K
£50K
£150K
£42K
£742K
£100K
£21K
£371K
£25K
£20K
£345K
£25K
£1K
£26K
£170K
£60K
£60K
£50K
£10K
£60K
£40K
£10K
£30K
£20K
£30K
£20K
£280K
£70K
£110K
£100K
TOTAL
£1022K
£441K
£455K
£126K
Revenue Savings
(recurrent)
Laboratory staff (MLAs)
A&C staff (lab)
A&C staff (Raigmore)
Printing costs
Total Revenue Savings
Cumulative (4
years)
£161K
£27K
£44K
£25K
£257K
£23K
£5K
£11K
£5K
£44K
£46K
£11K
£22K
£10K
£89K
£92K
£11K
£22K
£10K
£135K
Revenue
Software, hardware support
and licence
Legal costs
Implementation costs
Data transfer from current
systems
Total Revenue Costs
Additional to the revenue savings identified above, estimations presented in Appendix D
shows that nearly 4000 working days per year are spent within NHSH Primary Care simply
transferring data from laboratory results into separate systems. This equates to 17.8 WTE
involved in supporting the current inadequacies in the LIMS-Docman data transfer.
Replacement LIMS Business Case v1.1
10
Any savings in primary care associated with implementation of the LIMS project would not
offset the associated capital and revenue commitments but would reduce the overall cost per
reportable laboratory test.
6.
Project Management
The NHS Highland eHealth Implementation Services Team has established a project
governance infrastructure in accordance with NHS Highland guidelines and using PRINCE2
methodology and structure as source doctrine. The eHealth Implementation Services Team
are responsible, on behalf of the Laboratories Management team, for the Project
Management of this Business Case.
The Project is sponsored and led by the Laboratories Management Team with a strong focus
on enabling benefits to patients and improvements in the service offered to Primary and
Secondary care customers as well as any external agencies.
7.
Equality and Diversity Impact
There are no equality and diversity issues anticipated with this proposal.
8.
Benefits Assessment
The generic benefits expected of a Laboratory Information Management System for NHS
Highland are detailed below.
1.
To meet or exceed the current needs of the customer
The customer, whether GP Practice or secondary care department, is familiar with and
requires a certain level of service from the NHS Highland laboratories which must
continue to be met or exceeded to ensure their particular health care provision is not
adversely affected.
2.
To meet or exceed the needs of the user
The laboratory user, from consultant to data entry staff, provides a competent service to
both Primary and Secondary care using a LIMS functionality which must remain at
present levels or be improved in order for the level of service provided to be maintained
or enhanced.
3.
To represent value for money
Any LIMS should provide the expected or better functionality and service for the least
amount of expenditure.
4.
To provide a continuity of service beyond 2016
As the pathology element of LIMS, provided by GE Ultra is due to expire in July 2016, a
replacement system that meets or exceeds the needs of the customer and user must be
provided if the service is to continue beyond that date.
Replacement LIMS Business Case v1.1
11
5.
To improve specimen identification and tracking
A reported failing with the current systems, is the lack of uniformity and audit capability
for specimen identification and tracking.
6.
To provide improved results reporting for GPs, including discrete values.
GP Practices report that extensive time is spent manually transferring laboratory results
into discrete values for entry into secondary systems. If a replacement LIMS option is
chosen, then this would be a factored in feature.
7.
To reduce the manual transcription component.
As reported by Highland GP Practices, and detailed at Appendix C, a great deal of time
is expended manually transcribing results data. If a replacement option is chosen, then
this would be a factored in feature. Support for electronic order comms would negate
the need for laborious manual data entry at time of specimen booking.
The principal benefits for the preferred option of a unified replacement Laboratory
Information Management System for NHS Highland are detailed at Appendix A.
Replacement LIMS Business Case v1.1
12
9.
Conclusion
The requirements for a suitably functioning LIMS are:







Accurate registration and management of samples and requests using electronic
requesting (including those elements provided by order comms)
Interfacing with, and control of, a wide range of analysers, automated platforms,
printers and other external systems used in the performing and tracking of tests and
subsequent delivery of results
Scalability, allowing for inclusion of future diagnostic platforms, technologies such as
image capture and/or partner laboratories
The processing and quality control associated with the sample and reagent utilisation
Production and authorisation of results, with flagging of abnormal results
Production of a printed report as required, along with the electronic transfer of results
into SCI Store with onward transmission of discrete data values into other clinical
systems (such as EDT for GPs)
Storage of all data associated with the above in line with regulatory requirements and
future utilisation
The end of life notification for the Pathology LIMS system (provided by GE Ultra) means that
a replacement must be sourced and implemented before February 2016, otherwise all
Pathology caseload (including that provided to partner organisations) will have to be
outsourced.
There is an opportunity to redress the shortfall in functionality of the Medipath system used in
Microbiology at Raigmore Hospital and Blood Sciences in Raigmore, Caithness General and
Belford Hospitals at the same time as replacing the Pathology system and the
recommendation is that a single supplier be commissioned to provide a multi-laboratory,
multi-site solution. This would meet both the clinical requirements outlined earlier, along with
enhancing the management tools available (such as demand management and
measurement of KPIs) and facilitating the implementation of associated critical systems,
particularly order comms and electronic resulting to both internal and external users.
Recurrent revenue savings associated with electronic requesting and electronic results
transmission to users would arise from reduction in staff resource needed for booking in
samples and printing out and despatching reports
Should support be given to this business case the Laboratories, in conjunction with eHealth,
will produce a specification describing their requirements in support of the tendering and
procurement process. Potential suppliers will be measured against their ability to deliver to
the organisational and laboratory level requirements to allow the benefits outlined earlier to
be delivered in full.
Replacement LIMS Business Case v1.1
13
APPENDIX A TO
REPLACEMENT LIMS
BUSINESS CASE
LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS) OPTIONS APPRAISAL
The purpose of this document is to generate discussion on the future strategy of the IT
provision to support the laboratory service in NHS Highland. It is supplementary to Item 15
on the NHS Highland eHealth Strategy Group meeting of 22 June 2011.
The plan is to take this appraisal to the eHealth Strategy Group, ask them to agree with the
recommendations of the Laboratory IT Sub Group and to progress with the development of
the associated Business Case.
This is section 5 of the outline Business Case for a replacement Laboratory Information
Management System (LIMS) for NHS Highland.
The list of options is not exhaustive.
LONG LIST OPTIONS
The following options are in scope:
1.
2.
3.
4.
5.
Do nothing (proceed with the existing systems).
Replace GE Ultra.
Replace both LIMS, GE Ultra and LRS MediPATH.
Purchase Pathology module of MediPATH.
Outsource the LIMS function to another Board (i.e. use the labs system run by
another Board and purchase support from them, similar model to NHS Orkney)
These are described in greater detail below.
1
DO NOTHING (PROCEED WITH THE EXISTING SYSTEMS)
BENEFITS



This option would not require any impact on the capital budget.
No impact of implementation on the laboratory operation.
Users familiar with using LIMS.
RISKS




GE are currently running down the support and services levels for Ultra since end of
life for North American and Asian customers by July 2013. This is beginning to
impact on NHS Highland. The Central Legal Office have been asked about the
possibility of litigation.
GE have listed the end of life for their product in the UK as 23 February 2016. After
this date Pathology will have no LIMS and the service will be unable to function.
MediPATH is currently supported by Last Resort Support (LRS) from Australia. The
software has failed to meet the expectations of the users and laboratory
management. Significant investment would be required to reach an appropriate level
of functionality.
Medipath does not support Lab Links (electronic transfer of discrete values from SCI
Store to GP Practices). As an interim measure, the EDT (Electronic Document
Replacement LIMS Business Case v1.1
14
Transfer) project relays an image of the printed report into the GP Docman systems.
No discrete values can be transmitted via this route and this is a GP requirement.
2
REPLACE GE ULTRA
BENEFITS

Impact of implementation would only affect the Pathology Department. (Histology,
Non-Cervical Cytology and Mortuary).
Pathology Department would be able to maintain a service.
Having recently undertaken the implementation of the current LIMS, there is expert
knowledge available and a wealth of lessons learned information.


RISKS





3
eHealth will still need to support two different LIMS.
MediPATH is currently supported by Last Resort Support (LRS) from Australia. The
software has failed to meet the expectations of the users and laboratory
management. Significant investment would be required to reach an appropriate level
of functionality.
The last procurement took 5 years, as a result of a major supplier walking away at the
contract stage. There is a possibility that a new procurement would take as long
resulting in Ultra being decommissioned prior to it’s successor being implemented.
The introduction of order comms would be more problematic.
Medipath does not support Lab Links (electronic transfer of discrete values from SCI
Store to GP Practices). As an interim measure, the EDT (Electronic Document
Transfer) project relays an image of the printed report into the GP Docman systems.
No discrete values can be transmitted via this route and this is a GP requirement.
REPLACE BOTH LIMS (GE ULTRA AND LRS MEDIPATH)
BENEFITS







This would offer the greatest flexibility to allow the laboratory’s operation to run most
effectively.
The benefits would include instigation of order comms and integration with other
laboratory services.
In Microbiology many requests are pre-screened prior to testing which has had the
effect of reducing unnecessary requests and duplicate testing and has resulted in
significant savings. In contrast the workload in Blood Sciences is too high to prescreen requests. A rule based order comms system would be beneficial in controlling
workload which in turn will result in savings.
LRS is based in Australia and has a small customer base with fourteen laboratories in
Australia and only one other user (Western Isles Health Board) in the northern
hemisphere. Therefore current support is limited. Replacing MediPATH with a LIMS
that has more prevalence in the UK would be beneficial.
Currently any development in MediPATH requires NHS Highland requesting the work.
LRS are not pro-active in keeping up with current NHS Scotland requirements.
In house support will only have to maintain one LIMS.
 Knowledge could therefore be more in depth.
 New data (addition of referring clinicians etc.) would only need to be entered
once.
A LIMS that supports Lab Links could be purchased and would meet GP
requirements.
Replacement LIMS Business Case v1.1
15
RISKS

This option would maximise our capital spend and create the greatest impact on all
operational areas.
The savings caused by efficiency gains would only be fully realised in an environment
where headcount reduction was possible.
No saving on revenue as an currently support costs are very cost effective.
The last procurement took 5 years, as a result of a major supplier walking away at the
contract stage. There is a possibility that a new procurement would take as long
resulting in Ultra being decommissioned prior to its successor being implemented.
Unless all data could be migrated from MediPATH there would be maintenance costs
to be paid for the upkeep of a legacy system to access historical Blood Transfusion
Service records.
Unless a single pan-laboratory system was purchased, eHealth would have to
support two or more LIMS. There would also be the likely increase in maintenance
costs from multiple suppliers over a single supplier.





4
PURCHASE PATHOLOGY MODULE OF MEDIPATH
BENEFITS


No anticipated disruption of the existing services in laboratories other than Pathology.
This option would be cheaper in capital terms than replacing everything or replacing
Ultra directly.
RISKS








LRS is based in Australia and has a small customer base with fourteen laboratories in
Australia and only one other user (Western Isles Health Board) in the northern
hemisphere.
Currently any development in MediPATH requires NHS Highland requesting the work.
LRS are not pro-active in keeping up with current NHS Scotland requirements.
MediPATH has failed to meet the expectations of the users and laboratory
management. Significant investment would be required to reach this level.
Staff resourcing – specific skill sets within and out with the labs would be difficult to
recruit/ get consultancy for or replace.
The introduction of order comms would only be possible if all disciplines upgraded to
the latest version of MediPATH, which would have an associated cost.
There would be limited benefits to Laboratories and the organisation unless
MediPATH was also upgraded for Microbiology and Blood Sciences as well as
Pathology.
MediPATH does not support Lab Links (electronic transfer of discrete values from SCI
Store to GP Practices). As an interim measure, the EDT (Electronic Document
Transfer) project relays an image of the printed report into the GP Docman systems.
No discrete values are transmitted and this is a GP requirement.
The Pathology module of MediPATH has previously been reviewed and found to be
deficient in a number of key areas of functionality. Purchase of this system would be
a retrograde step and negate the efficiencies created by the implementation of Ultra 2
years ago. There would be an undoubted reduction in quality and an increase in
clinical risk (patient identification errors etc). Staffing reductions since implementation
would need to be reversed to maintain Turn-Around-Times.
Replacement LIMS Business Case v1.1
16
5
OUTSOURCE THE LIMS FUNCTION TO ANOTHER BOARD (I.E. USE THE LABS
SYSTEM RUN BY ANOTHER BOARD AND PURCHASE SUPPORT FROM THEM).
BENEFITS



We would no longer be exposed to a shortage of technical expertise or if this were
the case it would not be exacerbated by the size of this organisation (NHS Highland).
We currently have infrastructure in place for this. This is currently modelled to allow
NHS Tayside in Ninewells, Dundee access Ultra for the writing and authorisation of
Cytogenetics reports.
We would have a greater leverage with our software supplier.
RISKS








We are unaware if another Board actually wants or has capacity to offer this service.
The obvious candidates would be NHS Grampian, NHS Tayside, NHS Greater
Glasgow & Clyde – (other Boards are available) and NSS for Transfusion functions.
Other Health Boards may not have the capacity to be able to undertake this.
The local wishes of the Board would be of secondary consideration with the provision
of this service – we would have to accept a junior role in the decision making process.
NHS Highland’s laboratory service provision will be negatively affected as a result of
having to use a LIMS that has been set up to suit the working practices of another
Health Board. None of the other systems offer the high level of functionality currently
used in NHS Highland. This will result in a degradation in quality and reporting TurnAround-Times.
As a consequence NHS Highland’s purchasing policies regarding analysers and
reagents would need to flex to meet the needs of the host organisation.
If MediPATH is replaced in this process, there may be an associated cost in coming
out of the Managed Service Contract with Siemens.
MediPATH does not support Lab Links (electronic transfer of discrete values from SCI
Store to GP Practices). As an interim measure, the EDT (Electronic Document
Transfer) project relays an image of the printed report into the GP Docman systems.
No discrete values are transmitted and this is a GP requirement. If MediPATH is not
replaced then GP requirements are not met.
MARKET APPRAISAL
There are several LIMS currently for sale on the open market that offer pan-laboratory
systems. The companies with current UK sites include Integrated Software Solutions;
Sunquest, Intersystems, Cerner, Sysmex, iSOFT and CliniSyS.
Supplier
UK NHS Customers
Omnilab
(Integrated Addenbrooke’s Hospital
Software Solutions)
Birmingham Children’s Hospital
Great Ormond Street Hospital
North Tees – Hartlepool Hospitals
Doncaster and Bassetlaw Hospitals
States of Jersey Hospital
Sunquest
Royal Liverpool and Broadgreen University Hospitals NHS Trust
University College London Hospital NHS Trust
Norfolk and Norwich University Hospitals NHS Trust
Central Manchester Healthcare Trust
Preston Acute Hospitals NHS Trust
Barnsley District General Hospital NHS Trust
West London Pathology Consortium (Hammersmith, Charing
Cross, Chelsea & Westminster, St Mary's Hospitals)
United Leeds Teaching Hospitals NHS Trust
Replacement LIMS Business Case v1.1
17
Bradford Hospitals NHS Trust
United Birmingham Hospitals NHS Trust
Intersystems
Pan – Wales. 18 laboratories across 7 Boards for a population of
3 million.
HNA
Millennium Wirral University Teaching Hospital NHS Foundation Trust
PathNet (Cerner)
(currently on Ultra, but moving to PathNet)
North West Hospitals NHS Trust (London)
MOLIS (Sysmex)
The Walton Centre for Neurology and Neurosurgery (Liverpool)
Warrington Hospital NHS Trust
APEX (iSOFT)
Aberdeen Royal Hospitals NHS Trust
(No longer marketed)
East Cheshire NHS Trust (Macclesfield)
Freeman Group of Hospitals NHS Trust (Newcastle upon Tyne)
Multiple
sites
also Leicester General Hospital NHS Trust
running Telepath
Glenfield Hospital NHS Trust (Leicester)
Leicester Royal Infirmary NHS Trust
Western General Hospitals NHS Trust (Edinburgh)
Royal Infirmary of Edinburgh NHS Trust
Pinderfields (Wakefield) & Pontefract Hospitals NHS Trust
James Paget Hospital NHS Trust (Great Yarmouth)
West Suffolk Hospitals NHS Trust (Bury St Edmunds)
Chesterfield & North Derbyshire Royal Hospital NHS Trust
North Middlesex Hospital NHS Trust
Surrey & Sussex healthcare NHS Trust (Crawley & Redhill)
PathLinks (Grimsby, Scunthorpe, Boston, Lincoln and Grantham)
WinPath (CliniSys)
East London Consortium (Homerton, Newham, Barts and the
London)
Kingston Hospital NHS Trust
Richmond Twickenham & Roehampton Healthcare NHS Trust
North Hampshire Hospitals NHS Trust (Basingstoke)
Royal Brompton Hospital (London)
The Royal Marsden NHS Trust
Winchester & Eastleigh Healthcare NHS Trust
Swindon & Marlborough Hospital NHS Trust
Royal Free Hampstead NHS Trust (London)
Nottingham Group of Trusts (University Hospital NHS Trust,
Nottingham City Hospital NHS Trust, Sherwood Forest Hospitals
NHS Trust)
King’s College Hospital NHS Foundation Trust (London)
Most data correct as of November 2009. It is believed that they are still currently marketing
their software.
There are other companies supplying pan-laboratory LIMS in Europe and they include
Autoscribe, Labware and Swisslab. Meditech supply a fully integrated LIMS, however, they
have no UK LIMS customers only 14 customers of Meditech’s EPR system.
Sunquest bought Misys which were the original preferred supplier of the Pathology LIMS.
They withdrew due to their unwillingness to meet NHS Scotland IT requirements at the time.
This requirement has now been rescinded.
Intersystems supply the TrakCare Lab LIMS which is a module of the National PMS that is
being rolled out. Go Live for the pan Wales system starts in February 2012.
Replacement LIMS Business Case v1.1
18
COST
This section would review the capital cost of replacing the LIMS (single or both) and the
subsequent revenue costs.





The capital purchase cost for Ultra was £550K.
The current maintenance cost for MediPATH is approx £25K a year excluding licence
costs (TBC).
The maintenance of Ultra cost £37,428.88 for the year April 2010-11.
Any anticipated savings as a result of the various options will be listed, although it is
difficult to confirm how much purchase and maintenance of a completely new LIMS
(not MediPATH) would be.
There may be cost implications and other complications if transfusion functions are
supplied by NSS/SNBTS – also provides patient safety elements that would not be
available if Highland uses an independent IT system for transfusion
RISK APPRAISAL
Whichever option is decided upon, there will be common risks involved. These include:




The upcoming loss of critical resources including staff.
 Some staff involved in the implementation of the GE Ultra LIMS have already left
NHS Highland.
 Others involved are currently awaiting retiral dates.
 Staff with knowledge of the LRS MediPATH LIMS are also in a similar position.
 None of this takes into account staff who may leave for other employment.
 Key personnel need to be identified.
Backfill required to facilitate planning, specification and implementation
There are significant risks regardless of which option is approved especially with the
migration of data to a new system.
Wirral UTH NHS Foundation Trust is moving from Ultra to PathNet because it is the
laboratory system owned by Cerner who supply them with an enterprise solution
covering the whole hospital. They are unhappy with this move as it gives them a
drastic reduction in functionality from Ultra.
Replacement LIMS Business Case v1.1
19
APPENDIX B TO
REPLACEMENT LIMS
BUSINESS CASE
Benefits Analysis
Who will
receive the
benefit
1
X
X
X
2
3
X
4
H= NHSH
S= Staff
P=Patients
Provides a faster and more accurate service to the
patients including improved turnaround times.
Provides support to enable NHSH to be at the
forefront linking with partners as part of the
partnership strategy
X
X
X
Replacement LIMS Business Case v1.1
X
Likelihood
Impact
Priority
score
(5= high,
3=med.,
1=low)
(5= high,
3=med.,
1=low)
(likelihood x
impact)
Benefit description
Equitable
Patient-Cent.
Timely
Effective
Efficient
Safe
Benefit ID
Quality Dimensions
Supports and streamlines the processes involved in
performing tests and services for institutions either
within or outwith NHSH
Contains systems to allow NHSH to promote its
services to external organisations.
20
S&P
5
5
25
4
5
20
5
4
20
4
4
16
H
H&S
H&S
Financial
Quality
Dimensions:
Safe - Patient safety is increased
Efficient - Use of resources is maximised
Effective - Positive patient outcomes are increased
Timely - Waiting times for care are reduced
Patient-centred - Patients are involved in their care
Equitable - Accessibility to care is increased
5
X
Ability for the vast majority of laboratory activity to be
recorded and maintained on a single robust and
reliable infrastructure
X
6
X
X
7
X
To make it easier for staff to cross train and work in
all laboratory areas across NHSH as the service
develops by establishing a common look and feel to
the system. This too could aid staff retention as
redeployment or staff rotation would become more
feasible
X
8
Flexible enough to facilitate service re-configuration
as appropriate, allowing the seamless transfer of
orders and results between clinical locations and
processing sites both within and external to NHSH
X
9
X
10
X
X
X
11
X
12
Easier to use, more flexible and intuitive allowing for
streamlining of processes to accommodate
increasing workload without requiring a pro-rata
increase in staff, thereby increasing operating
efficiency as well as potentially aiding staff retention
by removing hindrances to their work
Removes any IT-related barriers to crossdepartmental methods of service development
An Industry standard system which will be able easily
and economically to interface to external systems
(order comms, PMS, GP and other primary care
systems etc) allowing bi-directional information
transfer
25
5
4
20
3
5
15
5
5
25
4
4
16
5
5
25
4
4
16
S
S
H&S
S
S
X
H&S
X
Scalable in ongoing additions of analysers and other
hardware/software requiring interfacing
S
21
5
S
To allow costs (pay and non-pay) to be attributed to
all aspects of the diagnostic testing process in
support of an activity based costing approach to
budgetary management
Replacement LIMS Business Case v1.1
5
X
4
4
16
13
X
X
X
Demonstrates functionality that at least and in many
cases exceeds modern Laboratory Good Practice
guidelines
X
Develops and enhances current LIMS functionalities,
building on previous developments (to be defined in a
stringent specification)
14
15
X
X
16
X
X
17
X
X
18
Utilises highly developed rules based systems to
promote good clinical practice and to ensure
appropriate testing of the patient (including demand
management). Some of this functionality will reside
within NHSH systems but in some sections (in
particular the more specialised areas) clinicians rely
on the laboratory to select the testing profile as they
have a greater experience
To allow for the production of more comprehensive
and complete management and clinical information in
a timely manner. To be less resource intensive,
enabling a wider range of queries to be run for which
there is no staffing capacity currently
To achieve as much as possible a “paperless”
system within Laboratories as well as in their
interactions throughout NHSH, including primary care
X
To conform to CPA standards (better audit
information for example) and close the numerous
gaps in the current systems audit capabilities
X
To facilitate Laboratory systems being compliant with
any legal requirements such as European Union
Blood Tracking Directives as specified by the MHRA
X
To ensure more robust back up facilities (data loss
caused by a major disaster) - using modern
technology it will be possible to restore the system in
a much more efficient and timely manner resulting in
minimum downtime.
19
20
Replacement LIMS Business Case v1.1
22
4
5
20
4
5
20
5
5
25
4
4
16
4
5
20
S
S
S&P
H, S & P
X
H&S
5
5
25
5
5
25
5
5
25
H
H&S
H&S
Taking up the option of a remotely hosted system
transfers much of the risk associated with having the
training and equipment to perform disaster recovery
to the party hosting the system
21
To reduce maintenance/repair costs of propping up
an ageing system with ad hoc expenditure
X
22
X
23
X
X
24
X
X
X
X
25
26
X
X
27
In conjunction with a modern PMS, diagnostic reports
will be made available to treating clinicians much
more quickly and comprehensively
Plugs current data gaps by receiving improved
clinical information for other systems e.g. PMS
Chain of custody: allow for auditable ownership and
responsibility for samples and requests at preanalytical, analytical and post-analytical phases of
the processing
Allows laboratory based clinicians to view, comment
on and report together all patient’s results.
Allows clinical staff to view results securely (results
can be graphed to show trends and images can be
attached to reports)
X
Rules based system ensures the Laboratory aspects
of any protocols or care pathways are followed i.e.
requesting protocols and the ability to make
appropriate comments on results
X
Compliance with national guidelines: British Society
For Clinical Cytology (BSCC) “Requirements for the
Cytopathology Component of a Laboratory Computer
System”, the Pritchard Report and the BSCC
“Recommended Code of Practice for laboratories
providing a Cytopathology Service of 1997”. It also
fully complies with Data Protection legislation and
Caldicott Guidance
28
Replacement LIMS Business Case v1.1
23
5
5
25
5
5
25
5
5
25
5
5
25
5
4
20
4
5
20
4
4
16
4
5
20
H
P
S&P
S&P
S
S&P
S
H&S
X
29
Development of Cancer and Royal College Minimum
data sets: Reports can be developed that utilise the
Royal College of Pathologists and National Cancer
minimum data sets. This will make the data collation
process easier and enable better benchmarking data
due to consistent data assumptions applied through
the UK
X
30
Support for SNOMED-CT clinical terminology: The
LIMS solution will support the use of SNOMED CT
for the unambiguous identification of clinical concepts
such as diseases, findings, and procedures.
Integration with other clinical services will then be
possible, providing a standard terminology for clinical
reporting and governance
X
31
X
Definition of Standard Operating Procedures:
“Standard Operating Procedures” can be defined and
modified. These enable laboratories to meet their
obligations for CPA by providing a standard format
for the documentation and publication of a defined
standard for working practice
X
Blood Stock Management: Management of blood
products and their stock control with interfaces to the
Scottish National Blood Transfusion Service
(SNBTS)
32
X
X
33
X
X
Replacement LIMS Business Case v1.1
X
Interfaced to the Health Protection (Scotland) system
for the notification of infectious diseases as part of a
Hospital-based Infection Control system
24
4
5
20
4
5
20
4
4
16
5
4
20
4
5
20
H&S
H&S
S
S
H&S
APPENDIX C TO
REPLACEMENT LIMS
BUSINESS CASE
RISK ANALYSIS
Potential
Impact of
Risk (a)
Low 1 –
High 5
Annual support costs for replacement LIMS potentially higher than with
previous system.
5
Likelihood
of Risk
Escalating
(b)
Low 1 – 5
High
4
Failure to upgrade MediPath
5
4
20
The financial benefits associated with replacement of MediPath
impinge on services out with laboratories, notably primary care.
These cannot be realised without implementing a system that
supports electronic requesting and transfer of discrete results,
with associated reduced reliance on administration staff
Extended developmental timeframe
5
4
20
A large multi-laboratory IM system may well require a
developmental timeframe that could impact on the deadline of
February 2016.
Additional training burden with replacement system
4
4
16
The training burden will be unknown until the agreed system is
chosen.
Potential maintenance costs associated with the provision of a legacy
system to allow access to historical blood transfusion records
5
3
15
There is a likelihood that historical blood transfusion records
held in Medipath may not be able to migrate into a replacement
system. Accordingly, an additional system with associated
support costs may be required. This cannot be verified until the
functionality of the agreed system and interface practicalities are
known. A paper copy of all records mitigates the risk
Potential requirement for separate storage of historical data
5
3
15
This cannot be verified until the functionality of the agreed
system and interface practicalities are known.
RISK
Replacement LIMS Business Case v1.1
25
Score
(axb)
20
Support costs with MediPath are reflected in the limited
functionality and lack of development. A unified system that
replaces both Medipath and GE Ultra is most likely to incur a
higher support cost.
QUALIFICATION
APPENDIX D TO
REPLACEMENT LIMS
BUSINESS CASE
NHS HIGHLAND HIGH LEVEL REPLACEMENT LIMS IMPLEMENTATION PLAN
Activity/Month
Phase 1 - Research and procurement
Produce LIMS specification
Negotiate with potential suppliers
Establish final specification and cost
Evaluate systems and establish supplier
Negotiate contract
Procure preferred solution
Inform all stakeholders and customers
Phase 2 - Implementation
System installation
Process and documentation
Initial Training
Database set up
Develop interfaces and data migration
Prepare Order Communications
Test system
Train users
Phase 3 - Operation
Go live
Evaluate system operation
Replacement LIMS Business Case v1.1
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
26
APPENDIX E TO
REPLACEMENT LIMS
BUSINESS CASE
Dear GP Practice Manager.
A business case is currently being drafted by the Laboratory manager to explore the possibilities and costs involved in the procurement of a new laboratory system
for NHS Highland. Were this business case to get a positive reception from senior management one of the absolutes in the specification would be that any new
system should be able to transfer the discreet values of laboratory results to GP practice systems. This would reduce greatly the amount of manual input work
associated with laboratory results.
In order quantify and support this as a benefit to GP practices it would be useful to quantify the amount of time that GP practice staff currently spend transcribing
lab result values into your practice system. I would therefore be grateful if you would be so kind as to complete the attached form to allow the laboratory
Manager to use this information in the Business case.
REPLACEMENT LIMS BUSINESS CASE - GP PRACTICE QUESTIONNAIRE RETURNS
1
2
GP PRACTICE
Canisbay & Castletown Group Practice
Tweeddale Medical Practice
ID
Hrs/Day
55080
4
55624
2
3
Ullapool Medical Practice
55451
5
25
This would greatly enhance patient safety as it would remove the possibility of
human error in entering test results.
4
Aird Medical Practice
55696
2
10
It would be very helpful to have results automatically populating the clinical system
in Highland as I believe this is what happens throughout the rest of Scotland.
5
Armadale Medical Practice
55183
1.5
7.5
None
Replacement LIMS Business Case v1.1
27
Hrs/Wk
20
10
COMMENTS
None
Include an electronic sample request facility for practices. Include risk
management reports e.g. sample requested and not received at lab or lab reports a
result but it is not received at the practice. Include risk management reports e.g.
sample requested and not received at lab or lab reports a result but it is not
received at the practice. Include option to record reason for sample or a comment
and to have this displayed on incoming results. Results out with normal lab ranges
to be highlighted in red in incoming mail & clinical system.
6
Dunbeath
55075
2
2
Approximately 2 hours of staff time (list size 530) plus extra 15-20 minutes GP time
clicking button "add to records"
7
Lybster Medical Centre
55094
6
6
The process of inputting the information into the practice systems is quite difficult
as you have to work between 2 different screens. This means it can easily lead to
inputting the wrong values into the patient's record.
8
9
Kingussie Medical Practice
Culloden Medical Practice
55930
55766
1
5
7
None
We currently use DOCMAN EDT so the entire process is electronic and fairly
efficient as it stands.
10 Tain and District Medical Group
55427
1
6
I think it would be very helpful to circulate the suggestions around the practices
because it may trigger thoughts from other practices. One of the main things we
would like is access to measurements etc taken in hospital and OP clinics – e.g. all
patients attending for clinics are asked for their smoking status, given advice about
stopping etc, additionally they are all weighed and BPs checked. I’m not sure what
black hole of information this goes into but if all of these things could wend their
way back to us this would be great
11 Small Isles Medical Practice
12 Kinlochleven Medical Practice
55677
55639
2
2
1
None
We spend only 15 minutes approx putting lab results onto our GP system. Most of
the results are posted to us electronically and this saves us time. So on average we
spend less than an hour a week inputting data on the system.
13 Portree Medical Centre
55573
4
20
The Safety Improvement in Primary Care took this forward as a project in phase 2
and NHS Borders undertook this work. I don’t know the outcome but if you contact
Neil Houston he may be able to give you some additional information to support
the business case from a safety perspective. neil.houston@nhs.net.
There are huge concerns, with the current system: duplication of work,
transcribing /transposing errors, values don’t always go in against the date that the
tests were taken so it can look as it test results are missing or duplicate tests have
been ordered, human error – wrong read codes used e.g. recent change from
HbA1C to new codes, Time delay in getting results into clinical system and Missing
tests or results.
Please tell me that you are looking at a complete order comms system and not just
one that reports. A full order comm would be beneficial to the labs as it would
allow them to know what work is coming in, and management.
Replacement LIMS Business Case v1.1
28
14 Riverview Practice
55131
2
Unfortunately it is difficult for us to quantify this as we only enter pertinent results
and values required for QOF and enhanced services. We do not enter all results.
Therefore the amount of time spent on this depends on several factors: time of
year, what recalls we are working on and obviously number of other bloods taken.
A laboratory system that populated our clinical system in some way would be very
useful though!
15 Dunedin Medical Practice
16 Golspie Medical Practice
17 Thurso and Halkirk Medical Practice
56011
55220
55003
3.25
17.5
6
17
None
None
It was in the early 1990s that we first raised the subject of being able to receive
result values direct into our GP clinical systems. We have always believed that this
would be a huge step forward from a patient safety point of view and the
consequent saving in admin time. We are pleased that the option is now being
explored.
18 Dornoch Medical Practice
19 Prison
20 Culloden Surgery
55201
55751
1
0
2
5
0
10
None
unknown still waiting for Docman to be set up in the prison
This project is long overdue and in comparison to other health boards in Scotland,
NHS Highland is way behind. It is not just time saved in General Practice but an
issue of patient safety - as the number of steps grows in any process so does the
risk of human error. Having lab results going directly into our clinical systems will
not only save valuable time but also reduce the risk of error. For the above reasons
this has to be a high priority area.
21 Fortrose Medical Practice
55381
5
25
LabLinks would obviously remove a huge burden of rather boring work from our
staff and would eliminate the risk of human error. As the last health board to offer
this service to link directly with GP systems I think it is long overdue and would
finally bring us up in line with all other GP practices.
22 Kinmylies Medical Practice
55860
0.5
2.5
None
Replacement LIMS Business Case v1.1
29
3.5
23 Glenelg Health Centre
55554
1
5
The administration staff will scan in or file EDT lab results for work flow daily. This
time can vary anything from 10 mins to an hour depending on amount/number of
patients and number of lab results received. The GP on average can then take
10ish mins per patient just inputting the data from multiple lab results into vision
alone before contacting patients with results and writing notes. On average we
might have 4 - 5 patients with lab results in a morning.
24 Brora and Helmsdale Medical Practice
55287
2
14
Staff inputting results to patient notes is open to mistakes being made entering
wrong values and entering to wrong patient.
25 Assynt Medical Practice
26 Craig Nevis Surgery
27 Riverside Medical Practice
55253
55605
55841
1
3
1.5
4
15
7.5
None
None
The numbers above are based on my average manual input speed of 70 lab
documents per hour, 500 documents per week. To make things easier and faster
for myself I’ve developed an app (written in AutoIt) which has increased my speed
by 13% in addition to other benefits. As you know, it is not enough for discrete test
results to end up in the clinical system. Results, even if they are normal, often
trigger other actions (i.e. in our Practice low eGFR requires a CKD form to be
printed, filled and passed to the relevant doctor, abnormal Glucose is re-routed to
our Diabetic Nurse, HbA1c required additional ReadCode for annual review to be
added, and so on). All these actions can be triggered and at least semi-automated
by the system, which my app does. From my point of view there is a huge potential
in making computers do more of our human work, or at least make it easier and
faster. I’m sure the new system you’re exploring now is worth developing, so if you
think our Practice can help with your project, please don’t hesitate to contact us.
28 Riverbank
55037
1.5
7.5
None
Replacement LIMS Business Case v1.1
30
29 Aultbea and Gairloch Medical Practice
55357
30 Grantown Medical Practice
55925
Replacement LIMS Business Case v1.1
31
2
10
0.5
Any Business Case should not be just based on this estimate, as it needs to be
justified against the additional administrative and clinical workload of any
replacement system. This is at present an unknown.
The Business Case should be instead justified on the following points:
1. Clinical Governance - The existing Highland primary care results model relies
upon manual transcription of result values, comments and value limits by nonclinical staff. This is potentially unsafe and can lead to significant patient harm due
to human error.
2. Inconsistency - Different practices code different values based on local
preference. This leads to a combination of manual and electronic results decision
making, which will be made worse once GP to GP transfer of Read codes is
introduced in Scotland.
3. Archaic systems - It is clear the current lab system is well beyond its useful life
and is often quoted as the reason in Highland why things cannot be done, changed
or improved. The majority of other UK health boards have had an electronic results
service for many years. It is time for Highland to attempt to catch up.
3.75 At this practice we do not code every single result which comes in, although I am
aware in other practices that they do and so they will have additional time savings
(and we will have additional benefit). With EDT we have found our error rate
(misfiling) has been virtually eliminated because of the automatic tagging of clinical
correspondence, and consistency of information has been better because the
templates used are automatically selected. I would expect we would get a similar
result from an automated results system as the element of human choice in where
to record data is taken away. We made savings in admin hours when we went fully
live on EDT and I would expect a similar benefit from automated results coding.
Finally, automated data entry removes an element of clinical risk which is always a
good thing.
31 Glen Mor Medical Practice
55610
5
32 Nairn Healthcare Group
55041
6
33
34 Dunvegan Medical Practice
55874
55535
2
0.5
35 Lochcarron
36 Lairg Medical Practice
55395
55249
1
0.5
Replacement LIMS Business Case v1.1
32
The current system also "loses" the clinical data input by the clinicians / lab staff.
This used to be very useful in helping determine the route of the result - e.g.
diabetic screening or CKD monitoring could be sent to a group of recipients
simultaneously. We still have to write this on the lab forms but it doesn't appear
on the result, even though I understand the lab staff can still enter it into the
system it gets suppressed and not printed on the result. Consequently a single
result for diabetic screening could go to the registered GP instead of the Diabetic
clinic nurse Diabetes GP. That means one GP who didn't want the result in the first
place has to open it, read it and forward it to the correct recipients. Hugely
retrograde step and adds unnecessary delay to processing results at the practice.
Manually keying results will always have an inherent risk and it is possible that an
incorrect entry could lead to incorrect interpretation and treatment, thereby
impacting on patient safety.
Moving from an image-based system to a data transfer would also open up the
system to more flexibility for audit by 3rd parties and may provide a strong
research tool.
30 I’m told by our Docman lead that this is generally around 6-8 hours of work per day,
depending on the volume of results & the skill of the individual entering – we are
the largest practice in the Highlands now, at 14.5k patients, so this will be at the
top end of the scale, I’d expect. It would be great to free up such resource at the
practice, especially given the additional pressures that we’re facing in various ways
with cuts to our income streams & the expectation that we take on more & more
un-resourced work. However, one thing that is difficult to measure is the value in
increased patient safety. We have had a significant event analysis in the last couple
of months that revolved around incorrect data being entered manually from a lab
result, which could have ended up causing our patient significant harm. I do hope
that this is a big consideration when making the decision around whether to
advance with a new system in the labs.
10 None
2.5 We are only a small practice of 1650 patients, hence the relatively small amount of
time we spend on this each day
5 None
4 None
TOTAL HOURS
EST AVERAGE TOTAL (67 GP Practices)
73.25 303.25
136.326 564.382
EST AVERAGE CUMULATIVE ANNUAL HOURS
EQUATES TO WORKING DAYS/YEAR
Number of Practices Contacted
67
36
Number of returns received
Response
53%
29347.9
3913.05
Notes:
If the Practice Manager has provided a range of estimated hours, the lower values
have been inserted.
Values in red are extrapolated minimums based on respondent's text.
Replacement LIMS Business Case v1.1
33
LABORATORY INFORMATION MANAGEMENT SYSTEMS BUSINESS CASE
Background
The business case supporting the replacement of the NHS Highland Laboratory Information
Management Systems (LIMS) was presented at the December 2012 Asset Management
Group meeting, following its ratification by the eHealth Strategy Group on October 30th 2012.
The benefits and risk analysis are shown in the accompanying appendix.
Funding
Costs contained within the Business Case are indicative and are used for illustrative
purposes only. The funding stream for this proposal lies within the existing eHealth capital
allocation built into their five year plan. Implementation and therefore funding can be phased,
commencing with the Pathology module of the chosen system, to allow flexibility and spread
of financial commitment over financial years 2013/14, 2014/15 and 2015/16.
Alex Javed
Service Manager – Laboratories and Radiology
1
APPENDIX A TO
REPLACEMENT LIMS
BUSINESS CASE
Benefits Analysis
X
Benefit ID
Equitable
Patient-Cent.
Timely
Effective
Efficient
Safe
Quality Dimensions
1
Provides a faster and more accurate service to
the patients including improved turnaround
times.
2
Provides support to enable NHSH to be at the
forefront linking with partners as part of the
partnership strategy
3
Supports and streamlines the processes
involved in performing tests and services for
institutions either within or outwith NHSH
4
Contains systems to allow NHSH to promote its
services to external organisations.
X
X
X
X
Who will
receive the
benefit
Benefit description
2
GPs,
2ndary
care,
patients
Likelihood
Impact
Priority
score
(5= high,
3=med.,
1=low)
(5= high,
3=med.,
1=low)
(likelihood x
impact)
5
5
25
4
5
20
Financial
Quality
Dimensions:
Safe - Patient safety is increased
Efficient - Use of resources is maximised
Effective - Positive patient outcomes are increased
Timely - Waiting times for care are reduced
Patient-centred - Patients are involved in their care
Equitable - Accessibility to care is increased
X
5
Ability for the vast majority of laboratory activity
to be recorded and maintained on a single
robust and reliable infrastructure
6
Easier to use, more flexible and intuitive
allowing for streamlining of processes to
accommodate increasing workload without
requiring a pro-rata increase in staff, thereby
increasing operating efficiency as well as
potentially aiding staff retention by removing
hindrances to their work
7
To make it easier for staff to cross train and
work in all laboratory areas across NHSH as the
service develops by establishing a common
look and feel to the system. This too could aid
staff retention as redeployment or staff rotation
would become more feasible.
8
Flexible enough to facilitate service reconfiguration as appropriate, allowing the
seamless transfer of orders and results
between clinical locations and processing sites
both within and external to NHSH
9
Removes any IT-related barriers to crossdepartmental methods of service development
X
X
X
X
X
X
X
X
10
An Industry standard system which will be able
easily and economically to interface to external
systems (order comms, PMS, GP and other
primary care systems etc) allowing bi-directional
information transfer
11
To allow costs (pay and non-pay) to be
attributed to all aspects of the diagnostic testing
process in support of an activity based costing
approach to budgetary management
X
3
X
X
X
X
X
12
Scalable in ongoing additions of analysers and
other hardware/software requiring interfacing
13 Demonstrates functionality that at least and in
many cases exceeds modern Laboratory Good
Practice guidelines
14
Develops and enhances current LIMS
functionalities, building on previous
developments (to be defined in a stringent
specification)
15
Utilises highly developed rules based systems
to promote good clinical practice and to ensure
appropriate testing of the patient (including
demand management). Some of this
functionality will reside within NHSH systems
but in some sections (in particular the more
specialised areas) clinicians rely on the
laboratory to select the testing profile as they
have a greater experience
16
To bring the support and development of
eHealth product specialists together on one
system, giving less reliance on key individuals
and providing economies of scale in areas such
as adding new sources and tests, code
maintenance, out of hours support
17
To allow for the production of more
comprehensive and complete management and
clinical information in a timely manner. To be
less resource intensive, enabling a wider range
of queries to be run for which there is no
staffing capacity currently
18
To achieve as much as possible a “paperless”
system within Laboratories as well as in their
interactions throughout NHSH, including
primary care
X
X
X
X
X
X
4
X
19
To conform to CPA standards (better audit
information for example) and close the
numerous gaps in the current systems audit
capabilities
20
To facilitate Laboratory systems being
compliant with any legal requirements such as
European Union Blood Tracking Directives as
specified by the MHRA
21
To ensure more robust back up facilities (data
loss caused by a major disaster) - using modern
technology it will be possible to restore the
system in a much more efficient and timely
manner resulting in minimum downtime. Taking
up the option of a remotely hosted system
transfers much of the risk associated with
having the training and equipment to perform
disaster recovery to the party hosting the
system
22
To reduce maintenance/repair costs of propping
up an ageing system with ad hoc expenditure
23
In conjunction with a modern PMS, diagnostic
reports will be made available to treating
clinicians much more quickly and
comprehensively
24
Plugs current data gaps by receiving improved
clinical information for other systems e.g. PMS
25
Chain of custody: allow for auditable ownership
and responsibility for samples and requests at
pre-analytical, analytical and post-analytical
phases of the processing
26
Allows laboratory based clinicians to view,
comment on and report together all patients’
results.
X
X
X
X
X
X
X
X
5
NHSH
X
Labs staff
27
Allows clinical staff to view results securely
(results can be graphed to show trends and
images can be attached to reports)
28
Rules based system ensures the Laboratory
aspects of any protocols or care pathways are
followed i.e. requesting protocols and the ability
to make appropriate comments on results
29
Compliance with national guidelines: British
Society For Clinical Cytology (BSCC)
“Requirements for the Cytopathology
Component of a Laboratory Computer System”,
the Pritchard Report and the BSCC
“Recommended Code of Practice for
laboratories providing a Cytopathology Service
of 1997”. It also fully complies with Data
Protection legislation and Caldicott Guidance
30
Development of Cancer and Royal College
Minimum data sets: Reports can be developed
that utilise the Royal College of Pathologists
and National Cancer minimum data sets. This
will make the data collation process easier and
enable better benchmarking data due to
consistent data assumptions applied through
the UK
31
Support for SNOMED-CT clinical terminology:
The LIMS solution will support the use of
SNOMED CT for the unambiguous identification
of clinical concepts such as diseases, findings,
and procedures. Integration with other clinical
services will then be possible, providing a
standard terminology for clinical reporting and
governance
X
X
X
X
X
6
32
Definition of Standard Operating Procedures:
“Standard Operating Procedures” can be
defined and modified. These enable
laboratories to meet their obligations for CPA by
providing a standard format for the
documentation and publication of a defined
standard for working practice
33
Blood Stock Management: Management of
blood products and their stock control with
interfaces to the Scottish National Blood
Transfusion Service (SNBTS)
34
Interfaced to the Health Protection (Scotland)
system for the notification of infectious diseases
as part of a Hospital-based Infection Control
system
X
X
X
X
X
7
APPENDIX B TO
REPLACEMENT LIMS
BUSINESS CASE
RISK ANALYSIS
Annual support costs for replacement LIMS potentially higher than with
previous system.
5
Likelihood
of Risk
Escalating
(b)
Low 1 – 5
High
4
Extended developmental timeframe
5
4
20
A large multi-laboratory IM system may well require a
developmental timeframe that could impact on the deadline of
July 2016.
Additional training burden with replacement system
4
4
16
The training burden will be unknown until the agreed system is
chosen.
Potential maintenance costs associated with the provision of a legacy
system to allow access to historical blood transfusion records
5
3
15
There is a likelihood that historical blood transfusion records
held in Medipath may not be able to migrate into a replacement
system. Accordingly, an additional system with associated
support costs may be required. This cannot be verified until the
functionality of the agreed system and interface practicalities are
known. A paper copy of all records mitigates the risk
Potential requirement for separate storage of historical data
5
3
15
This cannot be verified until the functionality of the agreed
system and interface practicalities are known.
RISK
Potential
Impact of
Risk (a)
Low 1 –
High 5
8
Score
(axb)
20
Support costs with Medipath are reflected in the limited
functionality and lack of development. A unified system that
replaces both Medipath and GE Ultra is most likely to incur a
higher support cost.
QUALIFICATION
APPENDIX C TO
REPLACEMENT LIMS
BUSINESS CASE
NHS HIGHLAND HIGH LEVEL REPLACEMENT LIMS IMPLEMENTATION PLAN
Activity/Month
Phase 1 - Research and procurement
Produce LIMS specification
Negotiate with potential suppliers
Establish final specification and cost
Evaluate systems and establish supplier
Negotiate contract
Procure preferred solution
Inform all stakeholders and customers
Phase 2 - Implementation
System installation
Process and documentation
Initial Training
Database set up
Develop interfaces and data migration
Prepare Order Communications
Test system
Train users
Phase 3 - Operation
Go live
Evaluate system operation
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
9