GREATER MANCHESTER PATHOLOGY NETWORK SINGLE LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS)

STRATEGIC OUTLINE CASE GREATER MANCHESTER PATHOLOGY NETWORK SINGLE LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS) Release: Version 1.0 Date: 9 th April 2010 Author: David Slater Healthcare Diagnostics Project Management Ltd 22 Heron Close Blackburn Lancashire BB1 8NU Tel: 07876 502834 E.Mail: slater.david@virgin.net V1.0 9 th April 2010 Page 1 of 23

Table of Contents 1. STRATEGIC CONTEXT... 3 2. NATIONAL CONTEXT... 3 3. LOCAL CONTEXT... 3 3.1. PATHOLOGY... 3 3.1.1. Current Pathology laboratories...3 3.1.2. Laboratory disciplines...3 3.1.3. Background to Pathology LIMS in Greater Manchester...3 3.1.4. Current Pathology IT systems and their links to other IT systems...3 4. ORGANISATIONAL CONTEXT... 3 5. THE CASE FOR CHANGE... 3 6. SCOPE AND SERVICE REQUIREMENT... 3 7. OPTIONS... 3 7.1. Solution options... 3 8. SINGLE LIMS FUTURE STATE CONFIGURATION... 3 9. BUDGETRY COSTS FOR THE IMPLEMENTATION OF A SINGLE PATHOLOGY LIMS SYSTEM... 3 10.1. Greater Manchester Patient flows... 3 10.1.1. Background to Greater Manchester patient flows... 3 10.1.2. icats... 3 10.1.3. Demand Management... 3 10.1.4. Accident & Emergency... 3 10.1.5. Moving to a Single LIMS cost releasing benefits... 3 11. POTENTIAL FUTURE SERVICE REORGANISATION... 3 12. FINANCIAL BENEFITS... 3 14. BENEFITS... 3 15. RISKS... 3 16. IMPLEMENTATION TIMETABLE... 3 17. RECOMMENDATIONS... 3 V1.0 9 th April 2010 Page 2 of 23

1. STRATEGIC CONTEXT STRATEGIC OUTLINE CASE The Pathology Modernisation programme began in 1999 with a view to improving quality and efficiency. Since then a number of strategies have been developed culminating in the Independent Review of NHS Pathology Services chaired by Lord Carter of Coles. This review made 20 specific recommendations with IT being one of the main themes. It states IT connectivity should be put in place for NHS Pathology services as a matter of priority In response to this NHS Pathology Review, the GMPN has setup a feasibility study for the redesign of Pathology Services in Greater Manchester called the 20:20 The Emerging Vision. In this document, the Greater Manchester Chief Executives set the GMPN a challenging agenda for pathology The achievement of efficiency savings of 20% Measurement and improvement of quality by 20% Sustaining on-site presence of necessary personnel and services in each Trust Ensuring sustainability of future pathology services in Greater Manchester Over the years, pathology laboratories have been subject to cost improvements programmes to improve efficiency within their disciplines. To achieve the challenge stated above, the pathology laboratories may need to look at the feasibility of changing the configuration of pathology services to achieve these targets. In order to reconfigure pathology services, the requirement for a single Pathology LIMS system across Greater Manchester will provide the IT infrastructure to achieve pathology reconfiguration. This needs to be read in partnership with the GMPN document titled 20:20 The Emerging Vision A Feasibility Study for the Redesign of Pathology Services in Greater Manchester The objectives of this are: 1.1. To define the options for the replacement of Greater Manchester Pathology departments LIMS systems 1.2. To assess the costs, cost releasing savings, benefits and complexity associated with each option 1.3. To identify the preferred option V1.0 9 th April 2010 Page 3 of 23

2. NATIONAL CONTEXT Over the past 5 years, the delivery of Pathology services has been reviewed by a panel of experts, chaired by Lord Carter of Coles. Two reports have been published, the first in August 2006 followed by the latest, in 2008 called the Report of the second phase of the Independent Review of NHS Pathology Services. In the second report, Lord Carter details the need for the service to meet the growing and changing demands that will be placed on Pathology provision in England. His report focuses on three main themes: Improving quality and patient safety Improving efficiency Identifying the mechanisms for delivering change One of the areas for delivering a good consolidated service is IT connectivity and the efficient and effective use of resources. Lord Carter s report has a specific paragraph on IT connectivity which states: In our earlier report (August 2006), we emphasised the importance of IT connectivity. Good electronic communication for example, between the pathology service provider on one hand and the healthcare providers on the other is an essential element of any effective and efficient service. In Pathology it can help to address unnecessary and inappropriate demand and reduce the risk of errors (as identified by the Healthcare Commission report on March 2007). The collection and analysis of IT-based data can improve the way that pathology enables decisions about diagnosis and treatment to be made. We recommend therefore that IT connectivity be put in place for NHS pathology services as a matter of priority. We welcome the initiative taken by the Department of Health in piloting electronic order communications for primary care in two sites to complement the roll-out in secondary care, and look forward to them being rolled out across the country as soon as possible. Such IT links could be extended to cover other primary care settings such as pharmacies. A second main theme of Lord Carter s report is the improvement of standards, quality and patient safety. In his second report, he quotes the following paragraph: Everyone we have spoken to acknowledge the driving up standards, quality and patient safety, at the same time as reducing costs by between 250 and 500 million a year for reinvestment in the service, is a prize worth pursuing vigorously. In January 2010, the Department of Health published the 2009 update for their Pathology Programme. The document is their response to the report of the Independent Review of NHS Pathology Services (detailed above). This document includes specific detail of how the Department of Health intends to respond to the 20 recommendations. Under the section, IT developments, the following IT developments are specifically listed: National Laboratory Medicine Catalogue HL7 v3 messaging for GPs Lab2Lab Combining data Patient choice Decision support Interoperability Benchmarking for Primary Care V1.0 9 th April 2010 Page 4 of 23

3. LOCAL CONTEXT The Greater Manchester Single LIMS Outline Strategic Case focuses on two important areas that the project will improve. These are: The Pathology benefits of the implementation of a single LIMS across Greater Manchester Patient flows between NHS Trusts and the achievable cost releasing savings 3.1. PATHOLOGY 3.1.1. Current Pathology laboratories Across Greater Manchester, there are different types of Pathology laboratories providing either local and/or regional services. The services provided and their locations are provided below: 3.1.2. Laboratory disciplines The following laboratories provide local services for the following disciplines Clinical Chemistry Haematology Microbiology Cellular Pathology Blood Transfusion NHS Trusts where Pathology laboratories are sited: Royal Bolton Hospital NHS Foundation Trust Stockport NHS Foundation Trust Tameside General NHS Foundation Trust Wrightington, Wigan and Leigh NHS Foundation Trust Salford Royal NHS Foundation Trust University Hospital of South Manchester NHS Foundation Trust Trafford Healthcare NHS Trust Central Manchester University Hospitals NHS Foundation Trust Christie Hospital Foundation NHS Trust Pennine Acute Hospitals NHS Trust with the hub laboratory at the Royal Oldham Hospital and satellite laboratories (essential services laboratories (ESL)) at North Manchester General Hospital, Fairfield General Hospital and Rochdale Infirmary. Specialist Services are provided as follows: Immunology Services are provided by Central Manchester University Hospitals NHS Foundation Trust and Salford Royal NHS Foundation Trust Cytogenetics By Christie Hospital NHS Foundation Trust Ante Natal Screening (Downs) by Royal Bolton Hospital NHS Foundation Trust Metabolic Diseases by the Willink laboratory based in Central Manchester University Hospitals NHS Foundation Trust Microbiology, Serology and Virology by the Manchester Medical Microbiology Partnership (MMMP) based at Central Manchester University Hospitals NHS Foundation Trust Referral of patients for cancer treatment at Christie Hospital NHS Foundation Trust with specialist Cellular Pathology and Haematology laboratory services V1.0 9 th April 2010 Page 5 of 23

3.1.3. Background to Pathology LIMS in Greater Manchester Prior to 1992, no laboratories in Greater Manchester had installed Pathology IT systems across all the disciplines of Pathology. There were single discipline IT systems e.g. Ferranti Phoenix in Clinical Chemistry and Blood Transfusion IT systems. In 1992-93, the North West Regional Health Authority funded the purchase and implementation of Pathology IT systems with the individual Trusts Pathology departments choosing an IT from a preferred supplier list. The original supplier list had a choice of 2 suppliers isoft Telepath and ACT Medisys. Due to difficulties with the implementation of ACT Medisys, this supplier was withdrawn from the preferred supplier list and replaced with Berkeley Computer Services Masterlab. Due to supplier takeover, the current situation with the supplier is as follows: ACT Medisys was taken over by isoft and is now known as isoft ilab (Apex) Berkeley Computer Services Masterlab has been owned by a number of companies but current is part of the Clinisys Group and their product is known as Labcentre Renaming of Pathology IT systems The Pathology IT systems software has been renamed over time as follows Original Pathology IT system name Interim Pathology IT system name Current Pathology IT system name isoft Telepath isoft Ilaboratory TP ACT Medisys isoft Apex isoft Ilaboratory AP BCS Masterlab Torex Labcentre Clinisys Labcentre Current Pathology IT systems The current Pathology IT systems across Greater Manchester NHS Trusts are as follows: Trust Royal Bolton Hospital NHS Foundation Trust Central Manchester University Hospitals NHS Foundation Trust Christie Hospital Foundation NHS Trust Health Protection Agency (MMMP) Pennine Acute Hospitals NHS Trust Salford Royal NHS Foundation Trust University Hospital of South Manchester NHS Foundation Trust Stockport NHS Foundation Trust Pathology IT system Version Clinisys Labcentre V1.6 All isoft ilaboratory AP Disciplines Chemistry Haematology Immunology Clinisys Labcentre V1.5 Histology Technidata V21.01A All isoft ilaboratory TP Cytology V1.9 Microbiology Clinisys Labcentre V1.6 All isoft ilaboratory TP isoft ilaboratory TP isoft ilaboratory TP V1.9 All V1.8 All V1.9 All Tameside Hospital NHS isoft ilaboratory V1.8 All V1.0 9 th April 2010 Page 6 of 23

Foundation Trust Trafford Healthcare NHS Trust Wrightington, Wigan & Leigh NHS Foundation Trust TP isoft ilaboratory TP V1.6 All Clinisys Labcentre V1.7 All 3.1.4. Current Pathology IT systems and their links to other IT systems Over the years, each Pathology laboratory has developed their system, both within the laboratory disciplines and to external systems. The current data flow diagrams show the current complexity of the existing systems by showing the links to other IT systems. Each Trust details are shown in the appendices as follows: Appendix A Royal Bolton Hospital NHS Foundation Trust Appendix B Central Manchester Univ. Hospitals NHS Foundation Trust Appendix C Christie Hospital Foundation NHS Trust Appendix D Health Protection Agency (MMMP) Appendix E Pennine Acute Hospitals NHS Trust Appendix F Salford Royal NHS Foundation Trust Appendix G Univ. Hospital of South Manchester NHS Foundation Trust Appendix H Stockport NHS Foundation Trust Appendix I Tameside Hospital NHS Foundation Trust Appendix J Trafford Healthcare NHS Trust Appendix K Wrightington, Wigan and Leigh NHS Foundation Trust 4. ORGANISATIONAL CONTEXT 4.1. GMPN staffing and workload figures for 2008-09 During 2008-09, the Pathology laboratories of Greater Manchester had the following workload Discipline No of staff Total tests Total Requests Biochemistry 360 16,053,336 2,094,299 Cytology 370 (inc Histology) 355,106 Haematology 370 5,318,737 3,767,528 Histology 370 (inc Cytology) 193,415 Immunology 42.54 413174 Microbiology 422.3 3,150,391 5. THE CASE FOR CHANGE For nearly 20 years, the pathology departments in Greater Manchester have been operating on Pathology IT systems installed in the early to mid 1990 s. The only exceptions are: Manchester Children s Hospital who have merged with Manchester Royal Infirmary in 2009. The Pathology departments have merged and are using the existing IT systems i.e. Clinical Chemistry and Haematology are using the isoft Apex IT system whist Histopathology and Cervical Cytologyare using Clinisys Labcentre. Pennine Acute Hospitals NHS Trust which was formed in April 2002 as a merger of 4 previous Trusts, namely o North Manchester Healthcare Trust o Oldham NHS Trust o Bury NHS Trust o Rochdale NHS Trust V1.0 9 th April 2010 Page 7 of 23

The newly formed Trust reorganised the Pathology Services by have a Central laboratory at Royal Oldham Hospital with satellite labs at Fairfield Hospital, North Manchester General Hospital and Rochdale Infirmary. The satellite laboratories provide Clinical Chemistry, Haematology and Blood Transfusion services for in patients only. All GP and out patient samples are transported to the Royal Oldham Hospital. Cellular Pathology and Microbiology disciplines operate from the Royal Oldham Hospital central site only. There are other pathology services which operate on non proprietary IT software e.g. Willink laboratory at Manchester Royal Infirmary which provides laboratory services for metabolic diseases. Therefore, in most cases, the pathology IT systems are well established but operate internally for single NHS Trusts. Since the publication of the Report of the Second Phase of the Independent Review of NHS Pathology Services by Lord Carter of Coles in 2009, Pathology laboratories have been under pressure to find substantial financial savings. In order to achieve this level of savings, approx 20m for the Greater Manchester SHA, the type and location of pathology services provided needs to be reviewed. If pathology services are to change, expand, move then the bedrock for this change has to be a modern Pathology IT system. It is very difficult to change pathology services if an appropriate IT infra structure is not in place. (Please see the 20:20 Emerging Vision document regarding Greater Manchester Pathology reconfiguration) Patients are affected by pathology laboratories having their own pathology IT system. The current systems have records of patient s results that have been analysed locally. But the NHS is centralising specialist services in strategically placed NHS Trusts e.g. Children s services are being centralised at the Royal Bolton Hospital and Royal Oldham Hospital. If patient s are referred to these centres, their original investigations will be stored on their local pathology laboratory IT system. For these results to be available to the specialist service, the staff will have to contact the local pathology laboratory for their results or the tests will be repeated. In some cases, e.g. tissue biopsies, the tests are unrepeatable, therefore, the local pathology laboratory will have to be contacted, provided that the Trust receiving the patient knows that pathology tests have been performed previously. The contacting of other laboratories is a frequent exercise at Christie Hospital when patients are referred due to the original diagnosis at their local hospital and the need for specialist treatment. The provision of a single pathology LIMS system would allow 2 major benefits to be realised results to be available to clinicians and healthcare professionals for all patients who have had pathology tests performed in a pathology laboratory in Greater Manchester Pathology services to be reconfigured to provide a more cost effective pathology service 6. SCOPE AND SERVICE REQUIREMENT 6.1. Scope of Functionality The existing Pathology IT systems in Greater Manchester have been installed since the early/mid 1990 s with the exception of Pennine Acute Hospitals NHS Trust and Christie Hospital. If the project to fund a new single IT system is agreed, then the new system will need to have software which enhances existing functionality and includes: Connecting for Health compliant Uses the National Laboratory Medicine Catalogue SNOMED CT Decision support HL7 V3 messaging Duplicate test monitoring Interoperability with external systems Software allows separate site working V1.0 9 th April 2010 Page 8 of 23

Connection of Point of Care equipment Sample tracking Ability to link to multiple PAS systems Ability to link to multiple ward order communication systems Ability to send GP and/or OPD requests to nominated laboratory sites CfH GP requesting and reporting functionality 7. OPTIONS 7.1. Solution options The preferred solution must provide the pathology services across Greater Manchester with a system that will meet the strategic objectives and realise the benefits for patients, operational, managerial and financial outlined in Section 13. The following table lists the options available for consideration: Option Solution Positives Negatives 1 Do nothing - Unable to reconfigure services without a single pathology IT system for Greater Manchester. - Inability to share data - increase in repeat testing 2 Keep existing Pathology IT systems but provide a Greater Manchester wide pathology results data warehouse 3 Reconfigure pathology services on a NPfIT sector basis and use existing pathology IT systems 4 Procure separate pathology IT systems on a NPfIT sector basis Benefits the patient as all pathology results are available in one pathology results server Cheaper option than replacing with a single Pathology IT system across all laboratories - Old pathology IT systems are not replaced and pathology services cannot be reconfigured - clash of patient hospital numbers - multiple records for the same patient - different reference ranges for the same tests can lead to misinterpretation and clinical risk - Some current pathology IT systems use LIMS software which has not be updated over recent years and cannot be used for multi site working - reducing number of Pathology IT systems to one per sector will continue to be based on an old pathology IT system - data migration will be required from the Pathology IT systems that are shut down to the single pathology IT system in the sector - does not address the issue of cross sector patient flows - More expensive option - may have different suppliers per sector - does not address the V1.0 9 th April 2010 Page 9 of 23

5 Procure single fully supported networked pathology IT system for Greater Manchester - The service will be able to reconfigure pathology services as IT infra structure and a single Pathology IT system will be a available to all pathology services. - clinical users will see all pathology results for their patients - improved clinical management of patients - allows pathology to work towards one patient = one record - reduction in duplicate testing - patient flows between Trusts is not a concern issue of cross sector patient flows - extremely complex project 8. SINGLE LIMS FUTURE STATE CONFIGURATION 8.1. If a single Pathology LIMS is installed in the Greater Manchester area and all laboratories are connected to it, the following diagram shows one possible configuration. Royal Bolton Hospital NHS Foundation Trust Salford Royal NHS Foundation Trust University Hospital of South Manchester NHS Foundation Trust Central Manchester University Hospitals NHS Foundation Trust Christie Hospital Foundation NHS Trust Single Pathology LIMS System Stockport NHS Foundation Trust Tameside Hospital NHS Foundation Trust Health Protection Agency (MMMP) Trafford Healthcare NHS Trust Pennine Acute Hospitals NHS Trust PRIMARY CARE Wrightington, Wigan and Leigh NHS Foundation Trust V1.0 9 th April 2010 Page 10 of 23

8.2. The above diagram represents the simple links between the Trusts in Greater Manchester. The Single LIMS system will need to provide links for (list is not exhaustive): Individual Trust PAS systems Ward Order Communication systems GP Ordering and Reporting systems Analyser interfaces Accident and Emergency IT systems Infection Monitoring Systems Diabetes IT systems Point of Care testing requests and results Cancer reporting systems Anticoagulation Services National Chlamydia Screening Programme 9. BUDGETRY COSTS FOR THE IMPLEMENTATION OF A SINGLE PATHOLOGY LIMS SYSTEM 9.1. Current cost of support The Pathology laboratories across Greater Manchester have purchased IT systems from commercial suppliers. Their contracts with these suppliers include cost of support and maintenance. Some contracts provide cover Monday Friday only whilst others provide 24/7 cover. For reasons of confidentiality, individual Pathology laboratory IT support costs will not be published but an overall cost for all the laboratories in Greater Manchester will be published. The combined support costs for all laboratories in Greater Manchester is approximately 1,000,000 9.2. Predicted cost of replacing existing Pathology IT systems Most of the existing Pathology IT systems in Greater Manchester pathology laboratories were purchased in the early to mid 1990 s. Therefore, most of the systems are at least 15 years old. Under the NHS Supplies procurement rules, major equipment should be replaced in a 7-10 year time period. In the case of existing Pathology LIMS systems, their replacement on a like for like basis i.e. replacing existing Pathology LIMS with a new replacement by each Pathology laboratory would cost approx 500,000 with support costs of 25% ( 125,000). Procurement costs for each Trust will be approximately 100,000. Therefore, for Greater Manchester with 11 pathology laboratories, the total cost would be 6,600,000 with support costs of 1.375,000 9.3. Predicted cost of a new single Pathology LIMS 9.3.1. Costs of All Wales LIMS system The for an All Wales Laboratory Information Management System has been published by the Welsh Assembly Government on the Welsh NHS website. In this document they state the following: The capital cost for the scheme is stated as 7.285 million. It is expected that, business case approval not withstanding, this funding will be provided by the Health Departments All-Wales Capital Programme (AWCP) and the scheme is featured within the AWCP projections for future expenditure V1.0 9 th April 2010 Page 11 of 23

9.3.2. Costs for a Greater Manchester Single LIMS 2 major Pathology LIMS suppliers have been contacted and they have provided indicative costs based on the following requirements Requirement Hardware requirements - The system must be available 24/7 - There should be no down time for system software or application upgrades - The system should be fully fault tolerant Number of NHS Trusts - Royal Bolton Hospital NHS Foundation Trust - Stockport NHS Foundation Trust - Tameside General NHS Foundation Trust - Wrightington, Wigan and Leigh NHS Foundation Trust - Salford Royal NHS Foundation Trust - University Hospital of South Manchester NHS Foundation Trust - Trafford Healthcare NHS Trust - Central Manchester University Hospitals NHS Foundation Trust - Christie Hospital Foundation NHS Trust - Pennine Acute Hospitals NHS Trust with the hub laboratory at the Royal Oldham Hospital and satellite laboratories (essential services laboratories (ESL)) at North Manchester General Hospital, Fairfield General Hospital and Rochdale Infirmary. No of users - The number of pathology staff using the system will be approximately 1800 Patient Administration System interfaces Ward Order Communications systems GP requesting/reporting - The number of external users who will be allocated passwords to access pathology results will be over 5,000. Currently there are 10 NHS Trusts in Greater Manchester, each requiring an interface into the Single LIMS IT system including Admissions, Discharge Transfers (ADT) functionality Each Trust will require a request pathology tests interface and a results interface to their Trust Order Communications system Currently, the Pathology laboratories across Greater Manchester are providing electronic links from GPs to their Pathology laboratory for electronic requesting of pathology tests. For the purposes of this costing exercise, 2 request interfaces are required. Analyser interfaces All Pathology laboratories in Greater Manchester report their GP results via PMIP across the Data Transfer Service (DTS). This will continue but there will be a consolidation of PMIP reporting systems. Therefore, for the purposes of this exercise, 2 GP reporting interfaces are required Each laboratory will be interfacing their analysers into the Single LIMS IT system. It is V1.0 9 th April 2010 Page 12 of 23

Other interfaces assumed that the analysers interfaces will be consolidated through software which manages each analyser interface. For example, some laboratories use Instrument Manager to provide a single interface point from their current Pathology IT system to their analysers sited across the various disciplines in Pathology. Therefore, for the purposes of this exercise, the number of data managers required will be 20 (average of 2 per Trust) and the supplier must provide an average cost of an analyser interface into their data manager solution. Diabetic Registers Each laboratory will send results through to their local Diabetic Service. The Single LIMS will require 10 interfaces or a single interface which will distribute results to the correct Trust diabetic service. - ICNet Each Trust has an ICNet team who require information from their local laboratory. Therefore, there is a requirement for 10 interfaces to this product. CoServ A single CoServ interface will be required Data Migration Anticoagulant Services Each laboratory will send results through to their local Anticoagulation Services. The Single LIMS will require 10 interfaces or a single interface which will distribute results to the correct Trust anticoagulation service. Data will need to be migrated from the existing Pathology IT systems. The disciplines requiring data migration will be - Blood Transfusion - Cervical Cytology - Non Gyn Cytology - Histopathology All the data from the above disciplines needs to be migrated, either to the next GM Single LIMS system or to a separate database with secure access to the data by all appropriate users V1.0 9 th April 2010 Page 13 of 23

9.3.3. Single LIMS Financial Summary Financial indicative costs have been received from 2 major Pathology IT suppliers as follows: Supplier A Supplier B Average cost Hardware 1,000,000 1,000,000 1,000,000 Software 3,889,363 2,370,000 3,129,682 Professional Services* 3,470,637 2,400,000** 2,935,319 Total Network Price 8,360,000 5,770,000** 7,065,000 Annual Maintenance 1,500,000 Not provided * The professional services include staff training and project management ** Supplier B did not provide a figure for Professional Services. The figure given assumes that the professional Services will be a % of the total hardware and software costs. This figure has been added to the Total Network price. Annual Maintenance Supplier B has been contacted to provide the Professional Services and Annual Maintenance costs The above costs will be subject to VAT. The final price will be subject to detailed system specification and supplier negotiation. V1.0 9 th April 2010 Page 14 of 23

10. COST RELEASING SAVINGS ANALYSIS 10.1. Greater Manchester Patient flows 10.1.1. Background to Greater Manchester patient flows Secondary Care NHS Trusts across Greater Manchester refer patients between themselves for different specialties. The following table shows the number of patients referred between NHS Trusts for each Specialty and the Pathology disciplines where tests will be performed for each Specialty. Specialty Volume of Pathology tests requested for Clinical specialty patient transfers between Trusts in Greater Manchester Clinical Chemistry Haematology Microbiology Cellular Pathology Oncology 4900 Yes Yes Yes Yes Oral Surgery 1360 Yes Yes Yes Yes Ophthalmology 1260 Yes Yes Yes Gynaecology 1070 Yes Yes Yes Dermatology 860 Yes Yes Yes Yes Orthopaedics 610 Yes Yes Yes Yes General 510 Yes Yes Yes Yes Surgery ENT 470 Yes Yes Yes Thoracic 390 Yes Yes Yes Surgery Urology 330 Yes Yes Yes Yes Plastic Surgery 320 Yes Yes Yes General 310 Yes Yes Yes Medicine Thoracic 240 Yes Yes Yes Medicine Physiotherapy 230 No No No Nephrology 110 Yes Yes Yes Palliative Care 110 Yes Yes No Paediatrics 90 Yes Yes Yes A&E 50 Yes Yes Yes Elderly 10 Yes Yes Yes Medicine Haematology 10 Yes Yes No Pain 10 No No No Management Expected % of 90% 90% 70% 60% repeat requests No of Patients 13010 13010 12890 8570 tested per discipline Total 13230 In 2009-2010, there were 13,230 patients who were transferred from one Trust to another for a Consultant or Healthcare professional appointment. When the Consultant or Healthcare professional sees the patient, a part of the preparation for the consultation will be to review the patient s clinical history including diagnostic tests performed. V1.0 9 th April 2010 Page 15 of 23

During the patient s assessment at the originating NHS Trust, pathology diagnostic tests will have been performed. The number of pathology requests performed will be dependent on the specialty but, in general, tests will be performed in Clinical Chemistry and Haematology on 90% of patients whilst 70% of patients will have Microbiology tests and 60% will have their Cellular Pathology tests repeated. In Cellular Pathology, the tests are repeated on the same samples but by a different laboratory. Alternatively, if the Consultant at the receiving Trust does not wish to repeat the pathology tests and use the most recent pathology results available, contact will be made by telephone to either the Pathology laboratory or the referring Consultant s medical secretary. In this case, staff time will be used to obtain the pathology results which can be avoided by the results being available on a Single LIMS. Using these figures, the following table gives volumes of repeat requests performed and cost savings: Pathology discipline Volume of repeat requests Cost per repeat request Total savings per discipline Clinical Chemistry 11709 6.70 78,450 Haematology 11709 4.74 55,550 Microbiology 9023 8.51 76,786 Cellular Pathology 5142 114.79 590,250 Total Savings per year Total 37583 801,036 10.1.2. icats icats (Independent Clinical Assessment and Treatment Service) are being setup across across Greater Manchester using mobile icat medical units. Their purpose is to provide fast and convenient assessment, diagnostic tests and treatment (if appropriate) for NHS patients. The mobile clinics will be sited at Denton, Longsite, Stretford, Salford, Bolton, Rochdale and Oldham. The diagnostic tests requested by icats are performed using a contract with a Pathology provider, either private or a contract with a NHS Pathology laboratory. If the icat uses a private laboratory then the pathology results are not available to the NHS unless the results are written into documentation sent from the icat to the NHS Trust receiving the patient. The planned activity is expected to be in the region of 70,000 cases per year and it is expected that approximately 40% of cases will be referred for hospital treatment. The expected number of repeat tests for icats for 28,000 patients treated in the NHS will be as follows: Pathology % retesting Number of Cost per Cost per year Discipline repeat requests request Clinical Chemistry 90% 25,200 6.70 168,840 Haematology 90% 25,200 4.74 119,448 Microbiology 70% 19,600 8.51 166,796 Total 455,084 V1.0 9 th April 2010 Page 16 of 23

10.1.3. Demand Management In Pathology laboratories, some tests are performed within a timescale where its interpretation is not different from the previous time the test was performed. This is called duplicate testing. This situation occurs in most pathology disciplines but it occurs most frequently in Clinical Chemistry and Haematology. An analysis has been made of a number of frequently requested tests and two examples from Clinical Chemistry and Haematology are shown as examples where savings can be achieved. Discipline Test Frequency Total Number performed Clinical Chemistry Clinical Chemistry No of duplicate tests Cost per test Overall cost Haemoglobin A1C 8.3% 311,500 25855 2.00 51,709 TSH 1.8% 963,500 17,343 1.50 26,015 Haematology Factor V Leiden 14.8% 840 125 50.00 6,250 Haematology Haemoglobinopathy 8.7% 1800 157 10.00 1,570 Studies It can be expected that a minimum of 2% savings can be found by using IT software either in the hospital ward ordering software or in the Pathology IT software that flags duplicate tests at the time of request to prevent the test being performed. The Greater Manchester Pathology budget is 120,000,000. This can be broken down into staffing equipment and consumables/reagents. Consumables and reagents will account for 25% of this budget i.e. 30,000,000 The following table shows the expected saving at various % duplicate testing assuming the savings are made from the consumable portion of the overall pathology budget. % reduction in duplicate testing Yearly saving across Greater Manchester 2 600,000 3 900,000 4 1,200,000 These figures could be achieved if Pathology across Greater Manchester used the same duplicate identification criteria either using hospital ward ordering or pathology software to identify duplicate tests. The other area where cost savings could be achieved are: 10.1.4. Accident & Emergency In Accident and Emergency departments, a high percentage of patients have pathology tests requested but, in some cases, there isn t a standard set of tests requested for a clinical condition. This inconsistency is being addresses in some Trusts by the Pathology laboratory working with A&E Consultants to produce a standard set of tests for each clinical condition presented. For example, if a patient attends with chest pain, then the standard pathology requests will be: - Full Blood Count, Renal profile, Glucose and Cardiac enzymes. This removes the possibility of locum staff from requesting inappropriate tests and, therefore, cost savings could be achieved by standardisation across Greater Manchester V1.0 9 th April 2010 Page 17 of 23

10.1.5. Moving to a Single LIMS cost releasing benefits Cost releasing saving Number Cost saved Common GP electronic requesting to all GP practices in Greater Manchester There are 10 GP requesting software packages, each implemented differently, which can be reduced to 1 10,000 per site and assume a single system will have support costs of 20,000. Cost saving = Reduction in the number of PMIP reporting systems ICNet is a software package for reporting positive infections. Reduction in the number of analyser interfaces due to consolidation of services Reduction in Lab2Lab interfaces (project currently in progress) There are 10 PMIP software packages that can be reduced to 1 Moving to a single LIMS will reduce this from 10 to 1 If Microbiology was consolidated from 10 departments to 3, there will be a saving of 7 analyser interfaces if new analysers were leased/purchased Each Pathology IT system has a Lab2Lab interface to send and receive requests and reports between labs in Greater Manchester. A single LIMS will reduce this from 11 to 1 80,000 10,000 per site and assume a single system will have support costs of 20,000. Cost saving = 80,000 The average cost of an analyser interface is 15,000, resulting in an overall saving of 105,000. The overall savings will depend on the restructuring of the pathology disciplines and the lease/purchase of new equipment but a rough estimate will be approx 500,000 over 2 years Support costs for Lab2Lab will be 88,000 per year and interface support will be 30,000. This will be reduced to 20,000 Cost saving = 98,000 11. POTENTIAL FUTURE SERVICE REORGANISATION 11.1.1. Service Confederation In order to become more financially efficient, Secondary Care Trusts in Greater Manchester may need to consider service rationalisation of smaller specialisations e.g. Urology, ENT and Gynaecology. These services may be performed in 3 NHS Trusts across Greater Manchester but out patient clinics will be held in each Trust. The diagnostic tests requested in the Out Patient clinics will be analysed in the laboratory in the Trust where the clinic has been held. If this is the case, then the patient s diagnostic results will not be available on the host Trust Pathology or Order Communications systems. The Consultant or Healthcare professional will need to either, access the remote Pathology IT system, contact the sending Trust Pathology department for the most recent pathology results or repeat the diagnostic tests when the patient arrives in the host Trust. The following data for a single Trust broadly represents the expected cases for 2010 2011 for three specialties Urology ENT Gynaecology Elective in patients 6940 12830 8680 Day Cases 21570 9910 11130 First Out patient 18120 39910 21860 Out patient follow up 40520 90440 44830 V1.0 9 th April 2010 Page 18 of 23

From the 4 categories above, it is assumed that the elective in patients and day cases will have their pathology tests performed in the pathology laboratory at the specialty host Trust. The first out patient and out patient follow up appointments will be held in the patient s locality. Therefore, in these 2 categories, the pathology results will be held on a different pathology IT system that the host Trust, unless a Single Pathology IT system is available. Access to the most recent pathology results will require contact between the 2 Trusts either by letter, telephone call or remote pathology results access between the 2 Trusts. In any of these cases, it will use staff time to obtain the pathology results. From the above example, the interaction between confederated services which are provided on behalf of multiple Trusts or within Sectors of Greater Manchester will be considerable. The provision of a Single Pathology LIMS will provide pathology results at the required time and location and improve the patient s journey through their personal pathway Further ore, it will reduce the potential for the 18 week journey being exceeded and Trusts incurring fines. 12. FINANCIAL BENEFITS Using the financial benefits from the sections above, the expected yearly financial benefits are as follows: Financial benefit Yearly cost improvement Greater Manchester patient 801,036 flows icats 455,084 Demand management 600,000 Reduction of GP requesting 80,000 software packages Reduction of PMIP reporting 80,000 packages Reduction of ICNet packages Reduction in analyser 250,000 interfaces Lab2Lab interfaces 98,000 Total 2,364,120 Discussions have taken place with the All Wales Single IT Programme Manager and they have estimated that there will be a 1% cost benefit saving which is 1.40m but up to 5% could be achieved which is 7.0m 13. PAYMENT SCHEDULE If this project was approved by the Greater Manchester ICT Programme Board, then the amount of finance required per financial year would be dependent on the Payment schedule agreed at the outset of the contract with the supplier. Assuming that the project was approved with the above financial figures and the contract was awarded on 6 th April 2011, then the following finance would be required: Payment Milestone Payment percentage Payment value Financial Year Award of contract 20% 1,413,000 2011-12 Hardware on award 100% 1,000,000 2011-12 of contract Installation of software 30% 2,119,500 2011-12 First site go live 25% 1,766,250 2012-13 Last site go live 20% 1,413,000 2015-16 Final Acceptance 5% 353,250 2015-16 Total 7,065,000 V1.0 9 th April 2010 Page 19 of 23

14. BENEFITS The benefits of implementing a Single Pathology IT system across Greater Manchester have, for the purposes of this, been categorised as Patient, Operational, Managerial and Financial. The benefits identified are set out in the table below. Table: Benefits of Implementing a Single Pathology LIMS for Greater Manchester Patient Benefits Contributes to the 18 week journey reducing possibility of Trusts exceeding this timescale and incurring fines An integral part of a patient s pathway as pathology results contribute to a patient s diagnosis in 70% of cases Single database of patient results Improved clinical management of patients e.g. in Cervical Cytology Point of Care results stored on single database for Greater Manchester Improved treatment due to availability of results to clinicians independent of patient s home address or hospital visit Improved turnaround of samples if previous results are required for interpretation Reduction in duplicate testing Ability to include images into patient reports The CfH Choose and Book project allows patients to choose their preferred NHS Trust for treatment. If the patient lives in Greater Manchester and chooses a Greater Manchester Trust, the patient s previous results will be available to the clinician. The NHS forward planning includes the opening of referral centres for specialist treatment. Patient pathology results will be available to the clinicians across Greater Manchester Currently, when a patient moves their registered GP, their GP record will be transferred to their new GP practice using GP-to-GP record transfer. This new system has highlighted the difference in reference ranges and units for the same tests between different laboratories. The use of a single Pathology LIMS across Greater Manchester will harmonise reference ranges. The IT system will be CfH compliant allowing the system to be linked to the Personal Demographics Service (PDS) and the Spine In the future, patients will be allowed to access their own results and the harmonisation of reference ranges and units across Greater Manchester laboratories will be a pre-requisite for patient access. All patient results will be transmitted electronically to GP surgeries Operational Benefits Supports a more flexible organisation of pathology services across Greater Manchester Fully supported networked LIMS allows reconfiguration of pathology services Single IT supplier Modern IT system using current software and hardware technologies More resilience built into hardware specification Improved service resilience and disaster recovery facilities Standardisation of working practices and reporting Staff flexibility as working practices are standardised Single Pathology IT system allows multi-site working Standardisation of test units and reference ranges Disciplines can include images into their reports e.g. Cellular Pathology Reduction in number of interfaces due to single interface for multiple analysers thereby reducing support and maintenance costs Use of National Laboratory Medicine Catalogue in all disciplines Initial system setup based on the National Laboratory Medicine Catalogue allowing transfer of results between interoperable systems e.g. Primary and Secondary care systems Regional services may be included in the use of the IT system V1.0 9 th April 2010 Page 20 of 23

Reduction in phone calls between laboratories and users for sample results Reduction in time spent chasing results for patients who have been referred to a different hospital Referral of tests to specialist laboratories with Greater Manchester will be internal to a single LIMS system in place of a Laboratory2Laboratory software system All test results will be held on a single database Point of Care testing is a new pathology growth area and patient s results generated using point of care devices can be stored on the single LIMS with new interface technology If a major incident occurs, using standard working practices, staff could be transferred from nearby laboratories to assist. If a major analyser fails and work needs to be transferred to another laboratory, using a single IT system makes this possible as the requests will be on the IT system Blood Transfusion departments will be able to check blood stocks in other laboratories in Greater Manchester The Cervical Cytology service will use the same database thereby allowing work to be transferred between laboratories having access to historical records Use of data recognition software for data input Standardise structured reporting of Pathology reports e.g. Cancer Minimum Datasets Managerial Benefits In the current financial climate, the financing for the replacement of individual Trust pathology IT systems will be extremely difficult. The installation of a single Pathology IT system across Greater Manchester may be the only option available. Statistics for all laboratories will be produced from a single database Workload statistics will be calculated using the same interpretation of tests and requests and will be comparable between laboratories Dedicated IT staff with a formal IT management structure Able to modernise and reconfigure pathology services with a single IT system Managers will be able to move staff between laboratories due to same Pathology LIMS system and working practices Data quality for all laboratories can be standardised at the same high level Benchmarking data will be comparable Financial Benefits Expected lower maintenance costs for a single IT system Reduced maintenance costs for interfaces compared to existing systems Financial information for each laboratory in Greater Manchester available from the same IT system Ability to drive down costs by using a single supplier If equipment is standardised across the same discipline in all Pathology laboratories, interface costs will be substantially reduced Costs reduced by lowering duplicate testing 15. RISKS If the project is given approval, the project manager will maintain a Risk and Issues log throughout the life of the project. The risks already identified are included in the following table: Patient Risks Previous results will not be integrated if data migration onto new IT systems does not occur Operational Risks If a single LIMS is installed, the hardware specification needs to include a second, fail over server so that the system is available 100% of the time New releases of software need to be installed into a testing account prior to being installed onto the live system. The software upgrade must be installed with zero down time. The siting of the Pathology IT hardware will need to determined Harmonisation of reference ranges will be required but the system will be required to V1.0 9 th April 2010 Page 21 of 23

have different reference ranges for different analysis methodologies Secondary Care Trusts across Greater Manchester use similar number structures for District/Case numbers. Managerial Risks The single LIMS project may not be accepted by some Pathology laboratories or individual disciplines or Clinical/laboratory staff Centralised Pathology IT staff may result in the restructuring of the current Trust Pathology IT staff There will be transitional period of dual working for patients, operational and managerial staff Data migration from current systems will be expensive and, therefore, may not be taken over to a Single LIMS system. Previous results and statistics may not be easily accessible If previous patient results are not migrated onto the Single LIMS system, the pathology service may be at risk in cases of litigation Financial Risks There may be no financial savings from the changeover Initial capital outlay 16. IMPLEMENTATION TIMETABLE The specification, procurement and implementation of a Single LIMS system into the laboratories of Greater Manchester will be an extremely complex project. The author has looked at the specification, procurement and implementation of the Clinisys Labcentre pathology LIMS project at Pennine Acute Hospitals NHS Trust. This project replaced 4 Pathology IT systems, namely isoft Telepath (North Manchester General Hospital) Mysis (Royal Oldham Hospital) Clinisys Labcentre (at Bury General Hospital and Rochdale Infirmary/Birch Hill Hospital) The timescale for this project was 2 years and 6 months to complete the installation with all disciplines using the system. This did not include data migration of Cellular Pathology and Blood Transfusion data from the previous systems. This was a rapid implementation as the Pathology laboratory had considerable expertise in the setup and daily operation of Clinisys Labcentre. For a single LIMS to be installed across Greater Manchester, the timetable would be as follows: Process Write and agree specification Procurement process invitation to tender Short list preferred suppliers Select Supplier of choice Sign contract with Supplier Project Initiation Common application setup and user testing Software setup and user testing 1 st Lab (all disciplines) Rollout to other labs in Greater Manchester (will require significant parallel implementation) Total Time line 3 months 2 months 2 months 1 months 1 month 3 months 6 months 6 months 18 months 42 months (3 years and 6 months) V1.0 9 th April 2010 Page 22 of 23

In the All Wales Single LIMS project, they commenced their project in 2006 and do not expect it to be completed until 2012. A full project plan will be developed with the chosen supplier. To achieve the timetable detailed above, the IT system will need to be implemented in at least 2 laboratories simultaneously. 17. RECOMMENDATIONS The GMPN Board are requested to consider the benefits provided by the move across from existing Pathology IT systems to a single IT system for all pathology laboratories across Greater Manchester. This recommends that the case is approved due to financial benefits from moving to a single Pathology LIMS and it provides a basis for the Greater Manchester Pathology laboratories to reconfigure their services across all disciplines to provide major cost savings in line with the case made by Lord Carter of Coles. If this is approved, a full business case will need to be developed followed by a full system specification. V1.0 9 th April 2010 Page 23 of 23