Paul Britton | 25 April 2009

1. Reform of Laboratory Medicine Services:Assessment of Teamwork’s Proposals and Consideration of Alternative Options Paul Britton | 25 April 2009

2. Roadmap for Discussion I. Terms of reference II. Assessment of Teamwork report proposals III. Potential options not considered

3. Roadmap for Discussion I. Terms of reference II. Assessment of Teamwork report proposals III. Potential options not considered

4. Controversy Surrounding Teamwork Report Teamwork completed report in May 2007 Some Steering Group members disassociated themselves with report No Steering Group members asked to officially ‘sign-off’ report Report endorsed by HSE Board in May 2007 Report not published on HSE web-site until Feb 2009 Terms of Reference

5. Two Elements to the Commission Assess the conclusions of the Teamwork report Identify additional options for reform of medical laboratory services not considered within the Teamwork review Terms of Reference

6. Focus of the ECH RKW Review Methodology undertaken by Teamwork Conclusions of the Teamwork report, specifically those relating to: Benefits and risks of the current system International best practice Evidence of costs / benefits for proposed new model Future clinical model of care for the Republic Proposed new system for laboratory medicine Action plan for implementing the new system Terms of Reference

7. Roadmap for Discussion I. Terms of reference II. Assessment of Teamwork report proposals III. Potential options not considered

8. A Contrasting Methodology to Others Assessment of Teamwork’s Proposals “We were asked to prepare this report on independent basis without formal engagement and consultation with the public, patients, staff and other stakeholders in laboratory medicine services.” Teamwork Management Services

9. Lack of Stakeholder Engagement a Key Concern Teamwork’s understanding of the existing service informed by limited site visits, data collection, fact finding interviews and published reports Key concern is the level of stakeholder engagement in determining the proposed model Arguably more extensive engagement necessary to provide better understanding of the current system inform the generation and testing of additional future models Assessment of Teamwork’s Proposals

10. Current System – Benefits and Risks While identifying several benefits in the current system, Teamwork highlights the following problems: whole system quality of existing service not good enough limitations in the current organisation of hospital laboratories issues for the Public Health and Food Safety Laboratories Assessment of Teamwork’s Proposals “The people we have met during this review have consistently recognised the need to change the way in which the current system is managed and delivered.”

11. Lack of Documented Stakeholder Views Current issues with the service (local, regional or national level) Service aspirations and vision for the future Barriers to change (operational, logistical, political) Opinions regarding visions for pathology service arrangement (both managerial and organisational) Assessment of Teamwork’s Proposals To support this statement the report does not include any stakeholder views on the following: Inclusion of this information (if made available) within the report may have demonstrated links between stakeholder issues with current service and future vision

12. What is International Best Practice? Examination of current trends Australia (Queensland, NSW) Canada (British Columbia) Germany Japan New Zealand UK USA Global direction of travel Assessment of Teamwork’s Proposals New system based on complementary • ‘Hot’ labs (acute secondary / tertiary) • ‘Cold’ labs (custom designed) • Central • Latest automation, robotics, IT • Large volumes of routine samples • Point of Care Testing • Patient centred / networked services • Telepathology / new technologies & techniques

13. Advantages of Separating ‘Hot’ and ‘Cold’ meeting demands of acute patient care process ‘hot’ samples without competing pressures of the routine workload Assessment of Teamwork’s Proposals Teamwork provide several international examples of new lab systems based on advantages of separating ‘hot’ and ‘cold’ samples. Proposed benefits: All samples Cold samples Hot samples Hospital lab can focus on: ‘Cold’ lab free to provide: • More patient centred services (guaranteed standard of service for routine care) • Total end-to-end quality assurance • Fast turnaround times • Rapid results reporting / paradigm shift in productivity • Substantial economic savings

14. Argument Lacks Supporting Evidence Enhanced quality of patient centred service Shifts in productivity Economies of scale Improved value for money Workforce planning issues e.g. enhanced staff specialisation Assessment of Teamwork’s Proposals While this model may represent best practice, the Teamwork report does not present a robust analysis of data to support assumptions, especially regarding: Without supporting evidence, the (persuasive) benefits of hot/cold separation are harder to quantify and difficult to accept as widely applicable best practice worthy of implementation prior to robust testing and evaluation.

15. Lessons to be Learnt from Carter Review (i) Observations appear to support Teamwork’s assumption that global direction of travel involves separation of ‘hot’ and ‘cold’ sample processing Recommended pilot studies to determine optimal way forward in terms of quality and economies of scale Likely that there may well not be any single solution (optimal model for reform) Assessment of Teamwork’s Proposals

16. Lessons to be Learnt from Carter Review (ii) Needs to be scope for local determination that considers views of stakeholders and reflects local / regional circumstances Identification of broader range of different organisational models and approaches would be beneficial (evaluate against one another) ECH RKW view: same principles applicable to Republic Evidence base indicates the likely requirement for consolidation It would appear that there is no evidence of a dominant model to achieve this goal Assessment of Teamwork’s Proposals

17. Proposed New Model – Evidence of Costs & Benefits? UCHL NHS Foundation Trust’s joint venture with independent service provider The Doctors Laboratory (significantly increased test processing; savings of £1M; origin unclear!) NHS Greater Glasgow and Clyde health area’s seven year managed service contract with Abbot Diagnostics in 2005 (savings of £9M over 7 years; due to managed service contract / centralisation / combination?) Lord Warner comment on the need to find substantial efficiency gains of at least 10% through new ways of working (by 2008/09)(not evidence!) Assessment of Teamwork’s Proposals Cost saving examples provided by Teamwork are not compelling:

18. Difficult to Conclude that Savings are Achievable Examples cited by Teamwork remain aspirational Teamwork has not advanced evidence of costs of implementation actual savings payback period Difficult to conclude (from these examples) that such savings would be achievable following implementation of similar models in the Republic Assessment of Teamwork’s Proposals

19. Proposed New System for Laboratory Medicine System creates a single framework to oversee all laboratory medicine services System makes use of Regional pathology networks (up to three) Appropriate point of care testing ‘Hot’ laboratories for acute hospital patient care ‘Cold’ laboratories for primary care Assessment of Teamwork’s Proposals

20. Clinical and Laboratory Model Assessment of Teamwork’s Proposals

21. Clinical and Laboratory Model (i) 24/7 clinical services in the home Self care, chronic disease management, home telecare, “smart” homes, social housing schemes, primary care, community care, social care, ambulance emergency care management, etc Supporting laboratory medicine system: POCT (self care and emerg. assessment), Phlebotomy, Sample processing by the ‘cold’ laboratory 24/7 general practice, primary care and community services Access to GP, nursing and community clinics, domiciliary services, support for self care, chronic disease, long term conditions, intensive case management, maternity and child health, mental health, special needs, etc Laboratory medicine in general practice, primary care and community: Phlebotomy and sample collection, POCT (routine and urgent), sample processing by the ‘cold’ laboratory Assessment of Teamwork’s Proposals

22. Clinical and Laboratory Model (ii) Clinical services at the local hospital Specialty outpatient clinics, diagnostics, planned care, community beds (non-acute), 24/7 minor injuries and illness service Laboratory medicine at the local hospital: Point of care testing, phlebotomy, sample collection point, processing by the ‘cold’ laboratory 24/7 acute clinical services at the regional hospital +/- tertiary specialties Provides treatment not provided at the local hospital and is supported by a national network of tertiary specialties. Some tertiary specialties may be collocated with the regional hospital, depending upon planning strategies Laboratory medicine services at the regional hospital: Phlebotomy service, sample collection system, ‘hot’ laboratory, urgent point of care testing. Clinical pathologists providing expert advice, direct patient care and operating across the clinical networks Assessment of Teamwork’s Proposals

23. Clinical and Laboratory Model (iii) ‘Cold’ and ‘hot’ laboratories may be standalone or collocated Clinical and laboratory services models will be supported by a range of specialised laboratories There will be several acceptable combinations of functions, collocations and stand-alone solutions (all compatible within the overall model). For example: Both the ‘cold’ and ‘hot’ laboratory may each have specialised roles or qualify as a designated national reference laboratory Typically, the academic laboratory will be collocated with a regional hospital and its ‘hot’ laboratory National reference laboratories do not need to be collocated with hospitals, except where their function is critical to supporting a particular clinical service or where it’s logical to group similar laboratory functions together on one site Assessment of Teamwork’s Proposals

24. Flexibility Required Within Overall Visions Laboratory medicine service must support the clinical vision Clinical vision for the Republic has yet to be clarified and is likely to respond to specific variations in regional requirements The overall clinical vision for Ireland should not necessarily predetermine the supporting laboratory medicine service model Possible that local and regional variations in the supporting laboratory medicine service model may ultimately meet the goals of the clinical vision Assessment of Teamwork’s Proposals

25. Workforce Implications Not Fully Considered Report states that implementation of new model will result in substantial reductions in number of medical laboratory scientists Report recommends HSE establish review to investigate future workforce requirements to support new model (cart before horse!) Unclear whether the report addresses the potential loss of ‘intellectual capital’ within the system (significant number of impending retirements) Recommends review to Align future educational & training with new model Develop retraining programme for current staff Framework for uniform approach to post-graduate CPD Assessment of Teamwork’s Proposals

26. Complexities of POCT Implementation Overlooked Significant potential for POCT to support the overall clinical strategy Agree with the importance of POCT in realisation of the clinical vision Teamwork report does not explicitly consider the complexities surrounding the successful implementation of POCT Report does not address the potential additional costs associated with POCT implementation Assessment of Teamwork’s Proposals

27. ‘Hot’ Laboratories Report does not make recommendations on the capacity and size of ‘hot’ laboratories (only assumes variations in size & complexity) Financial analysis not included within Teamwork report. Valuable to understand assumptions around: Non - routine activity retained within the ‘hot’ laboratories Any increases in cost per test associated with a reduced number of tests across which to spread fixed costs Any capital costs associated with the refurbishment of existing acute hospital laboratories to bring the estate up to the required condition The costs of maintaining a critical mass of staff within ‘hot’ laboratories following the centralisation of ‘cold’ testing Assessment of Teamwork’s Proposals

28. ‘Cold’ Laboratories Report suggests an immediate case for up to 3 ‘cold’ laboratories (1x serving Dublin, 1x serving the South, 1x serving the West) Recommend further testing during development of business case for ‘cold’ laboratory procurement (surely should be done prior to this!) Financial analysis not included within Teamwork report. Raises questions around following assumptions: What routine activity is relocated to centralised ‘cold’ laboratories The revenue costs associated with ‘cold’ laboratories Efficiency savings associated with reduced cost per test Capital costs (and cost of capital) allocated to the creation of laboratories Annual cost savings associated with the creation of up to three ‘cold’ labs Assessment of Teamwork’s Proposals

29. ‘Cold’ Laboratories Report lists criteria for consideration to determine location of ‘cold’ labs Cost effectiveness of solution listed as important criterion Teamwork note the possibility of locating ‘cold’ labs with an existing hospital laboratory. Were such options explored by Teamwork? Would assume that such options would be required to be explored and evaluated in comprehensive option evaluation process Assessment of Teamwork’s Proposals

30. Were Other Options Considered? Report does not present an option appraisal methodology that demonstrates the proposed model is best in terms of Cost Benefit Risk analysis Centralisation of routine testing within existing labs with available capacity / appropriate estates solution? Would appear to be excess testing capacity within the system Discussed in next section Assessment of Teamwork’s Proposals

31. Action Plan for Implementation – Some Concerns Teamwork report sets out comprehensive action plan to assist with implementation of new system (reasonable framework but some concerns) Preparation and approval of business case for ‘cold’ laboratories Does the information to support robust business case for ‘cold’ labs currently exist? What is the level of confidence that business case for ‘cold’ labs will demonstrate improvement in quality of care, cost effectiveness and value for money Has Teamwork prescribed a solution without necessary analysis of cost / benefits / risk? Assessment of Teamwork’s Proposals

32. Roadmap for Discussion I. Terms of reference II. Assessment of Teamwork report proposals III. Potential options not considered

33. Approach – Site Visits and Stakeholder Interviews Overview of the existing laboratory medicine service at key locations Service arrangement Infrastructure condition Local issues relevant to effective service provision Laboratory medicine service aspirations and vision for the future Potential barriers to change (operational, logistical, political) Opinions regarding visions for service arrangement nationally Potential Options not Considered

34. Sites Visited & Interviews Completed Potential Options not Considered • Following discussion with MLSA, the following visits / interview were completed • Never the intention to visit all labs in Republic but rather a representative sample

35. Local Service Issues / Aspirations – Main Themes General lack of certainty around emerging regional clinical (& laboratory) strategies HSE not engaged sufficiently with laboratory medicine stakeholders Most hospitals experiencing increasing levels of testing within context of hiring restrictions, budget cuts, and length of the current working day Significant amount of pay costs is typically allocated to on-call costs Existing infrastructure of some labs restricts delivery of efficient service Many hospitals experiencing space constraints within existing infrastructure Most hospital labs currently have spare analyser capacity to handle additional workload Unsatisfactory end-to-end information systems and the lack of a unique patient identification system as significant barriers to provision of an efficient service Lack of demand management initiatives Silo mentality of existing laboratories is typically a barrier to consolidation and rationalisation Some lab managers have limited authority to effect the required service change Laboratory medicine often has a lack of quality assurance control over hospital POCT Potential Options not Considered

36. Existing Hospital Locations & Lab Sizes Potential Options not Considered

37. Data Availability to Support Option Evaluation Collection and analysis of information from selection of hospitals Inform existing service evaluation Support indicative financial appraisal of alternative models 2005 national activity data collected during Teamwork review used to: Provide a more robust data set for evaluation Project activity and cost information to inform option evaluation Caveats associated with this approach discussed in ECH RKW report Potential Options not Considered

38. Additional Options Identified & Modelled Options for evaluation were based on the following: Inputs from laboratory medicine stakeholders Relevant experience / best practice from other sources Indicative high level quantitative evaluation of options has been modelled. Output from which includes: Conversion of activity projections to estimated space requirements Development of high level building costs Development of high level equipment costs. Potential Options not Considered

39. A Framework for Evaluation…Not the Answer! Intention of this quantitative analysis is not to provide a definitive evaluation of potential options Developed a modelling framework which could be used to undertake a more robust evaluation of options in the future This would be based on a comprehensive data set and significant input from stakeholders Potential Options not Considered

40. Options Identified Option 1 - Three regional laboratory medicine networks each with centralised routine testing (as per the Teamwork review proposal) Option 2 - Three regional laboratory medicine networks (each with centralised routine testing at regional hospital laboratories) Option 3 - Four regional laboratory medicine networks (Dublin x2, Cork x1 and Galway x1; each with centralised routine testing at regional hospital laboratories) Option 4 - Six regional laboratory medicine networks (Dublin x4, Cork x1 and Galway x1; each with centralised routine testing at regional hospital laboratories) Potential Options not Considered

41. Options Identified Potential Options not Considered

42. Options Identified Potential Options not Considered

43. Options Identified Potential Options not Considered

44. Options Identified Potential Options not Considered

45. Baseline for Analysis Options for laboratory medicine service arrangement must be driven by future clinical service arrangements support the respective clinical visions for the Republic in general and specific regions Important elements to consider include: A new National Paediatric Hospital on the Mater hospital site in Dublin Development of the new National Maternity Hospital on the Mater site A new regional hospital in the North East (potentially located in Navan) Location of the regional Cancer Centres and respective cancer networks Proposals for development of Academic Health Centres Recommendations to establish a unified and integrated Public Health Microbiology and Public Analyst Laboratory service Potential Options not Considered

46. Predicted Future Hospital Configuration Potential Options not Considered

47. Baseline for Analysis – Activity & Costs Potential Options not Considered

48. Capital Cost Estimates for Options Indicative capital cost estimates for each option have been modelled using the following: Conversion of activity projections to estimated space requirements Development of high level building costs Development of high level equipment costs For each option, can anticipate level of investment required in new and/or refurbished buildings and equipment This includes cost for centralised routine testing facilities and for the reprovision of hospital based facilities in line with clinical reconfiguration strategies Potential Options not Considered

49. Projected Annual Costs for Options Potential Options not Considered

50. Assumptions for Annual Cost Projections Current costs for medical laboratory services Annual cost of routine testing assumes work would initially transfer at current average gross cost per test Capital costs do not include land acquisition or disposal The annual cost of capital is calculated at 10% to include capital charges (or equivalent) and depreciation For option 1 it is assumed that an element of the costs of transferred workload would remain fixed within the hospital based laboratories Capital cost assumptions for upgrading facilities at UHG, CUH and St. James’ require clarification Capital costs do not include the cost of the required IT systems or transportation systems to support the networks Assume economies of scale would be achievable for all options Potential Options not Considered