National Clinical Programme in Pathology

As we enter a period of major change in the configuration of the Irish health system, the National Clinical Programme in Pathology seeks to ensure that each future trust hospital or hospital grouping will have the highest quality and most efficiently run clinical laboratories, writes Dr. Gerard P. Boran.

In April 2011, The HSE’s Clinical Strategy and Programmes Directorate established a National Clinical Programme in Pathology with the initial objectives of implementing a National Pathology Network and a Programme for Laboratory Modernisation. The Programme places clinical requirements and patient safety as top priorities as well as value for money and cost savings. This article will cover the background to this development including important clinical changes that are likely to impact. The Ten Principles of Laboratory Medicine Modernisation will be reviewed. These summarise the main requirements for service improvement, including patient confidence, user satisfaction, quality, safety, and value for money.

Dr. Gerard Boran
Dr. Gerard P. Boran
Objectives of the National Clinical Programme

Objectives for the Clinical Programme during the first three years are summarised in Table 1.

Table 1. Objectives of the National Clinical Programme in Pathology

  1. To implement a national pathology network and modernisation programme based on a whole-system approach with cooperative hubs and spokes organised according to clinical need
  2. To coordinate the pathology modernisation activities of individual laboratories using the 10 principles as the framework and to ensure this is integrated with government plans for future organisation of clinical services
  3. To rationalise referral patterns for specialist tests by developing a national network of specialised laboratory services, and to ensure that in-sourcing and out-sourcing of tests is appropriate
  4. To develop a National Pathology Catalogue so as to assist in demand management, together with Guidelines and Order Sets for common clinical diagnostic problems which lead to large scale laboratory investigations
  5. To determine and monitor laboratory quality, costs (including reagent contracts), and user satisfaction in Ireland by maintaining a central database and agreed set of dashboard metrics

A well-managed and clinically-driven National Pathology Network will be implemented which will eliminate waste and inefficiencies, thereby funding modernisation. Though the scope heretofore is limited to cold laboratory work from primary care settings, adoption of a cooperative Hub-and-Spoke model brings a wider range of tests in scope with higher savings potential. Also, changes in staffing levels, skill mix and work practices will apply to the whole system (both hot and cold work).

Though consolidation is required, the number of hubs (which may include co-operating “co-hubs”) and spokes is less critical provided that efficiency targets are reached. Reliance on too few hubs at the outset may also carry increased risks of clinical or logistics failure. All hubs and spokes will also have to meet stringent quality targets based on the Ten Principles. An incremental approach will be necessary to leverage improvements in quality and efficiency benefits throughout the laboratory system over the first three years of the Programme, with the possibility that hubs failing to meet expectations will have cold work transferred to more successful co-hubs. However, commitment to implement change at the outset will be essential.

The Clinical Programme also plans a national network of specialised laboratory services, and a National Pathology Catalogue to assist in demand management including clinical guidelines for common clinical diagnostic problems. Systems for central monitoring of laboratory quality, costs, user satisfaction and public confidence will be established. An appropriate governance structure with clinical leadership is also being established.

Laboratory services are driven by clinical requirements

The recently established Special Delivery Unit (SDU), as part of its efforts to eliminate hospital waiting lists and tackle lengthy trolley wait times, will need efficient acute laboratory medicine services including order sets, demand management, and turnaround times. Hospital reconfiguration in the Acute Medicine Programme will also drive the provision of laboratory services at acute hospital sites (principally Model 4 and Model 3 hospitals with acute services).

Modernisation is driven by the Ten Principles

Modernisation needs to be focused on quality improvement and public confidence in the pathology service as well as saving money. The issues which need to be addressed in order to modernise Ireland’s clinical laboratory service have been agreed by the stakeholders and summarised into the Ten Principles of Laboratory Medicine Modernisation (Table 2) which have the aim of promoting a high quality service while also improving efficiency, effectiveness and value for money.

Since 2008, many hospitals and hospital groups have developed modernisation plans driven by local clinical needs as well as national and international trends. There is a critical need however to coordinate these developments so as to maximise efficiency, effectiveness, productivity, and value for money.

Table 2. Ten Principles for Modernisation of Laboratory Medicine

  1. Accreditation of all laboratories
  2. Provide Clinical Input in all pathology disciplines
  3. Networks – develop a network of National, Regional, Local laboratories
  4. Manage Demand in Primary and Secondary Care
  5. Improved ICT Connectivity – upgrade ICT to support new network/hot and cold lab
  6. Improved work practices
  7. Use Core Labs Technology
  8. Improved Phlebotomy and Transport Logistics
  9. Develop a charging/ cost/workload model using standardised test codes
  10. Regulated Point of Care Testing – support implementation of National POCT Guidelines
Work Practice Reform

Reformed work practices have been identified as a key driver of increased productivity, particularly so if we are to maximise the use of spare laboratory capacity. Several components of existing work practice in pathology are being reviewed (Table 3).

Table 3. Components of Work Practice reform

  1. Skill mix changes (more lab aides)
  2. Extended hours
  3. Multidisciplinary working (especially for lab aides and basic scientist grades)

Staff turnover will also have to be examined as the number of scientific staff required is expected to decrease. There will also be a need for new staff appointments, e.g. supervisory scientist posts for Core Automation Laboratories, and more cross-discipline scientific staff. The most significant staff reform is likely to be related to the development of Integrated Blood Science laboratories.

An incremental approach will be necessary to leverage improvements in quality and efficiency benefits throughout the laboratory system over the first three years of the Programme

Integrated Blood Sciences with Lean Automated Core Laboratories

The development of Core Automation Laboratories is a vital step in achieving greater efficiencies throughout the whole laboratory system. These laboratories, which integrate many biochemistry, haematology, immunology, and serology tests onto a common analytical platform with preanalytical robotics and track automation, should be implemented in all of the existing hospital groups though will require careful planning. Core/Automation Laboratories are expected to have the characteristics outlined in Table 4. Use of Lean Six Sigma methodology is also useful to identify and eliminate inefficiencies in existing laboratory workflow processes.

Table 4. Characteristics of Core/Automation Laboratories

  • Under direct subspecialist consultant supervision in all relevant pathology disciplines
  • Operationally managed by a Core/Automation Lab scientist
  • Operated by cross-discipline lab aides and junior scientists
  • Guaranteed STAT, semi-urgent, and routine TATs that have been agreed with users
  • Consist of preanalytical, analytical, and postanalytical (biorepository) modules
  • Autovalidation of most results (e.g. using middleware to achieve an average 80% autovalidation), with a small number of senior scientists (specialised in their discipline) manually validating the remainder
  • Serviced by good logistics (pneumatic tube system, courier system)
  • Computerised Physician Order Entry
  • Electronic reporting
Conclusion

Clinical Programmes are now established across most of the clinical spectrum and will be offering guidance, standards and targets for quality improvement and efficient delivery of a wide range of clinical services, with major implications for pathology services. As we enter a period of major change in the configuration of the Irish health system, the National Clinical Programme in Pathology seeks to ensure that each future trust hospital or hospital grouping will have the highest quality and most efficiently run clinical laboratories.

Gerard P. Boran FRCPI, FRCPath, FFPath. Programme Director, National Clinical Programme in Pathology. Consultant Chemical Pathologist, Adelaide, Meath incorporating National Children’s Hospital, Tallaght.