The Modernisation of Pathology and Laboratory Medicine in the UK: Networking into the Future

The National Health Service

In 2008 the United Kingdom (UK) celebrates the sixtieth anniversary of the National Health Service (NHS). The NHS continues to provide comprehensive health care to everyone in the UK that is free at the point of delivery. The NHS embraces hospital and primary care services and increasingly it is entering into partnership with local authorities to support care in the community for the elderly and those with debilitating chronic disease. The NHS is funded through central taxation. The NHS employs 1.3 million people making it the third biggest employer in the world after the Chinese army and the Indian railways. There is a small but growing trend towards the use of private contractors within the NHS. A small proportion of the UK population choose to ‘top up’ their free NHS care with private health insurance that gives them greater freedom of choice for their elective health care. Despite regular criticism of the NHS from politicians, the media and NHS staff, the service is well respected by the public and by patients. In a recent survey of six health services in the developed world the NHS came out first overall, ahead of Australia and New Zealand and well ahead of the United States.¹

The past ten years has seen massive investment into the NHS, bringing the percentage of gross domestic product that is spent on health care up to the average for Western Europe at around 9%. This investment has resulted in impressive reductions in waiting times, significant improvements in health outcomes and in much more patient focused services.

Within the UK health is a devolved responsibility and significant differences in the approach to the organisation, commissioning and delivery of health services are beginning to emerge. Northern Ireland, Scotland and Wales each has a population of less than six million people and each of these countries has maintained a national approach to health care based largely on a top down model of funding. England by contrast, with a population of more than 50 million has adopted a model based on 10 Strategic Health Authorities (SHA) with significant amounts of money being given to Primary Care Trusts (PCT) to commission services from hospital trusts. In the English model contestability is being introduced through the creation of self-governing Foundation Hospital Trusts and the introduction of the first national tariff.

Pathology and Laboratory Medicine

The majority of UK laboratory services are based in NHS hospitals. They provide a comprehensive range of services both to the hospital and to the local primary care sectors. There are approximately 250 NHS hospitals providing laboratory services for the 60 million people of the UK and so in comparison to much of Western Europe and the USA the pathology and laboratory medicine services have been organised around a relatively small number of large centres. Traditionally, laboratories have provided a 24/7 service for clinical biochemistry, haematology and blood transfusion. Core laboratory services for microbiology and histopathology have been provided at most hospitals, although not always on a 24/7 basis. Specialised laboratory services have been provided from a small number of expert centres, normally based in teaching hospitals. Various systems have evolved for sample collection and report delivery from and to the primary care sector; the local laboratory has usually taken responsibility for management of this service.

Within the NHS pathology and laboratory medicine services have evolved with a strong clinical element based on highly qualified senior staff. Medical consultants provide direct patient care within hospitals and clinical advice on patient management to all users. They also contribute actively to clinical audit and multidisciplinary team meetings. In clinical biochemistry and other disciplines clinical scientists attain the same high level qualification as medical consultants (Membership of the Royal College of Pathologists, MRCPath) and many are regarded as medical consultant equivalents. Clinical scientists undertake most of the reporting and clinical liaison, many are specialists who lead the collaborative research and development that takes place within the NHS and many are involved in high level laboratory management. The analytical work of the laboratory is undertaken by biomedical scientists who are all graduates and many have postgraduate qualifications to Masters level. Finally, there are assistant grades who have less formal education but who perform vital tasks, usually narrow in range, working under supervision.

This model of pathology and laboratory medicine service provision has enabled all NHS laboratories to benefit from economies of scale. It has also created a tight knit community of senior professionals who collaborate rather than compete. National workforce planning has been developed and although not perfect it does mean that in comparison to other developed countries there are few problems with the recruitment or retention of staff to work in laboratory services.

The four Departments of Health in the UK have determined that all pathology and laboratory medicine services should be registered with an approved laboratory accreditation body. The overwhelming majority of NHS laboratories are registered with and accredited by Clinical Pathology Accreditation (UK) Ltd,² which uses standards benchmarked against ISO 15189.³

Private laboratory medicine services in the UK have been small in number, mainly associated with small private hospitals with specialised services provided from London-based centres. Private laboratory medicine services operate to the same accreditation standards as their NHS equivalents.

Despite this traditional ‘joined up’ model the last eight years have seen unprecedented activity to ‘modernise’ laboratory services to improve quality, efficiency and cost effectiveness whilst making them more patient focused and fit for purpose. The modernisation journey is by no means complete but the direction of travel is becoming evident.

The modernisation of pathology and laboratory medicine has been driven by the Department of Health in England. The Pathology Modernisation Programme was launched in 1999. This led to the appointment of Dr Ian Barnes, a respected clinical biochemist, as National Pathology Adviser. Over the first three years £28 million was invested in 39 demonstration projects across England, most of which involved the introduction of new technology, especially information technology. A consultation paper was published in 2002⁴ which proposed future principles, goals and objectives for NHS pathology. Foremost amongst these proposals was the introduction of managed pathology networks. ‘Modernising Pathology Services’⁵ was the policy document arising out of this consultation and it comprised a combination of local strategies and national support mechanisms. A year later, in 2005, and frustrated by the apparent slow pace of change, the Department of Health published a follow up document which had the aim of ‘re-energising’ the modernisation program and promoting a service shaped around the patient using new technology and new ways of working.⁶ The most significant section of this document was the announcement of a radical independent review of pathology services under the chairmanship of Lord Carter of Coles. Thus the Carter review was born.

The announcement of the Carter review did not deflect the modernisation program in England. A practical guide to service improvement was published as a toolkit for use by individual laboratories⁷ and workshops were convened to encourage the local use of LEAN and Six Sigma methodology. Across the country hospital trusts formed and attempted to run network laboratory services with a sharing of resources and a rationalisation of services across a number of sites. The most successful of these networks were actively managed with support from the hospitals and the appointment of network managers.^8,9 Sadly, the more common experience was of informal federated networks where laboratory medicine professionals tried to drive the networking agenda without active support from the employing authority. The advent of self-managed, competitive, Foundation Hospital Trusts did not fit comfortably with networked laboratories and so some informal networks failed to consolidate.

Despite this mixed picture many examples of good local practice in the modernisation of laboratory medicine services were achieved through the action learning program. These examples were collated and published in two practical, hands-on documents.^10,11 These published case studies included:

• Workforce development and re-profiling

• Protocol-guided investigations using patient wristbands

• Network development

• Standardisation of reference intervals

• Improving primary care diagnostics

The announcement of the Carter review coincided with activity in the other three countries of the UK. In Northern Ireland a review group was established leading to the publication in November 2006 of a consultation document on the future of pathology services.¹² The recommendations for the future of pathology services in Northern Ireland were published in December 2007.¹³ Scotland took a slightly different approach by considering laboratory medicine as part of diagnostic services leading to the action team report that informed the main health policy document entitled ‘Delivering for Health’.¹⁴ In Wales a pathology modernisation project was initiated in 2005¹⁵ and after detailed consultation the final integrated programme will be published early in 2008.

The Carter Review

The Carter review team carried out a thorough and systematic evaluation of pathology and laboratory medicine services in England. In formulating recommendations for the future the team looked at examples of good practice from around the world. The report from the Carter review team was published in August 2006.¹⁶

The scope of pathology and laboratory medicine services in England was defined for the first time. The report estimated that 70–80% of all health care decisions affecting diagnosis or treatment are influenced by laboratory medicine results. Over 500 million clinical biochemistry and 130 million haematology tests are carried out, over 50 million microbiology requests are processed and over 13 million histopathology slides and 4 million cytology slides are examined each year. Overall laboratory services were estimated to cost the NHS in England £2.5 billion per annum and rising, of which the single largest element is workforce.

Key drivers for change to pathology and laboratory medicine services were identified to include:

• Greater need for patient focused services

• The need to embrace competitiveness and plurality of provision

• A requirement to re-profile the workforce to make it better suited to new technology and modern ways of working

• The need for the definition of core data to create a framework to measure efficiency and effectiveness

• Recognition of the status of a core clinical service in relation to impact on the patient’s journey leading to a requirement for laboratory services to be commissioned and delivered as part of an integrated health care system

• The need for strong clinical leadership

Several barriers to change were identified, including:

• Fragmentation of arrangements for collecting and transporting samples

• A lack of end to end information technology (IT) connectivity

• Variability in test repertoire, investigation protocols and reference ranges

• Uncoordinated use of point of care testing (POCT)

• A lack of knowledge and understanding of laboratory services amongst commissioners and senior managers

• A complex workforce lacking in appropriate planning and development

In making its recommendations the Carter review team identified the following priorities for change:

• The development of a national specification for improving quality

• The creation of stand-alone pathology service providers

• End to end IT connectivity, including where possible POCT

• A national tariff system for reimbursement

• Integrated service improvement and large scale workforce change

• Development of stronger clinical leadership

The report from the Carter review team contained several recommendations, some of which were seen as being radical. These recommendations required action from laboratory professionals, NHS hospital trust providers, those responsible for commissioning services and from the Department of Health in England. However, the two major recommendations were for the creation and use of managed pathology networks and for the establishment of pilot projects to gather data in a standard format that can be used to inform a national specification and a national system for reimbursement.

The reaction to the publication of the Carter report has been interesting. Notwithstanding the radical suggestions for workforce reform, the laboratory medicine profession has generally welcomed the report because of its comprehensive nature and its recommendations in favour of pathology and laboratory medicine services that are ‘joined up’ and clearly part of integrated healthcare. Whilst not commenting directly, it seems likely that the Departments of Health in Northern Ireland, Scotland and Wales have also appreciated the report for much the same reasons. The concepts of managed pathology networks and national specifications are likely to resonate in these three countries. Ironically, however, the Department of Health in England, who commissioned the report, have been somewhat less enthusiastic about its content. Approval was given to the pilot projects and there is enthusiasm for a tariff and workforce reform but the recommendations suggesting managed pathology networks and national initiatives do not fit comfortably with the general direction of health care reform in England. There has been speculation that the Department of Health would have preferred a report that recommended greater competition, more involvement of the private sector and, perhaps, a separation of the relatively simple laboratory services required by primary care from the more complex 24/7 services required by the hospital sector. In giving cautious welcome to the report the health minister indicated that he expected significant savings to be generated as a result of implementation of some of the key recommendations.

The Situation in January 2008

At the beginning of 2008 the modernisation of UK pathology and laboratory medicine services is in full swing, both at national level and through local initiatives. The twelve Carter pilot projects have been completed, the data has been analysed and a second report has been submitted to the Department of Health. At the time of writing, however, that report and the response of the Department are not known. Without this second report it is only possible to speculate on the way forward but it seems likely that there will be recommendations on:

• Workload definition, collection and analysis

• Relative costs between pilot sites and between England and other countries

• The methodology for commissioning laboratory services

• The organisation and funding of specialised laboratory services

There has been activity in other areas recommended by the original Carter report. Work has commenced on a national tariff for laboratory medicine services. This is complex and there is still uncertainty about the extent to which the costs for individual tests may be unbundled. This author suspects that the eventual model will be based on the relatively simple Australian system of reimbursement.

The Department of Health has established a group to look at the particular requirements for best laboratory medicine practice in primary care. This will look at a range of issues including evidence based practice guidelines, IT connectivity, and quality standards for extra-laboratory testing using POCT. It may also consider the roles for and competences required of laboratory personnel specialising in primary care.

A major initiative has commenced on laboratory workforce re-profiling. Medically qualified laboratory medicine professionals will have more responsibility for direct patient care and for work at the clinical interface. In clinical biochemistry this means that medical practitioners will increasingly become metabolic medicine specialists working in areas such as diabetes, cardiovascular risk, nutrition, metabolic bone disease and inborn errors of metabolism. All the other staff working in laboratories will be included in the new group of healthcare scientists (HCS) for whom a career framework has been developed.¹⁷ A major project entitled Modernising Scientific Careers has been initiated to look at the roles to be undertaken by HCS and the competences and training required to undertake these roles. This will entail revision of education and training to the level of general registration and a range of post-registration training and support, including MRCPath, and the introduction of a higher level of registration, perhaps equivalent to the medical specialist register. Active workforce planning and development will be central to this process. The workforce of the future is likely to have a different skill mix and be more flexible than at present. Fewer people will be working in roles for which they are over qualified and it will be easier to develop specialists and clinical leaders to take on the future development of the service.

Work on IT connectivity continues and some excellent integrated systems exist at hospital trust and local level. However, England is still some way short of IT, integrated at national level, that will support an electronic patient record that includes the facility to order and receive pathology and laboratory medicine results from anywhere in the NHS. In anticipation of the availability of such an IT system work is ongoing on the harmonisation of minimum data sets, reference ranges and the creation of a national electronic handbook for laboratory medicine.

Pathology and laboratory medicine networks continue to develop in order to take advantage of economies of scale, modern technology and shared expertise and experience. At national level there are networks for screening services and for specialised laboratory services for all of the disciplines of pathology and laboratory medicine. National screening services are actively managed whilst most specialised laboratory services remain federated networks.

At local level more pathology and laboratory medicine networks are developing within and between hospital trusts. These networks assume differing shapes, sizes and management responsibilities. Few have yet approached the vision of the disseminated laboratory that is shown in Figure 1. In this vision there is a single management structure for a hub and spoke arrangement of laboratories and for extra-laboratory testing in clinics, theatres, primary care and elsewhere using POCT.

Figure 1.

Illustration of the hub and spoke or disseminated laboratory medicine network. Numbers 1 to 5 represent laboratories on different sites that share common equipment, reference ranges and quality management system. All laboratories provide a common core service and specialised laboratory services are rationalised in line with clinical services. Small black circles represent centres outside the laboratory where laboratory testing is performed using point of care testing.

The concept of ‘blood sciences’ is emerging as an operational entity that embraces the high volume, automated components of clinical biochemistry and haematology. For example, in one major London teaching hospital a blood sciences laboratory has been created across two large sites and an open tender process is being used to select the service providers. At the same time all of the specialised laboratory medicine services from these disciplines are being combined under a single management structure and quality management system. Managed service contracts are increasingly being used, in which varying laboratory repertoires, sometimes wider than blood sciences, are being managed at an operational level by one of the large diagnostic companies on behalf of the hospital trust. The managed service contract arrangement retains local clinical direction of the service and continues to use NHS employees to deliver the service. The benefit of the managed service contract to the supplier lies in contract continuity over a period that is normally 5–10 years. The advantages to the laboratory and to the hospital trust lie in new equipment that is upgraded throughout the contract, a transfer of risk to the supplier and, where possible, the saving of value added tax on consumables. Thus plurality of supply of laboratory medicine service is being achieved within the framework of the NHS.

There is growing realisation that pathology and laboratory medicine should be considered and perhaps managed alongside imaging and endoscopy as part of a wider diagnostic services provision. A growing number of hospital trusts now have a diagnostics directorate or division with responsibility for all of these services. Such an approach makes sense in terms of patient focused care and the patient journey. It is significant that mergers within the diagnostics industry have created Siemens Medical Solutions Diagnostics as a company that will supply both laboratory medicine and imaging services together with the software to integrate results for individual patients. Looking to the future it is possible to see merit in an integrated diagnostic approach to screening the healthy population, making diagnoses, targeting therapy and monitoring the response to treatment.

In Northern Ireland the 2006 consultation document¹² recommended the creation of a single managed network for pathology and laboratory medicine services across the province and significant change to the existing pattern of service delivery. Following consultation the recommendations for the future of pathology services in Northern Ireland were published in December 2007.¹³ The single managed pathology network has been retained and this will provide a national framework for service specification. The recommendations for service delivery are less radical than originally proposed with core services being provided in a fairly traditional manner from five NHS Trusts accompanied by a concentration of specialised services in Belfast.

In Wales the report on the future of laboratory medicine services will be published in early 2008. It is likely that this report will recommend a national framework for laboratory medicine with harmonisation of practice wherever possible. Core services will be delivered through a small number of managed networks whilst there is likely to be national consolidation of specialised and tertiary pathology and laboratory medicine services.

In Scotland the approach is similar to that being pursued in Northern Ireland and Wales. Laboratory medicine services are organised through actively managed networks in each of the 14 Health Boards. National managed networks already exist for molecular genetics, microbiology, histopathology and blood transfusion and these are likely to develop in the other laboratory medicine disciplines. Specialised laboratory services are funded in part by National Services Scotland and in part by Health Boards and a recommendation has been made for national oversight of all specialised laboratory medicine services. Within NHS Scotland a Diagnostics Steering Group oversees policy and practice for laboratory medicine services, imaging and endoscopy.

Experience in the author’s own laboratory illustrates the benefit of the managed pathology network model. In 2001 four clinical biochemistry laboratories in North Glasgow formed a single managed network. Procurement of common equipment led to the adoption of common IT, harmonised practice and common reference ranges. Rationalisation of specialised investigations, clinical services and reporting procedures occurred. A single pool of staff was created with training on all sites and the network laboratory gained accreditation under a single quality management system. Service quality and efficiency were significantly better in the network laboratory compared to individual laboratories. Despite an increase in workload of almost 40% in four years it proved possible to reduce staffing by ~15% through natural wastage. Buoyed by this success the network was extended in 2005 to cover six adult and one children’s hospital across the whole of NHS Greater Glasgow. A managed service contract was introduced with a single supplier to ensure common equipment, procedures and reference intervals across the city and to improve cost effectiveness still further. The current managed network laboratory undertakes almost 20 million tests per annum including much of the specialised clinical biochemistry for Scotland. The network is rationalising the number of sites providing 24/7 cover and agreeing a revised staffing profile and new ways of working. An initiative has commenced to facilitate best laboratory practice in primary care and there is an agreed policy for the use and management of POCT. Clinical biochemistry in NHS Greater Glasgow is approaching the model depicted in Figure 1.

During this period of modernisation an audit of laboratory medicine services in England was undertaken by the Healthcare Commission.¹⁸ The report, published in March 2007, paints a picture of an efficient and effective service that is valued by users as a core clinical service. The service is praised for coping with rising workloads, introducing more flexible working practices and shorter turnaround times. It is noted that in England only 8% of laboratories are in managed networks whereas approximately 50% are in federated networks. The report makes recommendations for further improvement that align well with the recommendations in the Carter report. These include:

• A requirement for standardisation in the measurement of activity and costs

• Using pathology networks to facilitate service development

• Agreed turnaround times that balance practicality with clinical need

• Rationalisation of non-urgent and specialised services

• Greater patient focus, including appropriate quality assured POCT

• Reduction in geographical differences in demand for laboratory services

• More rigour in assuring value for money

Conclusion

The large majority of pathology and laboratory medicine services in the UK occur within the NHS. These services are comprehensive covering both secondary and primary care and they feature a strong clinical and interpretive component. The past eight years has seen unprecedented change as pathology and laboratory medicine services seek to modernise in line with new technology, patient focused care, evidence based practice and the demand for greater cost effectiveness. The direction of travel appears to be for an accredited service with end to end IT connectivity delivered by a modern re-profiled workforce that is trained fit for purpose. Pathology and laboratory medicine networks are becoming the preferred model for service organisation and delivery and it is likely that actively managed networks will be most successful in securing long term improvements in quality, efficiency and cost effectiveness. This model is likely to be established throughout Northern Ireland, Scotland and Wales but may not be fully adopted across England. There is little enthusiasm for disaggregating the current joined-up provision of pathology and laboratory medicine services in the UK or for taking significant elements of it outside the NHS. The next five years requires further modernisation if the vision is to be translated into reality but the way forward has clarified.