Laboratory medicine in the United Kingdom: 1948–1998 and beyond

Clinica Chimica Acta 290 (1999) 5–36 www.elsevier.com / locate / clinchim

Laboratory medicine in the United Kingdom: 1948–1998 and beyond a, b Christopher P. Price *, Ian C. Barnes a

Department of Clinical Biochemistry, St Bartholomew’ s and the Royal London School of Medicine and Dentistry, Turner Street, London E1 2 AD, UK b Department of Chemical Pathology, Leeds Teaching Hospitals, Leeds General Infirmary, Leeds LS1 3 EX, UK

Abstract The National Health Service in the United Kingdom was created in 1948, effectively becoming the main provider of healthcare and funded by the government from taxation. By the late 1970’s, and despite many achievements, it was seen to be approaching a financial crisis. Radical reforms were introduced in the early 1990’s bringing in general management, a split between purchaser and provider, and competition. Whilst there has been a change of government more recently several of these initiatives have been retained, with the exception of competition (the internal market) which has been abandoned. There is now a much greater focus on the quality of care with increased clinical and financial accountability. Laboratory medicine (generally termed pathology in the United Kingdom) has evolved to meet the demands of more patients, reducing turnaround times, a greater repertoire of investigations and a continuing improvement in productivity. There is an increasing focus on improved dialogue between the laboratory and the clinician covering interpretation of results, audit of services and outcomes, research and development and continuous education in the pursuit of a high quality service. The major challenges for the future focus on alternative modes of delivery, on issues relating to staffing and on quality of service, in the face of an ever increasing demand.  1999 Elsevier Science B.V. All rights reserved.

1. Background The first patients were treated in the National Health Service (NHS) on July 5th 1948, the culmination of a dream by the Labour Health Minister Aneurin *Corresponding author. 0009-8981 / 99 / $ – see front matter  1999 Elsevier Science B.V. All rights reserved. PII: S0009-8981( 99 )00175-8

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Bevan. He sought to create a single provider of healthcare for the whole of the United Kingdom accessible to all, irrespective of individual circumstances. The basic concept was an integrated provider system embracing what today would be called primary, secondary and tertiary care, centrally controlled and directed by the Department of Health and funded by government from tax revenue. The allocation of resources to healthcare providers (e.g., primary care physicians and hospitals) became the responsibility of regional and subregional authorities. There were several organisational changes over the years involving the number of tiers of management at central and local levels. The basic concept of free healthcare for all, from a single provider, obviated the need for contracting and billing between purchasers and providers. The free availability of services at the outset extended to pharmaceuticals, dental and eye care although that is no longer the case today. Effectively, the creation of the NHS nationalised the hospitals, doctors and dentists with the government paying for virtually all health care [1].

1.1. Organisation The service provision to the patient was (and remains) through contact at the primary care level with the general practitioner (except obviously in the case of accident and emergency services). An individual is registered with a general practitioner (or group practice) who is responsible for the referral of a patient to a hospital consultant (or specialist) if required. The individual is effectively limited in his / her choice of general practitioner and the hospital consultant is identified by the general practitioner depending on the specialist expertise required.

1.1.1. Location The general practitioners facilities vary from individual consulting rooms (referred to as ‘surgeries’) to health centres from which several doctors may work, and which can include facilities for consultations by other healthcare professionals, e.g., nurses, physiotherapists, counsellors, as well as for minor surgery. Typically a general practitioner has responsibility for between two and three thousand members of the population. At the inception of the NHS, hospital facilities varied from small cottage hospitals offering basic accident and emergency care, together with general medical and surgical services in smaller communities, to very large hospitals, often teaching hospitals, located in the big cities. In the bigger cities, there were often specialist hospitals dealing with particular diseases, e.g., children, eye, gastrointestinal, cardiothoracic, orthopaedic, etc. In recent times there has been a programme of rationalisation as the cost of hospital stay continues to rise. The current trend is toward rationalisation of specialist services into larger hospitals

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ensuring accessibility of basic services to all of the population with typically, in an urban area, one hospital serving a population of between 200 000 and 300 000 people.

1.1.2. Private healthcare There is a private healthcare sector and here there is individual choice of specialist on the part of the patient, although this has to be through referral by a general practitioner or another specialist. The specialists working in the private sector, in the main, also work in the public sector. The predominant reasons for choosing a consultant specialist in the private sector are shorter waiting time, choice of specialist and superior (hotel) facilities. A patient is billed for all services received in the private sector, although the costs are invariably covered by an insurance policy subscribed to either by the individual or his / her employer. 1.1.3. Statistics and resources In 1997 / 98 the total amount of money committed by the government to healthcare amounted to £36 billion. In 1996 when the last full set of statistics were available, the proportion of gross domestic product (GDP) spent on healthcare was 6.9 per cent compared with a figure of 5.9 per cent in 1986 [2]. Comparison with other countries is illustrated in Fig. 1 [2]; a more comparable statistic is the amount of money spent per member of the population and this data for 1986 and 1996 is shown in Fig. 2. The data on the expenditure per member of the population in the UK shows an increase from £37 in 1969 to £889 in 1997 [2]. Comparisons with other countries might be regarded as a crude form of benchmarking but it provides a valuable challenge to perceptions at a time of great change; these questions are being asked in relation to funding within the United Kingdom [3]. The OECD Health 98 database [2] shows that the UK has 1.7 doctors per 1000 population, one of the lowest proportions amongst developed countries. Analysis of the trend in the number of beds shows a fall from 7.2 to 4.5 beds per 1000 population over the period 1986–96. The trend in bed availability is reflected in a 35 per cent reduction in the average length of stay from 15.2 to 9.8 days; this data is summarised in comparison with that from some other developed countries in Figs. 3 and 4 [2]. Data reported in a recent newspaper article indicated a fall in the total number of hospital beds in the UK over the 1987 / 8 to 1997 / 8 period from 360 000 to 194 000; despite this reduction there was an increase in the number of patients treated from 8.2 to 11.5 million. 1.1.4. Outcomes It may not be surprising that there is a relatively limited variation between Western countries in the mortality data due to all causes [2] (Fig. 5) but it is

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Fig. 1. Comparative data on the proportion of GDP spent on healthcare in the years 1986 1996 j for several countries including the UK [2].

and

more difficult to make a robust assessment of value for money and effectiveness when comparing differences in expenditure with outcome measures. At the time of the 50th anniversary of the National Health Service last year, the NHS Executive published data to indicate some of the changes in the incidence of disease over the past five decades. A comparison of causes of death over that period for a group of diseases shows interesting trends (Fig. 6); some of the categories where the disease incidences have fallen to a low level mean that they may have been included for 1998 in the ‘other causes’ category. In this same time period, the average life expectancy for males has risen from 66.4 to 74.2 years and 71.2 to 79.4 years for females [4].

1.2. Laboratory services Over the past 50 years the laboratory medicine services (commonly termed pathology) have developed from a single laboratory directed by a general pathologist to comprise up to seven main disciplines, with specialisation by the

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Fig. 2. Comparative data on the amount of resources spent on healthcare per capita in the years 1986 and 1996 j for several countries including the UK [2].

medical, scientific and technical staff within pathology. The disciplines include clinical biochemistry, genetics, haematology, histopathology, immunology, microbiology and virology. The range of services has depended in part on the size of the hospital and the population served, together with the laboratory workload. The more specialised services have tended to be provided by university (teaching) hospital-based laboratories, often provided on a regional or national basis. All services have been provided until recently by laboratories located in hospital premises — including services to general practitioners.

1.2.1. Laboratories and funding There are about 400 NHS laboratories providing the core services with workloads ranging from 100 to 6000 specimens per weekday (a specimen in this context being a single sample sent to one discipline, albeit possibly for several tests). The estimated costs of the NHS providers of pathology services in 1997 / 98 was £1006 million, based on projection of data from the NHS Annual Accounts for the period from 1990 / 1 to 1993 / 4. In 1995 the NHS Executive

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Fig. 3. Comparative data on the number of hospital beds per 1000 population in the years 1986 and 1996 j for several countries including the UK [2].

report ‘Strategic Review of Pathology Services’ (Secton 4.1.2) estimated that the expenditure on pathology in 1992 / 3 was £630 million or 3.5% of NHS expenditure [5]. Laboratory services vary in their organisation and funding throughout the world. However, in the spirit of benchmarking, it is interesting to compare the spending on diagnostic services in different countries. One comparator that has been available for several years is the data on spending on in vitro diagnostics gathered by the European Diagnostics Manufacturers Association. Data for the year 1996 is shown in Fig. 7. Prior to 1990, the funding of pathology services was largely determined on an historical basis. The annual budget allocation for health was negotiated by the Minister of State for Health and dispersed through a regional and local structure of health authorities. The pathology element of this budget was embedded in the local budget allocation to the hospital sector and accountability was vested in the hospital management structure. Little attention (by modern standards) was paid to the workload, changes in technology or pattern of requests, etc. and budget adjustments were negotiated annually on the basis of local needs and pressures.

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Fig. 4. Comparative data on the average length of hospital stay in the years 1986 for several countries including the UK [2].

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and 1996 j

1.2.2. Specialist services One unique feature of the UK laboratory service provision was the establishment in 1974 of the Supraregional Assay Services (SAS) [6]. The SAS services in pathology were established with direct ‘top sliced’ funding to support the research of new methods (markers rather than technology), provision of an analytical and interpretive service for these methods and their subsequent dissemination into routine, local use as technology, knowledge, expertise and clinical requirement spread. Examples of the SAS analytes introduced were parathyroid hormone, vitamin D metabolites, specialist steroids, tumour markers, specific proteins and white cell enzymes. In addition to the SAS services there were national screening programmes established for phenylketonuria, hypothyroidism and cytology screening, under the guidance of a government National Screening Committee [7]. These services are still in existence but laboratories are not obliged to refer specimens (except in the case of screening programmes), and technology advances have enabled many previously designated SAS tests to be performed locally.

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Fig. 5. Comparative mortality data in the year 1994 for several countries including the UK [2].

1.2.3. Staffing There are three professions employed in NHS pathology laboratories: (i) pathologists, who are medically qualified specialists often with research degrees, whose responsibilities include direction of the service, interpretation of results, audit and development of services and, increasingly, direct patient care; (ii) clinical scientists who are scientifically qualified, often with a higher research degree, who specialise and whose responsibilities include direction of the service, interpretation of results, research and development and audit of services. As pathologists become more involved in direct patient care, the role of the clinical scientist at the ‘clinical interface’ is increasing. The most senior grade of clinical scientist is deemed to be equivalent to that of the (consultant) pathologist; (iii) medical laboratory scientific officers who are also scientifically qualified, although more often with a specialist vocational degree and whose responsibilities are technologically orientated toward the delivery of the analytical service, together with its routine management. More recently a new staffing grade has been introduced, the medical laboratory assistant, who

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Fig. 6. Comparative data on the distribution of the main causes of death in the UK for 1948 and 1994 j. The total number of deaths in 1948 was 469 898 and in 1994 it was 553 194. There has been some change in categories over the years but the overall picture remains the same in these groups. * The number of deaths has decreased significantly and cases will be included in ‘other causes’ for 1994.

undertakes duties such as specimen reception and loading of analysers under supervision. There has been a trend for pathologists to specialise in one discipline; in 1982 there were 205 general pathologists with this number falling to 25 in 1992 [8]. The trend has been similar for medical laboratory scientific officers up until the mid 1990’s, when the trend began to reverse with the establishment of ‘combined discipline laboratories’ — primarily with combination of clinical biochemistry and haematology laboratories. Clinical scientists have always been employed as specialists in a single discipline — primarily in clinical biochemistry, genetics and cytogenetics, microbiology and virology and to a lesser extent in haematology and immunology. The training of pathologists and clinical scientists is documented elsewhere and broadly follows the template for training of all medical and scientific staff [9]. The Royal College of Pathologists is committed to single speciality training

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Fig. 7. Comparative data for the spending on in vitro diagnostics in the year 1996 for several countries including the UK, expressed as pounds sterling per capita.

for pathologists and clinical scientists. This is emphasised in a recent report on staffing of multidisciplinary laboratories which points to the transferability of certain technical skills whilst emphasising the specialist knowledge base required by pathologists and clinical scientists [10].

1.2.4. Private sector It was indicated earlier that an individual may choose to seek medical care through the private healthcare system. This comprises about 200 private general practitioners and 1300 consultants working in individual consulting rooms, and approximately 240 private hospitals mostly offering general health care with some degree of specialisation. There are also private facilities within many NHS hospitals, with the income split between the hospital and the consultant. A report from the Monopolies and Mergers Commission in 1994 suggested that 74% of 23 100 consultants were engaged in private practice in 1992. The pathology service support for this private sector is provided by either independent laboratories, in-house private laboratories, or NHS laboratories. The

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profile of the private pathology laboratory organisations increased in the early 1990s with the introduction of the competitive market into healthcare provision (see discussion in Section 2.2.1) and whilst that influence still pertains there has been little development in this sector in more recent years, and it has remained at less than 15% of the total pathology service.

2. Changes in healthcare 1990–1997 The Conservative Government that came to power in 1989 embarked on a radical reform of the NHS beginning at the top with the separating of policymaking from management at national level and the creation of the NHS Executive. The reforms were designed to create more accountability within the service [11]. A key element of the reforms was that the money effectively allocated for the healthcare of an individual should be spent where the patient was treated — the concept of ‘money following the patient’. There was also an expressed intention to shift more responsibility for healthcare provision into the primary care sector and also to involve the private sector.

2.1. The health reforms 2.1.1. Purchaser /provider A key feature of the reforms was the separation of the purchaser of healthcare from the provider. A purchasing organisation was created (primarily from the tier of management above the hospital level) with the responsibility for purchasing services for the local population, to whom it was accountable. The funds to purchase services were provided from central government, as in the past, with the total sum based on a capitation allowance modified to take account of the type of population served (e.g. elderly, deprived, etc). Initially purchasing authorities were responsible for populations varying from 150 000 to 400 000 but there was subsequent consolidation with some of these authorities now covering populations up to 750 000. The provision of services became the responsibility of general practitioners in the primary care sector with self-governing organisations called Trusts providing secondary and tertiary care. The trusts were often split into providers of community and hospital-based services. 2.1.2. General practitioners The general practitioners were able to continue as direct contractors to the purchasing authority but the concept of independent fundholding was introduced [12]. Initially it was intended that fundholding was limited to general practices covering more than 11 000 patients (i.e. registered members of the local

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population) although this figure was subsequently lowered to 7000. The concept was that the fundholding practices would receive the full allocation of funds for their patients (rather than the primary care element as had been the case before the reforms). The fundholding general practitioners then had greater freedom to organise the services as they saw fit, in particular any services they wished to provide directly (e.g., minor surgery) and from which community and hospital trust they obtained care for their patients. In practice this meant that general practitioners could contract with hospital trusts that had shorter waiting lists, whose prices were cheaper or whose outcome statistics were better. In the case of non-fundholding general practitioners, services would be purchased for them as a block contract from a single provider, but again with the same objectives in mind, quality and value for money. In the context of pathology services, the fundholding general practitioner was able to choose from whom he / she purchased services and, in this way, was able to dictate the type of services required. Experience has shown that this strategy has improved the services provided to the primary care sector and combined with other strategies, e.g., information technology, transport, etc., has ensured that the general practitioner receives a much better service. The creation of fundholding was an illustration of one of the key philosophies of the reforms, namely that competition between providers would improve quality and value for money.

2.1.3. Trusts Hospital and community trusts were created as providers of secondary and tertiary services, operating on a strict contractual basis to the purchasing authorities. Initially the hospital and community services were kept strictly apart — often against logic and professional advice — although latterly mergers did take place. Typically in a rural area the purchaser would obtain all of its services from the local hospital and community trusts. However, in the bigger towns and cities there was an opportunity to contract with alternative providers; in addition there were specialist hospital trusts (e.g. cardiothoracic, eye, children services) who would provide services to a wider geographical range of purchasers. In parallel with the creation of trusts, there was a gradual move to rationalise provider services into a smaller number of trusts. The most spectacular examples of this rationalisation were the mergers of teaching hospitals in London, e.g., St Bartholomew’s and the Royal London, University College and the Middlesex, Kings, Guy’s and St Thomas’s and Charing Cross, Westminster, St Marys and the Royal Postgraduate Medical School. Latterly there have been mergers of community and hospital trusts, and more as a result of cost pressures (although also perhaps a recognition that competition was not working) there have been mergers between some major hospital trusts, e.g. the General Infirmary and St James in Leeds.

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Trusts are legal entities governed by a board of directors and led by a chairman appointed by the Minister of State for Health. Trusts are non-profit organisations providing services under contract to purchasers, with both purchasers and providers accountable to the NHS Executive through Regional Offices. All hospital trusts include pathology within their range of services; they may also act as purchasers of pathology services, e.g., in the case of specialist tests.

2.1.4. Supraregional services Whilst the majority of healthcare was purchased from local providers there were a few specialist clinical services, e.g. transplantation, that continued to be provided nationally (supraregional services). Whilst it became obvious that there was a reluctance to maintain national purchasing, it was clear that there were good clinical, as well as economic, reasons for doing so, with the maintenance of national centres of excellence. However, it also became evident in the mid 1990’s that there was an inequality of access to certain services and the Chief Medical Officer at the time, Sir Kenneth Calman, instigated a review of cancer services. The outcome of this review was the development of designated regional cancer centres linked to local providers in a hub and spoke arrangement [13] in such a way that every member of the population has equal access to specialist cancer care. It is envisaged that this arrangement will be extended to cover other services. 2.2. Government initiatives In addition to the major reforms the government embarked on a series of initiatives which had a major impact on the health service, including pathology.

2.2.1. Market testing The search for improved quality and value for money through competition led to the introduction of market testing in the late 1980s. The basic philosophy was that competition resulted in a better service; in practical terms it involved the preparation of a specification of services and then an invitation to suppliers to tender for services. This enabled private sector organisations to become involved in the provision of a public service. This was seen from a political standpoint as an attempt to ‘privatise the NHS’, ultimately leading to the abandonment of the Bevan vision of 1948. An apolitical view was that it was an attempt to bring private money into the public sector as well as introducing private sector business practices into a public sector organisation that had lacked any apparent financial accountability. Market testing became common practice for nonclinical support services, e.g. cleaning, catering, portering, estates management. Typically a contract was

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awarded for 3 to 5 years and then the service retested. A significant proportion of contracts went to in-house bidders, i.e. hospital staff. At one stage there was an intention to extend market testing to clinical services, and indeed private hospitals did receive some contracts to undertake NHS work [14,15]. It was seen that pathology might be the initial development with respect to clinical services and some market testing took place. However, there were only three locations where a private sector organisation was contracted to undertake the provision of pathology services. There have been a few examples of the local trust entering into some form of partnership in which the private sector has invested financial resources and management expertise in a form of joint venture.

2.2.2. Private Finance Initiative ( PFI) The PFI was a government-sponsored initiative designed to bring private sector capital (and methods) into public sector services, and which was closely linked to market testing [16]. It was not limited to healthcare and has been prominent in the education and housing sectors. In summary, any public sector project requiring investment of more than one million pounds was, in effect, required to go out to private tender. Effectively, any capital building programme had to be offered to the private sector. Thus, for example any hospital trust requiring new buildings, was required to prepare a business case setting out the requirement and an invitation to tender. Private consortia could then tender to construct the building. The return on investment was expected to come from the lease of the building back to the Trust, together with the provision of any services to the trust that were included in the invitation to tender (e.g. maintenance, cleaning, catering, portering, etc.). The contract for the leasing of the building was for an extended period, typically 25 years, and then the ownership reverted back to the NHS. The healthcare provider (a hospital Trust in the illustration above) remained responsible for the overall provision of services and monitored the provision of support services contracted to the private sector consortium. In establishing a PFI contract the Trust was required to demonstrate value for money against a public sector comparator, i.e. the private sector option must not cost more than the public sector alternative [17,18]. The NHS Executive set up a PFI panel to review all PFI projects in the NHS. 2.2.3. Management and contracting An inherent feature of the purchaser provider split was the need to establish a contractual relationship between the two, together with a more accountable management framework in order that a trust could meet its obligations. It is beyond the scope of this article to discuss the benefits and pitfalls of the introduction of contracting and a greater commitment to management. However, in the context of pathology services, it has provided a potential framework for a

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more rational approach to the allocation of resources — although in truth the benefits have yet to be realised. At least it has engendered more transparency in accounting for the workload increases seen year on year; in itself however this has been a double-edged sword when seen in the light of papers questioning the use of pathology services [19,20]. The reforms undoubtedly had an impact on management costs with claims of huge resources diverted away from patient care into management. There is no doubt that senior members of many of the professions became managers — some losing sight of the vocation for which they were originally trained! In more recent years there have been attempts to reduce management costs as part of annual efficiency targets imposed on providers by the NHS Executive.

2.2.4. Patient’ s Charter In an attempt to bring accountability closer to the patient, the government established a Patient’s Charter in 1996 [21]. The Charter dealt with a variety of performance issues, including waiting time for the initial appointment to see a specialist, waiting time for a surgical procedure, time spent in outpatients clinic prior to being seen and delay between admission through accident and emergency to being treated. In addition the Charter established a range of quality issues. Failure to meet standards inherent in the Charter, particularly with respect to delays in outpatient appointments and in-patient admissions, could result in financial penalties imposed by purchasers. 2.2.5. Research and development In 1991 the NHS Executive established a Research and Development Directorate to provide some national direction to healthcare related research and with the intention of committing 1.5 per cent of the total healthcare spend to research and development; the first director was Professor Sir Michael Peckham. This provided an opportunity to establish a dialogue between the NHS and the traditional research grant-giving bodies, e.g. the Medical Research Council, the Wellcome Trust and other charities, in relation to a strategic view of basic research, as well as establishing a strategy for health services related research. An important philosophy espoused by the initiative was that research and development could and should be practised by all healthcare professionals as part of the drive for continuous improvement and life-long learning [22]. The establishment of a research and development programme was a key driver in embracing the culture of evidence-based medicine because it provided a more obvious focus for a variety of initiatives in the field of health services ´ into the policy making research which had previously lacked the obvious entree machinery of government. One of the key elements of the initiative was a health technology assessment programme directed by a Standing Group on Health Technology Assessment.

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The Standing Group is advised by six panels, including one devoted to diagnostics and imaging. An annual consultation exercise helps to establish an ongoing programme of primary and secondary research designed to inform decision-making on the implementation of health technology [23]. After prioritisation, the projects are commissioned in a bidding process with peer review analogous to other research grant funding organisations. The results are widely published with summaries disseminated to purchasers as well as provider organisations.

3. Changes in healthcare since 1997 The Labour Party in their manifesto for the 1997 elections promised to restore the NHS to its former glory claiming that the previous reforms had created inequalities and wasted precious resources on increased tiers of management. Following the election, the Labour Government set out with the mandate to change the NHS, in their words ‘‘to modernise it for the next fifty years’’. A definitive perspective on healthcare provision was presented in a White Paper entitled ‘Our Healthier Nation’ [24], and a ten year modernisation programme has been outlined in two major policy documents, ‘The New NHS: Modern and Dependable’ [25] and ‘A First Class Service: Quality in the New NHS’ [26]. These policy documents have led to a large number of implementation documents coming from the NHS Executive during the past year (including Refs. [26–30]). The programme aims to put quality at the top of the agenda, with clear national standards, a system of integrated care based on partnership between the government and clinical professions, and driven by performance. The key elements of this quality strategy are reproduced in Fig. 8 [26]. In many ways the new agenda builds on initiatives set in place by the previous administration, but with the abolition of competition between providers; thus the internal market created by the previous government has been abolished and it is claimed that this will cut £1 billion of administration and management costs. The split between purchasers and providers will remain, but the terminology will be replaced by ‘the separation between planning and providing services’. For the first time, there will be joint working between Health Authorities and Local Authorities so that the NHS works locally with those who provide social care, housing, education and employment. Examples of the new developments are the creation of a 24-h telephone advice line staffed by nurses (NHS Direct) which will be available for the whole population by 2000, the connection of every GP health centre and hospital to the NHS information network by 2002, and a guarantee that everyone with suspected cancer will be able to see a specialist within two weeks of a GP

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Fig. 8. The key elements of the NHS quality strategy.

referral. The hotline is seen by some as an opportunity for telephone triageing which will alter workloads dramatically, and as a means of managing demand in primary care [31]. However, early experience of this service, as evidenced by a study of the use of telephone triage protocols in paediatrics, indicated concerns about the consistency of performance amongst operators with the recommendation that strategies must be thoroughly validated prior to implementation [32].

3.1. National standards and guidelines The government has proposed the development of National Service Frameworks [29] to ensure consistent access to services — an example is the development of an initiative for cancer services [13] and quality of care across the country.

3.2. National Institute for Clinical Excellence This Institute which is currently being established will give a strong lead on clinical and cost effectiveness drawing on new guidelines developed from the best evidence available. The establishment of this initiative will give additional support to the culture of evidence-based practice embodied within the health technology assessment programme and the implementation of clinical guidelines [33]. This will cover both diagnostic and intervention procedures, technologies and drugs. The commitment to clinical excellence will also be seen in the establishment of clinical effectiveness groups within all provider units and will contribute to the wider commitment to quality embodied in clinical governance

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[34]. There have been early critical comments about the creation of the Institute and its objectives, in part concerned with the burden of work associated with producing guidelines but more so the challenge of implementing guidelines and ensuring they are used consistently [35].

3.3. Clinical governance The NHS Executive discussion document ‘A First Class Service: Quality in the New NHS’ gives a working definition of clinical governance as ‘‘a framework through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’’. The elements of clinical governance are identified in Table 1 [33,36].

3.4. Primary-care-led service It is intended that the shape of services in the future will be determined by teams of local general practitioners and community nurses working in Primary Care Groups (PCGs). The PCGs will be the new purchasers of services [37] and will be responsible for commissioning of services for the local community. Typically a PCG will be responsible for about 100 000 people. A PCG will define standards and develop service level agreements with provider units (Trusts). However, the freedom to purchase services from outside the local environment will not be possible [38,39]. Managing demand will be an important feature of the PCG practice [40,41].

3.5. Commission for Health Improvement This initiative is designed to support and oversee the quality of clinical services provided. It will provide independent assurance that local systems Table 1 The key elements of clinical governance Clinical audit Quality Evidence-based practice Clinical risk reduction Identifying and building on good practice, ideas and innovation Professional development programmes Assessing and minimising risk of untoward events Learning lessons from complaints Identifying and tackling poor performance High standards of record keeping

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designed to maintain and improve quality are in place and working effectively [30].

3.6. Information strategy It has been recognised that information is central to improved management of resources. It is intended that the benchmarking initiative will be expanded with a national schedule of reference costs itemising the resources required for individual treatments with individual trusts publishing their figures on the same basis. It is intended also to publish information on outcomes from each trust. The new NHS information strategy ‘Information for Health’ [42] is very ambitious with an emphasis on putting information to work for patients and staff [43]. It is based firmly on a philosophy of clinically driven information provision and has a goal of developing a national system of electronic health records by 2005.

4. Focus on laboratory medicine

4.1. Background The pattern of change over the past five decades has seen a vast increase in the repertoire of tests available with an ever growing workload, together with an increasing level of specialisation from what was originally a single general pathology laboratory to a number of specialist laboratories. In addition the Public Health Laboratory Service was established at about the time of the creation of the NHS with the express purpose of protecting the public against infection. It provides a network of laboratories across the country dealing with diagnosis, epidemiology and control of infections. This includes the provision of specialist assays as well as testing undertaken on food and water in addition to biological samples. It also provides the microbiology and virology services for some trusts; in addition it provides a network of more specialist services across the country. The trend in workload over the past two decades is illustrated in Table 2. The proportion of requests for each of the major specialities is illustrated for the year 1993 / 4 in Table 3. The continuing rise in workload and costs, together with changes in government policy in the early 1990’s, led to a variety of initiatives of a general nature which have been referred to earlier and two of which were directly related to pathology. There is no doubt that the last decade has seen fairly radical changes in the NHS which have had an impact on pathology. The more recent change of government whilst continuing several of the initiatives established by the previous government has led to an expectation of further change, yet to be seen.

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Table 2 Data on workload received by laboratories in England over the years 1989 / 90 to 1993 / 94 obtained from the Department of Health KH II returns a Year

Total requests ( 3 10 6 )

Requests per 100 000 population ( 3 10 3 )

1989 / 90 1990 / 91 1991 / 92 1992 / 93 1993 / 94

82.41 84.34 87.10 90.08 95.32

172.8 176.3 181.2 186.2 196.4

a

These are the only years for which data was collected in this way

4.1.1. Audit Commission The Audit Commission (a government-funded agency with a remit to audit all public services) undertook two reviews of pathology, the latter a more fundamental review being published in 1993 [44]. The audit involved gathering information on workload, staffing levels and budgets together with interviews with laboratory, clinical and management staff. The report recognised that the ‘analytical and interpretative’ quality of the services was good, albeit communication between the pathologist and the clinician could be improved. It also observed that information technology and specimen transport were inadequate, recognising that this was often due to these services not being under the direct control of laboratory staff. It also claimed that pathology staff were slow to change working practices and staff skill mix in response to changes in technology. The report, importantly, recognised that the audit had concentrated primarily on the analytical element of the service. It concluded with what many regarded as a bizarre and damaging observation, that if all laboratories in the United Kingdom brought their costs to within the lowest quartile the NHS could save £40 million per annum! It had always been recognised that the quality of information throughout the NHS was poor and thus this statement was not given Table 3 Data on the workload received by laboratories in England according to speciality, obtained from the KH II returns to the Department of Health 1993 / 94 Speciality

Requests ( 3 10 6 )

Proportion (%)

Clinical biochemistry Haematology Histopathology (and cytology) Immunology Microbiology (and virology) Cytogenetics

33.69 32.39 7.33 1.19 20.63 0.08

35.3 34.0 7.7 1.3 21.6 0.1

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much credibility by laboratory professionals. It is also questionable whether this fundamental premise was tenable in terms of economic theory. On the other hand the report did recognise that there was significant over-capacity in most laboratories, that many were undertaking a small number of certain individual tests, and that rationalisation would save money. Whilst these latter observations were acknowledged it was recognised that they cut across two government philosophies at the time: (a) the creation of competition to improve quality; and (b) the devolution of all decision making to a local level — both of these potentially destroying the collaboration that had previously existed, a factor which the commission tacitly criticised in their proposals.

4.1.2. Strategic Review of Pathology Services Subsequently, and in part armed with the Audit Commission report, the (previous) government embarked on a strategic review of pathology services [5]. This was heralded as a review to promote ideas on alternative approaches to the delivery of services, and in the context of the philosophies of market testing and the Private Finance Initiative, was seen as seeking to involve the private sector. Individual committees worked on issues relating to: (i) quality standards; (ii) alternative means of delivering services; and (iii) staffing issues. One of the major outcomes of the review was a definition of the pathology (laboratory medicine) service which recognised that the service embraced more than analysis (Table 4). The review recognised the complexity of the service, the close integration with clinical practice and the difficulties associated with the provision of specialist laboratory services. In addition, it emphasised the Table 4 Elements of a pathology service identified in the Strategic Review of Pathology Services [5] Operation

— — — — —

Advice on selection of appropriate investigations High quality laboratory service Selection of suppliers Interpretation of results Ensure quality of results

Training

— —

Provide training and continuing education of staff Provide training and continuing education of users

Management

— —

Create and maintain effective management structures Manage and treat patients

Audit

— —

Contract negotiation and monitoring Participate in clinical audit

Other services

— — — —

Phlebotomy Control of infection Blood products provision Autopsy and mortuary services

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importance of participation in external quality assurance schemes, the involvement of the laboratory in point-of-care testing, the importance of accreditation — both of staff and laboratories and the value of training and continuing education.

4.1.3. Laboratory accreditation The Department of Health embarked on a pilot scheme for laboratory accreditation with the Trent Region as part of the latter’s audit programme in 1990. The project involved the definition of standards (Table 5) and a mechanism for inspection and assessment. After two pilot schemes that tested and refined the initial approach, a company was set up to run an accreditation scheme, Clinical Pathology Accreditation [CPA (UK)], in which the major shareholders were the main professional bodies involved in the delivery of pathology services. The scheme has been recognised by the Department of Health with the recommendation that trusts should only purchase services from accredited laboratories [45]. Subsequently, with the devolution of the management of external quality assurance schemes, CPA (UK) has taken on the responsibility for accrediting these schemes. 4.1.4. Benchmarking In the past few years a variety of benchmarking activities have been set up in order to compare practice across trusts [46]. This includes an exercise in pathology run by Professor Dyson of Keele University in collaboration with the professional bodies involved in pathology. It involves collection of data on workload, staffing levels, and budgetary information. In addition there are questions directed at patterns of requesting and working practices. The data is presented in tabular and graphic forms with responders split into groups based on the size of the laboratory or hospital with the individual responder identified together with mean and median values for the group. Some of the most helpful data in terms of assessing value for money is based on the productivity of staff and the costs of individual tests. It is recognised that this is a complex subject and there are concerns about variations in the way that data is collected. Table 5 The major categories of standards embodied in laboratory accreditation Organisation and administration Staffing and direction Facilities and equipment Policies and procedures Staff development and education Evaluation of performance

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However, there are annual meetings to discuss the results and plan the next year’s events, and responders within a group are encouraged to meet and to share experiences. The question remains whether benchmarking of laboratory services will become mandatory as part of the reference cost initiative.

4.2. Drivers for change There are several factors that are already recognised as driving the need for change.

4.2.1. Trust mergers There is no doubt that mergers will occur between trusts in the larger conurbations. The ideal model of provision at the present time is one hospital serving a population of 250 000 to 300 000 and incorporating specialist services as appropriate to the region. 4.2.2. Technology Automation has had a major impact on pathology, particularly in clinical biochemistry and haematology. In the last decade, the availability of automated immunoassay systems has improved the overall analytical performance of many assays and has radically altered the turnaround time for results. This benefit will increasingly be seen in immunology and virology over the next few years. Developments in image analysis and recognition have led to developments in the automation of cytology screening and this will have a major impact over the next decade. At the same time developments in point-of-care testing systems have enabled more testing to be undertaken at the bedside, in the clinic or the home. However, there has been only a limited impact of this technology outside the hospital environment and little evidence of such systems being bought ‘over the counter’ [47]. An important area of technological innovation that has advanced dramatically is communication. Improvements in vacuum tube delivery systems has reawakened interest in their use for specimen delivery, and the integration of hospital and laboratory information systems has meant more efficient delivery of results. Telepathology developments will in the future mean that interpretation of histopathological slides can be undertaken at a distance from the processing laboratory [48]. As a generator and repository of clinical information, pathology will be a major player in the new NHS information strategy. At present approximately 30% of all laboratories deliver results electronically to clinical users. By 2001 all primary care practitioners will be connected to the private, secure NHSNet and all laboratories will be equipped to deliver results in this way using UN-

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EDIFACT protocols. It is then expected that by 2003 intelligent, electronic test-ordering systems will be installed, providing laboratories with a potent means of applying evidence-based controls on work flow [43].

4.2.3. Cost Reference has already been made to the increasing level of resource allocation both in pathology as well as the NHS overall. The last five years have seen an annual cost improvement target of between 1 and 3 per cent applied to all provider units, which includes pathology. The observations of the Audit Commission have also no doubt been taken into account. In addition many trusts have sought to reduce their pathology costs, often regardless of changes in workload; in some situations this has also led to pressures to reduce estate and equipment requirements. 4.2.4. Recruitment and retention of staff This is now a major problem for all of the professions but is particularly acute for technical staff and in the bigger cities, e.g. London. It is thought to be due to a combination of factors, but primarily remuneration and workload. The productivity in laboratories has risen by over 50 per cent in the last decade, an observation that cannot be attributed to automation alone because it is applicable to all pathology disciplines. 4.2.5. Clinical service changes There are several changes in ward and clinic practice that are influencing demands on the laboratory. In particular the reduction in the hours of employment of junior doctors, and the greater commitment to recognise that junior doctors are in training, has meant that the turnaround time for results has decreased significantly. This has been exacerbated by the commitment to reducing bed stay times as a result of the reduction in the number of beds. In addition the commitment to a more patient-focused approach to care has resulted in a demand for more rapid delivery of results in order that the patient can be treated more quickly (related in part to Patient Charter standards). The focus on more rapid turnaround (of results and patients) has put pressure on all staff. 4.2.6. Quality issues Reference has already been made to the introduction of clinical governance although the issues of quality were highlighted in the previous health reforms with the introduction of clinical audit initiatives [49,50]. The greater emphasis on benchmarking of outcomes, requirements of accreditation, as well as the recent commitment to regular revalidation of competence of staff will all have an impact on the role of the pathology services [51].

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4.3. Impact on pathology Many of the changes and initiatives previously outlined are seen to be having an impact on the pathology services both now and in the future. Radical health reforms in the early 1990s which altered the established pattern of evolution in the NHS over the previous 40 years and the subsequent changes resulting from the change in government in 1997 are all seen to be contributing to a decade of major change which will continue into the new millennium. Whilst the last decade has seen considerable change it is likely that the delivery of pathology in the next decade will encompass even more rapid evolution.

4.3.1. Consolidation of laboratories There has been consolidation of hospitals over the past decade, particularly with the transfer of services from smaller hospitals into bigger units in the major towns and cities; there have been good clinical and economic reasons for this. The perception that competition did not work, and was in fact divisive, has meant that more consolidations are planned, in parallel with a promotion of partnership along the lines of the hub and spoke arrangements for cancer services. These consolidations have included the integration of previously small laboratories into larger units. In addition there have been some examples of partnerships developing between pathology services across Trusts. The model on which these changes have been made include a core laboratory, with local ‘hot’ laboratories providing rapid response services. However, there have been far more management consultant reviews of pathology services at a local level than there has been action taken! 4.3.2. Multidisciplinary laboratories The perception that automation reduces the skill requirement has probably been one of the main reasons for the creation of combined clinical biochemistry and haematology laboratories. It is a trend that has occurred in the smaller laboratories with the benefit of creating a greater critical mass of technical staff, enabling better cover for absences, etc [10]. However, in the larger laboratories the trend has been less evident. The advent of robotic sample handling systems may alter this situation, although there has been little evidence of the introduction of this technology to date — the investment not being justified in relation to the returns required. 4.3.3. Cost reduction As indicated earlier the government has established an annual cost improvement programme which requires savings of between 1 and 3 per cent. This may be increased by a local Trust if it is considered appropriate. In addition, although

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resources are usually made available to cover national pay awards and inflationary costs for consumables, they may not meet in full the actual increase in costs. This shortfall has often been met by not filling vacant posts which has put additional pressure on laboratories. Mergers of Trusts and laboratory organisations are usually seen as a means of reducing costs, although there is little evidence to support this contention with reduced management costs often counterbalanced by additional investment required in infrastructure, e.g., specimen transport and reception.

4.3.4. Point-of-care testing The centralisation of laboratory facilities, possibly to a core site, together with the increasing size of some hospitals will inevitably lead to an increase in point-of-care testing. This trend will be exacerbated by: (i) the demands of the Patients Charter to see and treat people more quickly; (ii) the need to reduce the requirement for doctors time; (iii) the requirement to reduce the overall length of hospital stay; and (iv) the increasing availability of POC devices. These operational benefits of point-of-care testing not withstanding there are several examples where rapid availability of a result, e.g., electrolyte status, is vital for patient management. The evidence for this to date is seen in the increasing use of point-of-care testing in emergency and admission units [52]. However, it is worth noting that the benefit of this faster service is not apparent in a recognition of the fact that the increased costs of testing produce savings in the facilities and nursing budgets. 4.3.5. Funding and contracting Whilst it is too early to comment on changes envisaged by the present government, the creation of the Primary Care Groups as purchasers of services will no doubt have an impact on pathology directly, with a continued increase in requests from general practitioners, as well as the effects of reduced hospital stays. One of the major challenges has to be the arrest of the rising workload against the background of static resources. One possible way forward is the development of service level agreements which are negotiated between the laboratory and its clinical users with close monitoring of performance. This arrangement creates the opportunity for dialogue on the one hand to curb any apparent abuse and explain demand whilst also offering the possibility of additional investment when benefits can be demonstrated. 4.3.6. Clinical effectiveness The pathology services play a vital part in clinical effectiveness both in terms of their role in clinical guidelines as well as providing surrogate or direct measures of outcome. It is envisaged that the agreement and implementation of

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guidelines — based on the best evidence available — will be a major determinant of the laboratory workload in the future. The involvement of the pathology service in providing surrogate or direct markers of outcome illustrates the important role that the laboratory disciplines play in all aspects of patient care from simple indicators of performance, e.g. the number and quality of biopsy samples indicates the ability of the surgeon to collect appropriate diagnostic material to making the definitive diagnosis.

4.3.7. Information technology From an IT viewpoint laboratories face additional challenges due to the processes of consolidation and rationalisation. The principle challenge is to integrate information arising from multiple sources and several key elements of the new NHS information strategy come into play. The introduction of the new unique NHS patient identifier will enable record linkage across systems. The expansion of the UN-EDIFACT Electronic Data Interchange (EDI) standards and the adoption of the universal READ/ SNOMED code dictionaries will ensure data equivalence. The rapid expansion of the NHSNet will increase laboratory interconnectivity and the use of LIMS based on centralised data processing centres will become possible. Alternatively, new architectures based on distributed network models may be developed. On a management level laboratories are being forced to adopt more sophisticated approaches to data analysis especially to support planning, audit, workload and cost control. Though the data collected by the conventional LIMS is central to this process the IT tools used to analyse and consolidate this information are increasingly drawn from the business world. One can expect this approach to accelerate with the introduction of benchmarking where complex models will be needed to underscore the comparison process. This will be especially the case if the analysis runs beyond raw production costs to include detailed qualitative outcome measures which will be needed to allow debates on service standards based on clinical effectiveness. 4.3.8. Research and development The management of research has become a major issue in both academic and service medicine. In 1994 the government became concerned that money allocated to the NHS for research was being spent on supporting the routine service. Following a review by Professor Culyer from York a new formula for disbursement of these funds was implemented. Essentially, whereas money had been allocated previously on an historical and little understood basis, in future the funding would be allocated on the basis of competition informed by a proper research strategy and objective measures of outcome [53]. The promotion of a research ethic amongst all healthcare professionals, together with a more strategically focused research agenda has meant that the research monies are

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being more widely distributed in terms of healthcare professionals and institutions, i.e. far beyond the traditional teaching hospital environment. Pathology laboratories will be able to bid for a research allocation against a defined programme and in addition will receive income for supporting the programmes of other clinical specialities.

4.3.9. Links to academic institutions Reforms have also taken place in the universities, including medical schools. There have now been two research assessment exercises designed to assess achievement in research as well as informing the allocation of resources from the Higher Education Funding Council. Medicine is unique in academic terms because teaching is so closely integrated with the provision of service as well as a significant proportion of its research being applied to the clinical area. The search for improved research output has created a significant tension between hospital trusts and their associated academic institutions; what was previously a close cooperation is put under strain by the need for each organisation to demonstrate stricter accountability for its own utilisation of resources.

5. Future challenges and opportunities Predictions for the future based on the changes and initiatives established over the last few years can all be viewed in the context of delivery, staffing and quality issues — interestingly the framework used in the NHS Strategic Review of Pathology Services [5].

5.1. Delivery issues The consolidation of hospital facilities and the model of delivery for cancer services [13], together with the observations on over-capacity in laboratories made by the Audit Commission [44], would all point to the consolidation of laboratory services into consortia covering more than one hospital or trust, adopting a hub and spoke structure. It is envisaged by some that in such a model, a core laboratory would serve a population of a million people with local satellite facilities covering more acute needs. Such a model would be able to take advantage of modern automated instrumentation together with robotic specimen handling systems. In addition it would enable the appropriate investment in more specialised techniques, e.g., tandem mass spectrometry for neonatal screening programmes [54], and molecular diagnostics. Such a strategy would have to be supported by an information system far beyond that currently existing in the NHS, encompassing

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transferable patient identity, patient and specimen tracking systems as well as proper communication between laboratories and all of their clients [43]. The creation of a core laboratory that is used to its full capacity will, by definition, create delays in the return of results — taking into account that much of acute patient care is still delivered broadly between the hours of 09.00 and 17.00. In a more patient-focused healthcare system where rapid turnaround of results will be required, point-of-care testing will then become far more prominent than it is today. The increased delivery of care in the primary sector will see the further development of point-of-care testing in this sphere [55].

5.2. Staffing issues Problems with the recruitment and retention of staff in the health service is one of the major employment issues of the 90’s; there appear to be many reasons for this, including poor remuneration, workforce planning and career prospects, exacerbated by tempting opportunities in other employment sectors. The problem is particularly acute in the technical grades. The potential changes in delivery of services, with the opportunity for multidisciplinary laboratories and the demands for a higher quality service have focused greater attention on education and training. Thus in the future there will be a more explicit commitment to education and training to a defined set of competencies which are then maintained through a mandatory programme of continuing education with revalidation at regular intervals — for all staff, not just doctors. The impact of automation on staffing levels has perceptually been toward deskilling, with expertise vested more in the manufacturer than the operator. However, this is a fallacy and there are many areas of the laboratory that will continue to require the highest level of technical skills. The NHS Executive recently announced a radical review of the workforce [56]. It is suggested that in the scientific and technical spheres there are too many professions and there is a vision of a generic workforce with a core of transferable skills which can be moved to meet changing demands as well as enabling more opportunities for career development.

5.3. Quality issues The government has placed quality high on the agenda for change in the NHS with a variety of initiatives based around clinical governance. It is envisaged that this agenda will have an increasing impact on the laboratory services with greater importance attached to accreditation of staff (state registration) and facilities. Quality assurance will play an increasing role both in terms of analytical services and through clinical effectiveness initiatives.

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The increasing emphasis on evidence based practice, whilst being demanding, also provides one of the most exciting opportunities enabling the pathology services to demonstrate both clinical and economic benefit. This has to be the approach to secure investment for the future.

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