Stake your life on a LIMS

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Doctors depend on pathology labs for accurate diagnoses, and path labs depend on ever more sophisticated LIMS, Peter Rees reports

In January, the President of the Royal Society, Lord May, opened Britain's largest automated pathology laboratory, in Whitfield St, West London. But this was no ordinary laboratory run by a National Health Service (NHS) Trust. It was instead a partnership between one NHS Trust (University College London Hospitals, UCLH) and the leading private-sector provider of pathology services in the UK, 'The Doctors Laboratory'. It is evidence of substantial changes in NHS pathology services - and the LIMS systems that support them. The NHS Plan, the blueprint for the improvement of the UK's health services, accords the pathology service a high priority. The Pathology Modernisation Programme (PMP), established in 1999/00, has its own 10-year plan and a capital budget of 28 million for the first three years.

Some 60 per cent of diagnoses are based on pathology, so modernisation of the service should lead to faster test results and shortened waiting times, the Government hopes. Together with fewer unnecessary repeat tests, this will mean shorter stays in hospital, and fewer delays for treatment - a boon to patients and the NHS as a whole.

Historically, pathology has been seen as a back-room service, and has suffered from old buildings, poor funding, and staff shortages. The British Government is also determined to involve the private sector in NHS modernisation through Public Private Partnerships - hence the UCLH NHS Trust's new pathology services share premises with a private company. The laboratory, which will be open 24 hours a day 365 days a year, will manage the greater part of the combined chemistry and haematology workload for both organisations. Its 38 staff will process more than 50,000 tests per day, using the WinPath LIMS system supplied by Sysmed.

Pathology services at UCLH are highly specialised, with strong academic links, and a thriving research base. This highlights one of the problems facing manufacturers of a pathology LIMS system - it must serve the needs of a hospital with high volumes of standard tests, but be flexible enough to satisfy medical researchers. 'Often the large teaching hospital, from an informatics requirement, is very challenging, because the system needs to meet the individual needs of departments,' says Donald Saum business development director at Sysmed. These hospitals have specialist departments, such as molecular genetics and tissue typing, as well as the traditional pathology disciplines of biochemistry, haematology, microbiology, and cellular pathology.

Because of specialist requirements, some major teaching hospitals still rely on databases that were developed in-house to support the research-based workers. This is an approach that ordinary hospitals abandoned 10-15 years ago. 'Most district-general sized hospitals have gone through a process of putting in commercial LIMS systems over the past decade,' says Saum. And because teaching hospitals are relatively few in number, commercial LIMS suppliers have seen little financial incentive to develop specialist databases for some of these areas.

Nevertheless, over the years LIMS suppliers have developed a lot of the functionality in the core system to support these various disciplines, says Saum. This means that what is often required is simply a modification of the system to meet the needs of an individual department. This, he suggests, is one of the strongest features of WinPath. It has a very modular system and is hence very scalable. 'It can be deployed in a small, private laboratory that's working in a multidiscipline-type environment, or it can be configured equally as well for a major teaching hospital that may have 10 or eleven different departments,' he says.

Sysmed is focused almost entirely on pathology. One result of this specialisation has been that, over the past 12 months, Sysmed has won every new procurement for pathology systems that has gone out to tender in the UK, claims Saum. As many as half the people within the firm have come from a background in the discipline, and this has enabled it to keep up with the shifts in the sector.

One of the main trends in clinical pathology has been the development of pathology networks. This has happened over a number of years. 'Initially, in fairly soft ways, with laboratories getting together and co-operating on purchasing. So that they can get better deals for consumables, for reagents, and things - and equipment,' says Saum. Then, as laboratories in neighbouring hospitals have combined to form a single NHS Trust, the trend has become stronger. 'They have actually looked at how best to share workload and maybe optimise processes, by increasing the volume of certain tests on one site and maybe doing more specialist tests on another site,' says Saum.

The most recent stage is the emergence of larger networks, where laboratories may be covering quite a sizeable geographical area, such as Path Links, a countywide pathology service covering a million people in greater Lincolnshire. 'You have almost the exact test repertoire going on in hospital A, which might only be three or four miles away from hospital B. That's one of the drivers for the development of the pathology network,' says Saum.

In fact, the 2002 contract for Path Links was won by APEX, a LIMS system supplied by one of Sysmed's main competitors iSOFT, currently involved in a legal wrangle over its proposed merger with Torex. APEX, now rebranded as i.Laboratory, has proved a popular choice with Trusts, and has one of the largest number of installations in the UK. In Lincolnshire, it is used to deliver pathology to two major Trusts: United Lincolnshire Hospitals NHS Trust; and Northern Lincolnshire and Goole NHS Trust, which includes laboratories at Boston, Grantham, Grimsby, Lincoln, Louth, and Scunthorpe, as well as phlebotomy centres at some smaller hospitals.

Because pathology LIMS systems deal with samples that come from patients, there is a significant requirement to record medical information and patient history. For example, in blood transfusions: 'You need to be able to view the transfusion history of the patient very rapidly; you need to see pretty much everything that has gone on during the life of that patient,' says Saum. There is also a growing demand for support for movement of samples and information about patients between departments and hospitals - what are known as electronically referred patients. This requirement is linked with the spread of electronic patient record systems (EPRS), another part of the NHS Plan. The target for this is that all acute hospitals will need to have implemented electronic patient records by the end of 2005. And by 2010, every NHS patient in England will have an individual electronic record, in a system run by the NHS Care Records Service connecting more than 30,000 GPs and 270 acute, community, and mental health NHS trusts in a single national system.

Another area that is becoming important is knowledge management. LIMS systems now include protocols that have been developed by the clinicians for reporting the results that come from the analytical instruments. There is an increasing demand for expert systems that support the process of prioritising samples and help automate more of the routine scheduling of tasks. For example, specimens that are out of range, and therefore present clinical problems, are directed for the early attention of the clinical pathologist. Those that fall within a range that has been defined as showing a negative result are automatically reported, once they have gone through the standard quality-control checks, says Saum.

The demand for this rules-based approach to managing samples is driven by the increasing sophistication of analytical equipment and a shortage of skilled pathologists in the NHS, says Saum. 'Within the clinical environment, there's a lot of pressure on resource and there's a significant challenge with recruiting scientific and clinical staff into the laboratory. In particular, there is a great shortage of consultant histopathologists.' Pathology LIMS systems are therefore being asked to replicate some of the decision processes that the consultant would use: 'to be able to support a more automated reporting on tests that maybe are within range, that could pass the clinical processes in terms of the rules, and therefore be reported,' says Saum.

Another key development is the inclusion in pathology LIMS of medical terminology and coding systems, a function that is essential to interfacing with the developing electronic patient record. The world-leading standard for this is the College of American Pathologists' Systematized Nomenclature of Medicine (or SNOMED), which the NHS has adopted as a replacement for its own coding system known as 'Read codes'.

Keeping abreast of these sector-specific developments has led to pathology becoming the preserve of specialist LIMS suppliers like Sysmed, Saum believes. Hence the WinPath's success in securing the contract with TDL and University London College Hospitals Trust. UCLH hospitals provide acute and surgical services for local people, commuters, and visitors to London, as well as highly specialised services to patients referred from all over the country. Trust hospitals include: University College Hospital; The Middlesex Hospital; Elizabeth Garrett Anderson and Obstetric Hospital; and specialist hospitals for tropical diseases, and neurology and neurosurgery.

The Trust is in the middle of a £422 million redevelopment scheme, which involves the building of an 18-storey, high-tech replacement for University College Hospital (UCH) and The Middlesex Hospital by 2005, and the installation of a 70 million EPRS, supplied by IDX Systems in partnership with IT consultants LogicaCMG.

At the Trust, routine high-volume, fast turnaround, automated tests in chemical pathology and haematology have been in urgent need of modernisation for some time. The services have been fragmented, and this has led to duplicated effort. Chemical pathology turnaround times, particularly for accident and emergency (A&E) have been unacceptably long. The Trust's out-of-hours haematology service - which includes the busiest transfusion laboratory in England - has been especially stretched. And there have been the same difficulties in recruiting scientific staff that pathology services throughout the UK experience.

The new laboratory in Whitfield Street will improve turnaround times for all the standard pathology and haematology tests, says Saum. Patient waiting times should fall in A&E, and hospital patients will no longer have to wait so long for results before they are discharged. The LIMS system will free up the time of biomedical scientists, who will be able to carry out more skilled, labour-intensive work, such as blood transfusions.

The other partner in the project, 'The Doctors Laboratory' (TDL), stands to benefit in a number of ways too. The lab will accommodate its need to grow - turnover is rising at around 20 per cent a year - and enable it to cut the cost of high-volume tests with short turnaround times. Run as Whitfield Street Laboratories Ltd, the public-private partnership will also provide a headquarters for the company and its new parent, the Sonic Healthcare group. Sonic is a provider of pathology services in Australia, New Zealand, and the Far East, where it operates around 70 laboratories. The Aus$1bn group, which is listed on the Australian Stock Exchange and employs more than 10,000 staff, acquired TDL in 2003.