LIMS implementation at a national microbiology reference laboratory sets new standards
The Central Public Health Laboratory (CPHL) in Colindale is the national reference centre for medical microbiology in the UK, and is part of the Specialist and Reference Microbiology Division (SRMD) of the Health Protection Agency (HPA). CPHL provides specialist expertise and advice to regional laboratories, NHS hospital laboratories, consultants in communicable disease control, community and hospital physicians, environmental health officers, government and industry.
The final phase of a two-year implementation of a Laboratory Information Management System (LIMS) at CPHL recently reached completion. The main objective of the project was to deliver a turnkey system, with a number of bespoke developments to meet specific CPHL laboratory needs.
CPHL consists of five Departments that house a total of nine Laboratories. A number of in-house Oracle systems had previously been developed to separately manage the data of four of the Laboratories. Others were running independent systems or were not computerised. There was an urgent need for an integrated laboratory information system to provide efficient and effective capture and processing of patient and specimen data. Improved analysis was required for outbreak situations and data sharing with other parts of the HPA including the Communicable Disease Surveillance Centre (CDSC).
Reports, statistics and other data are needed for local, regional, national, and international developments in communicable disease, and management information is required to provide key performance indicators.
Sysmex UK was awarded the LIMS contract, due to the seasonal nature of the work at CPHL, it was decided to phase the installation over two years rather than opt for a “big bang” approach.
The implementation process was carried out in five phases, with the majority of the bespoke software developed prior to go-live of the pilot unit in order to prove the developed functions. The pilot unit, the Immunisation and Diagnosis Unit, went live in January 2003. This unit processes 100-150 specimens per day and is part of the Enteric, Respiratory & Neurological Virus Laboratory (ERNVL). The order of the other go-live dates was agreed upon with Laboratory Directors and was dependent on the time of year, resource availability, and convenience to the Laboratory. This allowed Laboratories to avoid placing unnecessary strain on the staff at periods of high activity.
A single project team carried out the whole LIMS implementation. The team consisted of a single representative from each unit. These staff acted as the communication link between the project and the end users in the Laboratories and they recommended changes in policies and procedures within their Laboratories to optimise system benefits. The team members were trained as LIMS “super-users” enabling them to implement the system and carry out future changes, assist with any queries and provide internal training. CPHL could thus retain the expertise to manage the system rather than relying solely on the supplier. This was effectively achieved and each Laboratory now has a LIMS “super-user” who is familiar with the parameterisation of their Laboratory.
The team approach to this project was a major contributory factor to the success of the project. Communications with end-users was effective and a multidisciplinary approach to decision making was achieved.
User acceptability amongst staff was acknowledged as one of the biggest potential hurdles. There were regular team meetings in order to help facilitate the cultural shift towards a new universal system, which was particularly important for those who had been working with the previous Oracle systems for over ten years. Internal communications such as frequent newsletters, demonstrations, and meetings kept staff up to date with the changes.
CPHL had quickly realised the need to support the implementation team by providing additional resources for training, project administration and IT support in the form of user training, administrative and IT assistance. After the pilot go-live a training officer was employed to train all other end users and a help-desk was established to act as an interface between users and support via the LIMS teams and the Sysmex hotline where required.
The CPHL Laboratories now have a common LIMS system (Sysmex MOLIS) to which a number of specific developments have been added. It has been successfully implemented within eight Laboratories located at CPHL, including the Sexually Transmitted and Bacterial Reference Laboratory (STBRL) which was added to the last project phase.
The main benefits which are already being realised are: improved turn-around times for many requests; better recording of outbreak data; excellent sample tracking; improved accuracy; and real-time statistical analysis of data throughout CPHL. The system is compliant with the Caldicott data protection initiative and the level of auditing and result storage is a benefit for both CPA and UKAS accreditation.
The project has resulted in a number of business process changes to Laboratory workflows. Numerous specimen receptions in the Laboratories have been rationalised to a Central Accession facility, where approximately 800 specimens a day (both reference and surveillance) for all Laboratories are received to a new paperless environment. Request forms can be viewed on screen at any part of the process as they are scanned following sample registration. One of the key benefits of the system is that it allows the capture of greater amounts of data according to the specific requirements of each Laboratory e.g. immunisation dates and details for MMR surveillance work, travel history, and antimicrobial therapy for gastroenteritis tests.
The system helps Laboratory staff perform daily tasks and make decisions related to the different steps involved in microbiology testing. Each individual work step, result and user is recorded in detail in an electronic worksheet. These structured and searchable worksheets can be viewed as a tree with collapsing and expanding branches. During the implementation the team has defined about 230 different types of specimen with a choice of 1100 tests. Where a general hospital type microbiology department using MOLIS might have around 200 steps, CPHL have defined 3750 distinct steps with 15000 different result codes in the Microbiology Work Area Manager. Well-planned logical coding has simplified searches and helped avoid ambiguity during data entry. The new system has provided a greater degree of automation than previously by interfacing relatively “uncommunicative” equipment. The automatic download of results has been a particular time saver in the Sexually Transmitted and Bloodborne Virus Laboratory (SBVL). In addition to plate readers and analysers interfaces, Sysmex also interfaced with the CDSC surveillance system Labbase2.
Sample tracking and archiving had to be a key feature of the LIMS set-up due to the nature of its surveillance and research work. Every sample, aliquot and growth media can be barcoded and tracked from accession to archive. The archive function allows tracking and location of samples that are stored in freezers or culture stores for retrieval for further tests.
CPHL made extensive use of the MOLIS rule base and decision tables at various levels, such as phage type derivation and sample routing. Other features of the paperless environment include the generation of a set of standardised Laboratory reports with a common corporate design, and the newly developed outbreak module. An essential addition to the system, the module was designed and developed in collaboration with the implementation team and MOLIS developers to provide a vast information capability, exhaustive search and reporting functions.
With the rapidly changing nature of the work of CPHL and the continuous development of new testing methods, it was particularly important for MOLIS to allow rapid modifications and the addition of tests and codes without affecting the routine work or compromising historic data. This was demonstrated impressively last year when the SARS outbreak required the recently implemented ERNVL section to quickly add a whole new set of assays. The crucial aspect was that the generation of the tests, specific demographics, result codes, worklists, and sample routing were all set up by CPHL rather than Sysmex staff.
From the go-live of the pilot Laboratory and through the successive phases to the last go-live in January, a sound build up of trust developed between the organisations and their staff. Having gone live on time and on budget, the project is viewed by all parties as a resounding success. The initial partnership approach has proven to be a pivotal element of this achievement, and the high level of confidence of all involved allowed the addition of a number of extra deliverables.
The HPA and Sysmex envisage that the system will be rolled-out to other HPA Reference Laboratories/Units across the country in the near future. Both parties are looking forward to continuing the fruitful collaboration that has delivered so well for their organisations. Sysmex are particularly pleased to have such a prestigious reference site of interest to international visitors, an achievement of which both managers and technical personnel are proud.
By Fred Hilgers, Sysmex MOLIS Application Manager