Walter F Riesen
PhD MD hc
Head of the Institute for Clinical Chemistry and Haematology St Gallen
Kantonsspital St Gallen (KSSG) is a centre of medical excellence, providing cardiology services, a dedicated stroke unit and a large oncology department. It was the first in Switzerland to introduce a palliative care unit alongside a treatment centre. Other specialisations include endocrinology, allergy and dermatological medical services. The laboratory is based at the 800-bed St Gallen hospital, one of three which make up the Kantonsspital St Gallen medical network. The other hospitals are Rorschach, near Lake Constance, and Flawil.
While 70% of test requests come from the three hospitals, the laboratory covers a wide catchment area, handling testing requirements from 10 outlying hospitals, with a total of 1,200 beds and around 200 general practitioners (GPs). To improve the flow of information we have already developed a tailor-made laboratory information system (LIS) linking us to the 150-bed Rorschach hospital, which provides acute medical services.
Drive to centralise laboratory testing
Each year, the St Gallen laboratory performs 2.5 million tests on more than half a million samples – almost three times the volume of a decade earlier. In part, it was this significantly increased workload that motivated us to fundamentally re-evaluate our laboratory systems. Our first objective was to establish one core laboratory for all routine testing to improve our service to affiliate hospitals and GPs. Before the reorganisation, our services were divided into six distinct units. Routine testing and more specialised investigations within the same discipline, such as haematology/haemostasis and clinical chemistry, were carried out in different rooms and had their own department heads. There were separate teams for molecular genetics and immunochemistry. With too many working areas and specialist teams operating independently from each other, we were simply not making the best use of our staff or resources.
Fortunately, the facilities at St Gallen are large enough for this to be carried out with minimal disruption and have not involved major re-engineering. In addition, the creation of a core team has fostered greater collaboration between colleagues and a more efficient way of working. And it has also provided the opportunity to rethink exactly how the laboratory service should be contributing to the medical decision-making processes of the future. First, we wanted to allow more time for consultation between clinicians. Next, we thought it necessary to expand our test menu to include assays previously considered too time-consuming to perform, such as OH-vitamin D3 and mycophenylate on HPLC, and new tests in molecular genetics. Another goal was to allow colleagues to have the time and capacity to undertake more scientific studies. We also wanted to foster our relationship with customers, and to engage more actively in a diagnostic dialogue with our medical colleagues.
Minimising manual intervention through automation
Collectively, these imperatives spearheaded our drive for change. However, in order for us to achieve them, it became clear that we would have to employ new technologies and, whenever possible, automate processes. To help us, we have partnered with Beckman Coulter, Inc. to install an automation system – the AutoMate™ 800 – to enable us to minimise sample handling during the pre- and post-analytic processes. In addition to sample processing and identification via the barcode, the instrument also performs the key preanalytical steps of centrifugation, volume determination, decapping, aliquotting and sorting for analysis. Once the primary analysis is completed, it will then re-sort samples for storage or further analysis on secondary instruments. This is significant because the post-analytical process can be the most time-consuming process in a lab.
However, it is at the reception point that efficiencies are immediately obvious. With this instrument, samples of every kind – chemistry, immunoassay, haematology or coagulation – are loaded at one entry point. They are then tracked throughout the preparatory process. They pass the automatic barcode reader to confirm the patient’s identification and are then routed automatically through each of the sample preparation steps. The software automatically differentiates between Stat and routine samples, enabling us to prioritise Stat processing. For those samples requiring centrifugation, we are able to programme the instrument so that a sample requiring a spin of 3,000 g for five minutes to yield platelet-poor plasma will not inhibit the centrifugation of one requiring a lesser spin. Further, we can prioritise sample aliquots to make sure that enough is available for the most important assays. In the first three months after installation, we saw immediate improvements both to workflow and turnaround time variation. The new system is already handling 98% of our samples without manual intervention. However, we believe that the highest efficiency will be achieved when the second phase of our automation plan occurs, linking of the AutoMate 800 directly to immunoassay and chemistry analysers.
Linked workstations promise further efficiencies
While the AutoMate 800 currently functions as a stand-alone instrument, it offers further potential for workstation consolidation. We are currently participating as a “beta” research site for this concept, the first lab in the world to demonstrate how this can be achieved. Linking between the AutoMate 800 and immunoassay and chemistry analysers is possible because the AutoMate automatically prepares samples specific to the requirements of an analyser; for example, diverting tubes from the decapping module when they are to be processed at workstations with closed-tube sampling technology. The eventual installation of a routing track will allow samples to go directly from the AutoMate 800 to any one of the linked analysers, without manual intervention.
As part of our research to streamline laboratory operations, we first upgraded our analysers to Beckman Coulter’s fastest high-throughput systems – specifically, three UniCel®DxC 800 clinical chemistry analysers, each with the capacity to run up to 1,400 tests per hour, and two DxI 800 immunoassay instruments (capable of running up to 400 tests per hour). Both have extensive menus, and the reagents can be loaded while the systems are running, avoiding time lost having to stop and restart the instruments. Once the systems are linked, automatic sample processing will include the ability to automatically locate samples in storage, which may be needed for reflex testing. We are implementing the automation process in stages to allow sufficient time for full staff training, including access to an excellent online backup resource, all of which is being carried out with the active involvement of Beckman Coulter. One of the final stages of our reorganisation will be the completion of an electronic ordering system at all the different clinics.
At St Gallen we are already benefitting from the initial integration of automation. One of the reasons for automating our manual processes was to significantly reduce the fluctuations in the delivery of individual results and to standardise our routine processes. Furthermore, by implementing this we have been able to free qualified scientists for more specialised, analytic work. We can already see that the preanalytical module makes it possible to deal more quickly with urgent results, automatically prioritising them and then flagging an alert after they are processed. When the system is fully automated, we expect to see even more significant time savings and efficiencies in this part of our work.
This has been an extensive project – still not completed – with far-reaching ramifications for the entire system of handling routine testing in our laboratory. It has also required our staff to turn away from focusing on one discipline and learn new skills, including multitasking. Overall, the changes are positive. They will enable the laboratory to continue to develop its professional service to the medical teams, and in doing so to improve patient care.