Editorial staff: Wouter Oude Groothuis | Photography: Marco Vellinga | Translation: Word's Worth
A modern, largely robotized laboratory that connects departments and processes sample material quickly, safely and accurately according to standardized procedures. Too good to be true? It is already operational at the Leiden University Medical Center (LUMC).
The current generation of robots is compliant and made to help people. With that in mind, the LUMC has been working for years on a core lab that is sophisticated, well equipped and, moreover, future-proof. This was not an easy task because several laboratories had to be merged. And, on top of that, it was also necessary to redesign the diagnostic process and the laboratory information system (LIS), standardize the method and develop a new quality system. Practices in the Danish laboratories were a source of inspiration during this trying process. Prof. Christa Cobbaert EuSpLM said, “The Danes are at the forefront of lab robotization in Europe. Our “exploration” there was a real eye-opener. While we were talking about connecting departments, they were already talking about connecting hospitals. It was there that I became convinced of the feasibility of our approach, both in terms of the process and with regard to the ability of our employees to adapt and learn.”
Delft System Engineering
Cobbaert has been affiliated with the Clinical Chemistry and Laboratory Medicine department since the end of 2009. She fulfills the function of Head of Department and Laboratory Specialist in Clinical Chemistry. Since her appointment, she has been working on the centralization of outpatient blood sampling and the integration of the various 24/7 laboratory units. The focus was on structure-function relationships — a process-based approach built around Delft systems engineering — and ultimately resulted in a functional design of its own. Cobbaert explains, “The lab has been set up in such a way that both patient research and scientific research can be facilitated with the same infrastructure — with a workable, uniform and standardized process in mind.”
However, this turned out to be difficult because an initial inventory showed that the existing processes functioned suboptimally and that the track and trace process was insufficiently guaranteed. Cobbaert continued, “It was clear that there had to be a holistic approach, aimed at big-picture thinking. For this reason, in the proposed European tender, we only specified the functionality and left the specific details open. A competitive dialogue has been chosen. Manufacturers were given the opportunity to complete our design, taking into account 396 absolute requirements and 10 interchangeable criteria. This led to unique partnerships and has been very instructive for all parties.”
The first major change was the establishment of the central outpatient phlebotomy department, the CBA. On average, more than 700 patients are seen there every day, accounting for approximately 1,250 vials of blood. In addition to drawing blood, performance tests are carried out, training assistants learn how to take blood samples and blood collection is facilitated for examination in this department. Cobbaert says, “It goes without saying that we also invested heavily in analysis equipment and analysis lines during this period. The preparations for Total Lab Automation took place from 2015 to 2017. This resulted in a fully consolidated and connected core laboratory. At the same time, the GLIMS laboratory information system from LIS supplier MIPS has been redesigned for all laboratories using this package.” The combination of a Black Box DKM matrix switching solution and the facility’s analysis and diagnostic systems brings exceptional efficiency to lab operations. This enables staff to access multiple analyzers without switching workplaces. And the Black Box KVM solution streamlines critical workflows that support the lab's daily yield of analysis results. On November 3, 2017, the whole thing went live. “The whole operation required a lot of thinking, tight planning and control, but, above all, focus. Factors such as people, resources, and time were (and are) very important. The process required intensive cooperation between all those involved,” says Cobbaert.
The nerve center of the core lab is the ‘cockpit’, similar to the control room of a factory. This is where the track and trace process is monitored and the 27,500 daily analysis results are authorized. Depending on the complexity, this can be performed by analysts or laboratory specialists. These are academics specialized in clinical chemistry, hematology, blood transfusion, and coagulation. Apart from that, there is also staff that answers the phone because the core lab also fulfills the role of the front office for the other labs. Within the cockpit, a convenient touch-panel interface for the Black Box KVM system makes it easy for staff to monitor, access, and even control analyzers throughout the lab. Cobbaert says each member of the cockpit staff takes pride in their work: “That cockpit has been a golden opportunity, not only in terms of the learning curve of all those involved but also in terms of interaction and communication. There is now real unity: it really is a team.” After the analysis, the samples go from the lab straight to the ‘archive’ that is also linked to the track. In the case of post- assessments, the sample is automatically taken from the archive after it has been entered into the LIS and is then transported to the relevant analyzer. Samples that are eligible for further investigation in other units of the Clinical Chemical Lab (KCL, Klinisch Chemisch Lab) or external laboratories are filled out, labeled and sorted into specific racks based on the information on the label.
The fear of robotics and the far-reaching automation of staff — if any — has proved unfounded. In fact, decompartmentalization and systematic IT innovations have led to an enrichment of the content of the analyst’s work and a new focus for the laboratory specialists: the Total Test Process. Additional tasks for subject specialists and analysts, such as overseeing and managing the GLIMS and TLA process, have been established. This simplified the diagnostic process. The tests are qualitatively better, and the test results are available more quickly and securely. This offers added value for both patient care and research. Although the road was, at times, bumpy, Cobbaert is satisfied for now: “We’ve already achieved a lot, but we’re not there yet: things are developing very fast.” We are extremely ambitious, she assures us, “Connecting departments with critical lead times directly to the laboratory, linking the analyzers for urine sediment testing and therapeutic drug monitoring to the GLP track (of laboratory-automator GLP, ed.), and adjusting biobanking via robotized sample reception.” She concludes, “As a result of the changes that have been made, we have been able to achieve better quality care paths with better guaranteed lead times and better service provision. The system also lends itself to further optimization. I am not interested in the technology or the IT itself but in better results and patient care through adequate support from the attending physician. I, therefore, hope that we will continue to find the space and the means to continue on this path.”
The following analysis equipment links to the GLP laboratory automated track: • Chemical and immunochemistry analyzers (Cobas 8000 by Roche Diagnostics)s) • Hematology analyzers (Sysmex XN-9000 with an Interliner for sedimentation) • A coagulation analyzer (STAR Max from Stago) • Tosoh analyzers for the determination of HbA1c, an average blood sugar level measured over a long period of time See also: bit.ly/LUMC-infographicLUMC-infographic
Improving Quality and Efficiency
The redesign of the diagnostic test process and the LIS has resulted in improved functionality and service in the KCL of the LUMC in many ways: • Centralization of blood sampling at the CBA resulting in shorter and better-secured lead times • Miniaturization of blood sampling: the amount of collected material for the primary assessment was reduced by 40 to 50 percent • More transactions with 25 percent fewer people • Far fewer actions at the Central Sample Reception department (CMO, Centrale Monster Ontvangst) • Optimization of hardware and software using analysis lines and equipment with Intelligent Process Management • Uniformity of labeling, application processes, interfacing, and practices for the member laboratories • Time savings due to the reduction of manual work • Improved clinical care pathways, including the facilitation of carousel office hours • The ability to deliver customized solutions and further developments • More valuable input by analysts and staff: for example, with regard to the authorization of the test results See also: bit.ly/LUMC-bloedtestLUMC-bloedtest (Dutch)