In laboratory science, however, a technician-intensive work process has remained commonplace. Some labs are now aggressively catching up. Dwindling reimbursements, evolving technology and the persistent shortage of qualified technologists have stimulated decisions to automate an increasing number of pre-analytic functions or distinct workcell areas. Several hundred clinical labs worldwide have even taken the giant stride of converting to total laboratory automation, based on strong evidence that automation not only heightens profitability but also improves quality, timeliness and lab flexibility.
Pre-analytical processing is one of the most labor-intensive aspects of clinical work, occupying up to two-thirds of the total time spent by personnel on clinical laboratory procedures. Many labs are choosing to automate gradually, beginning with this front end of the test cyclesorting, decapping, barcode labeling, placing sample tubes in racks that may originate from a wide range of manufacturers, aliquoting, and centrifuging.
Among the major medical device companies that are producing equipment in this category, Tecan Group, Ltd., Zurich, Switzerland, manufactures the Genesis FE500, which combines all pre-analytical functions including pre-sorting, centrifugation, volume check and clot detection, decapping, secondary tube labeling, aliquoting and destination sorting into analyzer racks, on a small footprint instrument.
This system handles 500 tubes per hour and is easily reconfigured for a mix of clinical chemistry, immunoassay, hematology and other specimen tubes.
As an example of pre-analytical equipment that offers options for various configurations of computer and network controls and integration with analytic devices, Roche Diagnostics, a division of F. Hoffmann-La Roche Ltd, Basel, Switzerland, says that its RSD 800 and RSD 800A Preanalytic Systems Manager (PSM) products offer state-of-the-art sample handling functions and powerful data management all from one system. The systems sample flow management functions can support different levels of automation: manually via PC workstation and barcode scanner; automated with one or more connection to Roche Task-Targeted Automation devices, or; fully automated with the companys modular pre-analytics systems.
The systems can automate pre- and post-analytic steps including: pre-sorting by tube type; selective decapping; aliquoting into bar code labeled secondary tubes; sorting of tubes into analyzer specific sample carriers, and; recapping and archiving
Several firms are enabling both pre-analytic and analytic automation options with a considerable range of production capacity, but require the use of their own equipment, thereby enabling a robust, but essentially closed system approach. The Japanese conglomerate Olympus and its U.S. division, Olympus America Inc. Melville, N.Y., offer, for example, the Olympus OLA4000 workcell lab automation system This system fully automates labor-intensive specimen processing tasks within the chemistry-immunochemistry work area including sample identification, centrifugation, decapping and output sorting of specimen tubes. It also integrates two Olympus AU analyzers for automated rack loading and unloading along with centralized data processing.
System throughput is 400 tubes per hour for pre-analytical processes. Th e system uses Windows NT based software Its graphic user interface features real time update of system and instrument status and a specimen tracking feature enables quick identification of samples at the sorting areas. Several system configurations can integrate with specific Olympus analyzers to yield analysis of from 2,400 to 4,266 tests per hour.
Another closed system design comes from Bayer HealthCare Diagnostic Division, Tarrytown, N.Y., a unit of the German firm Bayer AG, in the form of its ADVIA LabCell Modular Automation System. This system provides a menu of pre-analytical components as well as interfaces for Bayers high volume analytical immunoassay, chemistry, hematology, urine chemistry and coagulation analyzers.
Beckman Coulter, Inc., Fullerton, Calif., also accommodates a progressive approach to automation, beginning with pre-analytic activity and proceeding to full laboratory integration. However, the company markets customized open system configurations that can connect 30 different models of instrumentation from a variety of manufacturers.
The longest-standing firm supporting total laboratory automation is LAB-InterLink, Inc. Omaha, Neb., founded in 1993. The companys system, which it characterizes as software driven, consists of several testing stages along over 100 feet of dual conveyor track. The systems robotic arm takes specimens from the lab racks and places them in centrifuges. After testing is complete, the specimens are cataloged and stored by a storage and retrieval module. Integrated devices include: an aliquotter, centrifuge, decapper, integrity monitor, loading station, recapper, sorter, storage and retrieval device, transport system and workstation, all coordinated by proprietary process control software.
Like Beckman Coulter, the systems design is based on an open system philosophy, so interface with a wide variety of analyzers from all major manufactures is easily implemented. It is also possible to bring the system components on-line in several stages over a period of months or years. [Note: The companys website includes a lengthy and highly informative white paper, Automation for the Clinical LaboratoryA Design and Planning Resource Manual, http://www.labinterlink.com/HTML/LIL_resource_manual_v2.pdf)]
The cottage industry aspects of laboratory science, even in large facilities, are unlikely to vanish over night. However, given the difficult financial challenges of modern health care and the quest for improved quality and resourcefulness, the spread of automation appears inevitable and highly desirable.
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