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A new direction in automated laboratory testing in Japan: five years of experience with total laboratory automation system management.

The introduction of integrated laboratory systems has proceeded rapidly in Japan in these 15 years, but they require large initial investment for installation and do not always succeed in reducing laboratory cost. We also experienced three major events that taught us that total laboratory systems are not always effective: these were an earthquake, a nerve gas attack, and an outbreak of food poisoning. Political changes in the national health care system in Japan have forced the cutting of expenses for laboratory testing. In this context, cost-effective laboratory testing has been considered, and many hospitals have replaced total laboratory systems with small laboratory systems. Our University Hospital introduced a mini-lab system consisting of compact instruments to increase laboratory efficiency, and we have begun point-of-care testing education for medical students. This combination enables rapid and convenient testing, and is responsive to the political changes in the Japanese health care system.

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Modular workcells: modern methods for laboratory automation.

Laboratory automation is beginning to become an indispensable survival tool for laboratories facing difficult market competition. However, estimates suggest that only 8% of laboratories will be able to afford total laboratory automation systems. Therefore, automation vendors have developed alternative hardware configurations called 'modular automation', to fit the smaller laboratory. Modular automation consists of consolidated analyzers, integrated analyzers, modular workcells, and pre- and post-analytical automation. These terms will be defined in this paper. Using a modular automation model, the automated core laboratory will become a site where laboratory data is evaluated by trained professionals to provide diagnostic information to practising physicians. Modem software information management and process control tools will complement modular hardware. Proper standardization that will allow vendor-independent modular configurations will assure success of this revolutionary new technology.

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[Recent trends in the standardization of laboratory automation].

Laboratory automation systems have been introduced to many clinical laboratories since early 1990s. Meanwhile, it was found that the difference in the specimen tube dimensions, specimen identification formats, specimen carrier transportation equipment architecture, electromechanical interfaces between the analyzers and the automation systems was preventing the systems from being introduced to a wider extent. To standardize the different interfaces and reduce the cost necessary for the laboratory automation, NCCLS and JCCLS started establishing standards for the laboratory automation in 1996 and 1997 respectively. NCCLS has published five proposed standards which that are expected to be approved by the end of 2000.

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Flexible software architecture for user-interface and machine control in laboratory automation.

We describe a modular, layered software architecture for automated laboratory instruments. The design consists of a sophisticated user interface, a machine controller and multiple individual hardware subsystems, each interacting through a client-server architecture built entirely on top of open Internet standards. In our implementation, the user-interface components are built as Java applets that are downloaded from a server integrated into the machine controller. The user-interface client can thereby provide laboratory personnel with a familiar environment for experiment design through a standard World Wide Web browser. Data management and security are seamlessly integrated at the machine-controller layer using QNX, a real-time operating system. This layer also controls hardware subsystems through a second client-server interface. This architecture has proven flexible and relatively easy to implement and allows users to operate laboratory automation instruments remotely through an Internet connection. The software architecture was implemented and demonstrated on the Acapella, an automated fluid-sample-processing system that is under development at the University of Washington.

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[Results of a questionnaire survey about "standardization" of connection methods in Laboratory Automation System or Laboratory Information System by the National University Hospital Clinical Laboratory Divisions].

"Standardization" is very important in the field of clinical laboratory medicine. Enzyme reference materials(ERM) and standard plasma proteins(CRM470) have already been developed. Reference methods for some clinical chemical tests have also been developed. We are studying "standardization" of electric communication methods between computers and automatic analyzers in Laboratory Automation System(LAS) or Laboratory Information System(LIS). We present the results of a questionnaire survey of 73 LAS or LIS making Companies in this paper. Although "standardization" of electric communications or local area network in LAS or LIS has been done in only 22 companies(34.9%), we are planning more functional standard electric communication methods such as Health Level 7(HL7) or American Society for Testing and Materials(ASTM).

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[Standardization of operation monitoring and control of the clinical laboratory automation system].

Laboratory automation systems showed up in the 1980s and have been introduced to many clinical laboratories since early 1990s. Meanwhile, it was found that the difference in the specimen tube dimensions, specimen identification formats, specimen carrier transportation equipment architecture, electromechanical interfaces between the analyzers and the automation systems was preventing the systems from being introduced to a wider extent. To standardize the different interfaces and reduce the cost of laboratory automation, NCCLS and JCCLS started establishing standards for laboratory automation in 1996 and 1997 respectively. Operation monitoring and control of the laboratory automation system have been included in their activities, resulting in the publication of an NCCLS proposed standard in 1999.

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[The new generation of laboratory automation systems].

Laboratory automation is essential to release laboratory technicians from simple routine work, allowing them to make use their time for more skilled tasks. In 1998, we developed a Total Infection Control System called "Dr. Fleming", and would like to introduce it into practical use. This systems is expected to help physicians by providing highly valuable test results and useful information.

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Accelerating drug discovery by integrative implementation of laboratory automation in the work flow.

Acceleration of the drug discovery process in pre-clinical pharmaceutical research is a highly desirable goal and combinatorial chemistry united with automation technology promised to accomplish this task. Through the accumulation of experience with automated devices over time it became evident that only by harmonisation and streamlining of work-flow procedures the efficiency of the overall process can be improved. An open architecture of efficient data management and appropriate utilisation of automated laboratory protocols provides the opportunity to react in a flexible and advisable way. Only an integrative workflow concept promotes the enhancement of the overall performance. However, the foundation of any efforts towards the accelerated synthesis of new and desired compound arrays lies in the development of reliable chemistry protocols amenable to solid- and solution phase chemistry.

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Laboratory automation: a model.

Today's health care providers are keenly aware of the need to do "better with less" in an environment of shrinking resources. This article describes a process for automating laboratory services that is based on expertise, safety, productivity, and a set of guiding principles. The process used to create this model, which integrates people with the flow of information and materials, can be used to re-engineer any knowledge-based process.

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The role of total laboratory automation in a consolidated laboratory network.

BACKGROUND: In an effort to reduce overall laboratory costs and improve overall laboratory efficiencies at all of its network hospitals, the North Shore-Long Island Health System recently established a Consolidated Laboratory Network with a Core Laboratory at its center. METHODS: We established and implemented a centralized Core Laboratory designed around the Roche/Hitachi CLAS Total Laboratory Automation system to perform the general and esoteric laboratory testing throughout the system in a timely and cost-effective fashion. All remaining STAT testing will be performed within the Rapid Response Laboratories (RRLs) at each of the system's hospitals. RESULTS: Results for this laboratory consolidation and implementation effort demonstrated a decrease in labor costs and improved turnaround time (TAT) at the core laboratory. Anticipated system savings are approximately $2.7 million. TATs averaged 1.3 h within the Core Laboratory and less than 30 min in the RRLs. CONCLUSIONS: When properly implemented, automation systems can reduce overall laboratory expenses, enhance patient services, and address the overall concerns facing the laboratory today: job satisfaction, decreased length of stay, and safety. The financial savings realized are primarily a result of labor reductions.

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Development of standards for laboratory automation.

In clinical laboratories, the installation of total laboratory automation systems and/or modular systems has grown dramatically in the 1990s, particularly in the US, Japan, and Europe. As the number of installations and level of interest grew, several individuals and corporations active in the automation field recognized that the development of prospective standards might enable customers of such systems or equipment to purchase analyzers, automation systems or devices, and software from different vendors and retain interconnectivity of such equipment. These individuals also believed that the total market for automation systems and equipment would be significantly greater with standards than without standards, especially if customers were not forced to purchase everything from one vendor, and that there might be competitive pricing and new technology fostered via the standards. This early interest in standards development led to the initiation of a program by NCCLS in 1996 to develop prospective standards for laboratory automation. Part of the NCCLS effort has involved interaction and cooperation with other standards organizations in the US and other countries. This report describes the current status of the development of prospective standards for laboratory automation by NCCLS and the relationship of those standards to those of other standards organizations.

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Laboratory automation: trajectory, technology, and tactics.

Laboratory automation is in its infancy, following a path parallel to the development of laboratory information systems in the late 1970s and early 1980s. Changes on the horizon in healthcare and clinical laboratory service that affect the delivery of laboratory results include the increasing age of the population in North America, the implementation of the Balanced Budget Act (1997), and the creation of disease management companies. Major technology drivers include outcomes optimization and phenotypically targeted drugs. Constant cost pressures in the clinical laboratory have forced diagnostic manufacturers into less than optimal profitability states. Laboratory automation can be a tool for the improvement of laboratory services and may decrease costs. The key to improvement of laboratory services is implementation of the correct automation technology. The design of this technology should be driven by required functionality. Automation design issues should be centered on the understanding of the laboratory and its relationship to healthcare delivery and the business and operational processes in the clinical laboratory. Automation design philosophy has evolved from a hardware-based approach to a software-based approach. Process control software to support repeat testing, reflex testing, and transportation management, and overall computer-integrated manufacturing approaches to laboratory automation implementation are rapidly expanding areas. It is clear that hardware and software are functionally interdependent and that the interface between the laboratory automation system and the laboratory information system is a key component. The cost-effectiveness of automation solutions suggested by vendors, however, has been difficult to evaluate because the number of automation installations are few and the precision with which operational data have been collected to determine payback is suboptimal. The trend in automation has moved from total laboratory automation to a modular approach, from a hardware-driven system to process control, from a one-of-a-kind novelty toward a standardized product, and from an in vitro diagnostics novelty to a marketing tool. Multiple vendors are present in the marketplace, many of whom are in vitro diagnostics manufacturers providing an automation solution coupled with their instruments, whereas others are focused automation companies. Automation technology continues to advance, acceptance continues to climb, and payback and cost justification methods are developing.

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[Dawning of laboratory automation; individually constructed automated systems].

In the early stages of laboratory automation, the first step toward automation was the use of a spectrophotometer equipped with a flow cell system. Then, automated machines were introduced. Furthermore, computing systems, which are necessary for automated machine systems, contributed to advances in laboratory automation. Under these primitive conditions, we devised a data processing system for clinical biochemistry and further advanced the first stage of automated laboratory system. These automated systems have gradually matured in to a total laboratory automation system. As described in this report, we designed and developed an automated system in our laboratory.

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Laboratory automation systems. An introduction to concepts and terminology.

The concept of laboratory automation has existed for years; such automation has been used primarily in nonclinical and industrial settings. The next step is to implement automation systems in the clinical laboratory. A laboratory automation system consists of robots, conveyor systems, machine vision, and computer hardware and software. Specimen movement and result reporting are based on the identification of specimens using bar coded specimens and bar coded specimen carriers. The implementation of a laboratory automation system is dependent on the presence of a laboratory information system. An interface between the laboratory information system and the laboratory automation system provides the information required to move the specimen through the laboratory. The reporting of results is dependent on the laboratory information system or manual input, depending on the type of work cell in which the results are produced. The greatest hurdle to overcome in developing and implementing a laboratory automation system is the integration of systems, including commercial laboratory instrumentation and user-defined work cells. The barriers to implementation primarily are proprietary in nature: instrument software and instrument hardware. When the instrument manufacturers realize the necessity for development of electronic and physical integration, the proliferation of laboratory automation systems will occur. Several opportunities exist for the reduction in laboratory expenses and the development of new positions, such as "robotechnologist," a staff member who would function in a manner similar to the current laboratory information systems manager. This article describes the author's concepts of laboratory automation.

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