Abstract
The clinical laboratory testing market is at a critical juncture with the medical economy on the verge of bankruptcy, and laboratory budgets at an all time low. Technological solutions are being sought to reduce the cost while maintaining, or possibly improving, the quality of diagnostic testing. Laboratory Automation Systems (LASs), which were first conceived and called the Sample Transportation System by Dr. Sasaki at the Kochi Medical School (Kochi, Japan) in 1981, have been expected to be the panacea to improve the quality of laboratory testing while reducing the cost of labor and errors. LASs have been gradually improving their utility and return on investment through careful introduction, operation and evaluation in many laboratories. However, the penetration of LASs into the market has not been as rapid as expected due to the necessity of high capital investment, unprofitable examples of early over-investing by adopters, poorly documented effectiveness on medical quality improvement, or the poor performance of the recent medical economy. There is an urgent need for a highly-integrated LAS with a minimal footprint so it can be easily incorporated in existing laboratories, may be operated with reasonable cost, and has sufficient flexible modularity to allow for future up-grades.
A careful examination of the current laboratory market yields two distinct trends, “Standardization” and “The Modular Concept”. Standardization is currently being promoted by the National Committee on Clinical Laboratory Standards (NCCLS) and Japan Society of Clinical Chemistry (JSCC) to provide a user-oriented laboratory environment that allows interconnectivity of all laboratory hardware to allow appropriate competition among all manufacturers of clinical laboratory instrumentation. The Modular Concept seems to be an ideal LAS architecture from the point of view of required space and cost. However, current trends in Modular Automation have favored a closed single vendor system that is represented by a few market dominant manufacturers. Therefore, there are two conflicting modular approaches at work in the market, one of which favors standardization and open connectivity.
In Japan, there has been a recent initiative to establish the Open Standard for Modular Automation, called the “Open LA21 Project” to chart a new course for the clinical laboratory automation market in the 21st century. The project aims to provide integrated, downsized, low cost LAS modules to the market in order to solve the current problems of LAS.
At the Japanese Association of Clinical Laboratory Automation (at Kobe) in September 1999, three companies - Aloka Co., Ltd., A&T Corporation, and JEOL Ltd., announced the basic concepts of the Open LA21 Project. Following that, two companies - TOY-OBO and NIPPON CHEMIPHAR joined the project. In 2000, Ortho-Clinical Diagnostics (K.K.), TOSOH, in 2001 Techno Medica and HORIBA joined. The number of participating companies has been increasing steadily. There are nine companies in total, as of September 2002 (Figure 1).
There are nine companies that have joined the Open LA 21 Project since the year 2000. The Open LA21 Project is promoted by the manufacturers and users as an open and user-oriented environment. In this project, we regard the integrated modular system as a standard. By realizing the open connection environment based on the open standards, we are able to promote and upgrade it in response to user needs quicker than competitors with the single vendor concept.
The road map that was developed in the year 2000 has been followed on schedule.
The missions of Open LA21 Project are to: 1) establish open standards for modular automation systems, 2) utilize new and advanced technologies, 3) provide for the earliest development of modular units by multiple vendors, and 4) create a fair and customer friendly competitive market. The Open LA21 Project has been progressing on schedule. The first stage focuses on establishing the standards (Open Module System Standards) with improving the connectivity of existing products of the participating companies. The second stage is expected to realize an integrated modular system which will allow the integration of multiple fields of laboratory testing capitalizing on the results of the development of the first stage.
The single most differentiating feature of the Open LA21 Project is the open nature of the systems. In the project, not only are the analyzers inter-connectable, but also the transportation system itself is “open”. By making them open, integration of Clinical (General) Chemistry, Immunology, Coagulation, Hematology, Qualitative Urinalysis, Urine Sedimentation and so on can be brought to early fruition through participation of many companies as a development team. A second important feature of the Open LA21 Project is that analytical, processing and transportation modules are considered separate systems that can be freely selected. The customer can make the most appropriate selection among rack transportation, single-tube transportation, and loop transportation.
Two years has passed since the first announcement of Open LA21 Project at the LA2000, in Palm Springs. Development work of each company with targeting the release of the first Integrated Modular Automation equipment by the end of 2002 has progressed from “concept” (standards) to “real” (design & prototype) (Figure 2).
OPEN LA21 STANDARDS
The standards that are the foundation of the Open LA21 Standard have been developed based on the NCCLS Standards. However, we have found that it was necessary to adopt and enforce a more stringent standard than the original (NCCLS) standard in order to realize true “Plug & Play” functionality.
Mechanical Standard : Open LA21
The Open LA21 Standard is comprised of four parts, the mechanical standard, electrical standard, data communication standard and utility standard. The detail of each standard is available through our homepage located on the web at the following address: (http://www.openla21.net/eng/std/index.html).
OVERVIEW OF THE OPEN LA21 PROJECT STANDARDS:
MECHANICAL STANDARD
Technical terms used in transportation system
Sampling position
External dimensions of the analyzer
Fed section of the analyzer
Drainage section of the analyzer
Connection between the analyzer and the transportation unit
Maintenance space
Overhang dimensions of the analyzer
Warning notice (PL) plates
Method for alterations in the standard installation height of analyzing equipment
Height from the surface of the floor to the bottom of the analyzing equipment
Suction and exhaust fan of analyzing equipment
ELECTRICAL STANDARD
Technical terms used in transportation system
Power Supply Specifications
Specifications regarding steel case grounding
Specifications for starting the specimen transportation system
Specifications regarding switch symbols (of the operations system)
Specifications regarding electrical safety / EMC
Specifications for ID read of the specimen or the carrier at the time of sampling
DATA COMMUNICATION
HL-7 Japan Edition has approved by Working Group of JAHIS on June 21, 2001. It has also presented on their Homepage and will be released as Online Regulation Version 2.0.
UTILITIES
The water specification for the analysis device
Power Supply Specifications
BASIC MODULES
SAMPLE STATION MODULE
This module is used for loading and unloading samples. Each Sample ID (Barcode) is read and the samples are fed to appropriate modules depends on what clinical tests have been ordered on the specimen.
TRACK LINE MODULES
In the case of A&T's Track Line, it uses Single Tube transportation with universal Sample Tube Holder. It can be adapted to any NCCLS Standard Tubes without a special adapter. Its unique double Moving Mechanism (Paddle Transportation in addition to conventional Chain Transportation) allows high-speed transportation while avoiding the waiting time at each module (Figure 5).
SAMPLE BUFFERING MODULE
After the pre-analytical transaction, the sample (mother sample or aliquot sample) will be fed to the Sample Buffering Module and then it is required to wait until the following module is ready to receive it. Subsequently, the sample will be fed immediately to the next module when it is ready (Figure 6). The sample will then be returned to the Sample Buffering Module after the sampling at necessary analysis modules and wait until the next order from LAS Controller. It may be fed to the analysis module again for Re-run or Reflex Testing or transported back to the Sample Station for Archiving.
In the Open LA21 Standard, the sampling point is from the backside of each analyzer. Space is also specified for instrument maintenance space. Each side of the modules must be free from obstructions to allow access by maintenance personnel. Since the specifications of each modules are strictly defined, they can be assembled without intervening dead space (Figure 5). The standard also allows for the connection of non-standard analyzers. However, non-standard analyzer connection may require an operation or maintenance space between the units. An independent conveyor belt, or track line, overcomes the obstacles associated with connections which will allow sampling directly from the conveyor. A number of clinical instrument units have already been developed, or are currently under development (Table 1)(Figure 8).
The Open LA21 Project standard has been engineered to allow ultimate flexibility in clinical laboratory design.
The development time schedule for a number of clinical analyzers that adhere to the Open LA21 Project standard is depicted. Some systems were completed in 2001.
The following modules have been under development as of September 2002.
There is no limitation to the number and functionality of modules that the project members hope to develop. In other words, as long as the manufacturer conforms to the Open LA 21 Project standard, they may develop and sell transportation, as well as analytical modules in competition with other participating companies. Thus, the only qualification to be a member of Open LA21 Project is whether you're interested in developing common standard modules or not. Ultimately, it is expected that there will be no market for equipment that does not adhere to the standard. The Open LA21 Project committee also welcomes laboratory equipment customers and users to join this initiative as advisors.