1-4.Standardization of laboratory automation systems:connection of analyzers

At present, many commercially available specimen transportation systems are restricted in that the number of available compatible auto analyzers and specimen transportation units is low. Users can not simply select different analyzers to construct a laboratory system. In particular, it is almost impossible to construct a User Oriented laboratory automation system using analyzers made by different manufacturers. The problem is two-fold: most manufacturers design their specimen transportation units to match their auto analyzers, and there is no standard for connecting auto analyzers and a specimen transportation unit.
To solve this problem, the entire concept of auto analyzers must be changed and its sample leading units must be designed independent from analysis part to adapt to STS. Furthermore, it is important that auto analyzers have Direct Track Sampling capability so that they can draw specimens from a specimen transportation line.
Moreover, it will be necessary to standardize the connection between specimen transportation units and auto analyzers: standardization of hardware specifications such as the height and width of transportation system units, and of aspects of software such as information exchange specifications. In this article, the standardization of laboratory automation systems is discussed, with an emphasis on the activities of the working group from the Committee on Analytical Systems of the Japan Society of Clinical Chemistry.

This Committee on Analytical Systems began a project on the standardization of specimen transportation systems in 1995, and recommended the standardization of specimen racks in January, 1996. This committee is currently studying the standardization of the connections between specimen transportation units and auto analyzers in two stages: in part 1, the standardization of sampling locations (physical relationship between analyzers and specimen transportation units) is investigated, and in part 2, the standardization of communication protocol between auto analyzers and the sample transportation systems (STS) that control specimen transportation lines is evaluated.

This standardization aims at instruments that sample specimens placed on a transportation line. These instruments are auto analyzers and auto aliquot units, and they are connected to a specimen transportation unit as shown in figure 1.
In other words, a specimen transportation unit identifies incoming specimens, and when specimens that need to be analyzed by the attached sampling machine arrive, the unit will direct such specimens to the sampling point (marked by in figure 1). Once a specimen reaches the sampling point, the instrument will extend a nozzle and sample the specimen. After the completion of sampling, the specimen will be returned to the main transportation line. These types of specimen sampling instruments that are connected to a specimen transportation unit are the subjects of this standardization.

Figure 2 shows an overview of this standardization. The height of a specimen transportation unit is defined as the distance between the floor and the top of the belt, and the position of a specimen container is defined as the distance between the top of the belt and the bottom of the container. In addition, the height of a sampling nozzle is defined as the distance between the floor and the tip of the nozzle when it is positioned on top of the specimen container, and the distance that the nozzle travels to the top of the specimen container is defined as the distance between the side of the instrument and the center of the nozzle.
However, these numeric values have not been finalized, and in particular, the distance a nozzle extends from an instrument needs further discussion.

By standardizing specimen sampling instruments and specimen transportation units, it is possible to construct an effective laboratory system using auto analyzers made by any manufacturer. In addition, as shown in figure 3, each auto analyzer can easily be exchanged with any analyzer and connected to a specimen transportation unit. Furthermore, since the same software can be used to connect each analyzer to the LIS, it is not necessary to use new software. This type of configuration is known as "plug and play" among U.S. industries.
The biggest advantage of standardization is the enabling of the plug and play function, and furthermore, considerable cost savings can be realized by eliminating the need to purchase attachments, modify existing instruments and units, and develop new connection software.

The importance of standardization is recognized throughout the world, and working groups from the NCCLS and the JCCLS are actively tackling this vital issue. Many believe that an integrated standardization will be established in the near future. Nonetheless, the most important point will be how manufactures and users react to the implementation of standardization. It will be necessary for users and manufacturers to reconfirm the importance and necessity of standardization so that standardized instruments and units can be manufactured and laboratory automation systems can be constructed using standardized parts.