1-1.Recent trends in the standardization of laboratory automation systems

Masahide Sasaki
(Professor of Laboratory Medicine, Kochi Medical School)


In recent years, there has been a global trend to standardize laboratory systems. The significance of this standardization is discussed in this article, exemplifying a case of Japan.
As the effectiveness of complete automated laboratory systems in laboratory operation continues to be proven in more and more laboratories, manufacturers are starting to develop similar laboratory systems.
Meanwhile, users have also begun to pursue the construction of increasingly advanced laboratory systems. As a result, various automated instruments, which are convenient and ideal if they are possibly constructed, such as, bar code printers, bar code labelers, high performance automated centrifuges, sample aliquot units, de-cap units, and automated storage refrigerators for analyzed specimens were developed, thus increasing the implementation costs of laboratory systems from several hundred million to several billion yen (US$1= about 120 yen/1997).
Since the implementation costs of such ideal laboratory systems are so high, the financial status of laboratory operations is in serious jeopardy. Expensive laboratory systems can not be installed in most laboratories, so if this trend persists, LASs will be successfully implemented only in large commercial laboratories and large hospital laboratories, and LASs will eventually be a high price beyond reach useless to most laboratories.

2.Origin of standardization

One of the reasons for the high costs of Lass is the fact that the shape of the specimen racks used for specimen transportation is not standardized. The shape of specimen racks differs greatly among manufacturers. As a result, when users attempt to construct a laboratory system using analyzers made by different manufacturers, since there is no common rack that can be used by all analyzers, the analyzers can not be linked as a single system.
One of the ways to solve this problem is to use a robot arm or other special apparatus to force all analyzers to use a common rack. However, it costs about 10 million yen (US$80,000.-) per analyzer to construct a robot arm and to improve the connection between each analyzer and the robot. Hence, the installation of ten analyzers would increase the cost of the system at least 100 million yen (US$800,000.-).
In order to deal with the above situation, it would be natural to think that a standardization of the shape of specimen racks at least should be pursued for rationalization. This is the origin of necessity of the standardization in LAS.

3.Standardization of computer systems

It appears that the same type of standardization is also necessary for computer systems. When computers were in their research and development phase, different computer makers developed their own hardware and software. New computers were developed with such alacrity that new products were introduced every six months, and new versions of software were also introduced continuously.
As a result, users who attempted to install increasingly reliable and faster systems, (then they) were forced to purchase new equipment continuously in order to update their systems. Furthermore, some newly developed hardware and software were not compatible with existing hardware and software. Consequently, every time the laboratory system was upgraded, users often had no other choice but to discard older software.
To avoid this type of wasteful investment in the future, laboratory system computer software must also be standardized.

4.Achieving standardization

Standardization is easier said than done.
This problem would have been easily solved in the era of monarchism. What mattered then was merely the opinion of the ruler, but now it is very difficult to make many opinions and reach a global consensus. For example, even though the metric system is widely being used in European countries, it is hardly used in America.
Someone must take the initiative and jumpstart the global standardization of LASs.
In 1992, Professor Takashi Kanno of Hamamatsu University School of Medicine proposed a plan to standardize the configuration of specimen collection cups and tubes at the Japan Society of Clinical Laboratory Automation. However, to this day, Japanese manufacturers have not made any changes to conform to the proposal. Their reasons are two-fold: one is that they will not change their products based on a proposal that was enacted in some society, and the other is that their sales are still rising despite ignore to conform to the proposal. Unfortunately, many Japanese manufacturers are still concentrating too much on short-term profits.

5.The Japan Society of Clinical Chemistry’s standardization

Some members of the Japan Society of Clinical Chemistry (JSCC) were also keenly aware of the need to standardize specimen racks to achieve total automation of all laboratory processes, including specimen transportation. To make the basis of standardization in Japan, they then hosted a forum on the “Necessary Standardization in Automated Analytical Systems” at the 14th Summer Seminar of the JSCC in 1994 ( The state was far ahead of the other countries). As one of the outcomes of the forum, the Machinery committee formed a specimen transportation rack project group.
This group formed the framework for a preliminary plan for standardizing specimen racks, then formed a working group with concerned manufacturers and studied the preliminary plan for two years. In 1996, JSCC introduced the following specifications as the draft for multiple specimen racks: maximum capacity of five specimens, 100 mm long, 25 mm wide, 20 mm pitch, and 60 mm high.
Furthermore, the same committee began standardizing the connection between specimen transportation systems and analyzers. First of all, the position of sampling probe was investigated [the height from the floor to the lower end of the probe, and the traveling distance of the probe from the analyzer], and at present, a preliminary plan is being drafted.
The same committee is also attempting to standardize the communication between analyzers and specimen transportation systems, so that analyzers and specimen transportation systems that are manufactured by different makers can send and receive data without difficulty. Currently, various areas of communication are being investigated: hardware, communication procedures and formats, control information interchange procedures, and information exchange with laboratory information system (LIS).
Many expect that by standardizing the connection specifications of both hardware and software, analyzers can be connected to transportation systems more easily, saving time and money.

6.Role of NCCLS

In 1991, scientists in the U.S. and Europe hosted the first International Conference of Automation and Robotics (ICAR). I became a member of ICAR in 1992, and participated in various discuss automation and robotics conferences overseas. Since 1994, I have stressed the importance of standardization in automation using various examples from Japan’s medical industry. Subsequently, debates arouse in the U.S. on the standardization of comprehensive automated laboratory systems that included an automated transportation system, before a new section on automated systems was established within the NCCLS to deal with issues related to the standardization of automated laboratories.
Meanwhile, the Japan Council for Clinical Laboratory Standardization (JCCLS) was formed several years ago, and the standardization of automated laboratories has been investigated along with the NCCLS since September of last year(1996). Consequently, the standardization of specimen racks that has been studied by the JSCC was also formally adopted by the NCCLS, and this issue is currently being investigated by both organizations.

7.Direction of standardization

Future standardization can not be accurately predicted. Nevertheless, I am confident that the NCCLS’s standard specifications will be established within several years. The reason is that the U.S. as a nation tends to take action to realize its goals rather than waste time idealizing objectives. Unlike Japan, America will spend money to achieve goals that have been set. For example, I have heard that a great deal of money has already been collected from related manufacturers as part of the effort to standardize automated systems. Unfortunately, the JSCC does not yet have sufficient funds to achieve standardization.

I would like to emphasize that it will be counterproductive to gather only eminent scientists and well-known professors to study standardization and draft proposals. It will be equally important to get feedback from experienced and knowledgeable technologists and laboratory personnel. We must not limit voting rights to those who provide funds. Furthermore, the standardization of laboratory systems must not be a platform for the self-advertisement of individuals or to increase the profit of individual manufacturers.
Once standardization plans are finalized, manufacturers and users should unite to promote standardization. If everyone adopts standardization and wasteful use of systems can be minimized, then LASs should be available at reasonable prices and be accessible to many laboratories. To deliver prompt and accurate the laboratory test results to physicians is to help ailing patients, and this need is what ultimately will contribute to the wide spread acceptance of LASs.