1-2.Trends in the standardization of laboratory automation systems

Takashi Kanno
(Professor of Laboratory Medicine, Hamamatsu University School of Medicine)

It is (almost) impossible that a laboratory automation system can be constructed using analyzers made by only one manufacturer. Analyzers that make up a laboratory automation system vary greatly from biochemical tests to hematological tests and to immunochemical tests, and it is clear that laboratory systems including specimen transportation will consist of components that are made by various manufacturers. It is thus absolutely necessary to standardize components. NCCLS have started an area committee for laboratory automation in 1996, and their activities have considerable impact on trends in the standardization of laboratory automation systems. This article will focus on trends in the standardization, introducing the activities of this committee.

1.Five approaches to standardization

NCCLS decided to approach the standardization of clinical laboratories in five ways, and formed one subcommittee for each subject.

a. Communication
Focuses on information exchange between computers, and the standardization of test names and methods is also included.
b. Electromechanical interface
Focuses on the integration of mechanical equipment, but electric signals are also studied.
c. Specimen containers and racks
Focuses on transportation systems, but the standardization of size and specimen containers and racks in automated analyzers is also included.
d. Specimen ID
Focuses on specifications of bar code labeling and identification
e. Status indicator and troubleshooting
Focuses on trouble-shooting, namely, methods for displaying the system status and ensuring proper response to problems. This area of standardization must also be discussed from the viewpoint of medical treatment.

2.Necessity of propaganda in the standardization

In certain respects, propagation of the standardization is much more important than making up drafts of the standardization when dealing with laboratory systems. Even when members of the committee come to agreements, if they are not enforced and/or manufacturers ignore them, then such agreements are basically meaningless. In the above-mentioned five approaches, they are also attempting to establish international standardization. Once adopted in all areas of laboratory operation, it needs to be strictly enforced by everybody.

3.Economical effects of standardization

In the past, when constructing a laboratory system, there were many problems associated with information exchange between analyzers, and the interface between analyzers and laboratory systems, resulting in considerable waste of time and money. Since standardization will solve these problems, both manufacturers and laboratory staff can save both time and money by standardizing all aspects of laboratory automation systems.

4.Responses to the NCCLS's committee for laboratory

automation and subcommittees in Japan
NCCLS has asked for the cooperation of JCCLS in the standardization of laboratory automation systems. JCCLS formed a Japan committee for laboratory automation, and a working group (WG) to examine certain specific issues which have been standardized by NCCLS subcommittees. The working group was formed by selected members from such organizations as the Japan Society of Clinical Chemistry, Japan Society of Clinical Pathology, Japan Association of Medical Technologist, The Association of Clinical Laboratory Reagent, and Japan Association of Laboratory Automation.
Some items will not be applicable to the Japanese market, while others will need to be analyzed further. Another exciting aspect of this process is that many of these issues are being debated mainly via e-mail.


Once the need for standardization became clear, I was keenly aware that, based on the history of laboratory automation, the standardization of laboratory systems must be investigated on a global scale. Many of my colleagues who have studied transportation systems are making considerable contributions to the standardization of laboratory automation systems. The activities of the above working group, committee and NCCLS will be discussed further in many future publications. I am grateful to be given a chance to introduce these important activities, and am looking forward to news of their progress in the future.