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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.
- Communication
Focuses on information exchange between computers, and the standardization
of test names and methods is also included.
- Electromechanical interface
Focuses on the integration of mechanical equipment, but electric signals
are also studied.
- Specimen containers and racks
Focuses on transportation systems, but the standardization of size and
specimen containers and racks in automated analyzers is also included.
- Specimen ID
Focuses on specifications of bar code labeling and identification
- 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.
5.Conclusion
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.
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