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The 3rd Cherry Blossom Symposium

Clinical Laboratory Automation System in Korea - System Design and Application-

Yong-Joom Lee (National Cancer Center of Korea)


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Slide#1
Thank you!
Good afternoon, ladies and gentlemen!
I'm Young-Joon Lee of Korean National Cancer Center.
I appreciate that the Organizing Committee of the 3rd Cherry Blossom Symposium give me a chance for the first oral presentation today.
I will talk about Clinical Laboratory Automation System (CLAS) in Korea with the view point of system design and application.
This presentation was prepared with a kind help from Professor Jin Q Kim of Seoul National University Hospital, chairman of this session and Jinsung Meditech company.

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This presentation includes current status of LAS in Korea, some considerations for establishment and upgrade of LAS, its layout and application, its problems, and the future.

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First of all, I summarized current status of LAS in Korea.

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This table shows the list of Korean hospitals that have LAS, the year of installation, and their manufacturers.
Since Samsung Medical Center established LAS of IDS in 1994, nine hospitals installed LAS up to now and many hospitals have a plan to use LAS in Korea.
IDS, Hitachi, and A&T are all famous Japanese LAS manufacturers and they have supplied LAS to large or medium sized hospitals.
Our National Cancer Center Hospital is a medium-sized hospital and I have used A&T system for two years.
And, a couple of days ago, I heard that Kosin University Hospital decided to install LAS of Ortho-Clinical Diagnostics.

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Next, I will mention about general considerations for establishment of a LAS.
This helps you to understand the characteristics of various AS in Korea.

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Open or Closed systems must be compared. A&T and IDS provide a open AS but Ortho-Clinical Diagnostics developed a closed system only for their Vitros analyzers.
Space of clinical laboratory is a very important factor for system design and installation.
Test items must be determined before selecting analyzers. It depends on the characteristics of each hospitals.
And then distribution and workflow of tests should be clearly defined.
An emergency laboratory could be integrated in or separated from the main AS.
It would be better to prepare compatible back-up analyzers in the LAS.
Another supportive conditions include laboratory access floor, UPS (urgent power supply), fire prevention, and water supply with stable pressure.

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From now, I'll show you some examples of layout and application of LAS.
You can find various combinations of analyzers in LAS and the characteristics of each hospital may explain the differences.
As I mentioned previously, in 1994 Samsung Medical Center installed LAS for the first time in Korea and this large hospital is testing thousands of samples per day.
It is composed of two Hitachi chemistry analyzers, a Sysmex HST hematology and a Stago coagulation analyzers.
It was designed as a large integrated laboratory and it had a great effect on the AS in Korea.

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Asan Medical Center is the biggest hospital in Korea and in 1995 they installed LAS in the laboratory only for outpatient test.
Only one Hitachi chemistry analyzer is linked to the Hitachi preanalytical module and hematology, coagulation, and esr analyzer is not connected to the LAS.
It shows a different kind of application only for chemistry sample preparation.

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Daejin University Bundang Hospital is a medium-sized general hospital.
They integrated not only a Toshiba chemistry, a Axsym immunoassay, and Coulter hematology analyzers but also a urine analyzer. It is an interesting combination of analyzers.
It is a good example of integrated AS with various test items suitable for medium sized laboratories.
But, the preanalytical units need relatively large space.

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Ilsan Hospital is also a medium-sized general hospital established by Health Insurance Facilities of Government.
Their system has two Hitachi, an Abbott Architect for immunoassay, and a Sysmex HST hematology analyzer.
As one Hitachi-747 analyzer has capacity of more than 300 samples per day, the other Hitachi-747 seems to be prepared for an intermittent large scale-test of routine health check program and also for a back-up analyzer.

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Chungnam National University Hospital is a relatively large hospital and has an A&T system with a Hitachi-747 for routine chemistry, an A&T 502X analyzer for special proteins, electrolyte and TDM, and an Architect for hormone and tumor marker assays.
This system has short and compact preanalytical unit compared with IDS system.
Although it does not always mean that the compacter the better, A&T system has a benefit for a narrow laboratory space.

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Soonchunhyang University Hospital is a medium-sized general hospital, but the LAS seems to be prepared for a future large hospital according to their plan.
I think that one Toshiba for routine chemistry and one 502X for electrolyte, special protein and urine chemistry is sufficient for their present need.
They use Bayer Centaur for hormone and tumor marker assay.

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Our National Cancer Center Hospital is a medium-sized but cancer-oriented hospital.
Our LAS is very similar to that of Chungnam National University Hospital except for integration of a coagulation analyzer, Coagrex-800.
Tumor marker tests are main items of Architect and Centaur is used for off-line back-up analyzer.
But, the coagulation analyzer has some problems such as speed and duration of centrifugation and short CTAD tube is not suitable for A&T's centrifugation block.
I think our A&T system is the most compact and the analyzers are well arranged for efficient operation except the coagulation analyzer. It means that preanalytical units and analyzers could be observed and controlled even by one technician in the center of the system.

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Seoul National University Hospital is a Big hospital and the LAS is designed only for chemistry analysis by professor Kim.
There are two Toshiba and one Hitachi-747 for routine chemistry, 502X for urine and special chemistry, and two A&T EA07S analyzers for electrolyte.

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Slide#15
Kosin University Hospital is a medium-sized hospital and they will install an Ortho LAS this year.
Ortho LAS is a 'closed' system but has a well organized and compact design with the dual line conveyor system.
There are two Vitros 950 for routine chemistry, one Vitros 250 for urine tests, one Vitros Linx 30 for TDM and special chemistry, and one Vitros ECi for immunoassay.

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Next I'll talk about some Problems of currently used CLAS.

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There is no integrated QC data management program in the LAS controllers.
The stability of LAS main control program should be guaranteed by the manufacturers. I experienced control program errors that have a direct effect on test results. These are under investigation.
Flexible analyzers for immunoassays are needed for more efficient application of LAS.
Standardization of LAS hardware and software should be achieved for easy application of various analyzers to different LAS.
Flexibility of preanalytical units is also important for broad use of LAS. For example, decapping units that could open all kinds of sample tubes should be developed.
Rapid technical support of high quality is to be prepared for LAS users.
And the high cost is still a negative factor of LAS installation.

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This is a comparative table for immunology analyzers.
Here you can see the limitation of Architect and Centaur especially for viral marker, tumor marker, and cardiovascular marker.
Analyzers such as Axsym and Vitros ECi have various test items compared with others, so they seem to be good candidates for LAS.

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Some hospitals started to consider upgrade of their LAS.
So I would like to tell you some important factors to be considered.

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First, exchange or expansion of previous system,
Second, establishment of additional LAS with a different role at a new place,
Third, flexibility and capacity of analyzers
Fourth, need for remodeling of laboratory,
And finally, redistribution of laboratory technicians.
I'll show you some examples in the next two slides.

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This picture is a LAS of our National Cancer Center Hospital.
I want to replace the coagulation analyzer with a new immunology analyzer that covers nearly all items of tumor markers and viral markers.

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This is the tentative upgrade design of Seoul National University Hospital in the near future.
Conveyor system should be expanded to include Architect and Coagrex system.

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CLAS will bring us great changes in the future.

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Laboratory tests will be integrated to on-line LAS more and more.
We will have to reclassify laboratory sections because of the highly integrated test items.
Doctors and technitians of laboratory medicine will be able to improve laboratory quality and clinical service.
Automated analyzers for molecular tests using DNA chips or protein chips will be developed and integrated in CLAS.
And all of these will change the paradigm of Laboratory Medicine.

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Slide#25
Now we are in the time of dawning in terms of CLAS, and I hope to see the glory of sunlight, soon !!!

Thank you very much for your attention.

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