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Slide#1
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Today, I would like to talk about provisions that should be built into the next generation laboratory automation system. |
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Slide#2
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First of all, why is laboratory automation necessary?
There are several reasons as follow.
The main reason is to make laboratory testing procedures much more efficient. As a result of that, labor cost decreases and test reports are sent to doctors quicker, which improves productivity. Also, the quality of test results is improved (much higher) compared with the quality before LAS is installed. In order to improve quality, two tasks need to be done: quality control for test accuracy and individual data assurance.
This will be explained more later. Stabilized turnaround time and protection from biohazard infection are a couple of the benefits of automation. |
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Slide#3
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Automation has been believed to improve laboratories.
However, there were cases in the past where automation did not make improvements. Here are some examples. One example is excess investment. This is where the user purchased an expensive high-throughput analyzer that did not suit the laboratory. There were cases where there were no reduction in running cost, which includes labor, reagent and space.
In some cases, overinvestment in a large-scale LAS caused laboratories to run out of space. In other cases, because the surrounding environment such as LIS and/or sample transportation system to the laboratory were not set up, no effect of installing LAS took place. |
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Slide#4
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From these past unsuccessful cases we just saw, how could we optimize LAS? Here are steps to take in constructing an effective LAS. The most important is the designing of the entire laboratory. Designing includes operational procedures with hardware. The next step is constructing the sample transportation system, which is followed by selecting analyzers. Proceeding in this order, a high performance laboratory can be realized.
The next question is in order to construct an optimum LAS from a users point of view, what do manufacturers need to provide? |
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Slide#5
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The first provision is to build an integrated system of both LIS and LAS.
I will expand on this later. The second is to provide an open transportation
system that can connect optimum analyzers for high quality testing. Systems
which can only connect single manufacturer's analyzers, such as the workcell,
is not a user oriented system.
Standardization is essential for the implementation of open architectural connectivity.
For LAS standard, NCCLS standard is recommended. However, there is a problem
with efficiency because this recommended standard is partially based on
ready-made products. The standard which solves this problem is the Open LA21 standard.
Our laboratory automation system based on this Open LA21 standard is exhibited
here at this symposium. Please come and visit the display. Also, please
visit our website for details. |
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Slide#6
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In the recent medical field, quality of testing and security are starting to be emphasized. We see that the necessity for integration with LIS in terms of software is raised. In achieving this, the same manufacturer providing LIS and LAS is most ideal but in most cases they are different.
To handle these cases, a high performance middle ware as a LAS controller becomes essential. Once these systems are established, high quality testing can be carried out. |
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Slide#7
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This slide shows the main construction of LIS/LAS communication.
The types of systems we currently distribute are in the center and on the right. |
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Slide#8
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As you can see, capability for high quality testing can be built into LIS/LAS integrated systems. To improve the quality of testing, individual data management is necessary in addition to conventional quality control. Individual data management is a measure taken to search for sample mix-up.
Zone verification method we have developed is one of the methods which certifies individual testing data. The attempt to reflect the collective results of internal quality control within hospital laboratories as an external quality control is being experimented in Japan. Conducting external quality control a few times a year is not enough for the verification between facilities.
For this purpose, real-time communication function with external database would become required. |
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Slide#9
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This slide summarizes my explanation. Quality control and individual data
management together will make quality assurance possible. |
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Slide#10
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Next, I will explain about zone verification method. Zone verification
method will give assurance to each individual testing data in real-time.
This method is a verification function for assuring real-time individual testing data.
Acceptable range is set based on past testing results of each facility. |
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Slide#11
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This slide shows the acceptable range of both delta check method and zone method. In delta check method, acceptable range is sectioned by a straight line. In contrast, acceptable range of zone method is sectioned by a curved line based on past data. This varies depending on the hospital, consulting division, and the duration of elapsed number of days.
In zone method, verification is conducted with consideration in the condition
testing was done.
Needless to say, data from LAS are verified and retesting order is sent if necessary. |
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Slide#12
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Here is a summary of the navigation system necessary for laboratories.
RefDB is a tool which provides information on each testing to mainly clinical
doctors and nurses. Details on RefDB will be presented by A&T's Mr.
Makoto Yoshino in symposium 4, tomorrow.
There are other functions which also need to be installed: monitoring of
analyzers' conditions, taking appropriate measures for problems, as well
as remote function for manufacturer based on necessity.
Saving function for documentation of standard operating method or ISO related documents is also needed. |
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Slide#13
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This slide shows test information displayed on IBM ordering screen which is the client of Hospital Information System. If clinical doctors have any questions about the test items, they could search through HIS client
As you can see, providing testing information using the web is possible with the next generation LIS. |
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Slide#14
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Now I would like to talk about security function.
In terms of security of testing data, traceability function of testing process is required.
For security reasons, all operations are logged to server database. As you can see, as long as all processes are under control, it is easy to restore data at a time of an accident. In addition, TAT measurement is possible as a result of traceability.
And as a result, testing rate-determining process improves and leads to the construction of high quality laboratory. |
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Slide#15
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This slide showsthe journal viewer on LIS client screen. Each operational log is indicated along the time course. This screen shows operational logs by patients. |
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Slide#16
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In conclusion, the next generation testing system shall be an integrated system of conventional LIS and LAS.
To make this happen, same system design is required for the development of LIS and LAS. By having high intelligence in each transportation component, establishment of an efficient LAS will become possible. |
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Slide#17
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Thank you for your attention. |
