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Slide#1
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I wish to thank our hosts for their kind invitation to lecture to the 3rd
biannual Cherry Blossom Symposium: Dr. Takashi Kanno, Vice President, Hamamatsu
University School of Medicine, Dr. Jutaro Tadano, in the Department of
Laboratory Medicine at Saga Medical School, and Dr. Masahide Sasaki, at
the Yamaguchi Red Cross Blood Center. My special thanks also goes to Akira
Iragashi from the A&T Corporation who is a sponsor of this event.
Over the last several days of the Cherry Blossom conference we have hear
about how great improvements in automation technology have impacted the
biochemistry, analytical instruments, infrastructure, and the management
of clinical laboratories. The automation revolution in medicine was started
primarily by the successful implementation of automation by Japanese laboratories
in the early 1980s. In particular, Dr. Masahide Sasaki has been viewed
as one of the pioneers in anticipating the need for significant error and
cost reduction in clinical laboratories. Anticipating and implementing
new technologies will be the primary focus of successful laboratories in
the future. The focus of this lecture will be the many opportunities for
automating not only the laboratory but the hospital as well.
New technologies promise to revolutionize medicine in a way that automation
has begun to change the practice of laboratory medicine. |
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Slide#2
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The Medical Automation Research Center and Carilion Biomedical Institute
has as its mission to improve healthcare quality and efficiency through
the development of advanced technologies. |
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Slide#3
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This is a picture of the famous Rotunda at The University of Virginia.
This building and the entire academic campus was designed by Thomas Jefferson,
the third president of the United States. |
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Slide#4
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In order to orient you geographically as to where the Medical Automation
Research Center is located, I have marked the University of Virginia with
a red circle in the middle of this map of Virginia. The MARC has two additional
collaborating partners, The Carilion Biomedical Institute in Roanoke, and
the Optical Sciences and Engineering Research center in Virginia's engineering
university, Virginia Tech. I have also marked the capital of The United
States, Washington D.C. which is located between Virginia and Maryland.
The University of Virginia is only a two hour drive from Washington D.C. |
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Slide#5
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The University of Virginia has approximately 15,000 students and faculty.
The MARC is located in the Health Sciences Center pictured here in the
picture. We have also started a new business incubator near the Medical
Center. |
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Slide#6
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The ALA was founded at The University of Virginia. We host 2 international
conferences each year, LabAutomation in California in January, and smallTalk
(a nanotechnology conference) in California in July. We also publish the
Journal of the Association for Laboratory Automation (JALA) to keep our
members aware of the latest developments in the field. |
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Slide#7
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The motivation for our focus on medical automation is the rising cost of
medicine, the documented high error rate in diagnosis and treatment of
patients, and the global increase in the elderly in the general population.
In addition, patients are demanding tools in order to manage their own
health care. |
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Slide#8
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The impact of technology on hospitals will be and improved physician efficiency
and efficacy by linking health outcomes to medical practice. Specific technologies
are already having a major impact on medical practice including: Pharmacy
assistants (palm pilots equipped with pharmacy data), Electronic medical
records that allow rapid diagnosis, and Point of Care diagnostic devices.
Technology is allowing the laboratory to partner with physicians in providing
rapid and reliable testing leading to better diagnosis and justifiable
therapies.
Hospital efficiency will be improved through new technologies such as resource
tracking, schedule optimization, inventory control, skill level assessment
and training, as well as process control. Ultimately, the patient will
be empowered by technology to play a greater role in their own diagnosis
and health care thereby creating even greater opportunities for laboratories
in data management and result interpretation. |
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Slide#9
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The motivations for automation within the USA medical system include a
rapidly rising cost of medicine, intolerable error rate, and a need for
increased hospital efficiency. Technology is not making a significant impact
on the cost, error rate or efficiency of medicine despite the fact that
in 1998 nearly 50% of the world?fs production for medical device and diagnostics
technology is in the USA, accounting for $70B in production, and that the
USA produces 3 fold more medically oriented patents than the rest of the
world, (1). Many technologies are difficult to use, require user training,
and are not accessible to patients for home care.
1. Innovation and Invention in Medical Devices: Workshop Summary (2001),
Kathi E. Hanna, Frederick J. Manning, Peter Bouxsine, Andrew Pope, Eds.
Institute of Medicine, National Academy Press, Washington, D.C., http://books.nap.edu/books/0309082552/html/R1.html#pagetop |
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Slide#10
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If one compares Japanese medical expenses to other industrialized countries,
it is obvious that the Japanese have been able to contain costs per capita
(or per individual) to almost half of the United States. Some would argue
that lower costs are a result of lower paid medical personnel, and using
medical care more judiciously. However, even in countries where medical
care is less costly, technology can improve medical care delivery while
maintaining lower costs. |
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Slide#11
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The Japanese medical system achieved their goals of greater equity in the
access to health care as well as greater empowerment in allowing the patient
to determine the kind of health care they wish to receive. There is a diversity
in health insurance methods, but these are generally accessible to every
Japanese citizen. Japanese health care seems to be delivering a quality
product if one measures life expectancy and
infant mortality rate. However, according to Hiroya Ogata, Professor, Department
of Health Care Management and Administration Graduate School of Medicine
, Kyushu University, the Japanese medical system does not seem to deliver
increased efficiency and patient empowerment. Japan performs well in medical
care costs when compared to the top 7 industrialized countries. However,
there is much internal discussion about poor efficiency and over use of
medications in the elderly Japanese. The issue of efficiency has been addressed
in laboratories in Japan through extensive use of automation. However,
there are significant new opportunities for the use of automation in improving
hospital efficiency. |
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Slide#12
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The cost associated with elder care is a large part of health care in Japan.
In this slide I show the increase in Japanese health care per year from
1993 to 1997. In Japan, the cost of health care in 1997 was 29 Trillion
Yen. The cost of caring for the elderly accounts for 30% of health care
costs. This is one of the highest percentages in the world for the costs
of caring for the elderly. |
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Slide#13
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The demographics of the elderly patient population in Japan suggests that
you are nearer a crisis level of elderly patients entering the health care
system as compared to the United States. However, given the much higher
cost of medicine in the USA, the cost of caring for the elderly far exceeds
that of eldercare in Japan. |
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Slide#14
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The costs in medicine will closely parallel the prevalence of chronic disease.
It has been estimated that caring for patients with chronic disease contributes
to 50% of the total cost of medicine. This graph from the US government
shows that the leading chronic diseases in men and women over the age of
69. In men the leading chronic diseases are arthritis, hypertension, heart
disease. In women the leading chronic diseases are arthritis, and hypertension.
Hypertension causes more deaths than all the other chronic diseases combined. |
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Slide#15
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Errors in medicine result from professionals who are overwhelmed by the
complexity of operating technology that was developed with minimal regard
to the user interface. |
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Slide#16
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While I am on the subject of errors medical errors, I will briefly discuss
error reduction strategies. Many have tried to reduce errors by altering
fundamental human behavior including continuing education, positive feedback
and reinforcement, guidance in process improvement, administrative rules,
financial incentives, and finally financial penalties. Obviously, changing
human behavior is time consuming, and rarely successful. |
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Slide#17
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Instead of using traditional solutions to medical errors I have just described;
retraining or penalties, Automation provides an alternative approach is
to simplify technologies so that errors cannot occur. In addition, it is
important to monitor the use of technology on a continuous basis by providing
computer oversight of all medical procedures. Computers are capable of
alerting the user as soon as or before an error has occurred. |
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Slide#18
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Let us turn our attention for a moment to the future of laboratory automation |
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Slide#19
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This slide shows the specimen arrival rates in seven US laboratories. It
is obvious from many of these graphs that there is a large peak in the
middle of the day when many of the specimens arrive. Laboratories must
size their automation to accommodate the turnaround needs of physicians
that need their data in time for patient rounds in the morning, or while
the out patient is sill in the physician?fs office. |
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Slide#20
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The selection of automation systems for the laboratory is challenging even
for automation professionals. There are a wide range of choices for automating
the laboratory. The choice of equipment is based on the cost and samples
per year (in millions). In relatively low volume laboratories, workstations
are the best selection for automation. Workcells can accommodate the needs
of laboratories with 1-2.5M tests. |
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Slide#21
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Three recent publications have suggested that laboratory automation may
be able to give laboratories a reasonable return on investment. For example,
Seaberg, Statland and Stallone at the North Shore ? Long Island Jewish
Health System in New York (USA) have demonstrated that a total laboratory
automation system can potentially save 49 full time individuals in a large
core laboratory. Seven hospitals were projected to send almost two thirds
of their total medical specimens to a centralized core laboratory. The
cost savings to the entire system was projected to be approximately 49
individuals or a reduction in 15% of the total number of employees.
Peterson from the University of Texas Medical Branch, Galveston, Texas
published a projected cost analysis for their laboratory automation (ref).
In their study, they projected a $2,350,000 savings from the reduction
in 30 FTE (25% reduction). This site was not able to justify the purchase
of the automation system. However, they have realized significant savings
following the reorganization of their laboratory. Pearlman at Centralized
Laboratory Services, Inc., Long Island City, NY projected a 3 year pay
back for a Roche Modular system. The CLS laboratories perform 7.2 million
laboratory tests per year. An added bonus for this system was the reduced
floor space that was used. Thus we have 3 published examples of cost savings
for large laboratories through the use of automation. However, are there
automation solutions for small laboratories, or laboratories that wish
to maintain a broad vendor base for analytical systems? |
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Slide#22
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Recently, vendors have completed the design and production of pre-analytical
processors. We tested a pre-analytical processor that was advertised to
operate at a rate of 500 samples per hour. We performed a clinical trial
of over 4000 specimens during a three month trial period. We tested input
rates of 40 to 300 tubes per hour creating from 1 to 5 aliquots. In addition
we calculated the return on investment and reduction in error rates for
this type of automation in laboratories. |
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Slide#23
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The preanalytical processor installed easily in under two weeks. |
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Slide#24
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In this slide we carefully examined the throughput of the pre-analytical
processor. For example, we loaded 40, 72, 104, 68 or 96 tubes. Each of
these batches were subjected to different sorting and processing conditions
to simulate events that will be encountered on a daily basis in most laboratories.
The average time necessary to complete the processing of the primary and
secondary tubes is shown on the x axis. The most important outcome of this
study demonstrated that over 500 tubes could be processed each hour when
80% of the tubes were centrifuged and split into two aliquots. |
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Slide#25
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This table compares several pre-anlaytical processors on the market. The
highest throughput achievable is approximately 600 tubes per hour by the
Roche MODULAR. The industry standard is closer to 300 tubes per hour. |
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Slide#26
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This slide was obtained from Dr. Demers at Penn State University Medical
Center (Hershey, PA). In his studies, he demonstrated that the number of
errors each month dropped from 10K to 2K for sorting and routine errors.
If you focus on the right hand column you can see that there was an 80%
reduction in sorting and routine errors, pour off errors, labeling errors,
and almost a complete elimination of biohazard exposure events. |
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Slide#27
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Pre-analytical processing was also a cost saver since there was a drop
in manual processing steps from 75K to 25K and a drop in laboratory personnel
from 12 to 8, or a 33% drop. |
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Slide#28
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In the future, there will be increasing opportunities for automation of
microbiology, molecular diagnostics, and proteomics through microfabrication
technologies. These tools will then enhance the ability to improve service
to patients. The greatest service delivery opportunities in laboratories
will be in the sectors of self care and eldercare.
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