Conference Speeches Offer Useful Insights

Asian labs approach automation in ways that are different from North American labs

CEO SUMMARY: There is an interesting dichotomy between Asia and North America. The same problems and challenges exist in both regions—declining reimbursement and budgets, labor force issues, and the need to spend more for new diagnostic technology. Yet laboratories in both regions see automation from different perspectives. Here’s a summary of several presentations given at the Seoul conference.

WITH SPEAKERS FROM NINE COUNTRIES talking about a broad range of topics, the laboratory automation and robotics conference offered a unique look at this field.

However, for many reasons, the strongest emphasis was given to laboratories from the host country, Korea, and from Japan, where laboratory automation was first developed in a serious way. It was obvious that laboratories in both Japan and Korea have gone further with laboratory automation than most laboratories in countries like the United States, Canada, the United Kingdom, and Australia.

Challenges Are The Same

Moreover, the challenges and themes discussed by speakers would ring true with pathologists and laboratory man- agers here in the United States. For example, the conference’s lead-off speaker was Eun Hee Lee, M.D., Ph.D., who is Vice President at Green Cross Reference Laboratory, located in Seoul, Korea.

At the start of her presentation, Dr. Lee observed that “unlike most businesses in Korea, clinical laboratories are not free to increase their prices in response to price increases. That’s because the government health program in Korea largely dictates the prices paid for laboratory testing.”

Green Cross Laboratory is a for- profit lab company that is a true reference/esoteric laboratory serving Korea. Specimens from hospitals and some physician clinics are referred to it each day. “Our workload [specimen volume] increased at the rate of 8% per year in recent years,” noted Dr. Lee. “By 2004, we had reached the maximum workload and could not process any more tests with our existing, stand-alone instrument systems.”

Confronted with increased volume, rising costs, and tight reimbursement, Green Cross opted for laboratory automation and the Bayer ADVIA Labcell was its solution. Once implemented, this automation not only resolved the throughput constraints of the existing laboratory, but gave Green Cross additional capacity to meet the increases in specimen volume projected for the coming years.

Dr. Lee noted that, after implementation, the number of tests per FTE increased from 1,250 to 1,600. Because of the shift to primary tube use and the reduction of aliquots, the number of tubes handled in the lab each day was reduced by 40%.

Following the conclusion of the conference, THE DARK REPORT was able to visit the Green Cross Laboratory. More comments about the site tour and this laboratory can be found on pages 11-14.

Open vs. Closed Systems

One of the interesting insights which emerged is that “open system” automation solutions are often found in laboratories in Asia. For example, Yuanchun Zang, M.D., Director of Laboratory Medicine at the China- Japan Friendship Hospital in Bejing, China, discussed the design and implementation of a pre-analytical system in his laboratory.

According to Dr. Zang, at the end of 2005, there were only seven laboratories in China with significant automation. Major vendors to date have been A&T, Beckman Coulter Corporation , and Olympus Corporation. Dr. Zang’s laboratory is implementing a pre-analytical automation system from A&T which connects to two Abbott Architect 1200s and a Hitachi 7600-PP.

Large hospitals, at 1,000 beds or more, are common in Asia. Further, these hospitals are generally connected to a related outpatient clinic of comparable size. For that reason, the hospital laboratory is frequently handling significant volumes of specimens. This is one reason why these laboratories were motivated to look at automation years ahead of labs in North America or Europe, for example.

An example of automation in a super-sized hospital is the Asan Medical Center and University of Ulsan College of Medicine, located in the eastern suburbs of Seoul, Korea. It is adding 400 beds to its existing 2,200-bed facility. Each day it serves 8,000 outpatients.

Large Laboratory Operation

The laboratory is large. During 2005, it performed 25 million tests. It handles 3,300 specimens and 2,300 specimens per a day in chemistry and hematology, respectively.

In his remarks, Won-Ki Min, M.D., Ph.D., Professor and Head of Clinical Chemistry for the Laboratory Department at Asan Medical Center, stated that the laboratory’s prime focus was to support the outpatient clinic’s goal of “same day” service. “The objective is for patients to visit their physician with test results as soon as possible in the same day that the sample was collected,” stated Dr. Min. “This was a change from the existing situation, which required the patient to come in for specimen collection several days before his or her visit with the doctor.”

Dr. Min noted that the laboratory was only one contributor to this goal. Efforts to reduce turnaround time are also under way in other diagnostic services at this facility, such as MRI, EKG, and endoscopy.

Same Day Reflexive Tests

To achieve faster turnaround time in support of same-day outpatient service, laboratory automation was only a fourth-phase solution. “We named our project ‘reflexive tests for physicians without additional sampling’,” explained Dr. Min. “We organized the laboratory so that routine results would all be reported to physicians by 11 a.m.,” he said. “That was stage one. Stage two was the implementation of a new information system.

“With the information system in place, stage three was the introduction of what we called ‘reflexive tests by clinicians without additional sampling’, Min continued. “One way the new information system supports this is by prompting the ordering physician to the possibilities of specific reflexive
tests. The system allows the physician to select these reflexive tests and produce bar labels for same-day reflexive tests.

“For SST specimens our laboratory offers 51 possibilities for a reflexive test,” explained Dr. Min. “For EDTA specimens, there are three tests that can be reflexed.”

Stage four will be further automation in the laboratory. “By 2010, we would like to have conventional laboratory automation in place, supplemented by the added functions of level detectors to determine if enough sample volume exists, refrigerated storage dedicated to storage of samples for reflexive testing, and management software for this system,” concluded Dr. Min.

Not every presentation w a s focused on automation of work processes in the laboratory. One fascinating presentation involved automation of hospital infection control through the use of the electronic medical record (EMR).

Reducing Infections

This presentation was made by Satoshi Kimura, M.D., Ph.D., who is Director of the Central Clinical Laboratory at the 661-bed Showa University Northern Yokohama Hospital in Yokohama City, Japan. Surveys of Japanese patients reveal that long waiting time is their major complaint. The second biggest source of dissatisfaction is hospital-acquired infections,” observed Dr. Kimura.

To address this problem, we developed four new capabilities to interact with our EMR,” he said. “First, we built a warning/advisory function into the EMR. Each patient name is coded in a color that represents one of four infection control precaution levels. This is to alert physicians and hospital staff about which patients have pathogenic agents and which situations might lead to transmission of such pathogens. As part of this function, the clinical laboratory sends information about detected micro-organisms directly to the EMR.

Color Codes For Risk

“The color blue is used for patients with active tuberculosis,” stated Dr. Kimura. “Green stands for patients with MRSA (methicillin-resistant S. aureus) and red represents active viral hepatitis.

“Our second enhancement is an automatic, real-time survey for hospital infections,” continued Kimura. “The EMR automatically counts the number of patients with infectious diseases. Statistics on control levels are built into the system. The infection control team then monitors the results and trends. Where warranted, they take action.

“The third feature we built into the EMR is an automatic survey for any patterns of antibiotic resistance,” he noted. ‘The EMR can present a single table which shows microbiology infection control patterns. Sensitivity to antibiotics is shown in this table.

Monitoring Antibiotics Use

“Our fourth feature is an automatic survey for antibiotics usage,” added Kimura. “Because over-prescribing of antibiotics is a factor in the development of multi-drug-resistant bacteria, we want to control use of antibiotics.

“Built into the EMR, this function monitors antibiotics usage by all the patients in our hospital. When the system detects excessive use of antibiotics, it flags the infection control team so it can advise the attending physician.”

Dr. Kimura did not provide specific data about outcomes and how this effort has changed the base line numbers of hospital-based infections. He did observe that, since adding these four functions to the EMR, there are fewer major outbreaks in his hospital.

Another fascinating topic was a project in Japan to harmonize and standardize laboratory tests across all laboratories within the Fukuoka Prefecture, an area with a population of about five million people. The presentation was made by Naotaka Hamasaki, M.D., Ph.D., Professor of Clinical Chemistry and Laboratory Medicine at Nagasaki International University in Nagasaki, Japan. In simplest terms, during the mid-1990s, baseline data was developed, using data from several large labs in the prefecture. The resulting standardization parameters were adopted by 97% of the institutions in Fukuoka Prefecture. These standards are updated every five years.

The project centers around “22 clinical chemistry analytes and serum protein constituents (IgG, A, M, C3, C4) in Fukuoka.” Dr. Hamasaki noted that “there is a daily survey of the reference laboratories and a monthly survey of all regional laboratories participating in the project.

“In the daily survey, 23 out of 27 analytes are within the allowable bias ofn0.25BA,” he said. “In the monthly survey, 13 out of 27 analytes were within the allowable bias of 0.25BA.”

“One outcome of this project is that the inter-laboratory variation has decreased, mainly in clinical chemistry measurements,” continued Hamasaki. “This has accomplished the primary aim of this project.

According to Hamasaki, the long term goal is to make this a national laboratory standardization effort. The parallels to this project and developments in the United States are intriguing.

“We are planning to increase the number of measured analytes and also expand the regions participating in this standardization project,” he said. “We now also use the Internet to allow the standardization project to work and report in real time.”

According to Hamasaki, the long term goal is to make this a national laboratory standardization effort. The parallels to this project and developments in the United States are intriguing.

In the United States, there are strong efforts to get all clinicians to consistently follow recommended practice guidelines. The goal is to reduce variability in care. As this happens, it is feasible that the American healthcare system might want more uniformity in the laboratory test results which would populate the patient’s universal electronic medical record (EMR).

Reduce Variation In Care

This could lead to calls for all laboratories in a region to standardize their tests and harmonize laboratory data. Seen from this perspective, the project to harmonize and standardize laboratory tests across all laboratories within the Fukuoka Prefecture could be an early look at something which might happen in the United States in future years.

As the summaries of these six presentations demonstrate, there is a wide variety of innovation occurring in different countries. In some cases, these projects are ahead of what is happening in North America. Certainly some of these innovations are a product of the cultural environment, allowing these laboratories to do things that would be difficult to implement in the United States.

For example, imagine how difficult it would be in this country to have all the laboratories in states like Arizona, Maryland, and Minnesota (each with a population of about five million people like Fukuoka), to agree to standardize tests and harmonize lab test data. Yet that is what laboratories in the Fukuoka Prefecture have achieved! And this project is already in its eleventh year.

“ROBO ROCHE”

What’s a conference on laboratory automation and robotics without a robot! This big fella, about eight foot tall, could be found guarding the Roche Diagnostics exhibit. He delighted the crowd. After all, Asians are known to be attracted to the very newest in technology and gadgets. No word on when you may be able to purchase a “Robo Roche” to work in your lab.

Sonic Uses Software To Automate Processes

ONE OF THE MORE INTRIGUING PRESENTATIONS involved the use of software to write and apply rules that prevent errors in the lab testing process. It was presented by Alan Lloyd, MB.ChB, M.Med, Chief Systems Officer of Sonic Healthcare, Ltd. of Sydney, Australia.

“We are using software to guide decisions in three functions,” explained Lloyd. “First, we developed a decision support product that interacts with the physician management systems in doctors’ offices. This allows us to suggest appropriate tests based on the patient’s circumstances.

“Second, we have a sophisticated capability for workstation routing within our lab,” continued Lloyd. “For example, 70% of our specimens go from accessioning directly to analyzers without aliquoting. Further, this system won’t let a tube be accepted at an incorrect workstation.

“Third, we developed an Episode Expert System that guides many decisions within our laboratory,” he noted. “This is rules-based, is triggered by specific events, and checks all the parameters affecting the situation to determine what response will appropriately correct the situation.”

This system uses pattern recognition to identify opportunities for rules and define those rules. “Information used to develop rules based on pattern recognition allows the system to handle, automatically, about 80% of the common error patterns,” observed Lloyd. “The other 20% are more complex and can be handled by pathologists.”

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