3-1.Transportation system-laboratory automation systems and one additional venue

Hirokazu Chikakiyo
(Chief technologist of Komatsujima Red Cross Hospital Laboratory)


As reform of the Japanese medical care system pushes forward, the role of clinical laboratories in new medical organizations is being questioned. Reform of insurance premiums related to clinical laboratories such as separation of premium for diagnosis and analysis, and "marume" the enclosure of insurance points for test groups began in 1988 forcing laboratories to perform fewer tests, thereby cutting the fees they can charge for each test. On the other hand, the usage and demand for laboratory tests continues to increase every year. Under these circumstances, it is necessary to establish laboratory management systems that are clinically and economically sound, so that they can function effectively within the limitations of current medical systems.

Automation of transportation systems

To achieve these goals, the old, outdated systems must be abolished, and laboratories must focus on satisfying customers (doctors and nurses) which in turn will lead to the satisfaction of patients, the ultimate goal of hospital reform. If this laboratory operation reform is not pushed forward, other services such as subcontracting, branch laboratory system or FMS will be proposed to replace hospital laboratories. Each hospital should therefore choose a laboratory system that is both rational and effective. In other words, if subcontractors can make a profit, then experienced medical technologists should have a chance to construct new clinical laboratories that are more economical and useful.
One of the main reasons for LAS's wide acceptance is that it actively deals with laboratory operation reform. LASs improve laboratory operations by automating the sections of laboratory operations that hinder efficiency, so production procedures can be standardized and improved.
Nevertheless, some hospitals have succeeded in constructing efficient laboratories without employing LAS by eliminating sectionalism (which is one existing problem of clinical laboratories) and simplifying laboratory operation and mechanizing special tests.
This article will introduce some of these laboratories for comparison with hospitals that use LASs.

Pre-analysis operation and transportation system LAS

The topic of the present article is transportation system LAS, and there are many variables associated with laboratory operation before specimens are placed on analyzers (reception, blood collection, transportation, separation and aliquot). Even though these are important aspects of laboratory operation, they are manually performed by medical technologists in many clinical laboratories. Furthermore, since these tasks are performed differently in each hospital, it is difficult to standardize them.
Nevertheless, the management of these procedures determines the direction of a laboratory. In addition, these pre-analysis procedures can have considerable impact on a hospital's effectiveness. Therefore, many university hospitals, public hospitals and various manufacturers have been independently researching and developing LASs. At first, transportation systems were viewed merely as something used to transport specimens, but they are now being developed as instruments that process specimens intelligently.
Furthermore, multiple-function and purpose analyzers are being developed in accordance with changes in the economics of medicine, so the function of LASs will continue to change with time. The ideology and effectiveness of LASs, the manufacturing stance of makers, the function of analyzers and future problems are discussed by other authors in this book, so this article will discuss the management of laboratories that depend on people, not on LASs.

Problems associated with improving the effectiveness of pre-processing and transportation system LAS

I was a little surprised when I was asked to write an article on over-investment and other disadvantages associated with LASs. Even though I often talk about efficiently operated laboratories that do not employ LASs, I believe that the decision to employ LAS is irrelevant to constructing clinically useful laboratories.
In considering the size of our hospital and the workload of our laboratory, there were no appropriate instruments, and since our laboratory technologists were cooperative with the laboratory management, there have been no major problems. Furthermore, users (doctors and nurses) are aware of the strengths of our laboratory.
Reception and pre-processing account for 60% to 70% of overall laboratory operations, and since more errors are made during these procedures, they are important from the viewpoint of quality control. Pre-processing must be performed accurately and promptly in a flexible manner, so any problems associated with pre-processing must be resolved by experienced medical technologists.
In addition, work load fluctuates greatly during the course of a day, so to operate a laboratory 24 hours a day at a stable rate, human errors made by medical technologists must be checked. At present, once specimens are set on analyzers, they can be processed at a certain rate, and accurate test results can easily be obtained. Therefore, the implementation of LASs makes sense in that they mechanize the portion of laboratory operations affected by unstable factors.

Basic framework of hospital clinical laboratories

Medical reform began about ten years ago, and it is necessary to evaluate how clinical laboratories can meet current needs. As the operation of hospital laboratories grows increasingly difficult, laboratories need to increase the value of delivered test results. In other words, as a stethoscope being the origin of medical information, clinical laboratories need to provide information in a timely manner. If the test results can be delivered in accordance with the timing of treatments and the economics of clinical laboratory (balance between insurance points and actual costs), then hospital laboratories are valuable, so it is crucial for hospital laboratories to deliver test results in accordance with the timing of treatments.
While medical records are digitalized and input at the source, and open information is pushed forward, in order to satisfy the needs of users (nurses and physicians), batch processing must be converted to random processing, and both STAT and routine tests should be performed at the same site using the same instruments 24 hours a day, 365 days a year. To achieve this, the entire laboratory operation had to be standardized, and it was necessary to construct a convenient laboratory that every medical technologist could control. The important factors were the effective usage of specimen labels and the randomization of laboratory procedures.
20 years ago, A.M company introduced a concept of random processing using bar codes (from blood collection, pre-processing, analysis, quality control to medical record management). In Japan, however, because company H's batch processing was already widely accepted, random processing never caught on. Nonetheless, I realized the effectiveness of random processing using bar codes, and I have been attempting to construct a laboratory using the bar code system by effectively utilizing instruments, reagents and information management software, while attempting to alter the thinking of medical technologists.

Operation reform and problem points

  1. Stability of reagents, individual differences in reagent preparation, and calibration during start-up
  2. Constant and stable instrument operation, sensors that read specimen identifications, and easy maintenance
  3. Changing computer software from batch to random specimen handling, and managing the analysis for each patient
  4. Specimen container labels, the usage of work labels, and the need of worksheet-less operation
  5. Integration and timing of reports, and simpler medical record organization

To solve these problems, each manufacturer has been developing useful products. Due to the development of liquid stable reagents, the problems associated with reagents have mostly been resolved. As to the function of instruments, the accuracy of analyzers was improved and the laboratory operation was simplified by the introduction of bar code readers, automatic dilution and rerun functions. Due to the development of multiple-function analyzers, several analyzers have been combined into one, thus reducing the need to separate and aliquot specimens, which in turn contributes to more stable and cost effective operations. Therefore, currently available products have mostly resolved the problems associated with instruments and reagents, so the next step is to change the thinking of medical technologists.

Problems associated with medical technologists and laboratory operations

  1. Positioning of a clinical laboratory within a hospital, and managing test requests and medical records.
  2. Cooperation of nurses and physicians, and elimination of steps that slow down the flow of specimens from the time when they are collected.
  3. Reforming the thinking of medical technologists, eliminating outdated ideas, planning for the aging of Japanese society, and expanding services.
  4. Separating medicine and treatment, separating mechanization and manual method, and separating mass and special processing.
  5. Distributing the workload equally through the mechanization of special tests and correcting technological gaps.
  6. Reorganizing sections, and evenly distributing the workforce and workload.
  7. Enhancing production efficiency, cost consciousness, and stable operations.

The basic goal was to develop user-friendly operation manuals. It is necessary to prepare laboratory operation manuals that are intended for users (nurses and physicians) rather than medical technologists. Although pre-processing is performed differently by different personnel, a situation that can create bottlenecks and delays in laboratory operation, it has not been possible to change the thinking of medical technologists. This refusal of technologists to change the system greatly affects the efficiency of laboratory operations. If pre-processing can not be performed smoothly, high-performance analyzers can not improve in production efficiency, so LASs are significant in this regard.

Significance of LASs in clinical laboratories

LASs enable laboratories to run more efficiently of various sections (biochemistry, immunology, hematology, coagulation, and urinary qualitative and sedimentation with integrated processing), which eliminates sectionalism, one of the disadvantages associated with past clinical laboratories. Nonetheless, since the capacity of analyzers has been improved, the implementation of an sample transportation system without integration of several testing field is wasteful in any laboratory that handles under 500 specimens per day.
On the other hand, when laboratories are operated via manpower rather than LAS, it is necessary to integrate the operations of medical technologists at each sections. This requires a great deal of effort and leadership by managers, so the success of laboratory operations varies greatly depending on the quality of managers. However, LASs contribute to reform the laboratory and standardizing laboratory operations. In other words, LAS facilitates laboratory management by reducing variable factors, simplifying and standardizing special technology. These effects also minimize differences in laboratory operations among various hospitals. Nonetheless, it is necessary to consider the size and workload of a hospital thoroughly when selecting a particular pre-processing system. In addition, as to the question of whether specimens should be placed directly and manually in racks attached to analyzers or fed into LAS, it is necessary to first evaluate peripheral instruments, such as computer communication as well as the thinking of medical technologists, which has considerable impact on the implementation effectiveness.

Hospital size and clinical laboratory profits

The Japanese medical care system is supported mainly by the national health insurance policy, so the profit margin of hospitals and laboratories is almost the same throughout Japan. Furthermore, as a result of "marume" an enclosure of insurance points for test groups, inter-institutional differences diminish, and the profit of any hospital can be predicted fairly accurately by the number of beds and patients. The average income of 15 hospitals which have 500 beds is 10.5 billion yen, and laboratory fees account for 11.5% (1.2 billion yen) and x-ray fees 6.7% (700 million yen) of this gross income. The gross income of this hospital is 11.3 billion yen, and the total laboratory fees (number of specimens x single item insurance points) are 700 million yen (77.8% expenses and 22.2% profits). From ten years ago, the profit has increased 1.4 times, and the expense 1.2 times. Under these circumstances, it was not economically feasible to implement LAS that costs several billion yen.
As shown in Table 1, the total list price of existing analyzers in our hospital is 250 million yen, and the actual purchase price is 150 million yen, about 180 million yen if the computer-assisted information management system is included. Since LAS is not directly related to productivity, it does not make economic sense to install LAS in this self-supporting hospital, and therefore the laboratory should be run efficiently using manpower.

Table 1. Analytical capacity and daily performance(process 90% of total specimens and 60% of tests)
Material Field Analyzer Cpty/hr No. of req/ Cpty(hr) Operation/day Listprice
Serum Biochemistry Hitachi7250 2000T 400spec(S)= 5300tests(T) 5090
Hitachi7070 360T 3080
INTEGRA 850T 5300T/ 3360T 1.5hr 3950
Immunology PAMIA50 150T 250T/ 150T 1.3hr 1500
Serology AIA600 60T 150T/ 60T 2.5hr 800
Blood sugar GA1140 150T 200T/ 150T 1.3hr 700
Hemogram SE9000 90T 4000
SD3500 90T 300S/ 180S 1.9hr 2215
Coagulation STA 350T 370T/ 350S 1.1hr 895
Determination SA425 140T 300S/ 140S 2.1hr 950
Sedimentation UF100 90T 250S/ 90S 2.1hr 1800

Hospital size, performance and processing capacity

The number of specimens, the number of requests per hour, and the processing capacity of analyzers are tabulated.
In a 500 bed hospital having 1,200 outpatients a day, about 750 people per day require tests (400 biochemistry specimens, 300 hematology specimens, 300 urine test specimens, 200 blood glucose test specimens, and 150 coagulation specimens). Hence, about 1,500 specimens must be processed in a day. Since the analyzers can process 1,500 specimens in one to two hours, it is possible to construct a laboratory that delivers clinically valuable medical information.

Reports in accordance to the timing of treatments

To deliver reports in a timely manner, it is necessary to coordinate tests and treatments. For example, this hospital opens at 8:40 a.m., and 25 physicians begin treating outpatients from 9:00 a.m., taking about 5 to 10 minutes per patient. The laboratory begins operations at 8:30 a.m., and the test results of 300 patients are processed before noon. Messengers collect the test specimens of two thirds of the hospitalized patients (about 200 patients) before 8:30 a.m., then the specimens of about 150 outpatients and 100 hospitalized patients are collected before closing (5:20 p.m.). In addition, the specimens of about 50 patients are collected after-hours on weekdays and about 150 patients on weekends. Therefore, to deliver reports that match the treatment schedule of each patient, since about 60% of outpatients require tests, 10 to 15 pages of reports need to be printed every five to ten minutes. For in-patients, since doctor's rounds begin at 10 a.m., there is about one hour to finish tests and print out results. Furthermore, some patients require only ECG, urine, blood, or serum tests, while others require a combination of these tests. As a result, it was necessary for us to integrate reports and develop progressive management systems that deliver more complete analyses for each patient.
These developments made it possible to treat outpatients based on medical records that show the results of tests that are ordered on the same day, and even for hospitalized in-patients, it is possible to obtain medical records showing the results of tests that were ordered the day before.
To operate this type of laboratory for 24 hours a day, and 365 days a year at a constant speed, it is necessary to understand that work density markedly fluctuates during a day. For example, in morning hours when many specimens arrive at the laboratory, several technologists should be present to process them in a short period of time. In this laboratory, the work density is highest during the first hour of operation, and it decreases gradually after that.
Therefore, the labor force is divided into three shifts: from 8:40 to 9:30, 9:30 to 12:00, and the entire afternoon during weekdays. During the lunch break, five technologists perform tests at a constant rate. During none-work hours, only one medical technologist oversees the laboratory. By arranging the schedule into five sections during a workday, the same analyzers are used to perform tests 24 hours a day at a constant rate, thus achieving a convenient, manually operable laboratory. Furthermore, since STAT tests are absorbed by routine tests, it is not necessary to invest space, money or labor for STAT Testing, and the laboratory is able to meet the demands of physicians with greater ease.
There is no marked differences in the total labor required by the batch method, in which all test results are output at once at about 11:00, and our method, in which 10-page reports are delivered at five-minute interval starting from 9:00. Nonetheless, the two-hour gap before obtaining test results has a large influence on how patients are treated and medical records are managed, and there is a clear difference in the value of the clinical laboratory between the two methods. The most important factor in achieving this type of efficient laboratory operation was the determination of medical technologists in charge of pre-processing to design a better laboratory. I personally hope that a "reasonable" LAS will be designed and implemented to mechanize, standardize and simplify pre-processing. In our laboratory, it became possible to arrange technologists to perform special tests after 10:00 a.m., when the bulk of the day's work is finished. Since the afternoon workload is about one third of the morning workload, maintenance is performed, reagents are prepared, quality control is ensured, and blood collection containers that will be used for the next day are prepared in the afternoon so that tests can be performed as soon as the laboratory is opened the following morning. In addition, operation manual study group meetings and training sessions could now be held in the afternoon to ensure stable 24 hour operation and investigate the next generation of laboratory operations.

Analytical capacity of instruments and section construction from the viewpoint of clinical application

Lab Colony MethodThe analyzers are fast enough to match the speed of treatment, and to realize that outpatients are seen by a physician after obtaining the results of all requested tests, the existing sectionalism is inefficient. As a result, I thought that lab colonies that combine frequently used analyzers should be formed.
Featuring analyzers that are capable of handling 90% of a day's specimens and 60% of test items, laboratory colonies were formed so that each colony can be operated by two or three technologists. It was then determined that tests that can not be processed by these lab colonies would be processed manually or by the special test section, and other infrequent and none-urgent tests (less than 100 specimens/month) would be outsourced. With this type of laboratory system, it became possible to assign more personnel to sections where special skills are required.
Although, laboratories were divided into sections according to the type of specimen in the past, it is more efficient to organize a laboratory according to factors such as report time (tests that require more than one hour and less than one hour) or diagnosis (diabetes-related, coagulation, lipid, tumor or cardiovascular tests). This type of classification reduces the need to aliquot specimens, utilizes each specimen more efficiently, and psychologically helps medical technologists by reorganizing their work environments.

Endpoints of the transportation line

There have been many advances in analyzers. For example, in the field of biochemistry, electrolyte and enzyme tests were performed separately in the past. However, at present, one analyzer can perform a variety of tests: electrolyte, enzyme, immunology, coagulation and urinalysis. In addition, in the field of hematology, one analyzer can perform CBC, hemogram and reticulocyte analysis. Urinary determination and sedimentation should be integrated in the near future, thus making it possible to use one or two analyzers to process 90% of specimens in a hospital laboratory. In the future, analyzers will be made so that once whole blood is placed in them, the results of all tests (STAT, initial visit, all type of disease and treatment) will be printed out. Fees will be charged depending on the number of tests performed, so analyzers will act like medical information "vending machines"; this is another step from the current reagent lease system.
One of the endpoints of transportation systems is the use of whole blood as specimens, and the development of multiple function analyzers that perform tests in various laboratory fields. As a result, it is thought that the functions of LASs will mostly be absorbed by the functions of analyzers.


There are several options for transportation systems: LASs, manpower or the machine concentration method. In addition, the composition of a laboratory consisting of several analyzers and management software differ markedly from one hospital to the next. Key points in improving laboratory operation are pre-processing and transportation, but they often assume supporting roles and the main emphasis is on analyzers. It is therefore important to determine the focal point of the laboratory: either transportation system or analyzers. Leadership is critical in establishing new rules and specifications by combining factors with multiple functions. In addition, it is time consuming to standardize instruments, communication software and special tests. Furthermore, it is essential to integrate the ideology of workers and medical technologists. The efficiency of a laboratory is based on the quantity and quality of completed work along with the amount of manpower, materials and money invested. Laboratory operations will continue to be enhanced, organized, integrated and simplified, but it is also necessary to be remained focused to catch up with the changing needs of medical treatment.