2-3.Effects of automation on laboratories:a transformation from a labor productivity type to an intelligence productivity type laboratory

Jutaro Tadano
(Director, Transfusion Department Chief, Laboratory Head and Professor at Saga Medical School)

1. Shift to clinical laboratory automation

Terms such as auto analyzers and clinical laboratory automation are frequently used in clinical laboratories. To those terms could also be added the term "automation of clinical laboratories." The word "automation" was first used in American industries around 1950, and it refers to integrated instruments that possess a self-regulating system. If this concept is applied to clinical laboratories, the automatic analyzer will perform all necessary tests once specimens are set and deliver the results. Nonetheless, as no analyzer is capable of achieving total automation at this point in time, automatic analyzers are defined in the article as instruments that can be regulated and controlled externally.
Before the 1940's, most clinical tests were performed manually until some procedures were automated (e.g., specimen and reagent collection or fractioning). True automation first begun in the 1950's when Technicon Ltd. developed Auto-Analyzer (chemical analyses) and Coulter Counter Ltd. developed a hematological analyzer. It can not be denied that, behind the implementation of this type of analyzer, there was a movement toward the centralization of clinical laboratories. More complete history of clinical laboratory centralization is discussed below.

(1) Centralization and automation of clinical laboratories

Before World War II, clinical laboratories were merely treated as a part of the diagnostic division, but after the War they began to function as an integral part of medical care. Even though the technological revolution of clinical laboratories (e.g., multiple-purpose automatic analyzers) during the 1970's supported this movement, the centralization of clinical laboratories that began in the 1950's played an important role in the automation movement.
Sometime around WWII, clinical laboratories were subdivided into groups such as chemistry, hematology, bacteriology, serology and pathology. In this environment, the First National Tokyo Hospital (currently, International Medical Center) was the first general hospital to achieve centralization. At this time, Japan was still under the command of the General Headquarters of the allied forces (GHQ), and laboratory centralization was pushed by GHQ as a part of the medical care system reform in 1950. The First National Tokyo Hospital was chosen as the first experimental hospital. From there, recognition of the need for laboratory centralization spread gradually, and a central clinical laboratory was established at Osaka University in 1954 then at Tokyo University in 1955. Laboratory centralization then spread rapidly to major hospitals. In 1957, Dr. Taro Takemi, a president of the Japan Physicians Association, ordered the establishment of clinical laboratory centers throughout Japan to assist laboratories in small clinics and hospitals.
Later, the focus of laboratory centralization shifted from the centralization of laboratories within a hospital to the centralization of laboratories within a district. As a result, many satellite laboratories were established in hospitals, and the decentralization of specimen analysis process was begun.
In the 1980's, many hospitals employed a computer-assisted medical support system, and clinical laboratories began adapting to this change by developing laboratory information processing systems. This transformation from specimen processing to information processing facilitated the centralization of information, and resulting in a change in laboratory functions focused on the automation and centralization of analysis procedures.
In 1983, the Ad-hoc Administrative System Study Council published the final report on the state of future medical care, which stated, "in promoting thorough institutional reorganization, the burden on citizens must be kept lower than by the current European standard." This is to prevent overloading the social welfare system when the aging of the Japanese population reaches its peak, and the council proposed to limit the increases of medical costs to within the increases in the national income. This plan was confirmed by the Ad-hoc Administrative Reform Council in 1990.
These factors forced a change in focus for clinical laboratories that had been expanding through automation since the 1960's. In other words, the automation and centralization of laboratories that processed specimens, which had lasted for approximately 30 years since the 1950's, was transformed into the systematization of specimen information processing. At present, medical care support systems that provide maximum clinical services with minimal investment are being studied.

(2) Laboratory centralization from the viewpoint of medical politics

National medical costs in Japan reached \27 trillion in 1996. Furthermore, due to the aging of the Japanese population and the implementation of advanced medicine, the ratio of medical cost to the national economy is expected to increase further. The fiscal resources of clinical laboratories that are required to install expensive systems (e.g. multiple-purpose automatic analyzers, automatic specimen processing systems and clinical laboratory information systems) are mostly provided by the national health insurance system. As a result, laboratories must always consider the status of national medical care politics.
In other words, clinical laboratory automation systems constructed since the 1960's to handle increases in the number of tests that are carried out in hospitals are being reevaluated due to factors such as the increased cost of labor, reagents and instruments, as well as reduced laboratory test fees.
Increases in medical costs in Japan can be attributed to four factors: increased population, increased elderly population, reform of medical care fees, and others. There is a definite increase in the elderly population. Reform of medical fees been successful in keeping the cost of compensation relatively low. In particular, the cost of clinical tests has been reevaluated at two-year intervals through arranging and reducing the fees.
The exact contents of "Others" have yet to been defined. Nonetheless, when compared to the other three factors, it is clearly increasing, and one of main tasks of the Japanese medical system is to control increases in this area. The contents and annual changes in "Others," or natural increases, fluctuated greatly along with advances in medical technology and changes in the medical system.
During the 1960's and 70's, "Others" increased largely due to an increase in drug administration, and the phrase "drug overdose medicine" was born. The ratio of the cost of drugs to total medical care cost peaked at 46% in 1970. Then, due to the standardization of drug costs, the ratio began to decrease. After the 1970's, instead of drugs, the cost of clinical laboratories began to rise. This was mostly due to the implementation of multiple-purpose automatic analyzers and the development of new test methods. Additionally, a problem with test overdose began to surface.
At this time, the automation of clinical laboratories was implemented and attracted a great deal of excitement. Recently, however, due to laboratory cost suppression measures, less money is being spent on laboratories. The thing most greatly affected by these laboratory cost suppression measures was batch processing systems such as clinical chemistry or hematological analyzers, which were touted as being the greatest advantage of laboratory automation. The cost performance of automatic specimen processing systems that were implemented in many national university hospitals in the latter half of the 1970's was very poor, and replacing these systems after their useful lives is almost impossible with current test fees.
On the other hand, subcontracting laboratories have increased in size, and are cutting costs by handling a larger volume of tests, bringing about a price war among competitors. In fact, except when test results are needed in a hurry, there is no need to pay premium rates to perform conventional chemical and hematological tests in a hospital. The price war among subcontracting laboratories also gives the Ministry of Health and Welfare a reason to reduce insurance expenditure by cutting test fees. As a result, except for extremely large institutions, laboratories are being forced to reorganize and to divide their functions.
For example, many national universities implemented automatic analyzers and an automatic specimen processing system to save labor costs, but they are now being forced to determine whether to implement the next generation of laboratory systems. On the other hand, most private universities have foregone expensive laboratory systems, and have been handling tests by hiring more technologists. As a result, they are now forced to confront higher labor costs. Laboratory automation, which has contributed greatly to the improved efficiency of specimen processing, is at a crossroad wherein many clinical laboratories must select or change their investment goal.

(3) Automation and economic effects

In the 1950's, Skeggs noted that even though the number of requests for clinical chemistry tests kept increasing each year, the number of laboratory technologists was actually declining. Therefore, Skeggs considered mechanizing clinical chemical tests, and in 1954, developed an instrument that could perform a series of chemical analyses (collecting the specimen, mixing the reagent, heating and measuring absorbency) in one tube. This machine was commercialized as Auto-Analyzer AA1 by Technicon Ltd. in 1957. This analyzer was rapidly updated, and then, in 1968, the same company introduced SMA 12/60, which could simultaneously perform twelve analyses. In the 1970's, automatic analyzers were developed mainly by Hitachi, Ltd., and Olympus, Ltd. in Japan. Presently, high speed analyzers that can simultaneously perform more than thirty analyses are being implemented in many clinical laboratories around the globe.
The implementation of this type of multiple-task automatic analyzer was easy for many clinical laboratories when the number of requests was constantly increasing and sufficient funds could be secured through fees. However, beginning in the 1980's, the fees that were being charged for tests performed by multiple-task analyzers began to be questioned, and the profit margin and cost performance of laboratory tests came under close studied.
As to the economics of clinical tests, Fineberg et al. reported in 1979 that when compared to medical treatment that require large equipment such as CTs or major surgical procedures, the majority of medical costs was attributable to minor laboratory tests. They stated that, even though the cost of performing each test is low, the accumulation of tests account for the majority of medical costs. Then, the effectiveness, efficiency and economics of laboratory tests were investigated by Dixon, Schroeder and Fineberg in the 1970's. In Japan, based on domestic and overseas reports, Nishimura summarized the economics of clinical laboratories (emphasis on automation) in a section on laboratory economics in "Analysis of Cost in Medicine."
To determine the effectiveness of laboratories, Weinstein and Fineberg conducted a cost-effectiveness analysis of vanillylmandelic acid (VMA) in the diagnosis of pheochromocytoma. Their study clarified that when a single test is effective in diagnosing a particular disease, additional tests contribute very little to the diagnosis of the disease. Multiple-task automatic analyzers are advantageous in that they can simultaneously perform many tests. However, unnecessary tests are performed in some cases, so simultaneous multiple-task analyses (which is a part of laboratory automation) may actually lose some of its effectiveness. Also, the effectiveness of clinical laboratories is greatly affected by the ability of clinical physicians to diagnose and treat patients based on test results. Since it is unlikely that any clinical physicians are thoroughly knowledgeable about over one thousand laboratory test results, the flood of laboratory information brought about by clinical laboratory automation may actually hinder the effectiveness of clinical laboratories.
Nonetheless, the role of automation in improving the economics of laboratories is great. When the use of clinical laboratories was unrestricted in the 1970's, the management of medical facilities was easily improved by increasing the number of tests performed by automatic analyzers. Nonetheless, the number of tests is currently being decreased gradually. In addition, since the costs and profits of tests do not show a linear correlation to the number of tests performed, the justification for the implementation of automatic analyzers is being questioned. Furthermore, increases in subcontracted tests have had a large effect on the performance and automation of laboratories. According to the Medical Institution Survey on Hospitals published by the Ministry of Health and Welfare in 1984, the average number of laboratory technologists in hospitals with less than 299 beds was 3.6. In other words, even though many automatic analyzers can be freely implemented, depending on the number of beds, it is economically advantageous to subcontract laboratories, so the effect of automation is seen here as well.

(4) Economics of automatic analyzers

Weinstein et al. reported on the economic costs of automatic analyzers in 1981. It is easy to calculate the economic costs of simple tests (e.g., urine test). Nonetheless, the economic cost of tests that are performed by an automatic analyzer are more difficult to determine since the fixed cost needed to run the analyzer and the variable cost required to perform one analysis must both be calculated. Even though each automatic analyzer costs between several million to several hundred million yen, necessary test materials such as reagents only cost between ten to several hundred yen per test.
Weinstein et al. proposed an average cost curve for fixed and variable costs. According to this report, regardless of the number of tests performed per request, if the number of tests exceeds 200,000 per year, the average cost is almost minimal. If a hospital performs an average of 5,600 tests a year, then the average cost of tests can only be halved by performing more than 300,000 tests a year.
Therefore, multiple-task automatic analyzers should only be installed in very large institutions on the basis of economic considerations.

2. Transformation from specimen processing to laboratory information processing

Automatic analyzers in clinical laboratories that were implemented in the 1970's revolutionized the field of clinical laboratory in terms of specimen processing. In truth, however, what actually benefited most from the automation of specimen processing was clinical laboratories, and actual benefits to clinical physicians, who are the users of laboratories, or improvements in clinical laboratory information service, are yet to be determined. Furthermore, the exacerbation of the economics of the medical care industry in recent years facilitated the compression of laboratory fees, thus forcing many laboratories to evaluate the implementation of the automatic analyzers and automation more carefully from the viewpoint of cost-effectiveness.
In other words, the time when increases in the number of tests linked to increases in the number of test items directly increased profit has ended, and clinical laboratories are currently being evaluated by the contents of the laboratory information service. As a result, clinical laboratories are forced to transform themselves from a specimen processing service centers to clinical laboratory information service centers.
The implementation of computers in clinical laboratories was achieved almost simultaneously with the development and implementation of multiple-task automatic analyzers. Although many felt that the large quantity of data that is output by automatic analyzers could no longer be handled manually using conventional methods. According to the medical institution survey by the Ministry of Health and Welfare, the computer-assisted systematization of clinical laboratories was only observed in approximately 15% of laboratories in 1988, and when compared to other industries, the systematization of laboratories has been far from universal. Furthermore, computer usage in clinical laboratories is mostly limited to mechanical control, data processing and quality control within laboratories. In general, except for some large general hospitals, computers in laboratories are not being used to support medical care system as planned.
The basic objective of a clinical laboratory is to deliver prompt high-quality analysis data to the patient care side. From the viewpoint of patient care, as long as highly reliable data can be obtained, the location of where the data is generated is totally irrelevant.
As the use of machines and reagents was the main concern, any laboratories lost sight of their main objectives, and the construction of a laboratory information system that truly satisfies the patient care side of medicine was neglected. As the goal of clinical laboratories is to support medical information services by providing test results, the implementation of computers should also be analyzed based on it.

3. Information in hospitals

Physicians' work can be roughly divided into three categories: (1)general clerical work, (2)research and education, and (3)patient care. In all these categories, due to the wide spread use of word processors, personal computers, and copying machines, the efficiency of office activities has improved greatly.
At present, the efficiency of clerical work that is a part of the medical care activities (e.g., recording prescriptions, test results and clinical findings on medical logs, and searching for records from medical records) is being closely examined as the most urgent and important problem. The computerization of information processing may be one way to resolve the above problem. In the past, it was impossible to exchange information among different departments within a hospital. However, with computers, all medical information is stored and managed for each patient, and the necessary data can be retrieved instantly. As a result, from the viewpoint of laboratories, all the information that is necessary for specimen processing can be retrieved from the data file of each patient. Obviously, it does not speak well for laboratory information management if all laboratory data is not stored in patient data files. At present, most laboratories utilize computers to process numerical information such as the results of chemical and hematological tests. However, for patient data files, laboratory information should include analog information such as electrocardiographs and electroencephalographs, or text information such as the results of pathological and cytological diagnosis. In other words, laboratories should have a system in which such information is stored in patient data files, and allow free access for other departments.

4. Clinical laboratory information and medical records

For physicians, clinical laboratory information is one of the most important pieces of information for patient treatment. Currently, however, this information is not provided to physicians in a satisfactory manner. The medical records of hospitalized patients in six departments of Medical Record Center of the Saga Medical School were randomly selected. Although there were differences with respect to departments in the duration of hospitalization, and the details of treatment, clinical laboratory data accounted for about 35% of the total medical records.
For example, out of a 106-page file for a child who was hospitalized for one month, six pages were for hematology and chemistry, two for serology, 25 for physiology, and four for pathology and cytological diagnoses. These pages were chronologically organized for each test item.
Nonetheless, when hematological, chemical, serological and physiological tests were performed on the same day, the test results are organized in four places. Hence, it is difficult to check data on a patient who has an extended stay in a hospital, and it is very complicated to retrieve data when patients are readmitted, especially in an emergency.
As laboratory data is used not only in treatment but also in education and research, the departments that are contacted by physicians to collect information for research purposes were examined. The results showed that, of discharge medical records that were borrowed between 1981 and 1986, surgery accounted for 15.4%, pathology and cytological diagnosis 12.3% and laboratory data 11.0%, proof that laboratory information is being accessed frequently.
To resolve these problems, clinical laboratories must establish a computer-assisted system that manages numerical, analog and text data, and physicians must establish a medical support system that utilizes the clinical laboratory system.
Therefore, ever since its opening in 1981, the clinical laboratory at Saga Medical School Hospital has been developing automatic specimen processing and integrated clinical laboratory information management systems that are linked to the overall hospital medical information system to transform their specimen processing clinical laboratory into a information processing clinical laboratory.
This system was developed based on the brain to brain loop concept that was proposed by Lundberg in 1991. This loop begins with a physician asking a patient questions, then it progresses from test order -> specimen collection -> confirmation -> transportation -> pretreatment -> analysis -> report, until the physician finally analyzes the results and takes appropriate action, effectively completing the brain to brain loop.
Since each step of this loop is interconnected like links on a chain, if one step is weak, then the strength of the entire chain is compromised. As a result, it only takes one weak point to weaken the whole loop. The responsibility of clinical laboratories within in this loop is to pretreat received specimens and to deliver test results for treatment. Through the use of automated, high speed multiple-task analyzers to link an automated specimen processing system, the objective of this loop has been achieved. In addition, computers are being used more often in large hospitals to manage data and report test results.
Furthermore, research on clinical laboratories and diagnosis contributing ratio has been conducted with an eye to improving intellectual productivity, and Lundberg's concept of the brain to brain loop is almost complete.

5. Clinical laboratories information and diagnosis contributing ratio

The ultimate objective of Lundberg's loop is for test results to return to the hands of a physician, so that he or she can use them to resolve problems. As a result, clinical laboratories need to clarify the diagnosis contributing ratio of each test item to the patient care side. In Europe and the U.S., this type of research has been conducted by Crombie, Hampton or Sandler, while in Japan, Fukui and colleagues at Saga Medical School General Clinical Laboratories were the first to investigate this issue.
Fukui et al. investigated the concordance rate between final and temporary diagnoses that were made at three different stages (after gathering medical history, after examination, and after obtaining the results of quick tests) on 142 patients with chest pains who were visiting the Division of General Medicine of Saga Medical School Hospital for the first time. In 1989, the following items were being measured by quick tests: blood count, erythrocyte sedimentation rate, CRP, total protein, albumin, BUN, uric acid, bilirubin, AST, ALT, LD, AL-P, GGT, cholinesterase, total cholesterol, neutral fat, general urinalysis, simple X-ray and electrocardiography.
The results showed that the concordance rate between the final and temporal diagnoses increased over time: after gathering medical history 71.1%, after examination 76.1%, and after obtaining the results of quick tests 81.4%. In addition, the concordance rate between the final and temporal diagnoses was compared between patients on whom quick tests were conducted and those on whom quick tests were not conducted, and the results showed that the rate of concordance was 87.5 and 63.6%, respectively, so the rate of concordance was clearly higher among those patients on whom quick tests were performed.
Due to the implementation of clinical laboratories systems or highly advanced test methods, the effectiveness of medicine has become an important issue. It is becoming increasingly important to investigate scientifically how effective diagnoses can be determined by clinical laboratories tests. Clinical laboratories not only must perform analyses and provide information, but also clarify the usefulness of each test item, and it is clear that if a clinical laboratories information system is simply implemented, clinical laboratories would remain merely places where tests are performed.

6. Integrated clinical laboratories information management system at Saga Medical School

This system was developed to accomplish the following things: (1)to store numerical data (chemical and hematological tests), analog data (electrocardiogram or electroencephalogram) and texts (pathology reports and cytological diagnoses) optically and electronically so that the above information can be retrieved at any time from any terminal; (2)to provide medical records that will be stored optically or electronically in the future; and (3)to be integrated with an overall medical care support system.
The following subsystems were developed for hospital total ordering systems in order to achieve the above objectives: (1) numerical data retrieval system; (2)analog data and numerical data integration system; (3)EEG optical filing system; (4)text data optical filing system; and (5)medical record optical filing system.

(1) Inter-department network system

In the current medical care support system of the Saga Medical School Hospital (January, 1997) is set up as a network, in which FACOM M770/10 is being utilized as the host computer, and subsystems such as clinical laboratory, pharmacy, radiology, nursing, clinics, and medical record systems are linked by optic LAN. As a result, all medical information of patients is stored and all medical staff can access the database from any terminal.

(2) Ordering system

This system is the center of the medical care support system, and data that is generated throughout the hospital is input manually at the time of generation. Services performed in the hospital include, drug administration, injection, clinical laboratories tests, radiological tests, reservations, food service and nursing instructions. This system accurately transmits information among different departments, reducing clerical duties, and facilitating the construction of databases.

(3) Clinical laboratories system

The clinical laboratories system is treated as a part of the inter-department subsystems. A sub-host computer (FACOM M730/8) that is linked to the hospital host computer is placed in the clinical laboratory.

The laboratory system stores numerical data (chemical and hematological tests), analog data (electrocardiogram or electroencephalogram) and texts (pathology reports and cytological diagnoses) optically or electronically so that the above information can be retrieved from any terminal at all times.
Furthermore, other services performed at the clinical laboratories are also regulated by this system (ordering, delivery or management of the results of subcontracted tests). This system is called the integrated clinical laboratories information management system, and it is linked with the optical filing of medical records (similar to electronic medical records).
As basic patient information and clinical laboratories information in the hospital are integrated, when they are combined, a better medical care support system can be developed.

7. The reality of the integrated clinical laboratories information management system

(1) Numerical information retrieval system

In this system, the majority of data that is output from emergency and urgent analyses and online analyses are numerical data. The data file on each patient is stored in M770/10, and can be retrieved by 400 character terminals and 84 image terminals that are placed in ambulatory sections and wards.
In tests conducted by subcontractors, the host computers of three subcontractors are connected with the computer in the clinical laboratories via a public line to send and receive test requests and results. Nonetheless, since test reports are printed in the clinical laboratories, data is downloaded from the terminal to a floppy disc and the data is displayed at the clinical laboratories to make the report. Like other information generated within the hospital, this data is also stored in the patient database.

(2) Analog and numerical data integration system

This system consists of 17 ECG terminals (nine terminals in wards, 3 in the ambulatory division, 1 in the emergency division, 1 in ICU, and 3 in the clinical laboratories). It is linked to the clinical laboratories Physiology-system computer (PANAFACOM FCP-1000) in order to carry out the following tasks: automatic analysis of ECG, optical filing of ECG, and outputting of ECG on ECG paper and major tests.
The central processing unit is FCP-1000 with an internal memory of 1 MB. ECG patterns are temporarily filed (primary file) on fixed disks (130 MB x 4).
Images are then read by a specialist and stored on an optic disc (secondary file). On a single optic disc, the results of about 80,000 tests can be stored at single density and about 50,000 tests at double density. Each optic disc unit contains 50 optic discs, so the results of 2.5 million tests can be stored at double density. In addition, this system is linked to the hospital host computer via the clinical laboratories sub-host system, and ECG and the results of tests that are performed at the same time are printed out on ECG paper. The access time of optic discs is extremely short, and the average access time from ambulatory and ward terminals is 58 seconds.

(3) EEG optical filing system

This system digitalizes EEG signals and stores them on an optic disc, and it enables the storage of large volumes of EEG data, the high speed access of data, the high-resolution regeneration of EEG, and the output to A4-size medical record forms at treatment rooms. The system helps physicians by automatically performing frequency conversion and pattern extraction.
This system is connected to the medical care support system of the hospital, and can be used to retrieve all patient information.
This system consists of a central processing unit (S station-230), one EEG collection machine, two portable EEG collection machines, system discs, optic discs and printers. Three workstations are placed in the ambulatory section of neurology, psychiatry and pediatrics departments, and data such as raw EEG, abnormal EEG, comments, and test requests can be instantly retrieved.
This EEG system possesses the following functions

  1. The use of paper can be avoided by managing EEG by optical filing. Also, raw EEG can be quickly regenerated and retrieved on a monitor (time series retrieval is also possible).
  2. Abnormal EEG on a monitor can be selectively isolated and printed on A4 medical care record forms.
  3. By connecting this system to the integrated information system, the result of EEG analyses can be retrieved from ambulatory terminals.
  4. EEG can be collected by a portable electroencephalograph in ambulatory sections or wards, and registered on optic discs via the intra-hospital LAN.
  5. This system possesses functions to perform calculations and frequency conversions in order to assist specialists interpret electroencephalograms.

When compared to other analog data (e.g., electrocardiograms), electroencephalograms hold a large volume of data. This system is capable of storing large EEG data files on optic discs. First of all, EEG signals are digitalized, registered in an EEG collecting machine, then automatically transmitted to a system disc. There, it is matched with patient information that is retrieved from the hospital host computer, and a primary file is made. Next, only EEG data is transferred to an optic disc to prepare a secondary file. File management is performed by separating raw EEG that will be stored for a short time and abnormal EEG that will be stored longer. Abnormal EEG is isolated from raw EEG by a specialist on a monitor as necessary. Currently, an automatic abnormal EEG check system is being developed. When the check system is completed, abnormal EEG will be automatically isolated from raw EEG.
On a single optic disc, sixty 20-channel, 30-minute standard EEG can be stored; it is also possible to compress raw EEG to 1/20 the size, and 1,200 raw EEG can be stored on a single optic disc using this method. The access time of recorded EEG from a terminal is about 90 seconds, significantly shorter than that of the EEG paper storage method.
Furthermore, each portable EEG can store 2 hours of 16 channels of data on a 30 MB disc, and it takes about five minutes for each test to be transferred to the host computer.

(4) Text data optical filing system

This system records, stores and retrieves all text data, including handwritten data (pathological, cytological and image diagnoses) and medical records through optical filing systems. The main components of this system (optic disc controller and optic disc library) are placed in the hospital host computer room and is under the command of the host computer.
Optic filing of the results of pathological and cytological diagnoses is performed by inputting patient ID, test date and specimen type through an image registration screen at a terminal, and this text and data is then read out by an image reader.
A4 paper can be stored on an optic disc, and it takes less than one minute to store a single sheet of A4 paper. Filed data is first stored on a hard disc, and then at night, all data for the day is transferred to an optic disc. Image terminals can magnify, rotate and scroll images, and high resolution images can be retrieved.
On a single optic disc, 44,000 pages of A4 documents can be stored, and the total capacity of the optic disc library, which contains 32 optic discs, is about 88 GB. By matching the retrieval code of medical records or patient information with the data on optic discs, the necessary patient records can be instantly retrieved from a terminal.
There are 84 image displaying terminals in the ambulatory sections, wards and each central dispensary.
The text optic filing system performs the following functions

  1. Numerical, analog and text data can be simultaneously retrieved.
  2. In addition to basic patient information, all patient medical records can also be retrieved from a terminal.
  3. On a single optic disc, about 44,000 pages of A4 documents can be stored, the equivalent of about 550 volumes of hospital records.
  4. One set of optic disk libraries, which contains 32 optic disks, has 88 GB of storage capacity and is therefore capable of storing about 18,000 volumes of inpatient charts.
  5. The access time from a terminal is only about three seconds, so this is a superior system for storing and managing a large volume of data.

(5) Pathological and cytological diagnosis subsystems

In pathological and cytological diagnoses, to perform department-specific, atypical processing, FACOM-9450 S is used to construct the pathology subsystem. Therefore, tasks such as outputting cytological diagnosis report and lending specimens management are efficiently performed apart from the main frame.
The results of cytological diagnosis are input using a coding scheme from the Result Input Screen, which looks exactly like the report form. Reception date and number, patient ID and background, and the type and volume of normal cells are numerically input. In "Others," extracellular substances are evaluated and input as a single digit code. Comments can be input up to 120 letters, 30 letters in each line. Overall image is on the first line, and cytological findings, nuclear findings and predicted diagnosis are written on lines 2, 3 and 4, respectively. When findings cannot be described easily using codes, short sentences can be added. In this system, when additional tests are performed, the results of and comments on previous tests can be viewed on the same screen. The diagnosis is written using a code: classes I, II, III, IV or V.
The printout of reports is performed with a randomly assigned number, and this procedure takes about 20 seconds.
When compared to the systematization of clinical laboratories tests such as biochemical and hematological tests (mostly numerical data), the systematization of pathological and cytological diagnoses is less likely to result in considerable labor savings or improvements in efficiency. The significance of the total systematization of pathological and cytological diagnoses is the incorporation of the results of pathological and cytological diagnoses into the medical care support system, so that numerical and other data that is processed by other subsystems can be retrieved simultaneously.
However, special attention must be paid to managing pathological data (consisting of a large amount of written text such as clinical symptoms, course, surgery, and the location of specimen collection), when it is managed with numerical data via an integrated system.

(6) Required conditions for integrated information

management To integrate clinical laboratories information, the following conditions must be met

  1. medical records are organized so that each patient has a single ID and one medical chart
  2. various department subsystems are integrated to enable unified operations
  3. patient medical information from each department in the hospital must be able to be shared with each other; and
  4. medical records that are common to various departments are standardized.

In addition, data such as written text documents that require large storage capacity should be stored on an optic disc rather than on the same database. When requested, the necessary data can be retrieved from a terminal by using a common ID.
The advantages of the optical filing system are.

  1. a enormous amount of handwritten data for pathological and cytological diagnoses can be electronically stored and retrieved.
  2. ever increasing amounts of information can be managed and stored in a limited space.
  3. by digitalizing text data, the extraction of patient information, and the time series comparison of data are facilitated.
  4. the speed and volume for the collection and accumulation of information in the medical care support data base are improved markedly.
  5. since numerical data and images can be simultaneously viewed on a terminal, the results of biochemical and hematological analyses for the same patient can be chronologically retrieved while the results of microscopic analyses are being examined
  6. when performing a postmortem examination, shifts and changes in symptoms can be retrieved beforehand
  7. by systemically utilizing separately stored medical information such as numerical, ECG, EEG and text data, more accurate decisions can be made in less time; and
  8. by integrating the retrieval method of various data bases, the access time required for retrieving medical information is reduced.

8. Effects of electrical and optical filing on clinical laboratory information

The effects of the electrical and optical filing of clinical laboratory information, which has been filed since the laboratory's conception in 1981, are as follows

  1. ever increasing amounts of medical information can be managed in a limited space;
  2. numerical, analog and text data are stored as data files in a common system, and it is now possible to provide useful information for treatments, educational applications and research;
  3. this system can be directly linked to the medical record management system using photo ID cards, which will be introduced in the future;
  4. the cost of accumulating information is markedly reduced, and the same information can be simultaneously accessed at multiple locations; and
  5. by making all patient information available to all medical personnel, the quality of overall medical care is improved.

In addition, the integration of medical information enables the cross-sectional use of patient information. In other words, if a patient visits several clinics, then each clinic will build up a separate data files (medical records). Since this information can not be retrieved freely among the clinics, the same tests are performed and the same drugs are administered unnecessarily, which is hardly beneficial to patients.
In recent years, the integration of medical information via the "one patient one medical record system," is implemented in many new hospitals. Under this system, all medical information is individually recorded in a single medical file. This makes it easy to ascertain information such as what kind of tests were performed in other clinics, which drugs were administered, and what diagnoses were made. Furthermore, since all medical information is controlled by computer, physicians can retrieve the medical information of other patients with the same condition.
As medicine grows increasingly specialized, the interest and expertise of physicians is becoming narrower. As a result, systemic problems of patients may be overlooked in some cases. Therefore, computer assisted medical information management is an effective way of realizing true cross-sectional use of patient information. In the near future, the implementation of this type of medical care support system will be essential for hospitals who wish to maintain a high medical standard. Therefore, clinical laboratories must also construct the systems to provide useful clinical data using computers. If hospitals fail to invest in these systems, then they will function as merely patient retaining centers, and a clinical laboratory will become simply a place to perform tests.
A large volume of data that is output by clinical laboratories every day is a valuable asset for patients and hospitals, and the effective usage of this data will also serve to elevate the overall medical standard.

9. Drawbacks of laboratory information systems

Once a laboratory information system is implemented, it may increase, but not decrease, in size. In other words, development and maintenance costs will continue to grow after it has been implemented. Like automatic analyzers, the implementation of this type of system is not economically viable under Japan's current medical insurance system. The objective of implementing clinical laboratory information systems (which takes the place of the implementation of automatic analyzers) is to improve the intellectual productivity of the patient care side of medicine, not to improve the labor productivity of clinical laboratories. Therefore, to improve the overall quality of medical care, hospitals must implement this type of system even if they experience an initial decline in profits.
The automation of clinical laboratories, which began as a means to improve efficiency and to handle a large quantity of specimens, is undergoing a shift toward computer-assisted, integrated clinical laboratories information processing systems. At present, even though large-scale automatic analyzers are suitable for ultra-large testing centers, they are becoming obsolete in many hospital clinical laboratories, where flexible information that matches the needs of ever changing clinical laboratory services must be delivered.
In the future, rather than manufacturing one automatic analyzer to perform multiple purpose, it will be important to construct comprehensive clinical laboratories by linking multiple analyzers with various functions via a network so that an entire clinical laboratories can function as one multiple-purpose automatic analyzer. Also, it will be desirable if useful medial information can be delivered to the patient care side. Therefore, although automatic analyzers were previously developed to improve specimen processing capacity, it will be important to develop analyzers that can easily adjust to the rapidly changing needs of today and tomorrow's clinical laboratories.

10. Conclusion

The ultimate goal of clinical laboratories is to provide useful information to the patient care side of medicine. In this context, an individual test result is not valuable, and it can only contribute to patient treatment after being processed by laboratory inspection. Currently, due to the emergence of automatic analyzers, raw data are provided more reliably.
Nonetheless, the design concept of current automatic analyzers are too outdated to construct the ideal clinical laboratory information system. The development of a new generation of automatic analyzers that could enable the provision of new clinical laboratory services is the next vital step.