LAS INFORMATION
3-1.Transportation system-laboratory automation systems and one additional venue
Hirokazu Chikakiyo
(Chief technologist of Komatsujima Red Cross Hospital Laboratory)
1.Introduction
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.
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To achieve these goals, the old, outdated systems must be abolished, and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
- Stability of reagents, individual differences in reagent preparation, and calibration during start-up
- Constant and stable instrument operation, sensors that read specimen identifications, and easy maintenance
- Changing computer software from batch to random specimen handling, and managing the analysis for each patient
- Specimen container labels, the usage of work labels, and the need of worksheet-less operation
- 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
- Positioning of a clinical laboratory within a hospital, and managing test requests and medical records.
- Cooperation of nurses and physicians, and elimination of steps that slow down the flow of specimens from the time when they are collected.
- Reforming the thinking of medical technologists, eliminating outdated ideas, planning for the aging of Japanese society, and expanding services.
- Separating medicine and treatment, separating mechanization and manual method, and separating mass and special processing.
- Distributing the workload equally through the mechanization of special tests and correcting technological gaps.
- Reorganizing sections, and evenly distributing the workforce and workload.
- 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 | |
ARRAY | 970 | ||||||
Blood sugar | GA1140 | 150T | 200T/ | 150T | 1.3hr | 700 | |
Blood |
Hemogram | SE9000 | 90T | 4000 | |||
SD3500 | 90T | 300S/ | 180S | 1.9hr | 2215 | ||
Coagulation | STA | 350T | 370T/ | 350S | 1.1hr | 895 | |
Urine |
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
The 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.
Conclusion
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.