HST-330 TM and Total Laboratory Automation

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1 HST-330 TM and Total Laboratory Automation Hyun-Sook CHI, MD* * Department of Clinical Pathology, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea. Total laboratory automation (TLA) is composed of laboratory information systems and automated instrumentation. Asan Medical Center was originally a 1,000-bed tertiary care university affiliated hospital which was expanded to 2,200 beds in October 1994 with a rapid increase in laboratory test numbers. Before introduction of TLA, patients had to visit the hospital twice, firstly for the sampling and secondly, to get the test results in an outpatient clinic. Since April 1995, Asan Medical Center has implemented TLA with a Clinical Laboratory Integration System (CLIS, Hitachi Co., Japan) for automated sample processing, HST-330 total hematology analysis system (TOA Medical Electronics Co., Ltd., Japan) and Hitachi automated chemistry analyzer at the satellite outpatient laboratory. The hospital information system and laboratory information system were connected with a client server system. After implementation of TLA, the turnaround time of outpatient laboratory tests were drastically shortened to less than 60 minutes and clinicians could retrieve the patient s data on the outpatient clinic monitor screen in the same day as sampling. (Sysmex J Int 7: , 1997) Key Words HST-330, Automated Hematology Analyzer, Total Laboratory Automation, Laboratory System INTRODUCTION In the management of today s clinical laboratory, operational improvement is becoming a major issue to be addressed. Operational improvement has been achieved through the development of sophisticated analyzers, sample transportation systems and data processing. The introduction of various automated instruments into the clinical laboratory has confirmed that systemization can greatly contribute to prompt reporting of clinical data, increased efficiency of laboratory work, labor savings and reduction in exposure to biohazards. Since October 1994, Asan Medical Center has expanded from 1,000 to 2,200 beds with doubling of laboratory tests performed. This expansion of services has led to work reengineering in order to create a more patient-oriented work flow. In the outpatient clinic, patients and clinicians had complained that patients were forced to make twice as many visits to the hospital due to the delayed reporting of laboratory test results. At that time, outpatient laboratory tests were performed in the central laboratory which was located on the second floor (above the clinic). We analyzed the reasons for this and found that delayed transportation, delayed pretreatment procedures of routine chemistry specimens and poor interfacing of the labo-ratory information system were the main causes. To accomplish a rapid reporting system (within 60 minutes after collection) of outpatient laboratory tests, we attempted to set up a separate outpatient laboratory on the first floor with a total laboratory automation system. This would include a sample transportation and processing system, automated chemistry and hematology analyzers and rapid interaction of laboratory and hospital information systems. We applied the Clinical Laboratory Integration System (CLIS, Hitachi Co., Japan) for automated sample processing, the Sysmex HST-330 for automated hematology analysis and the Hitachi for automated chemistry analysis. 1

2 MATERIALS AND METHODS Table 1 Critical limits for manual differential count Instrumentation The CLIS of Hitachi Co. was designed such that specimens were centrifuged by the robotic system and transported to the belt-line system. Caps were then opened and aliquoted automatically for manual tests, and transported to the automated chemistry analyzer. The HST-330 is composed of the SE-9000 automated hematology analyzer, the R-3000 automated reticulocyte analyzer, the SP-1 slide preparation unit and an automated sample transport system. The SP-1 performs blood film preparation based on information received from the SE The SP-1 dispenses an optimum amount of blood on the glass slide and automatically adjusts the angle and speed of the spreader blade based upon the specimen s hematocrit value measured by the SE The film is then fan dried as patient ID information is automatically printed on the frosted end of the slide. The smear surface is monitored at three points WBC RBC HGB HCT MCV MCH MCHC PLT RDW MPV Neut Lymph Mono Eo Baso Neut# LL 1 : Lower limits UL 2 : Upper limits Sampling LL 1 UL Unit x 10 6 / µl g/dl fl pg g/dl fl Order NCR3600 Server LAN Determination of result Interface client Ordering Sampling Automated instrument Fig. 2 Configuration of laboratory information system Analysis SP-1 R-3000 On-line input Real time QC Hitachi SE-9000 Reporting Off-line aliquot station Decapper Centrifuge Fig. 1 Flow of laboratory information system Fig. 3 Overall configuration of out-patient laboratory 2

3 by an optical sensor to check the quality of blood film. When the slide cassette was full (each cassette holds 20 slides), a technician removes the cassette and stains the slides on the automated stainer. Manual differential counts are then done under the microscope. In the outpatient laboratory, the WBC differential count is performed by the SE-9000, with the exception of pediatrics, oncology patients and patients out of critical limits (Table 1). The hospital information system and laboratory information system of Asan Medical Center was newly developed to the client server system. The server is the NCR 3600 (West Columbia, USA) and the client IBM 486 PC compatibles. The Oracle 7.1 (Oracle Co., Belmont, CA, USA) was used as the database of the server and the Powerbuilder (Powersoft, Burlington, UK). The operational flow of the laboratory information system consists of ordering, sampling, reception, analysis, online input, real time quality control and reporting (Fig. 1). The computer is bidirectionally connected with each analyzer and test orders are transferred to the analyzer from the computer. Test results are automatically transferred from the analyzer to the computer. The overall configuration of the laboratory information system is depicted in Fig. 2. In addition, there are the Midtron (Boehringer Mannheim, Germany) for routine urinalysis and the MLA-1000 automated analyzer for coagulation testing. A general overview of the instrumentation is shown in Fig. 3. Methods The physician directly enters orders for laboratory tests on a computer in the outpatient clinic, and the patient who has paid for services visits the blood-collecting room. Then a phlebotomist enters the patient s ID number into the computer, the computer screen shows the patient s information and laboratory tests requested and bar code labels are printed. Each barcode label contains the patient s ID number, sample number by character, barcode according to sample number and request number, and proper specimen containers. After labelling the tubes, the phlebotomist collects samples from patients. For rapid transport of specimens, we built the outpatient laboratory adjacent to the blood collecting room. From the blood-collecting room to the outpatient laboratory, a belt-line system was established. Phlebotomists place specimens on a belt-line near the blood collecting desk, and specimens are transported automatically to the specimen reception desk. Table 2 Turnaround time of various hematologic tests Total CBC CBC+Retic CBC+diff.* Test no. /day * CBC+manual differential count Turnaround time (min) Refrigerator Retic NE-8000 Coulter Refrigerator Staining Dry Smear Staining HST-330 (SE-9000, R-3000, SP-1) Microscopy Microscopy Report Report Fig. 4 Operational flow of hematology laboratory before introduction of HST-330 Fig. 5 Operational flow of hematology laboratory after introduction of HST-330 3

4 RESULTS Check of delta and panic value We employ a delta and panic value check system to ver-ify test results. The delta check is used to compare the patient s current results with previous results and to see if test results have deviated from the present criteria for allowable change. The panic value check is to check test results beyond given criteria which usually mean an emergency state clinically. After comparing these results with patient clinical information and previous results, the Clinical Pathologist interprets if the test results are consistent with the patient s condition. If they are, he reports the results ; if not, the Clinical Pathologist checks the possible sources of errors. Delta and panic value checks are included in quality control. At Asan Medical Center, delta and panic value checking are done at the moment test results are transferred to the computer. This way, checking can be performed immediately using the computer screen as soon as test results are obtained. The delta check screen contains information that includes the patient s personal records, laboratory test results, delta and panic value check results, previous test results and test day, clinical information and state of test process. The Clinical Pathologist can determine the possible cause of error and meaning of the delta check result, comparing patient s clinical information and cumulative test results right on the computer screen. Introduction of the HST-330 The introduction of this system makes it possible not only to improve the working environment through simplified handling and flow of specimens, but also to expect that the efficiency of clinical testing itself will be enhanced as a result of reduced movement and in-line processing. A simulation of simple workflow in the laboratory is shown in Figs 4 and 5, and indicates that the flow of specimens and smears is very complicated prior to the introduction of the automated hematology system, HST-330. After implementation of automation, the overall flow is simplified and turnaround time is shortened significantly with improved efficiency (Table 2). DISCUSSION Although the advantages of introducing the HST-330 and total laboratory automation system into a outpatient laboratory setting are many, the following three points are considered the most important : 1)Improvement of turnaround time of outpatient laboratory tests 2)Improvement of work flow 3)Safety enhancement The shortening of turnaround time of outpatient labora-tory tests results in the same-day sampling makes a same-day interview with doctors possible. We applied delta and panic value checks for the quality control of hematologic and clinical chemistry data and compared the difference between present and previous test results. With this process, we can be convinced of our test results before reporting, or discover the sources of error and solve the problems. CONCLUSION Asan Medical Center has improved outpatient laboratory service with this system that enables the clinician to retrieve and interpret patient s routine hematology test results within 30 minutes, and results of routine clinical chemistry, urinalysis and coagulation within 60 minutes. This is accomplished by creating a more efficient connection between the laboratory and hospital information systems, and by implementing automatic sample transportation, processing and advanced analyzers. 4

5 References 1 )Hayashi M, Gauthier S, Tatsumi N : Evaluation of an automated slide preparation and staining unit Sysmex SP-100. Sysmex J Int, 6 : 63-69, )Shimada Y : The latest information of total laboratory automation. Sysmex J Int, 6 : 80-82,