1 Introduction

Since the beginning of the twenty-first century, with the widespread application of advanced testing instruments and the substantial improvement of the quality of laboratory technicians, the degree of medical informatization in China has been greatly improved, and laboratory medicine has also achieved rapid development [1, 2]. Laboratory management in modern hospitals needs to serve for clinical laboratory work, which puts forward the requirements of improving work efficiency and ensuring clinical laboratory quality in the new era [3]. How to strengthen the laboratory informationization is the first problem to improve laboratory medicine level by implementing the laboratory network information system. The application of information communication technology and information processing technology in the management and service of clinical laboratory, so as to realize the informatization of hospital medical management, is the focus of current work [4, 5].

Laboratory information management systems (LIS) is a combination of computer technology, automatic control technology, quality management science and analysis technology, which is a new application technology that the laboratory uses to achieve automatic detection, quality control, automatic release, and automatic archiving of test results [6,7,8]. The rapid development of computer technology in recent 10 years, especially the increasingly maturity of network communication and database technology, has provided mature technology platforms and implementation means for LIS, making LIS continuously develop towards the direction of network-integrated management [9,10,11]. Through the opening and implementation of LIS system, better medical services can be provided for patients, online services can be provided for medical staff in wards, the accuracy and reliability of test results can be ensured, and unnecessary human errors can be minimized [12, 13].

In 1982, the United States first reported the IBM System34 Integrated Laboratory Information System (ILIS). This system can increase the effective working load and obtain a large amount of useful data without the need for additional staff [14]. In Japan, Hitachi uses the information management system, inspection instruments, and auxiliary equipment to form a large integrated system, which connects more than a dozen inspection instruments through the network and distributes specimens among them [15]. The development of LIS in China is relatively late, but after the rapid development of information technology in China, there is not much difference in laboratory information management at home and abroad. Many large hospitals have entered the LIS construction stage and finally achieved electronic data management [16,17,18]. According to the different requirements from different departments under the laboratory, they design as many functions as they need into the LIS product.

First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital) is a large Third Grade A general hospital in Guangzhou. The HIS of First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital) includes several functional modules, such as outpatient charge, patient management, medical record management, admission registration, and drug management. With the continuous development of science and technology, the widespread use of various automated analytical instruments, and the increasing progress of laboratory medicine, the hospital laboratory information system (LIS system) which is based on automatic processing information system software can connect various testing instruments with the network and has become indispensable and a very important part of clinical laboratory [19,20,21]. In order to further improve the service quality, strengthen the management means, and realize the information management, all the leaders of the hospital unanimously decided to plan and establish the LIS360 system in the hospital, and further improve the HIS, so as to finally realize the comprehensive integrated and digital hospital.

LIS360 system should use the most advanced design idea of multi-layer structure, and it runs on Microsoft SQL large database platform and has stable, fast, mass storage, and other advanced features. LIS360 system is a comprehensive laboratory management information system that integrates data collection, data sorting, data statistics and analysis, data transmission, department management, and instrument management. Based on the management mode, management standards, and advanced experience of laboratory automation process of foreign and domestic hospitals [22,23,24], combined with the actual situation of First Affiliated Hospital of Jinan University, and strictly following the development process of software engineering, the author collaborates with technical staff to develop a set of laboratory information management systems suitable for Overseas Chinese Hospital.

In order to realize the automation, standardization, and informatization of clinical laboratory work, this research topic develops and accomplishes a set of laboratory information systems (LISs). Through the analysis of the needs of inspection department personnel, the existing system network structure design scheme is learnt, to design the function required by this system. LIS360 system needs to be able to record patient test information quickly, analyze, and share test information at the same time, so as to save the time consumed in data transmission. At the same time, after the completion of the system design, we tested the system function to ensure the stable operation of LIS system.

2 Materials and Methods

2.1 System Requirement Analysis

In order to allow the software engineer to refine the basic requirements established in the preliminary requirements work, and establish the relationship between the hospital, laboratory department and the patient, we sought information management requirements from hospital workers, laboratory departments, and patients.

The design purpose of this system is to facilitate laboratory staff to complete daily sample pooling and data collection, and the system has a unified interface; unified safety certification, data integration, and system integration can be performed on existing system, but must ensure that the system interface and operating style is completely consistent. Quality, efficiency, and income in laboratory management are three indicators to ensure the quality of laboratory work [25], which can be quantified to facilitate the inspection, comparison, and supervision of daily work, and then effectively promote the development of work. The application of LIS360 system will streamline the inspection work, effectively assist the director’s supervision, solidified standardized operation process, automatic monitoring every links through promoting the whole quality management, help the laboratory to make a breakthrough in these three aspects, and comprehensively improve the comprehensive ability of laboratory operation and management.

At the same time, after analyzing and studying the system functions with the system requirements research method, we modified and summarized the system design through communication with users many times, and finally determined the main roles of the system and the functional division of each role. The LIS360 system is an information management system for the laboratory department. Therefore, the users of the system are mainly the staff of the laboratory department, including the leaders of the laboratory department, the inspection operators and the information staff of the laboratory department, who should meet the requirements of the staff of the laboratory department (Table 1). Based on the requirement of testing-related data, the LIS360 system needs to input patient basic information, test item information and test result data. The design of the system must meet the requirements of stability, security, fast, easy maintenance, easy expansion and so on, so that the system not only can meet the current needs and give users a good use experience, but also adapt to the future expansion.

Table 1 Description of user functional requirements
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2.2 System Total Design

2.2.1 Overview of Key Technologies

The hardware structure of the LIS360 laboratory management system includes Web server, database server, isolation machine, interchanger, router, hub, inspection instrument, and various terminals. The software technology platform uses Microsoft Windows as the application platform [26, 27]. The database is MS SQL Server2000, which is a large and commonly used database [28].

The system development platform can be PowerBuilder, Delphi, JSP, C++, etc. [29]. PowerBuilder 9.0 is used for developing C/S programs with two-level structure. The system uses the current relatively popular Client/Server (C/S structure) system, the server foreground operating system is windows2000professional/xp, the background database can use MS SQL Server [30], the Web server of B/S structure is IIS, the database management system uses SQL Server2000 [31], and the program development tool uses powerbuider8.0 Enterprise edition. The techniques used are listed in Table 2:

Table 2 Key technology selection table
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To connect the instrument and equipment with the server and personal computer, and realize the automatic detection and storage of the test results, a unified international standard interface must be used to solve the problem of data transmission. The full name of the RS-232 standard is EIARS-232C standard, which is very suitable for communication and transport between local devices. Therefore, in the setting of this system, the communication standard between the computer and the inspection instrument is RS-232 standard. Serial port communication has two data transmission modes: single channel and double channel. In this system, the transmission between the inspection equipment and the computer is also divided into two kinds: unidirectional transmission and bidirectional transmission. Unidirectional transmission indicates that the inspection equipment directly transmits the inspection data to the computer, and the working principle of bidirectional transmission is shown in Fig. 1.

Fig. 1
figure 1

Two-way communication flow chart

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2.2.2 The Network Structure of the System

From the point of view of network structure, LIS360 laboratory management system is a local network composed of various laboratory inspection instruments connected by computers. Through the close connection between the laboratory local network and the main hospital network, the LIS360 system can accurately and quickly input the test information of patients. After the examination and analysis of all kinds of specimens, the test instrument can remotely release the test report, and store the test report in the electronic case file, so as to realize the data sharing and the paperless transmission of the test report. For network security, we use intranet and external network isolation equipment, and HIS system and LIS360 system all exist in the hospital Intranet. In the LIS360 system, the system server and database form a local area network with inspection equipment, printers, and workstation computers. Figure 2 is the network topology of LIS360.

Fig. 2
figure 2

Network topology

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2.2.3 The Security Policy of the System

To ensure the system security is a necessary condition for the normal and orderly operation of the system. In order to protect the LIS360 server and LIS360 network from viruses and malicious software, it is necessary to take a series of technical measures to protect the system [32, 33]. This paper sets up a complete information security policy from three aspects: human, management, and security technology. The goal of this paper is to develop LIS360, so from the security technical level, we need to take several measures: external and internal network physical isolation, double hot standby, installation of antivirus software and firewall, information encryption, user rights hierarchical management, database backup, and security log.

2.2.4 Connection Scheme with HIS

After years of research and application, according to the needs and characteristics of the hospital, the connection scheme of LIS360 and HIS was developed. In this scheme, the doctor’s order can be automatically extracted from HIS database through the doctor’s order number, the basic information of the patient can be extracted according to the patient’s number, and the bar code can be printed according to the requirements of the hospital, so as to realize the remote release and automatic storage of the test results. Specific measures are as follows:

  1. 1.

    Use computer interface technology to connect all inspection equipment to local area network and automatically collect data of each instrument. All data are collected in parallel and sent to the network server in real time to realize a real-time network.

  2. 2.

    Through the seamless connection between the test network and the main hospital network, it provides clinical auxiliary support for clinicians and realizes the information sharing in the hospital. The inspection data can be transferred to other departments of the hospital after audit, so as to eliminate missing single and few items.

  3. 3.

    Open, expand and expand the interface, to provide a friendly, easy to learn and easy to use user interface.

2.2.5 System Function Design

The LIS360 laboratory information management system designed and implemented in this topic is composed of corresponding functional modules, each module has its specific function, the development of each module can be relatively independent, and then all modules can be horizontal joint debugging. Through the powerful and stable database, combined with the hospital server, completes the data management and data sharing.

After full communication with the staff of the laboratory department and the hospital, according to the actual needs of temporary inspection center laboratory, the whole system was designed into six modules: inspection, inquire and statistics, quality control, date dictionary, system configuration, and tools, as shown in Fig. 3.

Fig. 3
figure 3

System function module diagram

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2.2.5.1 Daily Inspection Work

Before daily inspection work, we need to log in to the LIS360 system. The main functions of the daily inspection work module include management of inspection reports, management of doctor’s advice, examination, inquiry, and printing of inspection results. The daily work of the laboratory department is mainly to test all kinds of specimens.

2.2.5.2 Inquire and Statistics

The clinical laboratory is a clinical medical technology department in the hospital, which is mainly aimed at serving doctors and patients on the clinical front line. The timely and accurate feedback of the inspection results to clinicians will bring great help to the diagnosis and treatment of patients. Inspection report query function can query the test results single or combined according to the inspection application number, visit number, name, inspection physician, and other information. The inspection results can be queried according to the single or multiple conditions combination and the historical results of the patient can be formed into a graph to facilitate the doctor’s diagnosis. The statistical analysis module is mainly used to summarize the patients’ situation and make statistics on workload and cost according to various query conditions. Statistical analysis of all kinds of data includes group workload statistics, detected bacterial species statistics, antibiotic resistance statistics, etc.

In the query and statistics module, we added an important financial query check function. Social relationship testing is a major feature of Chinese laboratories, and it is hard to refuse. LIS360 helps the laboratory to establish charge inquiry and check work. Through the close combination of the LIS360 system and HIS-related charge information, a certain obstacle is set up for the detection of missing charge samples, and a method is found for the laboratory personnel that does not damage the interpersonal relationship and does not sacrifice the interests of the laboratory. At the same time, LIS360 can carry out special statistics on the suspicious items of missing expenses in financial statistics, and expose specimens of leakage fee. Although the leakage fee situation cannot be eradicated from the system, it can also play a strong warning role. The laboratory can also use this function to analyze the rate of missing charges affecting normal charges.

2.2.5.3 Quality Control

Quality is the life of the inspection business. An artisan must first sharpen his tools if he is to do his work well. In order to develop the inspection business and improve the inspection ability, the laboratory must ensure the quality of inspection. LIS360 starts with equipment maintenance, pays attention to the three stages: before, during and after inspection. In addition, LIS360 pays attention to the four factors that affect quality, namely instrument maintenance, quality control operation, out-of-control analysis and specimen quality, to provide the whole quality management for the laboratory.

LIS360 can draw Levey-Jennings quality control chart, automatically calculate the standard deviation and CV of all kinds of data, and print the quality control chart. Once the instrument date exceeds the standard, the system will timely alarm and lock the instrument, and the instrument is not allowed to issue any report until the problem is solved. The system can set the standard range flexibly.

2.2.5.4 Data Dictionary

Data dictionary is a collection of data objects or items descriptions in a data model. LIS360 data dictionary module, in addition to the basic project settings, contains online instrument settings, project settings and other functions, in particular to join the knowledge base system. The knowledge base system provides sample classification and definition, explains the operation requirements, quality requirements, project definition interpretation, description of test method and the hints of clinical significance and other operation specifications, and can put forward the suggestion of further testing based on the test results.

2.2.5.5 System Configuration

The system configuration module is composed of user basic information maintenance, device management, user management, rights management, department management, and other functions.

All kinds of inspection equipment are important fixed assets of the inspection department and important tools for inspection work, most of which are of high value. This function can register the basic device information, record the change information of equipment repair, maintenance and use, statistics the cost information of equipment, query and print all kinds of data of equipment.

Corresponding to the right management function, the system adopts the “user-role-right” three-level management mode, that is, the user is not directly assigned rights, but the user is first designated as the corresponding role, and the corresponding rights are assigned to the role. For example, if an “operator” is assigned data entry, report printing, etc., the user will have all the rights of an “operator” as long as his role identity is designated as “operator”. This avoids duplication of work and is easy to manage and maintain.

2.2.5.6 Other Tools

Other tools include system options, custom keyboard shortcuts, and data backup and recovery. These tools can back up, sort out, and repair inspection data to ensure the inspection work can be carried out normally.

2.2.6 Database Design

The design of system database must conform to the three paradigms of relational database design to make the data storage structure more reasonable. The load is evenly distributed between the client and server, through batch commit and rollback transactions, the network traffic and CPU occupancy are greatly reduced, and the load on the network and CPU is reduced.

According to the demand analysis of the clinical laboratory information system of our hospital, and the overall analysis and design of the system, this LIS360 system uses the database entity relationship diagram (E-R diagram) to analyze and explain. First, the E-R diagram of each entity is analyzed, and then the E-R model of each entity is established according to the relationship between each entity, so as to complete the conceptual design of the database.

Through the analysis and design of LIS360 system database entity relationship model, gradually complete the establishment of database table, such as system user information table, patient basic information table, specimen information table, medical order management information table, quality control item table, inspection instrument information table, and inspection item application form. For example, the main function of the system user information table is to display the user number, user account, user password, personnel number, and role number. Table 3 is the system user information table.

Table 3 System user information table
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3 Results

3.1 The Realization of the Main Module Functions

According to the work nature and characteristics of different laboratories, the system main interface shows the entrance of six functions of the system, which are inspection, query and statistics, quality control, data dictionary, system configuration, tools, and help (Fig. 4). Using inspection instruments and project, quality control, result query, and other database information can establish data information quickly and easily, according to the standard business process to manage the database. The result data generated by LIS360 information system can be easily and quickly exchanged with HIS in real time, so as to realize a wider range of information sharing and result release.

Fig. 4
figure 4

Main interface of LIS360 system

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3.1.1 Inspection Function

The LIS360 information management system adds a new test item; in the actual situation of adding departments connection instruments to select the instrument item, you can select the corresponding instrument model under the installation of new instruments, and if the network system has installed instruments, you can select the appropriate instrument under the default instrument.

After the experimental instrument receives the instruction, only if the sample programming is successful, the experimental instrument can carry out the next experiment, which is an important link to completing the experiment. The evolution programming is shown in Fig. 5. After entering the sample programming interface, first select the test instrument, then enter the detailed test item, select the item you need to test and click save. Put the sample into the test instrument, and then click start, the instrument will automatically complete the test of the sample. After the test, the test results will be automatically uploaded to the system to complete the whole experiment.

Fig. 5
figure 5

Sample programming capabilities

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3.1.2 Inquire and Statistics

This module is the inquire and statistics function, which is most commonly used by the director of the laboratory department. In addition to the laboratory status summary function, it also integrates a number of commonly used laboratory information processing and management functions to facilitate the laboratory director to participate in the first-line operation. The implementation of the query function is shown in Fig. 6.

Fig. 6
figure 6

System query function

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After entering the search criteria, user can query all modification records that meet the search criteria. The query criteria include the specimen date and the modification date.

The statistical function can count the sample size and charges of inspection according to various conditions. The system also has the function of classification statistics, such as classification statistics physical examination business and printing clinical business reports and graphics.

3.1.3 Quality Control

The quality control management module takes automation, information, network, and intelligent management of quality control data as the core to meet the needs of total quality management. The powerful indoor quality control data management function covers the whole process of quality control limit setting, quality control rule setting, quality control data browsing, quality control data audit, and quality control result output (quality control chart and quality control report). The system supports multiple quality control rules at the same time, and the daily quality control data can be judged to be out of control or in control according to the rules. In addition, the system supports daily multi-point quality control. Users can view the quality control curve in the same time period or in a continuous quality control point mode. The quality control chart is shown in Fig. 7.

Fig. 7
figure 7

Quality control diagram

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3.1.4 Data Dictionary

The system has many functional modules, which can set inspection items, combination rules, manual template input, clinical departments, clinical doctors for examination, graphical information in the main interface, and set the reference value details, clinical significance, and knowledge base system in the main interface. In data dictionary, an important feature is charge confirmation. Charge confirmation can check whether the whole experiment is complete charge, to ensure that the experiment will not appear wrong charge and missed charge, and it can be set in the LIS360 main menu.

3.1.5 System Configuration

In this system, there are many settings function, and instrument management, user management, and other information maintenance are included in the system configuration function. After entering the corresponding function interface by clicking the corresponding option, enter the corresponding system function according to the system prompts. The instrument management interface is used to manage information about instruments and reagents, including saving, deleting, printing, and searching information about instruments. Instrument management interface including local instrument settings, input interface settings, and instrument function settings. The report setting module can provide the user to select the report type, customize the paper of the report and other printing options, and provide the user to define the report.

3.1.6 Other Tools

In addition to the above mode functions, this system can also optimize the system, and the system log can view all the actions and data changes of the operator in the use process. Entering the “Modify Record” interface, user can view all the modification records of specimen after the report sheet is saved. The realization of data synchronization record solves the problem of data synchronization between local database and network database.

3.2 System Testing

System testing is an indispensable part of software engineering or program development, and it can be used to find software errors and defective parts, which is an extremely important work. The development of laboratory management software also needs to be tested in the laboratory, so that errors can be found as early as possible, greatly reducing the cost of correcting errors. For example, system testing can be used to test the usability of software on various inspection instruments. If different inspection instruments need different management software, it will undoubtedly increase the cost and overhead of users. Therefore, in most cases, an information management software will be tested on various inspection instruments, and when all the functions have been completed, the final usability test will be carried out. Of course, testing is not the ultimate goal. The ultimate goal of testing is to detect as many system errors as possible so as to correct them, this process is called debugging, which is an important means for us to improve the system. The whole debugging process is carried out from four perspectives, namely functionality, reliability, application performance, and system performance.

Generally, software testing has two phases in the software development life cycle. The first phase is to make necessary tests on the code after writing the code for each module. In this case, the writer of the module code and the tester of the system are the same person. In the second phase, after the end of the first phase, in order to detect the software errors as much as possible, a variety of comprehensive tests should be carried out on the system, and then repeated debugging and retesting, so as to improve the reliability of the software system. The second phase is a separate phase in the software development, which is also a dedicated testing phase. The system will be tested by dedicated testers. In the system testing, the system running results are good, each system function is stable, and the system network structure is successful.

3.3 System Maintenance

In terms of system maintenance, we have taken the following measures:

  1. 1.

    Special LIS360 system maintenance personnel, called system administrator, should be set up in the laboratory. The system administrator should not only need to be familiar with the basic knowledge of computer and database operation, and be able to deal with common problems in time, but also must be familiar with the inspection workflow (such as the addition of new inspection items and the setting of reference values and reference units).

  2. 2.

    Assign different roles to different laboratory staff to obtain different user rights.

  3. 3.

    Organize laboratory staff to conduct LIS360 system knowledge training every month, including the use of each functional module, and document daily problems and solutions.

  4. 4.

    Install LIS system program files and graphics files to the disk D on the computer. It will avoid data loss caused by system reinstallation.

4 Discussion and Conclusion

The development and application of the LIS360 laboratory information management system can greatly improve the management level of the laboratory and promote the standardization, modernization, and science of laboratory management. This system has solved the traditional mode of sending test report sheet manually for many years in the laboratory, and won valuable time for clinicians to know the patient’s condition in time.

At present, the design of LIS360 laboratory information management system has been completed, and the function of the system has been tested and put into clinical use. LIS360 system all functions can run stably, easy to operate quickly. LIS360 laboratory information management system realizes streamlined operation and shortens the workflow and testing cycle. After all kinds of instruments are tested, the test data were automatically saved to the database, and the experimental data can be saved accurately and will not be lost, which improves the work efficiency. The LIS360 system allows users to quickly find the test information of patients and improve the work efficiency of medical staff. Second, the quality control management system of LIS360 laboratory information management system ensures the whole quality management of the test results. Quality management provides a safe and effective guarantee for the laboratory sample inspection process, improves the quality of medical services, and ensures the rapid, accurate and timely return of test results. At the same time, the quality management also reduces and avoids the most common medical errors in the laboratory, such as sample loss, time-out detection and incorrect results, promotes the inspection personnel to improve the quality awareness, meets the requirements of the hospital, and provides more high-quality services for patients.

At present, HIS is widely used in hospitals at home and abroad. HIS can help doctors better monitor the status of patients in the clinic. For example, the clinical data of patients in the hospital information system can accurately pick out the cases of arrhythmia, and further improve the accuracy of the alert value of abnormal indicators by analyzing the data [34]. At present, the system can also judge and mark the abnormal indicators of patients to improve the diagnostic efficiency of doctors. The future development direction of LIS system is to develop towards artificial intelligence, which will give signs and different colors (already done) to the results beyond the reference value range and even issue sound warnings. LIS system can make judgment on the results of microbial examination and identification of patients, drug sensitivity test and infection rate of patients, and guide the clinical medication of patients. Moreover, an expert system was established to put forward possible diagnostic opinions according to the test results and comprehensive analysis and processing of patient data for the reference of clinicians. LIS system is also connected with Internet to realize the social sharing of inspection information resources. The LIS system is powerful and widely used, and also has great application value to other clinical institutions. For example, the LIS system can assist in tracing the input and use of blood products when it is applied to the blood products library in health institutions. The application of LIS system in electron microscope laboratory can help users share information resources [35, 36]

Due to the urgency of time, the author’s project development experience is not very rich. In computer technology proficiency, system theoretical knowledge reserve, design scheme selection, and system function realization, the author has many shortcomings, making this paper not perfect, and there are many shortcomings. Due to the progress of science and technology and higher requirements for inspection work, the system can be further improved in interface design, service-oriented architecture (SOA), system performance, and other aspects in the future. At the same time, this system only covers the functions of the inspection department temporarily. In the future, more functions can be developed on the basis of this system to improve the work efficiency of the hospital.