Five factors that must be considered when choosing an inspection automation assembly line

Laboratory automation system, also known as automated assembly line, refers to the functional integration of one or several detection systems in the clinical laboratory, which connects different analytical instruments and related equipment before and after analysis through hardware and information networks Related equipment integration. The main components include sample pre-processing system, sample transport system, sample analysis system, sample storage system and software control system.

Due to the rapid development of clinical departments in hospitals, on the one hand, the amount of specimens in the laboratory has doubled and increased, and the service targets have to shorten the return time for results. On the other hand, the limited space of the laboratory and insufficient staff have become constraints on the development of the hospital. bottleneck. Having a scientific and rationalized laboratory automation system is the development direction of large-scale comprehensive laboratories, and it is also the general trend.

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For any clinical laboratory, the actual needs and status of the laboratory must be combined with the actual needs and current situation of the laboratory before selecting the laboratory automation system, in line with the daily work habits of the staff in the department, consider improving the processing capacity of the equipment, improving the functions of the information system, and improving the quality of the personnel , And then make a reasonable and scientific decision.

1. Planning of automated laboratory

Compared with traditional medical laboratories, automated laboratories have greatly improved the degree of automation and intelligence, and have higher requirements in laboratory design, but defects in laboratory planning and design often cause the effectiveness of the instrument to not be fully utilized. It is impossible to automate the entire detection process in a true sense. First, the proposal of automated laboratory design should refer to various standards issued by the country, such as "General Requirements for Laboratory Biosafety", "Technical Specifications for Building Biosafety Laboratories", "General Guidelines for Biosafety of Microbiology and Biomedical Laboratories" Etc., the details of laboratory hydropower, illuminance, noise, communication interface, etc. should be planned in advance. In addition, the planning and design of automated laboratories is not only the placement of related equipment, but also the specification and improvement of the work process. The design should fully consider the flow of personnel, specimens, medical waste, and cleaning materials in and out of the laboratory.

Second, the choice of automation system and laboratory integration

There are currently 3 types of automation product combinations (as follows) to choose from:

1. IVD manufacturers provide automated systems with completely independent property rights, connected to independent brand analytical instruments. Covers sample analysis pre-processing, analysis detection, post-analysis processing and information management, compatible with the entire laboratory.

2. Based on the automation system provided by an IVD manufacturer, the hardware is compatible with the instruments and equipment of other IVD suppliers.

3. Based on automation rail suppliers, connecting with equipment provided by various IVD manufacturers.

At present, some IVD manufacturers in the domestic market can connect hardware through rails to achieve cross-platform physical connection, but the interfaces of different manufacturers’ instruments and system software control platforms are not compatible. How to realize cross-platform data sharing and other information functions of instruments is often in the process of instrument integration. The difficulty.

For the analytical instruments of the same manufacturer, due to the consistent communication standards, the same management can be conveniently carried out through the intermediate software, such as monitoring the real-time status of the specimens on each analysis module. However, for instruments of different brands, only basic communication can be set up, or even two-way communication with the intermediate software is not realized. The actual effect of automation and informationization is greatly reduced.

For manufacturers that are integrated into a single brand through acquisitions by different manufacturers, there are also differences in the way of managing samples due to the different design concepts of the original equipment, but in fact they are still different operating systems. After the acquisition and integration, although the instruments are connected on the same automated assembly line, which makes up for the shortcomings of the incomplete detection menu, it also introduces new problems. For example, samples are transported in a single tube on the automated assembly line track, and sample racks are transported on the testing instrument. , The different sample management methods add an additional step of transferring samples before testing on the computer, causing the overall speed to be unmatched and becoming a bottleneck for the entire pipeline.

3. Sorting of unqualified samples

In order to ensure the quality of testing, the automated system should have automatic identification functions for hemolysis and lipemia samples. Different manufacturers shall identify unqualified specimens through chemical tests and physical methods. Chemical methods require the purchase of relevant reagents, so that the degree of hemolysis and lipemia of the specimens can be determined. It is more accurate, but it has the problem of increased detection cost and time. Physical methods can make preliminary judgments on the properties of specimens. Roche’s pre-processing system uses digital camera systems to identify abnormal specimens and warns of suspicious specimens.

Physical detection is relatively simple and no cost increase. If chemical methods are not used for detection, the identification of abnormal specimens is in a disordered state and can only be found when it has a greater impact on the results.

Fourth, the issue of informatization construction

Laboratory information system is an important part of clinical laboratory operation. Initially established to collect, record, display, organize and archive laboratory results, usually focusing on generating appropriate laboratory financial management information. Although general information technology is advancing at an increasingly rapid rate of development, laboratory LIS has not been developed accordingly.

The intermediate software equipped with the automated assembly line serves as an effective supplement to the laboratory’s LIS, so that the form of laboratory results is not limited to digital results, but may also be text, pictures, or other images. Intermediate software not only pays attention to the detection efficiency in the entire detection process, but also the quality of the sample detection results. As a tool that can better improve detection efficiency and ensure quality, it can achieve sample overview, sample tracking, sample archiving and searching, quality control, automatic review, statistics and other functions.

Five, personnel issues

From a comprehensive point of view, today, the higher the degree of automation, it is not that people's requirements are lower, but people's requirements are higher. The testing personnel are required to have a very clear understanding of testing technology, testing principles, and clinical related knowledge in order to confirm that the corresponding testing results are accurate. In the automated flow operation, a problem in a certain link may affect the detection of the entire automation system. Therefore, it is necessary for the operator to have a high sense of responsibility and a strong professional technical level. The automation system involves a lot of testing items, the number of reagents and consumables that need to be filled every day is very large, and the maintenance of testing instruments and related supporting facilities also requires a lot of energy. This not only requires laboratories to have corresponding management systems and SOPs to ensure the effective conduct of departmental work.

Taking into account the continuous development and change of the department, we can also analyze the existing workload and process of the department through corresponding training and learning, and combine the concept of 5s and lean to help the laboratory understand key issues such as TAT and process bottlenecks, and help the laboratory Balance workload, reduce work pressure, improve department management level, and achieve optimization goals.