Sample location and patient information entry system for fully automatic coagulation tester

Abstract

The present invention discloses a sample position and patient information entry system of a fully automatic coagulation tester, and specifically relates to the technical field of medical testing equipment; a residual risk judgment module is used to analyze the pressure fluctuation of a sample needle during sample aspiration at different positions to determine whether there is a trace residual risk; a cross-contamination assessment module is used to dynamically analyze aerosol diffusion conditions to assess the sample cross-contamination risk; a safety determination module determines the safety of the sample detection process according to the residual risk and the cross-contamination risk; a positioning deviation assessment module assesses the influence of the sample positioning deviation by analyzing the temperature distribution gradient; a consistency assessment module analyzes information transmission errors to assess the consistency of sample source and patient information entry; a comprehensive adjustment module performs comprehensive analysis to assess the reliability of sample detection results, and dynamically adjusts sample site allocation and information entry processes to provide more scientific and robust support for clinical diagnosis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical testing equipment, and more specifically, to a sample position and patient information input system of a fully automatic blood coagulation tester. Background Art

[0002] Fully automatic coagulation testers are widely used in medical testing for rapid and accurate testing of the coagulation function of blood samples. However, with the increasing number of samples and test batches, traditional fully automatic coagulation testers often face many problems such as cross-contamination and sample residue when processing high-throughput blood samples. In addition, in a high-load testing environment, the correlation between the uneven temperature distribution of the sample rack and the positioning deviation may also be ignored, causing sample positioning errors and affecting the accuracy of the test results. At the same time, if there are data transmission or entry errors in the process of entering patient information, it is easy to cause confusion in the correspondence between the sample source and the patient's identity, thereby affecting the reliability of the test results.

[0003] In order to solve the above problems, a sample position and patient information input system of a fully automatic coagulation tester is provided. Summary of the invention

[0004] In order to overcome the above-mentioned defects of the prior art, an embodiment of the present invention provides a sample position and patient information entry system of a fully automatic coagulation tester to solve the problems raised in the above-mentioned background technology.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] The sample location and patient information entry system of the fully automatic coagulation tester includes: residual risk judgment module, cross contamination assessment module, safety determination module, positioning deviation assessment module, consistency assessment module and comprehensive adjustment module;

[0007] The residual risk judgment module determines whether there is a trace residual risk on the surface of the sample needle by analyzing the pressure fluctuations of the sample needle during the sample aspiration process at different positions;

[0008] The cross-contamination assessment module dynamically analyzes the aerosol diffusion generated during sample aspiration and assesses the potential risk of sample cross-contamination;

[0009] The safety determination module determines the safety of the sample detection process according to the judgment result of whether there is a trace amount of residual risk on the surface of the sample needle and the potential risk of sample cross contamination. The safety of the sample detection process includes high safety and low safety;

[0010] When the safety of the sample detection process is high: the positioning deviation assessment module evaluates the influence of the sample positioning deviation by analyzing the temperature distribution gradient of the sample rack position; the consistency assessment module evaluates the consistency between the sample source and the patient information input by analyzing the information transmission error during the sample information input process;

[0011] Comprehensive adjustment module: Comprehensively analyze the potential risk of sample cross-contamination, the impact of sample positioning deviation, and the consistency between sample source and patient information entry, evaluate the reliability of sample test results, and adjust sample site allocation and information entry processes.

[0012] In a preferred embodiment, the pressure fluctuation of the sample needle during the sample aspiration process at different positions is analyzed, specifically: the pressure change data of the sample needle during the sample aspiration process at different positions is collected by a sensor, and the pressure change is pre-processed;

[0013] Compare the preprocessed pressure change data with the standard pressure fluctuation model to determine whether there is any situation beyond the normal fluctuation range:

[0014] If abnormal fluctuations are detected, analyze whether the abnormal fluctuations are related to potential trace residues on the surface of the sample needle and evaluate the residual risk: the abnormal fluctuations are decomposed into high-frequency pressure residual components and low-frequency pressure residual components; based on the high-frequency pressure residual components, the residual risk index is calculated :

[0015] ;in, is the residual risk index; Indicates the allowable pressure fluctuation error range; The total time range for monitoring the sample needle pressure fluctuation data; is the high-frequency pressure residual component.

[0016] In a preferred embodiment, determining whether there is a trace amount of residual risk on the surface of the sample needle is specifically as follows:

[0017] Preset the residual risk index threshold and compare the residual risk index with the residual risk index threshold:

[0018] When the residual risk index is greater than or equal to the residual risk index threshold, it is determined that there is a trace residual risk on the surface of the sample needle;

[0019] When the residual risk index is less than the residual risk index threshold, it is determined that there is no trace residual risk on the surface of the sample needle.

[0020] In a preferred embodiment, aerosol diffusion generated during sample aspiration is dynamically analyzed to assess the potential risk of sample cross contamination, specifically by: monitoring air flow characteristic data around the sample needle during sample aspiration;

[0021] Detect the concentration distribution of aerosols and generate a spatiotemporal distribution model of aerosol diffusion during sample aspiration;

[0022] Quantitatively analyze the aerosol concentrations at adjacent sample locations to assess the potential impact of sample cross-contamination;

[0023] Combined with the aerosol concentration analysis results of adjacent sample locations, the cross-contamination risk index is calculated to assess the potential risk of sample cross-contamination: Define the cross-contamination risk index:

[0024] ;in, is the cross contamination risk index; For in time Aerosol concentration in the spatial region adjacent to the sample at ; is the time weighting function; The total length of time for aerosol diffusion to be monitored during sample aspiration.

[0025] In a preferred embodiment, the safety of the sample detection process is determined based on the judgment result of whether there is a trace residual risk on the surface of the sample needle and the potential risk of sample cross contamination. The safety of the sample detection process includes high safety and low safety. Specifically, a cross contamination risk index threshold is preset, and the cross contamination risk index is compared with the cross contamination risk index threshold:

[0026] When the cross-contamination risk index is greater than or equal to the cross-contamination risk index threshold, it indicates that the potential risk of sample cross-contamination is high;

[0027] When the cross-contamination risk index is less than the cross-contamination risk index threshold, it indicates that the potential risk of sample cross-contamination is low;

[0028] When the residual risk index is less than the residual risk index threshold, and the cross-contamination risk index is less than the cross-contamination risk index threshold, the safety of the sample detection process is judged to be high safety; otherwise, the safety of the sample detection process is judged to be low safety.

[0029] In a preferred embodiment, the influence of the sample positioning deviation is evaluated by analyzing the temperature distribution gradient of the sample rack position, specifically: the temperature change of each position in the sample rack is monitored in real time by a temperature sensor to obtain temperature data of different positions of the sample rack;

[0030] The temperature data is used to construct a three-dimensional temperature distribution model of the sample rack position and calculate the temperature gradient between the positions of the sample rack;

[0031] Compare the calculated temperature gradient with the preset standard gradient to determine whether there is a temperature change beyond the normal range, indicating a sample positioning deviation;

[0032] Based on the results of temperature gradient analysis, the influence of sample positioning deviation is evaluated: the positioning deviation index is defined and the calculation formula is: ;in, Indicates the positioning deviation index; represents the standard temperature gradient; Indicates the sample rack position The temperature gradient at .

[0033] In a preferred embodiment, the consistency between the sample source and the patient information entry is evaluated by analyzing the information transmission error during the sample information entry process, specifically: collecting the entry data;

[0034] Compare input data with source information to identify transmission error types;

[0035] Construct a mapping between sample sources and patient information to quantify the degree of consistency: define the consistency index, and the calculation formula is:

[0036] ;in, is the consistency index; Indicates the amount of source information; Indicates the number of input data; is an element in the mapping matrix, Indicates data entry; Indicates source information.

[0037] In a preferred embodiment, the potential risk of sample cross-contamination, the degree of influence of sample positioning deviation, and the consistency between the sample source and the patient information entry are comprehensively analyzed to evaluate the reliability of the sample test results, and the sample site allocation and information entry process are adjusted, specifically: the cross-contamination risk index corresponding to the potential risk of sample cross-contamination, the positioning deviation index corresponding to the degree of influence of sample positioning deviation, and the consistency index corresponding to the consistency between the sample source and the patient information entry are normalized; the normalized cross-contamination risk index, positioning deviation index, and consistency index are calculated to obtain the reliability coefficient, and the calculation formula is:

[0038] ;in, is the reliability coefficient; is the cross contamination risk index; Indicates the positioning deviation index; is the consistency index;

[0039] Preset the reliability coefficient threshold and compare the reliability coefficient with the reliability coefficient threshold:

[0040] When the reliability coefficient is greater than or equal to the reliability coefficient threshold, it indicates that the reliability of the sample test result is high;

[0041] When the reliability coefficient is less than the reliability coefficient threshold, it indicates that the reliability of the sample test results is low, and the sample site allocation and information entry process need to be adjusted.

[0042] Technical effects and advantages of the sample position and patient information input system of the fully automatic coagulation tester of the present invention:

[0043] 1. The residual risk judgment module can accurately identify the trace residual risk on the surface of the sample needle and reduce the possibility of contamination between samples; the cross-contamination assessment module dynamically analyzes the aerosol diffusion situation, effectively assesses and warns of sample contamination risks; the safety determination module comprehensively assesses the residual risk and contamination hazards, providing reliable protection for the safety of the detection process. In the case of higher safety, the positioning deviation assessment module and the consistency assessment module further refine the detection, respectively analyzing the sample positioning deviation and information entry consistency issues, thereby improving the accuracy and traceability of the test results.

[0044] 2. The comprehensive adjustment module not only optimizes the sample site allocation and information entry process through multi-dimensional comprehensive analysis and dynamic adjustment mechanism, but also greatly improves the operational stability and reliability of test results. It can significantly reduce the detection deviation caused by cross-contamination and data errors, and provide efficient and safe solutions for modern medical testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 It is a structural schematic diagram of the sample position and patient information input system of the fully automatic coagulation tester of the present invention. DETAILED DESCRIPTION

[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0047] Embodiment 1:

[0048] Figure 1A schematic diagram of the structure of the sample position and patient information input system of the fully automatic coagulation tester of the present invention is given, including: a residual risk judgment module, a risk hidden danger assessment module, a cross contamination assessment module, a safety determination module, a positioning deviation assessment module, a consistency assessment module and a comprehensive adjustment module;

[0049] The residual risk judgment module determines whether there is a trace residual risk on the surface of the sample needle by analyzing the pressure fluctuations of the sample needle during the sample aspiration process at different positions;

[0050] The risk hazard assessment module assesses the risk hazard degree of trace residue on the surface of the sample needle when there is no trace residue risk on the surface of the sample needle;

[0051] The cross-contamination assessment module dynamically analyzes the aerosol diffusion generated during sample aspiration and assesses the potential risk of sample cross-contamination;

[0052] The safety determination module determines the safety of the sample detection process according to the judgment result of whether there is a trace amount of residual risk on the surface of the sample needle and the potential risk of sample cross contamination. The safety of the sample detection process includes high safety and low safety;

[0053] When the safety of the sample detection process is high: the positioning deviation assessment module evaluates the influence of the sample positioning deviation by analyzing the temperature distribution gradient of the sample rack position; the consistency assessment module evaluates the consistency between the sample source and the patient information input by analyzing the information transmission error during the sample information input process;

[0054] Comprehensive adjustment module: Comprehensively analyze the potential risk of sample cross-contamination, the impact of sample positioning deviation, and the accuracy of patient information association, evaluate the reliability of sample test results, and adjust the sample site allocation and information entry process.

[0055] Specifically, by analyzing the pressure fluctuations of the sample needle during the sample aspiration process at different positions, it is determined whether there is a trace amount of residual risk on the surface of the sample needle, including:

[0056] The pressure change data of the sample needle during the absorption process at different positions is collected through the sensor, and the pressure change is preprocessed: during the absorption process of the sample needle, the pressure sensor installed in the tester monitors the pressure change data of the sample needle in real time. The pressure data will be affected by the viscosity of the liquid, the pressure environment in the sample container, and the physical properties of the sample needle itself at each stage of the sample absorption. To ensure the accuracy of the data, the pressure signal collected by the sensor is quantified as time series data ,in, Indicates the sample needle at time The instantaneous pressure in Pascals; Indicates time in seconds, with a sampling interval of .

[0057] Time series data needs to be smoothed to remove high-frequency noise. The smoothed signal is expressed as , the formula is as follows: ;in, Indicates the sample needle pressure value after smoothing; Indicates the length of the time window for smoothing.

[0058] The sample needle pressure value after smoothing , the pressure change trend of the sample needle when sucking at different positions can be observed more clearly.

[0059] Compare the preprocessed pressure change data with the standard pressure fluctuation model to determine whether there is a situation beyond the normal fluctuation range: In order to determine whether the pressure fluctuation is abnormal, it is necessary to establish a standard pressure fluctuation model The standard pressure fluctuation model is a reference curve obtained based on multiple normal sample aspiration experiments, which is used to reflect the pressure fluctuation range under ideal conditions during sample aspiration. The standard pressure model is expressed as: ;in, Indicates time Standard pressure fluctuation value under ; is the pressure fluctuation amplitude in Pascals, which represents the pressure fluctuation range in the standard pressure model and is obtained through experimental fitting; is the angular frequency of pressure fluctuations, in radians per second, reflecting the periodicity of pressure fluctuations, which is determined by the liquid flow rate during the suction process; is the initial phase angle of pressure fluctuation, in radians, determined by the initial suction conditions; It is the pressure reference value in Pascal, indicating the average pressure during stable suction.

[0060] The smoothed sample needle pressure value Compared with the standard pressure fluctuation model The comparison is done through the residual function The calculation results are: ;in, Residual value representing the sample needle pressure fluctuation.

[0061] when When , it is judged as abnormal pressure; is the allowable pressure error range.

[0062] If abnormal fluctuations are detected, analyze whether the abnormal fluctuations are related to potential trace residues on the surface of the sample needle and assess the residual risk: When abnormal pressure fluctuations are detected, further analyze whether the source of the abnormality is related to trace residues on the surface of the sample needle. The abnormal fluctuations are decomposed into high-frequency pressure residual components. and the low-frequency pressure residual component :

[0063] ; ;in, is the low-frequency pressure residual component; It is the high-frequency pressure residual component, which reflects the rapidly changing part of the residual signal and may be related to trace residues; is the smoothing window length of the low frequency component.

[0064] High frequency components It is believed to be closely related to the pressure fluctuation caused by trace residue, and its frequency component It can be analyzed by fast Fourier transform. Within the specified residual effect frequency range, the abnormal fluctuation is determined to be related to trace residues.

[0065] According to the high-frequency pressure residual component , calculate the residual risk index :

[0066] ;in, is the residual risk index; Indicates the allowable pressure fluctuation error range; The total time range for monitoring the sample needle pressure fluctuation data; is the high-frequency pressure residual component.

[0067] Preset the residual risk index threshold and compare the residual risk index with the residual risk index threshold:

[0068] When the residual risk index is greater than or equal to the residual risk index threshold, it is determined that there is a trace residual risk on the surface of the sample needle. At this time, the needle cleaning procedure should be triggered immediately or the needle should be replaced, and the needle should be high-pressure washed or other cleaning methods should be used according to the actual operating procedures;

[0069] When the residual risk index is less than the residual risk index threshold, it is determined that there is no trace residual risk on the surface of the sample needle, and the sample needle can be directly put into the next sample suction operation. There is no need to start the cleaning procedure at this time;

[0070] The residual risk index threshold is a benchmark value for judging residual risk, which is determined based on a large amount of experimental data and the comprehensive requirements for the sensitivity of trace residues. It is usually set by considering factors such as the test environment, sample type, equipment model and cleaning efficiency.

[0071] Specifically, the aerosol diffusion generated during sample aspiration is dynamically analyzed to assess the potential risk of sample cross-contamination, including:

[0072] Monitoring the air flow characteristics around the sample needle during the sample aspiration process: During the sample aspiration process, the air flow data is collected by high-speed fluid sensors installed near the sample needle. These sensors can record the changes in the air velocity field and pressure field in real time. Assume that the air flow velocity vector is ,in, Represents a spatial coordinate point In time Air flow velocity at 100 Hz; Represents three-dimensional space coordinates; Indicates time.

[0073] Detect the concentration distribution of aerosols and generate a spatiotemporal distribution model of aerosol diffusion during sample absorption:

[0074] The aerosol sensor is located around the sample needle and detects the concentration of aerosol particles by light scattering method, recording its distribution over time and space. Assume that the aerosol concentration distribution function is ,in, Indicates the aerosol particles at the coordinate point and time The concentration at , in units of particles per cubic meter;

[0075] Combined air flow velocity vector , the rate of change of aerosol concentration can be expressed as:

[0076] ;in, It represents the rate of change of aerosol concentration over time; It represents the rate of change of aerosol concentration due to flow; Indicates the intensity of aerosol source generated during sample aspiration; Represents the rate of aerosol reduction due to deposition, diffusion or capture.

[0077] By solving the equations, a spatiotemporal distribution model of aerosol diffusion during sample aspiration is generated .

[0078] Quantitative analysis of aerosol concentrations at adjacent sample locations to assess the potential impact of sample cross-contamination: the spatiotemporal distribution model of aerosol diffusion Spatial region with adjacent samples Intersection, calculated in time The potential impact concentration of aerosol on adjacent samples is :

[0079] ;in, For in time Aerosol concentration in the spatial region adjacent to the sample at ; is the spatial region of adjacent samples.

[0080] When the aerosol concentration in the spatial area of ​​adjacent samples exceeds a certain threshold, it indicates that the risk of cross-contamination may exist, and the adjacent samples are contaminated.

[0081] Combined with the aerosol concentration analysis results of adjacent sample locations, the cross-contamination risk index is calculated to assess the potential risk of sample cross-contamination: Define the cross-contamination risk index:

[0082] ;in, is the cross contamination risk index; For in time Aerosol concentration in the spatial region adjacent to the sample at ; It is a time-weighted function, which is used to highlight the period of high pollution incidence; The total length of time for aerosol diffusion to be monitored during sample aspiration.

[0083] The larger the cross-contamination risk index, the more serious the impact of aerosol diffusion generated during sample aspiration on the contamination of adjacent samples. This indicates that during the aerosol diffusion process, the air flow and aerosol concentration around the sample needle are high, which may cause trace amounts of pollutants to spread through the air to adjacent sample locations, thereby increasing the risk of cross-contamination. Specifically, a higher risk index usually means that the physical isolation between samples is poor, the air flow rate is higher, or the concentration of aerosol particles is higher, resulting in a larger potential range of cross-contamination. Measures should be taken to make adjustments, such as optimizing the sample position, improving air flow control during sample aspiration, or reducing contamination transmission through physical isolation.

[0084] Specifically, the safety of the sample detection process is determined based on the judgment result of whether there is a trace amount of residual risk on the surface of the sample needle and the potential risk of sample cross contamination. The safety of the sample detection process includes high safety and low safety, including:

[0085] A cross-contamination risk index threshold is preset, and the cross-contamination risk index is compared with the cross-contamination risk index threshold:

[0086] When the cross-contamination risk index is greater than or equal to the cross-contamination risk index threshold, it indicates that the potential risk of sample cross-contamination is high, that is, the aerosol diffusion generated during the sample aspiration process has reached the predetermined contamination risk level, which may cause significant cross-contamination to adjacent samples. At this time, an alarm should be issued immediately and preventive measures should be initiated, such as adjusting the sample aspiration process, strengthening physical isolation, optimizing air flow, or reducing the possibility of aerosol transmission. It is also necessary to re-evaluate the allocation plan of the sample aspiration position to reduce the potential impact of cross-contamination;

[0087] When the cross-contamination risk index is less than the cross-contamination risk index threshold, it indicates that the potential risk of sample cross-contamination is low, that is, the contamination risk of aerosol diffusion generated during sample aspiration to adjacent samples is low and within an acceptable range;

[0088] The setting of the cross-contamination risk index threshold is based on many considerations, including the design characteristics of the equipment, the operating environment, the sample type and its processing requirements. First, through a large amount of experimental data analysis, the degree of influence of aerosol diffusion on sample contamination under different operating conditions is determined, and then a relationship model between the cross-contamination risk index and the actual degree of contamination is established. Secondly, combined with the physical layout and airflow control system of the equipment, the aerosol propagation path and diffusion range in different sample processing processes are evaluated. In addition, it is necessary to refer to industry standards and laboratory specifications to ensure that the threshold setting meets safety and quality control requirements.

[0089] When the residual risk index is less than the residual risk index threshold, and the cross-contamination risk index is less than the cross-contamination risk index threshold, the safety of the sample detection process is judged to be high; otherwise, the safety of the sample detection process is judged to be low.

[0090] Specifically, by analyzing the temperature distribution gradient at the sample holder position, the influence of the sample positioning deviation is evaluated, including:

[0091] Use temperature sensors to monitor the temperature changes at various locations in the sample rack in real time and obtain temperature data at different locations in the sample rack: Install accurate temperature sensors at multiple key locations in the sample rack to monitor the temperature changes at various locations in the sample rack in real time. These sensors can measure the temperature at different locations in the sample rack (for example, the four corners, the center, the upper layer, the lower layer, etc.). The temperature data at each location of the sample rack can be expressed in the following ways:

[0092] Define the position of the sample rack in three-dimensional space as ,in is the spatial coordinate of each monitoring point in the sample rack.

[0093] The temperature sensor is located at The measured temperature value is .

[0094] Use temperature data to build a three-dimensional temperature distribution model of the sample rack position and calculate the temperature gradient between each position of the sample rack: After obtaining the temperature data of each position, use mathematical modeling methods to build a three-dimensional temperature distribution model of the sample rack position. This model spatializes the temperature change in the sample rack and can accurately display the distribution of temperature in space. According to the position coordinates of the sample rack and measured temperature data , establish the temperature distribution function: ;in, Represents the temperature data at different locations obtained by the temperature sensor. Apply numerical analysis methods, such as interpolation, to map the temperature data into the three-dimensional spatial model of the sample rack.

[0095] Calculating the temperature gradient means analyzing the temperature changes at each location in the sample rack through the temperature distribution model, thereby calculating the rate of change of temperature in space. The temperature gradient formula can be expressed as:

[0096] ;in, For sample rack position The temperature gradient at the sample rack indicates the rate of change of temperature in each direction. By calculating the temperature gradient, the intensity of temperature change between different positions of the sample rack can be obtained.

[0097] Compare the calculated temperature gradient with the preset standard gradient to determine whether there is a temperature change beyond the normal range, indicating a sample positioning deviation: After the temperature gradient is calculated, it is compared with the preset standard temperature gradient value. The standard temperature gradient is based on the theoretical temperature distribution range of the equipment design, usually derived from the equipment manufacturer or laboratory experience, to ensure that the sample is not affected by excessive temperature changes within the normal temperature range. The standard gradient value can be expressed in the following ways:

[0098] ;in, represents the standard temperature gradient; when the calculated temperature gradient Greater than the preset standard temperature gradient , it indicates that the temperature distribution is abnormal and may cause deviation in the sample position.

[0099] Based on the results of temperature gradient analysis, the influence of sample positioning deviation is evaluated: abnormal temperature distribution may lead to deviation of sample position. In order to quantify this influence, the positioning deviation index is defined, and the calculation formula is: ;in, Indicates the positioning deviation index; represents the standard temperature gradient; Indicates the sample rack position The temperature gradient at .

[0100] The larger the positioning deviation index, the greater the temperature distribution gradient at the sample rack position, and the more dramatic the temperature changes between different areas, which increases the possibility of sample positioning deviation. Specifically, a larger positioning deviation index reflects that the temperature changes in different areas of the sample rack are dramatic, which may cause uneven thermal expansion of the sample rack material or slight deformation of the sample support structure, resulting in a deviation between the actual position of the sample and its target position. This deviation will not only affect the accurate detection of the sample, but may also cause errors in the sample transmission or processing process during the automated operation of the test instrument. Immediate remedial measures need to be taken, such as adjusting the sample rack temperature distribution or readjusting the sample position, to reduce the risk of positioning deviation caused by temperature gradients, thereby ensuring the normal operation of the test instrument.

[0101] Specifically, by analyzing the information transmission errors during the sample information entry process, the consistency between the sample source and the patient information entry is evaluated, including:

[0102] Collect input data: During the data entry and transmission process, collect input data of patient information in real time , including entered patient information and sample identifiers. Indicates The content of the entry data.

[0103] Compare the input data with the source information to identify the type of transmission error: In order to identify the error pattern in the information transmission, the collected input data is compared with the source information. Source information about the sample The source information is the original record generated by the sample collection device and stored in the database, indicating what should be transmitted under ideal conditions. The transmission error can be expressed as: ;in, Indicates Transmission errors of records are used to describe the differences between the input data and the source information; Indicates The source information of the input data.

[0104] Through the transmission error Statistical analysis of the error classification function , which is used to classify errors into different types:

[0105] ;in, Indicates The classification results of the input data transmission errors are used to identify the types of errors in the input data transmission process; The returned value is categorical, with each value corresponding to an error type.

[0106] Construct a mapping between sample sources and patient information to quantify the degree of consistency: Based on the comparison results, model the relationship between sample sources and patient information as a mapping matrix , to quantify the degree of consistency. The construction of the mapping matrix is ​​based on the matching of the input data with the source information:

[0107] .

[0108] In order to quantify the degree of consistency, the consistency index is introduced, and the calculation formula is:

[0109] ;in, is the consistency index; Indicates the amount of source information; Indicates the number of input data; An element in the mapping matrix, used to represent the input data Source information The matching relationship, Indicates data entry; Indicates source information.

[0110] The larger the consistency index, the higher the consistency between the sample source and the patient information input. This means that during the information transmission and input process, there are fewer errors between the sample information and the patient source information, and the input of key fields (such as sample number, patient name, test items, etc.) is more consistent with the source information. A higher consistency index helps reduce problems such as sample detection errors or patient reporting errors caused by inconsistent information, improves the operating efficiency of the entire fully automatic coagulation instrument, and provides a quantitative basis for error monitoring. The consistency index is a key indicator to ensure that the fully automatic coagulation tester accurately associates patient information, optimizes the detection process, and improves overall operating efficiency in high-throughput sample testing.

[0111] Specifically, the potential risk of sample cross-contamination, the impact of sample positioning deviation, and the consistency between sample source and patient information entry are comprehensively analyzed to evaluate the reliability of sample test results, and adjust the sample site allocation and information entry process, including:

[0112] The cross-contamination risk index corresponding to the potential risk of sample cross-contamination, the positioning deviation index corresponding to the degree of influence of sample positioning deviation, and the consistency index corresponding to the consistency between the sample source and the patient information entry are normalized. The normalized cross-contamination risk index, positioning deviation index, and consistency index are calculated to obtain the reliability coefficient, and the sample site allocation and information entry process are adjusted according to the reliability coefficient.

[0113] The calculation formula of the reliability coefficient is: ;in, is the reliability coefficient; is the cross contamination risk index; Indicates the positioning deviation index; is the consistency index.

[0114] Preset the reliability coefficient threshold and compare the reliability coefficient with the reliability coefficient threshold:

[0115] When the reliability coefficient is greater than or equal to the reliability coefficient threshold, it indicates that the reliability of the sample test results reaches or exceeds the set standard, and the reliability of the sample test results is high. This means that in the current testing environment, the risk of cross-contamination is low, the sample positioning deviation is controllable, and the consistency of information entry is good. At this time, the stability of the testing process and the credibility of the test results can be effectively guaranteed;

[0116] When the reliability coefficient is less than the reliability coefficient threshold, it indicates that the reliability of the sample test results does not meet the set standard, the reliability of the sample test results is low, and the sample site allocation and information entry process need to be adjusted. Adjustment measures include:

[0117] Retest sample data that has been flagged as potentially affected;

[0118] Optimize sample site allocation: re-plan the location distribution of samples in the tester to avoid adjacent sample arrangements that may cause cross-contamination; set up independent processing areas based on sample characteristics (such as high-risk samples) to increase physical isolation effects.

[0119] Improve the information entry process: enhance the data entry verification mechanism, introduce real-time comparison function during the entry process, and ensure that the sample information is consistent with the patient's source data.

[0120] The above formulas are dimensionless and numerical calculations. The formula is a formula obtained by collecting a large amount of data and performing software simulation to obtain the most recent real situation. The preset parameters and thresholds in the formula are set by technicians in this field according to actual conditions. The parts not described in the present invention are applicable to the prior art.

Claims

1. The sample position and patient information input system of the fully automatic coagulation tester is characterized by: include: Residual risk judgment module, cross contamination assessment module, safety determination module, positioning deviation assessment module, consistency assessment module and comprehensive adjustment module; The residual risk judgment module determines whether there is a trace residual risk on the surface of the sample needle by analyzing the pressure fluctuations of the sample needle during the sample aspiration process at different positions; The cross-contamination assessment module dynamically analyzes the aerosol diffusion generated during sample aspiration and assesses the potential risk of sample cross-contamination; The safety determination module determines the safety of the sample detection process according to the judgment result of whether there is a trace amount of residual risk on the surface of the sample needle and the potential risk of sample cross contamination. The safety of the sample detection process includes high safety and low safety; When the safety of the sample detection process is high: the positioning deviation evaluation module evaluates the influence of the sample positioning deviation by analyzing the temperature distribution gradient of the sample rack position; The positioning deviation assessment module evaluates the consistency between the sample source and the patient information input by analyzing the information transmission error during the sample information input process; Comprehensive adjustment module: Comprehensively analyze the potential risk of sample cross-contamination, the impact of sample positioning deviation, and the consistency between sample source and patient information entry, evaluate the reliability of sample test results, and adjust sample site allocation and information entry processes.

2. The sample position and patient information input system of the fully automatic coagulation tester according to claim 1, characterized in that: Analyze the pressure fluctuations of the sample needle during sample aspiration at different positions, specifically: The pressure change data of the sample needle during the suction process at different positions are collected through the sensor, and the pressure change is pre-processed; Compare the preprocessed pressure change data with the standard pressure fluctuation model to determine whether there is any situation beyond the normal fluctuation range: If abnormal fluctuations are detected, analyze whether the abnormal fluctuations are related to potential trace residues on the surface of the sample needle and evaluate the residual risk: the abnormal fluctuations are decomposed into high-frequency pressure residual components and low-frequency pressure residual components; based on the high-frequency pressure residual components, the residual risk index is calculated : ;in, is the residual risk index; Indicates the allowable pressure fluctuation error range; The total time range for monitoring the sample needle pressure fluctuation data; is the high-frequency pressure residual component.

3. The sample position and patient information input system of the fully automatic coagulation tester according to claim 2, characterized in that: Determine whether there is a trace amount of residual risk on the surface of the sample needle, specifically: Preset the residual risk index threshold and compare the residual risk index with the residual risk index threshold: When the residual risk index is greater than or equal to the residual risk index threshold, it is determined that there is a trace residual risk on the surface of the sample needle; When the residual risk index is less than the residual risk index threshold, it is determined that there is no trace residual risk on the surface of the sample needle.

4. The sample position and patient information input system of the fully automatic coagulation tester according to claim 3, characterized in that: Dynamically analyze the aerosol diffusion generated during sample aspiration to assess the potential risk of sample cross contamination, specifically: Monitor the air flow characteristic data around the sample needle during sample aspiration; Detect the concentration distribution of aerosols and generate a spatiotemporal distribution model of aerosol diffusion during sample aspiration; Quantitatively analyze the aerosol concentrations at adjacent sample locations to assess the potential impact of sample cross-contamination; Combined with the aerosol concentration analysis results of adjacent sample locations, the cross-contamination risk index is calculated to assess the potential risk of sample cross-contamination: Define the cross-contamination risk index: ;in, is the cross contamination risk index; For in time Aerosol concentration in the spatial region adjacent to the sample at ; is the time weighting function; The total length of time for aerosol diffusion to be monitored during sample aspiration.

5. The sample position and patient information input system of the fully automatic coagulation tester according to claim 4, characterized in that: The safety of the sample testing process is determined based on the judgment result of whether there is a trace amount of residual risk on the surface of the sample needle and the potential risk of sample cross contamination. The safety of the sample testing process includes high safety and low safety, specifically: A cross-contamination risk index threshold is preset, and the cross-contamination risk index is compared with the cross-contamination risk index threshold: When the cross-contamination risk index is greater than or equal to the cross-contamination risk index threshold, it indicates that the potential risk of sample cross-contamination is high; When the cross-contamination risk index is less than the cross-contamination risk index threshold, it indicates that the potential risk of sample cross-contamination is low; When the residual risk index is less than the residual risk index threshold, and the cross-contamination risk index is less than the cross-contamination risk index threshold, the safety of the sample testing process is determined to be high safety; Otherwise, the security of the sample detection process is determined to be low.

6. The sample position and patient information input system of the fully automatic coagulation tester according to claim 5, characterized in that: By analyzing the temperature distribution gradient at the sample holder position, the influence of sample positioning deviation is evaluated, specifically: The temperature changes at various positions in the sample rack are monitored in real time by a temperature sensor to obtain temperature data at different positions of the sample rack; The temperature data is used to construct a three-dimensional temperature distribution model of the sample rack position and calculate the temperature gradient between the positions of the sample rack; Compare the calculated temperature gradient with the preset standard gradient to determine whether there is a temperature change beyond the normal range, indicating a sample positioning deviation; Based on the results of temperature gradient analysis, the influence of sample positioning deviation is evaluated: the positioning deviation index is defined and the calculation formula is: ;in, Indicates the positioning deviation index; represents the standard temperature gradient; Indicates the sample rack position The temperature gradient at .

7. The sample position and patient information input system of the fully automatic coagulation tester according to claim 6, characterized in that: By analyzing the information transmission errors during the sample information entry process, the consistency between the sample source and the patient information entry is evaluated, specifically: Collect and input data; Compare input data with source information to identify transmission error types; Construct a mapping between sample sources and patient information to quantify the degree of consistency: define the consistency index, and the calculation formula is: ;in, is the consistency index; Indicates the amount of source information; Indicates the number of input data; is an element in the mapping matrix, Indicates data entry; Indicates source information.

8. The sample position and patient information input system of the fully automatic coagulation tester according to claim 7, characterized in that: Comprehensively analyze the potential risk of sample cross-contamination, the impact of sample positioning deviation, and the consistency between sample source and patient information entry, evaluate the reliability of sample test results, and adjust the sample site allocation and information entry process, specifically: The cross-contamination risk index corresponding to the potential risk of sample cross-contamination, the positioning deviation index corresponding to the degree of influence of sample positioning deviation, and the consistency index corresponding to the consistency between the sample source and the patient information entry are normalized; the normalized cross-contamination risk index, positioning deviation index, and consistency index are calculated to obtain the reliability coefficient, and the calculation formula is: ;in, is the reliability coefficient; is the cross contamination risk index; Indicates the positioning deviation index; is the consistency index; Preset the reliability coefficient threshold and compare the reliability coefficient with the reliability coefficient threshold: When the reliability coefficient is greater than or equal to the reliability coefficient threshold, it indicates that the reliability of the sample test result is high; When the reliability coefficient is less than the reliability coefficient threshold, it indicates that the reliability of the sample test results is low, and the sample site allocation and information entry process need to be adjusted.

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