DE19830891A1 - Control software for automated pathology laboratory analytical equipment allowing interactive operation and continuous task progress assessment to obtain optimum information from measured parameters - Google Patents

Abstract

An analytical system for body fluids and solubilized body tissues, consists of a processor unit to which is entered the logic for the analytical procedure, a controller for integrating the use and control functions available, at least one analyzer , a reagent dosing unit , and a measurement device. The controller electronically provides: a menu of available options for the specific analyzer; a library of sets of operating instructions required for measurement of the options offered; an interface module that directly provides the program for determining the selected option; a decision assisting system that continually assesses the nature and the overall degree of completion of the task; and an output unit that provides the results in accordance with an output protocol .

Description

The invention relates to an analysis system for laboratory-specific Application for automatic analysis of body fluids and in Solution brought body parts, consisting of an order acceptance, in which describes the order for correct processing, and off at least one analyzer with a system control for one Sample distribution unit, a chemical dosing unit, a measuring unit to determine the measured values from the body fluid and in solution brought body parts, an evaluation unit and a Data transmission unit.

It is generally known that every analysis system which relates to the automatic analysis of body fluids and body parts brought into solution, the units:

• - order acceptance,
• - sample preparation,
• - sample distribution,
• - chemical dosing,
• - measuring unit,
• - assessment unit and
• - data transfer

includes.

The order acceptance forms the interface between users (Client) and the service provider. Here is done communication between those involved. Sample preparation takes place before the actual measuring process. The units Sample distribution, chemical dosing, measuring unit, data transfer are integrated in one device and form the actual analyzer. The  Results are made available on a computer-readable basis and can be accessed via a Computer network can be received. The evaluation of the results will after completion of the measuring process in the evaluation unit carried out. Then the analysis result is available as a data file, as Print output or as a monitor display for further processing Available.

In the case of sequential operation, the measurement parameters determined are in the data transmission unit until the end of the measurement process cached. To solve certain application tasks it may also be necessary to measure at least several parameters two analyzers to determine, their interaction manually or is organized via a network of computers. At the state of the However, the network computer only works for the Organization of processes without task-oriented interventions in to carry out predetermined processes. The use of multiple analyzers can be viewed as a sequential processing because the possible Simultaneity of the measuring processes is not of a fundamental nature.

The determination of measurement parameters from body fluids and in Body parts brought solution for medical diagnostics of great importance. The measured values serve the user as Indicators to find, confirm or justify diagnoses discard. It is generally accepted that on the one hand a single value can answer a task of the user, on the other hand an individual case, but not always clear clarification enables. Therefore, it is necessary and generally practiced for one To request the task of several measurement parameters to get one bring about a problem solution that is as unambiguous as possible. The Selection of measurement parameters between one  Minimum number that are known and common from medical practice applies, and a maximum number that potentially provides information about the solution the question can be contributed by the experience of User and significantly by the economic consequences embossed. A cost-oriented minimization of the number of In practice, measurement parameters can lead to the effect that in In individual cases, the diagnostic task does not help with the laboratory result can be solved sufficiently. The resulting subsequent Triggering a supplementary laboratory order leads to increased costs and delay, possibly even to reload the Patients due to necessary second sampling. Another Sampling also provides the previous laboratory results to the extent that the temporal relationship between different measurement parameters no longer exist.

At the current state of the art, it is up to the user to necessary measurement parameters to solve the task to be determined. These measurement parameters are detached when the order is accepted fixed by the task, the actual task is after this point of time no longer accessible for the measurement process. Technologically justified (e.g. due to the limited amount of Sample substrate, sample preparation or measurement duration) it proves for the user as necessary, the maximum requested To determine the number of measurement parameters, even if it is known, that with selected measurement parameter-value constellations less Sufficient information to solve the actual task would. A subsequent intervention in the process without Participation of the user is also not permitted, as such Interference with the measurement parameters only in the context of Task can be done. The specified measuring program is therefore completely processed in principle. Only then is a sample valid  measured as finished when all requested measured values, if applicable from multiple analyzers.

The object of the invention is an analysis system of the beginning to create the kind with which a requirement and result-oriented processing of the measurement task takes place.

According to the invention, the object is achieved in that the system controller uses a controller integrated in the analysis system

• - An electronic offer catalog of measurement parameters that can be measured by the specified analyzer;
• - a collection of tasks for which the Contribute measurement parameters from the catalog to the solution;
• - An interface module that a determined measurement parameter feeds directly to the program;
• - A decision support system, which at any time of the Measuring process determines the degree of solution of the task;
• - A control part that, depending on the results from the Decision support system a set of control parameters for the Provides measurement sequence control and finally
• an output unit that logs the results and the control interventions and transfers them to the data transmission unit after the measurement process has ended,
  so overlaid that it
• - with the order acceptance from the task and the special requirements of the user the maximum selection of Measurement parameters determined based on a task and the analyzers to be used, including the necessary ones Suggests measurement settings;  
• - Each measured value determined immediately after being made available by the Measuring unit sample-specific in the data transmission unit an assessment of its contribution to solving the Subject to task;
• - depending on the current solution of the task the continuation of the measurement process via the sample distribution in this way organizes that the determination of the next measurement parameter a can make the maximum contribution to solving the task;
• - the measurement process for when the task is solved this sample stops and
• - The result output by the data transmission unit Recommendations for the use of further analysis systems or Analysis activities supplemented.

The invention is explained in more detail using an exemplary embodiment.

The associated drawings show:

Fig. 1 is a block diagram of an analysis system

Fig. 2 is a flow chart to illustrate the process flow in an analysis system according to the invention.

An analysis system consists of order acceptance (AA), which forms the interface between the user and the facility. With the order acceptance (AA) the order for the correct processing is completely described. Subsequently, the sample preparation is typically carried out manually or semi-automatically before the actual measuring process. The technical units sample distribution unit (PV), chemical dosing unit (CD), measuring unit (ME), which delivers the measured values, and data transmission unit (DÜ) form the analyzer. This works largely computer-aided automatically after the program for measuring sequence control has been updated and started. Fig. 2 shows a process flow in an inventive analysis system. The order acceptance (AA) for solving a task of the user is triggered in that a task, possibly supplemented by selected parameters, is transferred with the sample material. The task is to confirm the diagnosis of a disease through laboratory analysis. In clinical practice, this confirmation is deemed to have been provided if at least one measured value of the measuring parameters M1, M2 or M3 exceeds a practically recognized threshold value. In addition, the specificity of these measurement parameters is known, that is to say the statistical proportion of people suffering from this disease who have a measurement value above these threshold values (cf. Table 1).

Table 1

List of threshold values and specificities for the diagnostic confirmation of a disease

This order is carried out according to a prompt from the Analysis system entered. In a first step, the software checked whether this task according to task collection (AS) feasible and the requested measurement parameters according to Offer catalog (AK) can be determined. If this is not the case, it is Return order to order acceptance (AA), otherwise from the collection of tasks (AS) the appropriate selection of Measurement parameters set. Supplemented with the additional  Measurement parameters take place in the module of the offer catalog (AK) Determination of the measurement settings for the measurement processes. This is based on a stored database that is integrated into the software for all feasible measurement requirements the associated measurement setting has ready. It is therefore necessary to check whether the Meßparanieter M1, M2 and M3 can be measured and at positive decision which measurement settings for the measurements must be made.

As a result of the evaluation of the catalog of offers for the Measurement task we the maximum measurement requirement Handover of decision support system (EH). An interface module (IM) carries a determined measurement parameter from the analyzer directly to the Decision support system (EH) too. On this basis, a Assessment of whether the task is already considered to be solved. At the start of the measuring process, this question is answered with "No" answered. A control instruction (ST) is then determined, making the greatest possible contribution to solving the task can be expected. According to the known specificities, the Measurement parameter M1 the probability, the diagnostic Finding confirmation is highest, making this reading the first Measurement task is to be selected. This control instruction will be the Control of the measurement sequence passed to the analyzer, the continuation of the Measurement sequence modified accordingly and the result of the Measurement parameters expected. For logging the measuring process these control instructions and the associated values of the Measurement parameters saved in a file. Once an identified Measurement parameters are available for evaluation, that will Decision support system (EH) reactivated to the state of the Evaluate task solution. This process continues until until the task is considered solved. In this case the measuring process canceled and the log for the valuation unit (BE)  transfer. If the measured value is above the known one Threshold 13 units / ml, the process can be stopped and the diagnostic confirmation has been provided. On the other hand, the measured value lies below that, the task is not yet solved. Corresponding The known specificity is the next measurement task of the measurement parameters M3 to select.

For use cases that require several needing at least two analyzers will determine the Measurement settings by determining the order of the required Analyzer added. The measurement process on the analyzer with higher priority is started as described. At the end of the measuring process is based on the measurement parameters previously determined on this analyzer decided on which analyzer to continue measuring. For a manually initiated measurement continuation is called this result Instructions issued (printer, monitor), in Computer network can directly electronic results passed on and processed.

Claims (1)

1.Analysis system for the laboratory-specific application for the automatic analysis of body fluids and parts of the body brought into solution, consisting of an order acceptance, in which the order for a correct processing is described, and at least one analyzer with a system control for a sample distribution unit, a chemical dosing unit, a Measuring unit for determining the measured values from the body fluid and body parts brought into solution, an evaluation unit and a data transmission unit, characterized in that the system controller uses a controller integrated in the analysis system

• - an electronic offer catalog (AK) of measurement parameters that can be measured by the specified analyzer;
• - an order collection of tasks (AS) for which the measurement parameters from the offer catalog (AK) can contribute to the solution;
• - An interface module (IM) that feeds a determined measurement parameter directly to the program;
• - A decision support system (EH) that determines the degree of solution of the task at any time during the measuring process;
• - A control part (ST) which, depending on the results from the decision support system (EH), provides a control parameter set for the measurement sequence control and finally
• - An output unit (AE) which logs the results and the control interventions and transfers them to the data transmission unit (DÜ) after the measurement process has ended; is so overlaid that it
• - with the order acceptance (AA) from the task and the special requirements of the user determined the maximum selection of measurement parameters based on a task and proposes the analyzers to be used, including the required measurement settings;
• - subject each measured value determined immediately after being made available by the measuring unit (ME) to a sample in the data transmission unit (DÜ) with regard to its contribution to solving the task;
• - Depending on the current solution status of the task, the continuation of the measurement process via the sample distribution (PV) is organized in such a way that the determination of the next measurement parameter can make a maximum contribution to solving the task;
• - When the solution to the task is reached, the measuring process for this sample is terminated and
• - The result output by the data transmission unit (DÜ) supplemented by recommendations for the use of further analysis systems or analysis activities.