Methods and devices for processing biological samples in a laboratory automation system

The method addresses inefficiencies in automated laboratory systems by maintaining the initial route plan for a waiting period and obtaining a new plan if the laboratory instrument remains unavailable, thereby enhancing processing efficiency and reliability.

WO2025059011A1PCT designated stage expired Publication Date: 2025-03-20BECKMAN COULTER INC
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Patent Information

Application Number
PCT/US2024/045940
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-14
Filing Date
2024-09-10
Publication Date
2025-03-20

AI Technical Summary

Technical Problem

Automated laboratory systems face inefficiencies when laboratory instruments become unavailable, leading to disruptions in the processing of biological samples and potential delays in clinical testing.

Method used

A computer-implemented method that determines when a laboratory instrument is unavailable, maintains the initial route plan for a predetermined waiting period, and then obtains a new route plan if the instrument remains unavailable, ensuring uninterrupted sample processing.

Benefits of technology

This method enhances the efficiency of biological sample processing by minimizing delays and ensuring reliable clinical testing, even when laboratory instruments become temporarily unavailable.

✦ Generated by Eureka AI based on patent content.

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Abstract

Summarising the invention, a computer-implemented method is provided. The method comprises obtaining a first route plan as processing route plan for processing a sample container within an automated laboratory system, wherein: the sample container contains a biological sample on which a first clinical test is to be carried out; the automated laboratory system comprises a first laboratory instrument configured to carry out the first clinical test; determining that the first laboratory instrument is unavailable to carry out the first clinical test; determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument; once a predetermined waiting time period has elapsed, checking whether the first laboratory instrument is still unavailable to carry out the first clinical test; if the first laboratory instrument is still unavailable to carry out the first clinical test, obtaining a second route plan different from the first route plan and setting the second route plan as the processing route plan.
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Description

[0001] Methods and devices for processing biological samples in a laboratory automation system

[0002] Description

[0003] Technical Field

[0004] The following description relates to the field of biological samples testing.

[0005] Background

[0006] Analytic and clinical laboratories typically comprise several laboratory instruments that are integrated in an automated laboratory system and are configured to automatically carry out one or more clinical tests on biological samples (such as blood samples).

[0007] Summary

[0008] It is an object of the invention to provide means for improving the efficiency of the processing of biological samples in an automated laboratory system.

[0009] The achievement of this object in accordance with the invention is set out in the independent claims. Further developments of the invention are the subject matter of the dependent claims.

[0010] According to one aspect, a computer-implemented method is provided. The method comprises:

[0011] - obtaining a first route plan as processing route plan for processing a sample container within an automated laboratory system, wherein: the sample container contains a biological sample on which a first clinical test is to be carried out; the automated laboratory system comprises a first laboratory instrument configured to carry out the first clinical test;

[0012] - determining that the first laboratory instrument is unavailable to carry out the first clinical test;

[0013] - determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument;

[0014] - once a predetermined waiting time period has elapsed, checking whether the first laboratory instrument is still unavailable to carry out the first clinical test;

[0015] - if the first laboratory instrument is still unavailable to carry out the first clinical test, obtaining a second route plan different from the first route plan and setting the second route plan as the processing route plan.

[0016] The method is a method for processing a biological sample within an automated laboratory system. The biological sample (or simply “sample”) may be a sample of a bodily fluid of a human or animal subject. For example, the bodily fluid may be a physiological fluid, such as blood, saliva, urine, sweat, amniotic fluid, cerebrospinal fluid, ascites fluid, or the like.

[0017] The biological sample is put into a sample container after collection. The sample container may be a sample tube. Typically, sample tubes comprise a closed tube end and an end opposite thereto. The latter end defines an opening for inserting the sample in the sample tube. The opening may be closed, e.g. sealed, by a cap.

[0018] In particular, the sample container contains a biological sample on which a first clinical test is to be carried out. Generally, a clinical test may comprise one or more procedures that, when carried out on the biological sample, allow for estimating the value of a parameter, e.g. a clinical parameter. In particular, a clinical test may comprise physical, biological, optical, mechanical, immunological, and / or chemical procedures. Exemplarily, a clinical test may be an immunoassay test or a chemical test.

[0019] In some examples, the first clinical test is the only clinical test that shall be carried out. In other examples, the first clinical test is one of a plurality of clinical tests that shall be carried out on the biological sample. Accordingly, it can be said that at least the first clinical test shall be carried out on the biological sample.

[0020] Generally, an automated laboratory system is an assembly comprising a plurality of components and a computing device, wherein the computing device is operatively connected to these components and is configured to control each component. The computing device carrying out the method described herein may be the computing device in the automated laboratory system or a computing device in communication with said computing device, but external to the automated laboratory system. A component may be an analytic instrument, a pre-analytic instrument, a post-analytic instrument, an input / output module, a transportation component (e.g. track, belt, tube carrier) configured to move a sample container. An analytic instrument (hereinafter referred to also as “laboratory instrument”) may be configured to carry out at least a clinical test.

[0021] Specifically, the automated laboratory system comprises a first laboratory instrument configured to carry out the first clinical test. In other words, the first laboratory instrument is able to carry out the first clinical test. For example, the first laboratory instrument may be suitable to handle the type of biological sample to be analysed for the first clinical test (e.g. blood), may store or have access to one or more reagents needed to carry out the first clinical test, and may comprise one or more units that execute actions necessary to carry out the first clinical test (e.g. an aspiration unit, a measuring unit etc.). Exemplarily, the first laboratory instrument may be configured to carry out a plurality of clinical test, which include the first clinical test.

[0022] The biological sample is processed within the automated laboratory system according to a processing route plan. Generally, a route plan for an automated laboratory system comprises information indicative of how to process the sample container by that automated laboratory system. In other words, a route plan comprises one or more processing steps, e.g. a chronological sequence thereof. An exemplary processing step is the execution of a clinical test on the biological sample. The expressions “processing the sample container” and “processing the biological sample” are used herein interchangeably.

[0023] In particular, the route plan may identify a plurality of components within the automated laboratory system and may indicate a path through the plurality of components that the sample should follow.

[0024] Exemplarily, the route plan may specify an order according to which the sample should be handled by the different components of the automated laboratory system, i.e. a temporal sequence of processing steps. Some processing steps may be carried out one after the other, other processing steps may be carried out with at least a partial time overlap, yet other processing steps may be carried out at any point in time and may, thus, not be included in the temporal sequence (while still being part of the route plan). Accordingly, the route plan may comprise an ordered list of processing steps that each component of the automated laboratory system should carry out.

[0025] The “processing route plan” denotes the specific route plan that is designated for use by the automated laboratory system when processing the sample container in question.

[0026] The method comprises obtaining a first route plan that shall be used as the processing route plan to process the sample container within the automated laboratory system. In other words, the first route plan is a concrete route plan that is provided for processing the sample container.

[0027] In the present disclosure, “obtaining” may comprise accessing the first route plan, i.e. retrieving the first route plan e.g. from a memory of the computing device that carries out the method of the present invention, from the memory of another computing device, or from another remote data storage (a database, a secondary memory, a cloud storage or the like). Accordingly, in some cases, retrieving the first route plan may comprise downloading the first route plan. Additionally or alternatively, accessing the first route plan may comprise receiving the first route plan, e.g. from a user or another computing device. The two options are not mutually exclusive. For instance, accessing the first route plan may comprise receiving the first route plan, storing the first route plan in the memory of the computer device and retrieving the first route plan by accessing said memory.

[0028] Alternatively, “obtaining the first route plan” may comprise generating the first route plan, e.g. creating the first route plan based on one or more inputs. In a particular example, the method may comprise accessing test order data, wherein the test order data comprise information specifying (at least) the first clinical test to be carried out on the biological sample, and the first route plan may be obtained based on the test order data. In other words, the first route plan may be generated using the test order data. The method may comprise accessing laboratory instrument data, wherein the laboratory instrument data comprise information specifying the availability and / or the workload of the laboratory instrument data comprised in the automated laboratory system. If this is the case, the first route plan may be generated using the laboratory instrument data.

[0029] The first route plan comprises one or more processing steps for carrying out the first clinical test. In particular, the first route plan includes the use of the first laboratory instrument. For example, the first route plan may include a transfer of the sample container to the first laboratory instrument and the execution of the first clinical test at the first laboratory instrument. Additionally, the first route plan may include one or more other processing steps, such as centrifuging the sample, transferring the sample container away from the first laboratory instrument after the first clinical test has been completed, executing one or more additional clinical tests at the first laboratory instrument.

[0030] In a particular example, after obtaining the first route plan, the method may comprise causing the automated laboratory system to process the sample container using the first route plan as the processing route plan. In particular, the method may comprise causing the automated laboratory system to start processing the sample container using the first route plan. Accordingly, the automated laboratory system may begin putting the first route plan into action, namely it may start executing the processing steps included in the first route plan.

[0031] In this particular example, the other steps of the method (which will discussed in more detail below), namely determining that the first laboratory instrument is unavailable to carry out the first clinical test, determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument, maintaining for a waiting time period the first route plan as the processing route plan and checking whether the first laboratory instrument is still unavailable to carry out the first clinical test, may be performed while the processing of the sample container according to the first route plan is ongoing.

[0032] In one example, causing the automated laboratory system to process the sample container according to a route plan (e.g. the first or the second route plan) may comprise instructing, by the computing device, the automated laboratory system to process the sample container according to that route plan. In this case, the computing device may be external to the automated laboratory system. In another example, causing the automated laboratory system to process the sample container according to a route plan may comprise controlling, by the computing device, the components of the automated laboratory system to process the sample container according to that route plan. In this case, the computing device may be the one internal to the automated laboratory system.

[0033] After obtaining the first route plan and, optionally, after causing the automated laboratory system to process the sample container using the first route plan, the method comprises determining that the first laboratory instrument is unavailable to carry out the first clinical test.

[0034] As explained above, the first laboratory instrument is configured to carry out the first clinical test, i.e. capable of performing the first clinical test. In some cases, the first laboratory instrument is unavailable to carry out the first clinical test when this constitutional feature of the first laboratory instrument is temporarily or permanently compromised. In other words, there may be a malfunction of the first laboratory instrument that prevents it from fulfilling its function of carrying out the first clinical test. In some examples, this malfunction may be an actual breakdown of the instrument, which may e.g. require a repair or a replacement. For example, the first laboratory instrument is unavailable to carry out the first clinical test when it cannot access and utilize a reagent needed to carry out the first clinical test, e.g. because the cartridge comprising the reagent is empty or the reagent in the cartridge is expired. If this is the case, the first laboratory instrument becomes again available to carry out the first clinical test once the cartridge loaded in that instrument has been replaced. In another example, the first laboratory instrument is unavailable to carry out the first clinical test when it is established that it can no longer provide reliable results for that test, e.g. because the first laboratory instrument needs to be calibrated. If this is the case, in particular, the first laboratory instrument becomes again available to carry out the first clinical test once that instrument has been calibrated.

[0035] In other cases, the malfunction may be a temporary glitch that leaves the first laboratory instrument unavailable to carry out the first clinical test for a very short amount of time, e.g. for an amount time shorter than about 6 seconds, more particularly shorter than about 5.5 seconds, even more particularly shorter than about 5 seconds.

[0036] For instance, the first laboratory instrument may experience a flip, i.e. go offline and then come back online, within this amount of time, or even more than one flip. In particular, the first laboratory instrument goes offline if it is not able, for at least a certain amount of time, to exchange data with the computing device that controls the automated laboratory system. In particular, during that amount of time, the first laboratory instrument is considered to be unavailable to carry out the first clinical test even if it may still be able to carry out the first clinical test. The first laboratory instrument may be offline if a data connection and / or a physical connection of the first laboratory instrument to the rest of the automated laboratory system is severed.

[0037] As discussed above, the first laboratory instrument may be configured to carry out a plurality of clinical tests. In this case, when the first laboratory instrument is unavailable to carry out the first clinical test, in one example it may be also unavailable to carry out one or more of the other clinical tests in the plurality of clinical tests, e.g. each clinical test of the plurality of clinical tests. In another example, the first laboratory instrument may be unavailable to carry out the first clinical test, but it may be available to carry out the other clinical tests in the plurality of clinical tests. Accordingly, it can also be said that the method comprises determining that the first laboratory instrument is unavailable to carry out at least the first clinical test.

[0038] Exemplarily, determining that the first laboratory instrument is unavailable to carry out the first clinical test may be achieved by continuously or periodically monitoring the first laboratory instrument. Accordingly, the computing device carrying out the method may check whether the first laboratory instrument is available or not for carrying out the first clinical test, e.g. by executing a check routine, which may include verifying whether the laboratory instrument is online or offline.

[0039] Alternatively, determining that the first laboratory instrument is unavailable to carry out the first clinical test may be achieved by receiving data comprising information indicative of the unavailability. For example, the first laboratory instrument may be configured to run self-evaluation routines and send a signal (e.g. via a middleware layer) to the computing device whenever an anomaly is detected. For example, another device (such as one implementing a middleware layer) and / or a sensor may monitor the first laboratory instrument and send data to the computing device carrying out the method.

[0040] After determining that the first laboratory instrument is unavailable to carry out the first clinical test, the method comprises determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument, in particular that the processing based on the first route plan is disrupted by the unavailability. In other words, the method comprises determining whether the fact that the first laboratory instrument is unavailable to carry out the first clinical test has an impact on the processing of the sample container, e.g. it prevents the processing of the sample container from being successfully carried out by the automated laboratory system. For instance, the unavailability of the first laboratory instrument may affect the processing in that it interrupts the processing, such as in a case in which the sample container gets stuck at one position, e.g. at the unavailable first laboratory instrument. Alternatively or additionally, the unavailability of the first laboratory instrument may affect the processing in that it prevents the automated laboratory system from carrying out the first clinical test on the biological sample.

[0041] Determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument may comprise determining whether one or more conditions are satisfied.

[0042] Exemplarily, determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument may comprise at least determining whether the first route plan includes the use of the first laboratory instrument. Accordingly, a first condition may be the condition that the use of the first laboratory instrument is included in the first route plan. If the first condition is satisfied, it is determined that the first route plan is affected by the unavailability of the first laboratory instrument.

[0043] If the first route plan did not include the use of the first laboratory instrument, the sample container could be processed by the automated laboratory system without any issues by following the first route plan as processing route plan. For instance, this may be the case if the automated laboratory system comprises another instrument configured to carry out the first clinical test and the first route plan includes the use of this other instrument.

[0044] Conversely, when the first route plan includes the use of the first laboratory instrument to carry out the first clinical test on the biological sample, the unavailability of the first laboratory instrument has the consequence that processing the sample container by following the first route plan would be unsuccessful, e.g. the sample container may remain stuck at the first laboratory instrument and / or the first clinical test will not be carried out.

[0045] As mentioned above, the first clinical test may be one of a plurality of clinical tests that shall be carried out on the biological sample. Similarly, the first laboratory instrument may be configured to carry out a plurality of clinical tests, which include the first clinical test in question.

[0046] Accordingly, it is possible that the first route plan may include the use of the first laboratory instrument but with the task of carrying out a clinical test that is not the first clinical test. Thus, exemplarily, a second condition may be the condition that the first clinical test shall be carried out on the sample container. Determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument may comprise checking both the first condition and the second condition. For instance, the method may comprise checking the test order data associated with the sample container to determine whether the first clinical test is in the test order data. If both the first condition and the second condition are satisfied, it is determined that the first route plan is affected by the unavailability of the first laboratory instrument.

[0047] Alternatively, a third condition may be the condition that the performance of the first clinical test by the first laboratory instrument is included in the first route plan. The third condition is a combination of the first and second conditions. Hence, in this case, determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument may comprise checking the third condition. If the third condition is satisfied, it is determined that the first route plan is affected by the unavailability of the first laboratory instrument.

[0048] As mentioned above, the method may comprise causing the automated laboratory system to start processing the sample container using the first route plan as the processing route plan before determining that the first laboratory instrument is unavailable to carry out the first clinical test.

[0049] In these cases, if the sample container has already been processed at the first laboratory instrument before it becomes unavailable, the processing of the sample container would not be affected by the unavailability of the first laboratory instrument. Thus, exemplarily, a fourth condition may by the condition that the sample container has not yet been processed by the first laboratory instrument.

[0050] In one example, determining whether processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument may comprise checking the first condition, the second condition and the fourth condition. In this example, it is determined that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument when the first condition, the second condition and the fourth condition are met.

[0051] In another example, determining whether processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument may comprise checking the third condition and the fourth condition. In this example, it is determined that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument when the third condition and the fourth condition are met.

[0052] Once a predetermined waiting time period has elapsed, the method further comprises checking whether the first laboratory instrument is still unavailable to carry out the first clinical test. In particular, this check does not take place at any time after the waiting time period is over, rather as soon as the waiting time period has elapsed. In other words, the time interval between the determination that the processing of the sample is (negatively) affected by the unavailability of the first laboratory instrument and the check of whether the unavailability still persists amounts to the waiting time period. Checking whether the first laboratory instrument is still unavailable to carry out the first clinical test may comprise executing a check routine, as discussed above.

[0053] The waiting time period is a predetermined amount of time and may be hardcoded or stored in a database or in a configuration file. Exemplarily, the waiting time period may be between about 4 seconds and 8 seconds, more particularly between about 4 seconds and 6 seconds, yet more particularly about 5 seconds.

[0054] In particular, when processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument, the method may further comprise maintaining for the predetermined waiting time period the first route plan as the processing route plan. Accordingly, there is a deliberate choice of temporarily keeping the first route plan as the processing route plan despite having determined that the first route plan is negatively affected by the unavailability of the first laboratory instrument.

[0055] In particular, maintaining for the predetermined waiting time period the first route plan as the processing route plan may comprise not obtaining a new route plan to replace the first route plan as the processing route plan. In other words, during the predetermined waiting time period, the computing device may be configured such that it does not take any steps to modify the processing route plan. Accordingly, “maintaining” may be an inactive step rather than an active one.

[0056] Maintaining for the predetermined waiting time period the first route plan as the processing route plan may e.g. comprise keeping the first route plan stored in a memory and not discarding it. Additionally or alternatively, it may comprise maintaining a setting according to which the processing route plan is the first route plan.

[0057] In the examples in which the processing of the sample container according to the first route plan has already been started, maintaining for a waiting time period the first route plan as the processing route plan may include causing the automated laboratory system to continue processing the sample container using the first route plan during the waiting time period. If the check reveals that the first laboratory instrument is still unavailable to carry out the first clinical test as it was before the start of the waiting time period, the method further comprises (after the check) obtaining a second route plan different from the first route plan and setting the second route plan as the processing route plan. In other words, the first route plan is replaced by the second route plan as the processing route plan for the sample container within the automated laboratory system. In particular, the second route plan is obtained after the waiting time period has passed and if the check reveals that the first laboratory instrument is still unavailable.

[0058] The second route plan is different from the first route plan in that the processing of the sample container according to the second route plan is not affected by the unavailability of the first laboratory instrument to carry out the first clinical test. In particular, the processing of the sample container according to the second route plan does not come to a halt because of the unavailability of the first laboratory instrument.

[0059] The second route plan may not comprise one or more processing steps that are included in the first route plan and that are affected by the unavailability of the first laboratory instrument. Exemplarily, the second route plan may not comprise the use of the first laboratory instrument, or, more specifically, the second route plan may not comprise the performance of the first clinical test by the first laboratory instrument.

[0060] Obtaining the second route plan may comprise accessing and / or generating the second route plan, as discussed above for the first route plan. When accessing and / or generating the second route plan, at least one constraint may be provided in order to address the unavailability of the first laboratory instrument. Thus, the second route plan may be obtained based on one or more constraints, e.g. that the use of the first laboratory instrument should not be included or that the performance of the first clinical test by the first laboratory instrument should not be included.

[0061] According to the method described herein, before coming up with a new route plan addressing the unavailability of the first laboratory instrument, it is ensured that the unavailability is not just temporary. Conventionally, the determination of an unavailability that affects processing of the sample is immediately addressed by switching to a new route plan for the sample container. Instead, according to the present invention, obtaining a second route plan is made contingent on a waiting step and on a subsequent check of the unavailability of the laboratory instrument. It is remarked that the waiting time period is not just an unavoidable time delay due to the finite speed of signals and so on, instead it is an intentional time interval during which the computing device does not act on the information that the processing of the sample container according to the first route plan is affected by the unavailability.

[0062] Accordingly, it is avoided that a new route plan is obtained when there is actually no need for it while at the same time still ensuring that the sample container is correctly processed when the unavailability of the first laboratory instrument represents an actual issue of the instrument. Therefore, the method leads to an increase in the efficiency of sample testing while preserving reliability.

[0063] In a particular example, the method may further comprise causing the automated laboratory system to process the sample container using the second route plan as the processing route plan. Accordingly, the automated laboratory system may put the second route plan into action, namely it may execute the processing steps included in the second route plan. As explained above, “causing” may comprise instructing or controlling.

[0064] As mentioned above, the first laboratory instrument may be configured to carry out a plurality of clinical tests, which include the first clinical test. In some examples, the method may further comprise, besides determining that the first laboratory instrument is unavailable to carry out the first clinical test, determining that the first laboratory instrument is unavailable to carry out the other clinical tests of the plurality of clinical tests. Exemplarily, in this case, the first route plan may be maintained as the processing route plan for the waiting time period only if the first laboratory instrument is unavailable to carry out all clinical tests of the plurality of clinical tests.

[0065] Accordingly, in a particular example, the method may comprise: obtaining a first route plan as processing route plan for processing a sample container within an automated laboratory system, wherein: the sample container contains a biological sample on which a first clinical test is to be carried out; the automated laboratory system comprises a first laboratory instrument configured to carry out a plurality of clinical tests including the first clinical test; determining that the first laboratory instrument is unavailable to carry out the plurality of clinical tests; determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument; once a predetermined waiting time period has elapsed, checking whether the first laboratory instrument is still unavailable to carry out the plurality of clinical tests; if the first laboratory instrument is still unavailable to carry out the plurality of clinical tests, obtaining a second route plan different from the first route plan and setting the second route plan as the processing route plan.

[0066] In other words, according to this example, the wait during the predetermined waiting time period (which may comprise maintaining the first route plan as the processing route plan) and the subsequent check of whether the first laboratory instrument is still unavailable take place on the condition that all clinical tests that the first laboratory instrument is configured to carry out be unavailable.

[0067] In a particular example, the automated laboratory system may be configured to handle and process a plurality of sample containers at the same time, e.g. at least partly in parallel to each other. The method may comprise determining for each sample container whether its processing is affected by the unavailability of the first laboratory instrument and the steps of checking and obtaining the second route plan may be carried out only for those sample containers whose processing is affected by the unavailability of the first laboratory instrument.

[0068] For instance, in these cases, the method may comprise: obtaining, for each sample container of a plurality of sample containers, a respective first route plan as respective processing route plan for processing said sample container within an automated laboratory system, wherein: each sample container contains a respective biological sample on which a respective first clinical test is to be carried out; the automated laboratory system comprises a first laboratory instrument configured to carry out a given first clinical test; determining that the first laboratory instrument is unavailable to carry out the given first clinical test; determining that processing of one or more affected sample containers of the plurality of sample containers according to their respective first route plans is affected by the unavailability of the first laboratory instrument; for each affected sample container: once a predetermined waiting time period has elapsed, checking whether the first laboratory instrument is still unavailable to carry out the given first clinical test; if the first laboratory instrument is still unavailable to carry out the given first clinical test, obtaining a second route plan different from the respective first route plan and setting the second route plan as the respective processing route plan.

[0069] In particular, the affected sample containers may be the ones that contain a respective biological sample on which the given first clinical test is to be carried out.

[0070] In a particular example the method may further comprise, after checking whether the first laboratory instrument is still unavailable to carry out the first clinical test and if the first laboratory instrument is no longer unavailable to carry out the first clinical test, maintaining the first route plan as the processing route plan.

[0071] Accordingly, if it is determined after the waiting time period that the first laboratory instrument is no longer unavailable to carry out the first clinical test, the sample container may be processed according to the first route plan, as originally planned. This may comprise initiating the implementation of the processing route plan or continuing the implementation of the processing route plan, if it had already been started after obtaining the first route plan.

[0072] Similarly, when it is checked whether the processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument and it is determined that the processing of the sample container according to the first route plan is not affected by the unavailability of the first laboratory instrument, the first route plan may be maintained as the processing route plan, and not just for the waiting time period.

[0073] In a particular example, the second route plan may include a transfer of the sample container to an error area.

[0074] The automated laboratory system may comprise a plurality of areas, e.g. physically delimited portions of space, wherein each area is configured to receive and support sample containers. The error area is an area where the sample containers can be located while awaiting further processing. In particular, the error area may be located such that the samples cannot be altered while at the error area.

[0075] By moving the sample container to the error area, it is prevented that the sample container be sent to the first laboratory instrument, where it could e.g. clog the first laboratory instrument, since the first clinical test cannot be carried out.

[0076] Exemplarily, the method may further comprise:

[0077] - determining that the first laboratory instrument is available again to carry out the first clinical test;

[0078] - determining that the sample container is still in the error area;

[0079] - obtaining a third route plan for the sample container, wherein the third route plan includes the use of the first laboratory instrument.

[0080] In particular, after the sample container has been transferred to the error area, it may be checked whether the first laboratory instrument is finally available again, after having been unavailable at the moment of the first determination and at the moment of checking after the waiting time period. If the first laboratory instrument is available again to carry out the first clinical test and the sample container has not been moved away from the error area in the meantime (e.g. moved to another laboratory instrument or out of the automated laboratory system), a third route plan may be obtained. The third route plan may include the use of the first laboratory instrument, e.g. a transfer of the sample container from the error area to the first laboratory instrument and the execution of the first clinical test at the first laboratory instrument. In this way it is ensured that the processing of the sample container is successfully completed.

[0081] In some cases, the second route plan may include a transfer of the sample container to a second laboratory instrument of the automated laboratory system, the second laboratory instrument being configured to carry out the first clinical test and available to carry out the first clinical test. More generally, the second route plan may include the use of the second laboratory instrument.

[0082] Accordingly, once it is established that the first laboratory instrument was not just unavailable for a time interval shorter than or equal to the waiting time period, the sample container may be moved to another laboratory instrument, the second laboratory instrument, which can also perform the first clinical test and is also available to do that. The method may comprise checking the availability of the second laboratory instrument.

[0083] In this way it is ensured that the processing of the sample container is efficiently and successfully completed.

[0084] In a particular example, the method may further comprise obtaining the waiting time period based on the first laboratory instrument.

[0085] In one example, the first laboratory instrument may be associated with an identifier identifying the first laboratory instrument. If this is the case, obtaining the waiting time period may comprise querying a database using the identifier and retrieving the waiting time period. More generally, if the automated laboratory system comprises a plurality of laboratory instruments, each laboratory instrument may be associated with a respective identifier.

[0086] For instance, the database may comprise a relational table that associates each identifier with one respective waiting time period, said waiting time period being the expected time interval into which the laboratory instrument may switch back to being available in case of a temporary glitch. The waiting time period may be set e.g. by a user. By having a waiting time period specific to the first laboratory instrument, the efficiency of sample testing can be further increased. In particular, the waiting time period can be fine-tuned to cover a characteristic flip time for a specific instrument without introducing unnecessary delay.

[0087] In another example, obtaining the waiting time period may comprise generating the waiting time period. In particular, the method may further comprise accessing historical data, the historical data comprising information specifying one or more unavailability time periods of the first laboratory instrument; and obtaining the waiting time period may comprise computing the waiting time period using the historical data.

[0088] Generally, the historical data may be data collected from previous instances of processing biological samples in automated laboratory systems and stored e.g. in a database, such as a local database or a cloud database. In some examples, the historical data may relate specifically to the first laboratory instrument of the present automated laboratory system. In other examples, the historical data may be collected from a plurality of first laboratory instruments, i.e. instruments of the same type of the first laboratory instrument that are included in different automated laboratory systems.

[0089] In particular, the historical data may comprise information specifying one or more unavailability time periods of the first laboratory instrument, which were recorded in previous instances of unavailability. Specifically, each unavailability time period may be measured and then stored in the database. An unavailability time period is the time period between the moment in which the first laboratory instrument becomes unavailable to the moment it becomes available again.

[0090] For instance, the waiting time period may be computed as the average or the median of a plurality of unavailability time periods. Optionally, a buffer factor may be added or subtracted from the average / median.

[0091] The use of historical data for obtaining the waiting time period makes the estimation of the waiting time period accurate. In a particular example, the method may further comprise, upon determining that the processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument, determining a distance between the sample container and the first laboratory instrument. For example, determining the distance between the sample container and the first laboratory instrument may be carried out after determining that the first laboratory instrument is unavailable to carry out the first clinical test and before the start of the waiting time period. For instance, determining the distance between the sample container and the first laboratory instrument may be carried out during the waiting time period.

[0092] In particular, obtaining the second route plan may be only performed if the distance was greater than a threshold based on the waiting time period. In other words, the second route plan may not be generated for those sample containers that are within a certain distance from the laboratory instrument, even if their processing is affected by the unavailability of the first laboratory instrument and it remains unavailable also after the waiting time period.

[0093] Generally, the distance between the sample container and the first laboratory instrument may be the distance between any two respective points, i.e. a first point belonging to the sample container and a second point belonging to the first laboratory instrument. For instance, it may be the shortest distance between the sample container and the first laboratory instrument. The distance between the sample container and the first laboratory instrument may be measured using various means and / or techniques. For example, an indoor position system may be implemented. For example, the automated laboratory system may comprise a plurality of checkpoints at known (e.g. predetermined and / or measured) distances from the first laboratory instrument, wherein a sensor configured to detect the presence of the sample container is provided at each checkpoint. Accordingly, the distance between the sample container and the first laboratory instrument may be inferred from the known distance between the checkpoint at which the sample container is detected and the first laboratory instrument. For example, the distance between the sample container and the first laboratory instrument may be the known distance between the first laboratory instrument and the checkpoint at which the sample container was last detected before the determination that the first laboratory instrument is unavailable to carry out the first clinical test. At the moment in which it is determined that the processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument, the sample container is located at a first position within the automated laboratory system. In this particular example, the method comprises determining the distance (hereinafter also referred to as “first distance”) between the sample container at the first position and the first laboratory instrument. The first distance may be stored in a storage, e.g. the memory of the computing device.

[0094] Once the waiting time period has elapsed and it is determined that the first laboratory instrument is still unavailable to carry out the first clinical test, the method further comprises checking whether the first distance is greater than a threshold based on the waiting time period. If the first laboratory instrument is still unavailable to carry out the first clinical test and the first distance was greater than the threshold, the second route plan is obtained and set as the processing route plan. Instead, if the distance between the sample container and the first laboratory instrument was equal to or smaller than the threshold, no second route plan may be obtained. For instance, in this latter case, a warning may be issued to a user, e.g. instructing the user to remove the sample container manually from the automated laboratory system.

[0095] The threshold is based on the waiting time period in that, for instance, it is a distance that corresponds to the waiting time period considering the speed at which the sample container is moved within the automated laboratory system. As mentioned above, in some cases processing of the sample container may already start after the first route plan is obtained, and in these cases the processing may continue according to the first route plan also during the waiting time period. Hence, the sample container may be moved from the first position to a second position during the waiting time period and while it is checked whether the first laboratory instrument is still unavailable.

[0096] If the first distance is not greater than the threshold, the second position of the sample container will be at the first laboratory instrument. In other words, it may be too late to obtain a new route plan for the sample container, and, thus, by checking whether the first distance was greater than the threshold obtaining the second route plan after the waiting time period is elapsed is avoided, thereby increasing the efficiency of the sample processing.

[0097] In some examples, not only obtaining the second route plan may be only performed if the distance was greater than the threshold, but also checking whether the first laboratory instrument is still unavailable to carry out the first clinical test is only performed if the distance was greater than the threshold. Optionally, also maintaining the first route plan as the processing route plan for the predetermined waiting time period may be performed only if the distance was greater than the threshold.

[0098] In these examples, if the distance was not greater than the threshold based on the predetermined waiting time period, the method may further comprise obtaining a fourth route plan different from the first route plan and setting the fourth route plan as the processing route plan.

[0099] Accordingly, based on whether the distance between the sample container and the first laboratory instrument (determined upon determining that the processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument) is greater than the threshold based on the predetermined waiting time period or not, the method may follow two different paths. When the distance is greater than threshold, the computing device waits for the predetermined waiting time period before checking whether the first laboratory instrument is still unavailable and, in case it is, it obtain the second route plan. When the distance is not greater than threshold, the computing device may immediately obtain the fourth route plan. In the latter case, the new route plan (the fourth route plan) is obtained before the sample container reaches the first laboratory instrument, thereby guaranteeing that the processing of the sample container is not jeopardised by the unavailability of the first laboratory instrument.

[0100] Another aspect of the present invention relates to a data processing system (e.g. a computing device) comprising a processor configured to perform the method described heretofore.

[0101] Yet another aspect of the present invention relates to an automated laboratory system comprising the data processing system of the previous aspect. According to another aspect of the invention, a computer program product is provided. The computer program product comprises instructions which, when the program is executed by a computer, cause the computer to carry out the method described herein.

[0102] A further aspect of the present invention refers to a computer-readable medium, e.g. a transitory computer readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the method described herein.

[0103] Brief Description of the Drawings

[0104] Details of exemplary embodiments are set forth below with reference to the exemplary drawings. Other features will be apparent from the description, the drawings, and from the claims. It should be understood, however, that even though embodiments are separately described, single features of different embodiments may be combined to further embodiments.

[0105] Figure 1 shows a schematic representation of an automated laboratory system comprising a computing device.

[0106] Figure 2 shows a flow chart of an exemplary method for obtaining a processing route plan for processing of a sample container within an automated laboratory system.

[0107] Detailed Description

[0108] In the following, a detailed description of examples will be given with reference to the drawings. It should be understood that various modifications to the examples may be made. Unless explicitly indicated otherwise, elements of one example may be combined and used in other examples to form new examples.

[0109] Figure 1 shows a schematic representation of an automated laboratory system 100 comprising a computing device 110. In this example, the computing device 110 is physically part of the automated laboratory system 100 and may be e.g. located within the automated laboratory system 100. The data communication between the computing device 110 and the other components of the automated laboratory system 100 may occur via a bus or via an internal network. In another example (not shown), the computing device 110 may be physically distinct from the automated laboratory system 100 and may be e.g. located remotely from the automated laboratory system 100.

[0110] Exemplarily, the computing device 110 comprises a processor 111 (e.g. a CPU, a GPU, or the like), and a memory 112. The memory 112 may comprise a primary memory and a secondary memory (not shown). The computing device 110 may also comprise a input output (I / O) interface 113 for communicating with input / output units, such as a screen, a keyboard, a touch screen, a printer, or the like.

[0111] Furthermore, the computing device 110 may comprise a Network Interface Controller (NIC) 114 configured to connect said device with one or more networks (e.g. an intranet, the internet, a cellular network, or the like). In other examples, the computing device may comprise a plurality of NICs. In examples in which the computing device 110 is external to the automated laboratory system 100 it may be in data communication with the automated laboratory system 100 by means of the NIC 114.

[0112] The automated laboratory system 100 further comprises a first laboratory instrument 120, an error area 130 and a second laboratory instrument 140. The first laboratory instrument 120 and the second laboratory instrument 140 are analytic instruments configured to carry out clinical tests. The error area 130 is an area where the sample containers can be located while awaiting further processing e.g. for inspection by a user of the automated laboratory system 100.

[0113] The automated laboratory system 100 comprises further components that are not shown in figure 1 , in particular a transportation component (e.g. track, belt, tube carrier) configured to move sample containers within the automated laboratory system 100.

[0114] The computing device 110 is configured to carry out the method according to the first aspect of the present invention. A particular example of this method is shown in figure 2. The method 200 comprises at step 210 obtaining a first route plan that is to serve as processing route plan for processing a sample container within the automated laboratory system 100. For instance, the sample container may arrive at an input area (not shown) of the automated laboratory system 100 and at the input area an indicium on the sample container, such as a barcode, may be scanned to access test order data comprising information specifying a set of clinical tests to be carried out on the biological sample contained in the sample container. A set may contain one or more elements. In particular, the set of clinical tests comprises at least a first clinical test.

[0115] Based on the set of clinical tests to be carried out on the biological sample, the computing device 110 may generate the first route plan to be used for processing the sample container within the automated laboratory system 100. In particular, the first route plan comprises one or more processing steps for carrying out the first clinical test.

[0116] Optionally, after obtaining the first route plan at step 210, the method may comprise causing the automated laboratory system 100 to start processing the sample container using the first route plan. Thus, the various components of the automated laboratory system 100 may begin handling the sample container following the first route plan, while being controlled by the computing device 110.

[0117] The first laboratory instrument 120 of the automated laboratory system 100 is configured to carry out a plurality of clinical tests including the first clinical test. At step 230, the computing device 110 determines that the first laboratory instrument 120 is unavailable to carry out the first clinical test. In particular, the computing device 110 may determine that the first laboratory instrument 120 is unavailable to carry out only the first clinical test or unavailable to carry out all clinical tests in the plurality of clinical tests, thus including the first clinical test. For example, the computing device 110 may determine that the first laboratory instrument 120 is offline.

[0118] Afterwards, at step 240, the computing device 110 determines whether the unavailability of the first laboratory instrument 120 affects the processing of the sample container as prescribed by the first route plan. For example, the computing device 110 checks whether the performance of the first clinical test by the first laboratory instrument is included in the first route plan. Indeed, the set of clinical tests to be carried out on the sample container comprises the first clinical test, however the automated laboratory system 100 may comprise another laboratory instrument configured to carry out the first clinical test (e.g. the second laboratory instrument 140) and the first route plan may include the use of the other laboratory instrument to perform the first clinical test.

[0119] Furthermore, even if the first route plan includes the use of the first laboratory instrument 120 to perform the first clinical test, if processing of the sample container according to the first route plan has already started, the computing device 110 may check whether the sample container has already been at the first laboratory instrument 120, i.e. whether the first clinical test has already been performed.

[0120] In a case in which the unavailability of the first laboratory instrument 120 does not affect the processing of the sample container according to the first route plan, the method may optionally proceed to step 280. For instance, this is the case when the first route plan does not include the use of the first laboratory instrument 120 to perform the first clinical test or the first clinical test has already been performed by the first laboratory instrument 120.

[0121] At step 280, the computing device 110 maintains the first route plan as the processing route plan for the sample container. In particular, the computing device 110 may do nothing that would modify the processing route plan. If step 220 has been performed, the computing device 110 may continue controlling the components of the automated laboratory system 100 to process the sample container according to the first route plan. Otherwise, the computing device 110 may start controlling the components of the automated laboratory system 100 to process the sample container according to the first route plan.

[0122] In a case in which the unavailability of the first laboratory instrument 120 affects the processing of the sample container according to the first route plan, the method may optionally proceed to step 250. For instance, this is the case when the first route plan includes the use of the first laboratory instrument 120 to perform the first clinical test and the first clinical test has not yet been performed.

[0123] At step 250, the computing device 110 maintains the first route plan as the processing route plan for a predetermined waiting time period, e.g. for 5 seconds. In particular, during the waiting time period, the computing device 110 does not take any action to address the unavailability of the first laboratory instrument 120, specifically it does not obtain a new plan to be used as processing route plan instead of the first route plan. Optionally, the predetermined waiting time period may be computed by the computing device 110 using historical data containing records of previous periods of unavailability of the first laboratory instrument 120. Step 250 differs from step 280 in that in step 250 the first route plan is maintained for a predefined, finite amount of time, the end of which triggers a specific action by the computing device 110 (step 260 discussed below), while in step 280 the first route plan is simply kept, possibly until all the clinical tests specified in the test order data have been carried out.

[0124] Once the predetermined waiting time period has elapsed, the method moves to step 260. Specifically, the computing device 110 waits for the waiting time period and then determines whether the first laboratory instrument 120 is still unavailable or has become available again. In particular, the computing device 110 checks whether the condition of the first laboratory instrument 120 has changed since the determination at step 230.

[0125] If the determination at step 260 is negative, i.e. the first laboratory instrument 120 is no longer unavailable, the method may optionally proceed to step 290. Step 290 is analogous to step 280, the computing device 110 maintains the first route plan as the processing route plan.

[0126] If the first laboratory instrument 120 is still unavailable to carry out the first clinical test, the method proceeds to step 270. At step 270, the computing device 110 obtains a second route plan and sets it as the processing route plan, thereby replacing the first route plan. The second route plan takes into account the unavailability of the first laboratory instrument 120, and, thus, avoids including the use of the first laboratory instrument 120. The computing device 110 may cause the automated laboratory system 100 to process the sample container using the second route plan as the processing route plan.

[0127] For example, the second route plan includes a transfer of the sample container to the error area 130. In this case, later on the computing device 110 may determine that the first laboratory instrument 120 is finally available again, while the sample container is still at the error area 130, and obtain a third route plan including the use of the first laboratory instrument 120. Accordingly, for a longer unavailability of the first laboratory instrument 120, the sample container may be held at the error area 130 until the first laboratory instrument 120 is available again to carry out the first clinical test.

[0128] If the second laboratory instrument 140 is also configured to carry out the first clinical test, the second route plan may include the use of the second laboratory instrument for carrying out the first clinical test. In particular, the sample container may be transferred to the second laboratory instrument 140.

[0129] In some examples, step 270 may be carried out only if an additional condition is satisfied, besides the condition that the first laboratory instrument 120 is still unavailable to carry out the first clinical test. The additional condition is that a distance between the sample container and the first laboratory instrument determined upon determining that the processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument is greater than a threshold based on the waiting time period.

[0130] In this way, sample containers that are too close to the first laboratory instrument 120 already, in that during the waiting time period they would already reach the first laboratory instrument 120, are excluded from obtaining a second route plan. Thus, the second route plan is only obtained when it can be actually implemented.

Claims

Claims1 . A computer-implemented method comprising: obtaining a first route plan as processing route plan for processing a sample container within an automated laboratory system, wherein: the sample container contains a biological sample on which a first clinical test is to be carried out; the automated laboratory system comprises a first laboratory instrument configured to carry out the first clinical test; determining that the first laboratory instrument is unavailable to carry out the first clinical test; determining that processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument; once a predetermined waiting time period has elapsed, checking whether the first laboratory instrument is still unavailable to carry out the first clinical test; if the first laboratory instrument is still unavailable to carry out the first clinical test, obtaining a second route plan different from the first route plan and setting the second route plan as the processing route plan.

2. The computer-implemented method of claim 1 , further comprising, if the first laboratory instrument is no longer unavailable to carry out the first clinical test, maintaining the first route plan as the processing route plan.

3. The computer-implemented method of claim 1 or 2, wherein the second route plan includes a transfer of the sample container to an error area.

4. The computer-implemented method of claim 3, further comprising:- determining that the first laboratory instrument is available again to carry out the first clinical test;- determining that the sample container is still in the error area;- obtaining a third route plan for the sample container, wherein the third route plan includes the use of the first laboratory instrument.

5. The computer-implemented method of claim 1 or 2, wherein the second routeplan includes a transfer of the sample container to a second laboratory instrument of the automated laboratory system configured to carry out the first clinical test and available to carry out the first clinical test.

6. The computer-implemented method of any one of claims 1 to 5, further comprising obtaining the predetermined waiting time period based on the first laboratory instrument.

7. The computer-implemented method of claim 6, further comprising accessing historical data, the historical data comprising information specifying one or more unavailability time periods of the first laboratory instrument; and wherein obtaining the predetermined waiting time period comprises computing the waiting time period using the historical data.

8. The computer-implemented method of any one of claims 1 to 7, further comprising causing the automated laboratory system to process the sample container using the second route plan as the processing route plan.

9. The computer-implemented method of any one of claims 1 to 8, further comprising: upon determining that the processing of the sample container according to the first route plan is affected by the unavailability of the first laboratory instrument, determining a distance between the sample container and the first laboratory instrument.

10. The computer-implemented method of clam 9, wherein obtaining the second route plan is only performed if the distance was greater than a threshold based on the predetermined waiting time period.11 . The computer-implemented method of clam 9, wherein:- checking whether the first laboratory instrument is still unavailable to carry out the first clinical test, and- obtaining a second route plan different from the first route plan and setting the second route plan as the processing route plan, are only performed if the distance was greater than a threshold based on thepredetermined waiting time period; and wherein, if the distance was not greater than the threshold based on the predetermined waiting time period, the method further comprises obtaining a fourth route plan different from the first route plan and setting the fourth route plan as the processing route plan.

12. A data processing system comprising a processor configured to carry out the method according to any one of the preceding claims.

13. An automated laboratory system comprising the data processing system according to the preceding claim.

14. A computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out the method according to any one of claims 1 to 11 .

15. A computer-readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the method according to any one of claims 1 to 11.

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