EP4713933A1 - Providing a state of a clinical test carried out on a biological sample via a laboratory instrument - Google Patents

Abstract

A method, a computer program, a computer-readable medium and a computer system for providing a state of a clinical test carried out on a biological sample via a laboratory instrument are provided. The clinical test comprises a plurality of processing steps, The method comprises determining, after starting the clinical test, an expected completion time for the clinical test based on one or more expected durations and one or more actual durations, wherein each processing step of the plurality of processing steps that has not been completed has a respective expected duration of the one or more expected durations and each processing step of the plurality of processing steps that has been completed has a respective actual duration of the one or more actual durations. The method further comprises displaying a warning when at least one warning condition of one or more warning conditions are met, wherein the one or more warning conditions comprise at least one warning condition on the expected completion date.

Description

PROVIDING A STATE OF A CLINICAL TEST CARRIED OUT ON A BIOLOGICAL SAMPLE VIA A LABORATORY INSTRUMENT

CROSS REFERENCE TO RELATED APPLICATIONS

This is a PCT International application of and claims the benefit of priority to Indian patent application 202341035166, filed on May 19, 2023, titled “Providing A State of A Clinical Test Carried Out On A Biological Sample Via A Laboratory Instrument”, the disclosure of which is hereby incorporate by reference in its entirety.

Description

The technical field of the application relates to devices and methods for biological samples testing. In particular, the present invention relates to devices and methods for providing states of clinical tests for ensuring that the clinical test is completed by the specified completion time and/or for ascertaining the state of the laboratory instrument carrying out the clinical tests. In some examples, the application relates to a graphical user interface for tracking a biological sample within a laboratory or within a laboratory instrument. Accordingly, a state of a clinical test carried out on a biological sample via a laboratory instrument is provided.

The laboratory may be a technical system including one or more laboratory instruments. The laboratory instruments may be capable of communicating with each other and/or communicating with other devices (e.g., computers). The laboratory instruments may also be referred to as laboratory devices or laboratory equipment and may include laboratory automation.

It may be desirable to carry out a clinical test on a biological sample within a specified period. The biological sample may be in a container and may be associated with a patient. For example, the container may include a machine-readable code (e.g., a barcode) identifying the patient. Accordingly, a surgical procedure may be scheduled and can only take place after results of the clinical test have been received. Moreover, a patient's life may depend on the results of the clinical test being received by a specified completion time, e.g., so that a life-saving surgical procedure may be performed. Hence, by providing a user with the state of the clinical test, it may be possible for the user to interact with the laboratory in order to ensure that the clinical test is completed by the specified completion time. In other words, providing the state of the clinical test may enable action to be taken to ensure that the clinical test is completed by the specified completion time.

According to a first aspect, a computer implemented method for providing a state of a clinical test carried out on a biological sample via a laboratory instrument is provided. The clinical test comprises a plurality of processing steps. The method comprises determining, after starting the clinical test, an expected completion time for the clinical test based on one or more expected durations and one or more actual durations, wherein each processing step of the plurality of processing steps that has not been completed has a respective expected duration of the one or more expected durations and each processing step of the plurality of processing steps that has been completed as a respective actual duration of the one or more actual durations. The method further comprises displaying a warning when at least one warning condition of the one or more warning conditions is met, wherein the one or more warning conditions comprise at least one warning condition on the expected completion time.

The present invention may enable a user to properly operate a technical system, i.e., a laboratory, by displaying information relating to a state (e.g., an internal state) prevailing in the technical system. The processing steps of the plurality of processing steps may bring about dynamic changes in the laboratory, more specifically, in the laboratory instrument of the laboratory. Meeting the at least one warning condition of the one or more warning conditions may be an automatically detected event related to the internal functioning of the laboratory (e.g., the internal function of the laboratory instrument) and display of the warning condition may prompt the user to interact with the laboratory or the laboratory instrument, e.g., to repair a technical malfunction or avoid that a potential problem of the laboratory becomes a problem.

In some cases, each processing step of the plurality of processing steps may have a corresponding expected duration. Hence, not only the processing steps that have not been completed but also the processing steps that have been completed may have corresponding expected durations. The plurality of processing steps may involve preparing to test the biological sample, testing the biological sample and postprocessing after the testing of the biological sample (e.g., storing the container).

The state of the clinical test may be provided via a graphical user interface. The state of the clinical test may be one of the following: as expected, delayed, stalled. The clinical test may be in an as expected state when the sum of the actual durations of the processing steps that have been completed is less than or equal to the sum of the expected durations of the processing steps that have been completed. In addition, the clinical test may be in the expected state when no warning is displayed, i.e., none of the warning conditions. The state of the clinical test may be a delayed state or a stalled state when the sum of the actual durations of the processing steps that have been completed is greater than the sum of the expected durations of the processing steps that have been completed, or when a warning is displayed and at least one of the warning conditions or at least one of the alert conditions are met. Alternatively or additionally, for example, a delayed state or a stalled state when the expected completion time for the clinical test is greater than or equal to a given threshold. The clinical test may be in the delayed state when a cause of a delay has a known or expected resolution time and/or the clinical test may be in the stalled state when the cause of the delay does not have a known or expected resolution time.

A clinical test (i.e., clinical laboratory test) may be diagnostic and/or medical. The clinical test may include use of a chemical and/or biological process to determine or measure a level of a chemical component in a bodily fluid and/or bodily tissue. The chemical component may include blood glucose, an electrolyte, an enzyme, a hormone, a lipid (fat), another metabolic substance or a protein. The clinical test may be used to identify a sign of a nutrient deficiency in a patient, detect a change in the health of the patient, evaluate bodily functions of the patient (e.g., kidney function, liver function or thyroid function), monitor treatment of the patient or disease progression in the patient. 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. The biological sample may be a material or specimen and may include blood, urine, tissue, cells, saliva, etc. The plurality of processing steps may be dependent on the clinical test and/or the plurality of processing steps may be specific to the clinical test. The one or more expected durations and the one or more actual durations may each be periods of time. The respective actual duration may be the time that has been required to complete a processing step.

In particular, according to the present disclosure, a processing step of the plurality of processing steps that has been completed is a processing step that: (i) is comprised in the plurality of processing steps and (ii) has been completed. Similarly, for instance, a processing step of the plurality of processing steps that has not been completed is a processing step that: (i) is comprised in the plurality of processing steps and (ii) has not been completed. Displaying a warning when at least one warning condition of the one or more warning conditions is met may be implemented by displaying the warning when at least one warning condition on the expected completion time is met.

The processing steps may be carried out in series and/or the processing steps may be carried out according to a specified order, e.g. a specific temporal order. In particular, the processing steps are carried out in series when a processing step is started after completion of the preceding processing step, the latter processing step being the step that precedes the former processing step according to the specific temporal order.

The state of the clinical test may reflect one of the following:

- a state of the laboratory instrument,

- a state of one or more laboratory instrument modules of the laboratory instrument,

- a load of the laboratory instrument,

- maintenance requirements of the laboratory instrument.

The state of the clinical test may reflect the state of the laboratory instrument in various ways. For example, when the laboratory instrument is in a depleted state, e.g., because a supply of reagent contained by the laboratory instrument is empty, this may also lead to the clinical test being in the delayed state. As another example, when the laboratory instrument is in an impaired state, this may lead to the clinical test being in the delayed state or the stalled state, depending on a level of impairment of the laboratory instrument.

The state of the one or more laboratory instrument modules of the laboratory instrument may affect the state of the laboratory instrument. For example, when a centrifuge or an aliquoter of a laboratory instrument is in an impaired state this may lead to the laboratory instrument being in the impaired state (e.g., transitioning from a normal state to the impaired state).

When the laboratory instrument is overloaded, this may lead to the clinical test being in the delayed state (e.g., by transitioning from the as expected state to the delayed state). The laboratory instrument being overloaded may also lead to the laboratory instrument being in the impaired state. The load or capacity level of the laboratory instrument may be determined based on an amount of work scheduled to be performed before a respective processing step of the plurality of processing steps can be carried out.

The laboratory instrument may require periodic maintenance and/or calibration. Maintenance and/or calibration requirements of the laboratory instrument may lead to the clinical test being in the delayed state. Since overloading, maintenance, and calibration can typically be resolved within a predictable time period, these issues typically bring the laboratory instrument into the delayed state rather than the stalled state.

The expected completion time for the clinical test may be based on a time required to bring the laboratory instrument to full functionality (e.g., the as expected state) and/or a time required for the laboratory instrument to carry out tasks scheduled to be performed before a processing step of the plurality of processing steps that has not been completed.

The plurality of processing steps may comprise one or more of the following:

- a processing step of collecting the biological sample in a container, wherein the container may be a tube;

- a processing step of sorting the container to a rack;

- a processing step of arranging the rack in a package based on an identity of a laboratory

- a processing step of transporting the package to the laboratory including the laboratory instrument;

- a processing step of acknowledging receipt of the container;

- a processing step of determining a tracking number for the biological sample;

- a processing step of transporting the container to or within the laboratory instrument for another processing step;

- a pre-analysis step to be performed via the laboratory instrument;

- a processing step of loading the container for testing;

- a processing step of testing the biological sample;

- a processing step of storing the container.

Hence, any one of the plurality of processing steps may be one of the processing steps listed above. Moreover, the processing step of transporting the container to or within the laboratory instrument for another processing step may be performed directly before a pre-analysis step. In this case, the pre-analysis step may be the other processing step for which the container is transported. The processing steps of loading the container and/or testing the biological sample may be performed via the laboratory instrument. The processing step of storing the container may be performed by storing the container in a storage unit, wherein the storage unit is separate from the laboratory instrument or part of the laboratory instrument. The processing step of transporting the container within the laboratory instrument for another processing step may be performed via the laboratory instrument, e.g. if the laboratory instrument is an automated laboratory system.

The laboratory may be a clinical or medical laboratory. The laboratory may include one or more laboratory instruments and/or at least one computer. The laboratory may be configured to receive biological samples from clinical or medical facilities, such as hospitals. Alternatively, the laboratory may be a part of a clinical or medical facility and may receive biological samples from another part of the clinical or medical facility.

At least one processing step of the plurality of processing steps may comprise using the laboratory instrument to perform a task.

The task may be a pre-analysis task, such as centrifuging or aliquoting, an analysis task, such as loading or testing the biological sample, or a post-analysis task, such as recapping or storing the container. In particular, the laboratory instrument may be configured to perform all the processing steps of the plurality of processing steps. This is the case when, for instance, the laboratory instrument is an automated laboratory instrument. In particular, each processing step of the plurality of processing steps may comprise using the laboratory instrument to perform a respective task.

In some cases, each processing step of the plurality of processing steps may comprise using the laboratory instrument to perform the task.

The laboratory instrument may be one of a laboratory analyzer and an automated laboratory system. In other words, the laboratory instrument may be the laboratory analyzer or the automated laboratory system.

The laboratory instrument may be a medical or clinical laboratory instrument, a pre-analysis laboratory instrument, an analysis laboratory instrument (hereinafter also referred to: “analyzer”), a post-analysis laboratory instrument, or an automation component. The laboratory instrument may also include one or more pre-analysis, analysis and post-analysis components.

An analyzer is in particular an instrument configured to carry out one or more analytic steps, such as measuring one or more characteristics of the sample, e.g. the concentration of a given analyte. A pre-analysis laboratory instrument is an instrument configured to carry out one or more pre-analytic steps on a biological sample to prepare said sample for the analytic instrument(s). A pre-analysis laboratory instrument may include a centrifuge, a decapper, a recapper and/or an aliquoter unit. The analysis laboratory instrument may be or include an immunoassay analyzer, a chemistry analyzer, an identification and antibiotic susceptibility analyzer, a bacteriology analyzer, a molecular analyzer, a hematology analyzer or a urinalysis instrument.

A post-analysis instrument is an instrument configured to carry out one or more post-analytic steps on the biological sample after the sample has been processed by one or more analytic instruments. A post-analysis laboratory instrument may include a recapper (e.g., for putting caps back on containers), a storage device, a refrigerator or an input/output device. Both pre-analysis and post-analysis laboratory instruments may be referred to as peri-analytical laboratory instruments.

An automation component may be for moving containers from one laboratory instrument to another laboratory instrument or for moving containers from one component of a laboratory instrument to another component of the same laboratory instrument or to another component of another laboratory instrument. The automation component may include a track, a belt and/or a tube carrier configured to move biological samples.

Generally, an automated laboratory system (hereinafter also referred to as: “ALS”) 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. A component may be an analyzer, a preanalysis laboratory instrument, a post-analysis laboratory instrument, an input/output module, an automation component (e.g. track, belt, tube carrier) configured to move a sample. In particular, an ALS may comprise one or more subsystems, wherein a subsystem comprises one or more components of the ALS. Exemplarily, (a subsystem of) an ALS may be configured to carry out the plurality of processing steps. In particular, processing steps that can be performed on a biological sample may comprise any (or combinations of) pre-analytic steps, post-analytic steps, analytic steps.

The expected completion time for the clinical test may be based on one or more of the following:

- a level of impairment of the laboratory instrument,

- a type or capability level of the laboratory instrument;

- a load or capacity level of the laboratory instrument,

- a supply of reagent contained by the laboratory instrument, and

- maintenance requirements of the laboratory instrument.

Accordingly, determining the expected completion time for the clinical test may be carried out based on (i.e., using) one or more of the five items in the list above.

In addition or alternatively, the expected completion time of the clinical test may be based on one or more characteristics of laboratory personnel of the laboratory. For example, the characteristics of laboratory personnel may include availability, a training level, a capability level and a qualification level. The laboratory personnel may be responsible for one or more of transportation of containers between laboratory instruments, laboratory instrument maintenance and refill of reagent.

The level of impairment of the laboratory instrument may be determined based on a time period required to bring the laboratory instrument to full functionality. For example, maintenance or calibration that can be resolved relatively quickly may lead to a relatively low level of impairment of the laboratory instrument. As another example, when multiple modules of the laboratory instrument are not functioning or when extensive work is required to bring a module of the laboratory instrument to full functionality, the laboratory instrument may have relatively high level of impairment. Each module of the laboratory instrument may have one or more components.

The reagent may be a substance or compound that can facilitate a chemical reaction and, in contrast to a reactant, is not necessarily consumed in the chemical reaction. The reagent may include one or more of the following: a solvent (e.g., water), an enzyme, a catalyst. Exemplary reagents include Grignard reagent, Tollens' reagent, Fehling's reagent, Millon's reagent, Collins reagent, and Fenton's reagent.

The type and/or capability level of the laboratory instrument may reflect the performance of the laboratory instrument under normal operating conditions, e.g., when the laboratory instrument is not overloaded.

At least one of the one or more expected durations may be based on one or more of the following:

- a level of impairment of one or more components of the laboratory instrument,

- a load or capacity level of the one or more components of the laboratory instrument,

- a supply of reagent contained by the one or more components of the laboratory instrument,

- maintenance requirements of the one or more components of the laboratory instrument.

In some cases, the at least one of the one or more expected durations may be calculated as follows:

ED, = Os + PDj where ED, is the expected duration of processing step i, O_ss is an estimated time required to process other biological samples that are scheduled to be processed before the biological sample and PDt is a predicted duration of processing step i once processing step i can be carried out. Hence, in cases where processing step i can be carried out immediately, PDt = ED,.

In other cases, the at least one of the one or more expected durations may be calculated as follows:

ED, = Os + PDt + R where R is the time required to reload the supply of reagent contained by the one or more components of the laboratory instrument.

The at least one of the one or more expected durations may also be affected by calibration or quality control procedures affecting the laboratory instrument that may be scheduled before the at least one of the one or more expected durations.

In some cases, a machine learning (ML) algorithm may be used to provide the at least one of the one or more expected durations. Training data for the machine learning algorithm may comprise an ordered list of information corresponding to a specified number (e.g., at least 1000, or at least 2000) of clinical tests. The ordered list of information may include one or more of the following for each of the clinical tests provided in the training data:

- an identifier of a container containing the biological sample,

- a type of the clinical test,

- a date on which the biological sample was placed in the container (i.e. , drawing date),

- a priority of the clinical test,

- a list of processing step states (e.g., completed, not applicable),

- a list of lab instruments and their current states, including scheduled availability of the respective instruments, planned maintenance, planned calibration,

- a list of peri-analytics lab instruments and their current states, including scheduled availability, planned maintenance, planned calibration,

- a list of lab personnel involved in the clinical test, including availability of the lab personnel and identifiers of the lab personnel.

In addition, e.g. during training of the ML algorithm the following two elements may be included in the ordered list of information for each of the clinical tests as a label or annotation.

- actual durations of each of the processing steps comprised in the clinical test,

- the completion time for the clinical test.

An input to the trained machine learning algorithm may include the ordered list above without the label elements. The output of the trained machine learning algorithm may be expected durations for each of the processing steps comprised in a clinical test and an expected completion time for the clinical test.

In order to provide consistent input to the machine learning algorithm, the identifiers of the containers may be renumbered such that the identifiers are in ascending order from newest to oldest. Accordingly, the most recently processed container in the ordered list might have the number 1 and the oldest container in the ordered list might have the highest number. Similarly, the ordered list for a respective clinical test may include states for all possible processing steps that may be carried out for a clinical test, even if a respective processing step is not relevant or not carried out for the respective clinical test. This may enable more efficient processing of the ordered list by the machine learning algorithm. Possible clinical test types may be a nutrient test (e.g., a test for glucose or potassium), a test for a virus or bacterium, or a genetic test.

Regarding the priority of the clinical test, this may be determined based on the drawing date or may be a user provided indication of how urgent the test result is (e.g., regarding the life of a patient or a procedure to be carried out).

The availability of the respective instruments and the availability of lab personnel may each be provided as an array of binary values. For example, each element of the array may represent a 5 minute time period and a 1 may indicate availability for the time period while a 0 indicates unavailability for the time period.

The machine learning algorithm may be a supervised machine learning algorithm. For example, the machine learning algorithm may be a random forest or a neural network, e.g. a deep neural network.

In some cases, each of the one or more expected durations is based on one or more items in the list provided above.

The one or more components of the laboratory instrument may be configured to carry out one or more processing steps of the plurality of processing (i.e., one or more processing steps comprised in the plurality of processing steps) steps that have not been completed.

At least one expected duration of a processing step of the plurality of processing steps that has not been completed may be determined based on historical duration data about the processing step of the plurality of processing steps that has not been completed. In particular, for each processing step that has not been completed, the expected duration of said each processing step is determined based on historical duration data about said each processing step. More particularly, for each processing step of the plurality of processing steps, the expected duration of said each processing step is determined based on historical duration data about said each processing step.

Optionally, the historical duration data includes statistical data. Optionally, the historical duration data includes one or more of the following: a mean (e.g., an average), a median, a mode, a standard deviation, a variance, a percentile rank.

For example, historical duration data about the pre-analysis step (e.g., centrifuging) to be performed via the laboratory instrument may indicate that the preanalysis step takes from 9 to 15 minutes, with a mean of 12 minutes and a standard deviation of about 2. If this is the case, for example, the least one expected duration of the processing step of the plurality of processing steps that has not been completed may be determined to be 12 + 2 = 14 minutes. As another example, historical duration data about the processing step of loading the container for testing may indicate that the processing step takes 4 to 12 minutes, with a mean of 8 minutes and a standard deviation of about 3. If this is the case, for example, the least one expected duration of the processing step of the plurality of processing steps that has not been completed may be determined to be 8 + 3 = 11 minutes.

For example, historical duration data about a processing step includes a time profile of historical time periods required to carry out said processing step. The time profile may refer to historical time periods including the most recent day, the most recent week, the most recent month, or the most recent year. In addition, the time profile may cover further historical time periods including a selectable number of days, a selectable number of weeks, a selectable number of months, a selectable number of years. In particular the time profile of historical time periods required to carry out a processing step may be displayed along with a mean of the time periods, a median of the time periods, a mode of the time periods, a standard deviation of the time periods, a variance of the time periods, percentile ranks of selected time periods (e.g., a range of time periods in the 95th percentile, a range of time periods in the 99th percentile, etc.). The time profile of a processing step e.g. that has not been completed can be shown before or alongside the corresponding processing step or may be displayed upon request, e.g., when the user clicks on a help button. In particular, the time profile of a processing step e.g. that has not been completed can be shown before or alongside the corresponding processing step or may be displayed upon request, e.g., when the user clicks on a help button.

In addition to historical duration data of the laboratory containing the laboratory instrument, historical duration data of another laboratory containing one or more other corresponding laboratory instruments (e.g., the corresponding laboratory instruments may have the same make, model, and functionality of the laboratory instrument) may be used. The historical duration data of the corresponding laboratory instruments may be accessible via a database, e.g., a distributed database. It may be more accurate to consider historical duration data of the laboratory rather than historical duration data of the other laboratory since the historical duration data of the laboratory may make it possible to account for availability of laboratory personnel and/or an organization (e.g., arrangement) of the laboratory as well as laboratory instruments within laboratory.

In some cases, each of the one or more expected durations may be determined based on historical duration data about a respective processing step that has not been completed.

The expected duration of the processing step of the plurality of processing steps that has not been completed may be determined based on the mean and/or the standard deviation. For example, the expected duration of the processing step of the plurality of processing steps that has not been completed may be a mean of historical instances of the processing step plus a standard deviation from the mean. Accordingly, the expected duration of the processing step of the plurality of processing steps that has not been completed may be determined as follows:

ED = M + SD where ED is the expected duration of the processing step of the plurality of processing steps that has not been completed, M is the mean of historical instances of the processing step of the plurality of processing steps that has not been completed and SD is the standard deviation from the mean.

The method may further comprise, before starting the clinical test, displaying at least one expected duration of a processing step of the plurality of processing steps, and prompting a user to accept or revise the expected duration of the processing step of the plurality of processing steps. For example, the expected duration of the processing step of the plurality of processing steps may be displayed to the user in a field such that the user can accept or revise (i.e., edit) the expected duration of the processing step of the plurality of processing steps.

In some cases, each processing step of the plurality of processing steps may have a respective expected duration, such that all of the processing steps of the plurality of processing steps have respective expected durations.

In some examples, each of the respective expected durations is displayed and the user prompted to accept or revise each of the respective expected durations. The expected completion time for the clinical test may be determined after completion of a first one of the plurality of processing steps. The expected completion time for the clinical test may be redetermined after completion of a second one of the plurality of processing steps, the completion of the second one of the plurality of processing steps taking place after the completion of the first one of the plurality of processing steps. In particular, the expected completion time for the clinical test may be determined a plurality of times. In particular, each time of the plurality of times a respective determination of the expected completion time is carried out at a respective time point or time interval. In particular, each time of the plurality of times, the respective determination is based on: o the expected duration of the processing steps that, before the respective time point or time interval, have not been completed and o the actual duration of the processing steps that have been completed before the respective time point or time interval.

Exemplarily, the expected completion time for the clinical test may be determined after completion of the first one of the plurality of processing steps. In particular, the expected completion time is based on: o the expected durations of the processing steps that, after completion of the first one of the plurality of processing steps and before completion of the second one of the plurality of processing steps, have not yet been completed and o the actual duration of the processing steps that, after completion of the first one of the plurality of processing steps and before completion of the second one of the plurality of processing steps, have been already completed.

Moreover, the method according to the present invention may further comprise determining, after completion of a second one of the plurality of processing steps, an updated expected completion time. In particular, the expected completion time is based on: o the expected durations of the processing steps that, after completion of the second one of the plurality of processing steps, have not been yet completed and o the actual duration of the processing steps that, after completion of the second one of the plurality of processing steps, have been already completed.

The method may further comprise displaying a warning when at least one warning condition of one or more updated warning conditions is met, wherein the one or more updated warning conditions comprise at least one warning condition on the updated expected completion time.

Hence the expected completion time of the test may be periodically determined and redetermined, such that an up to date indication of the state of the clinical test is provided to the user. In this way, the user is kept informed of a potential problem that might affect the outcome of the clinical test, such that the user can take action, e.g., interact with the laboratory instrument or another device in the laboratory, in order to prevent the potential problem from becoming a problem that affects the outcome of the clinical test.

For example, the expected completion time for a potassium (K) test may be determined to be 30 minutes. After one or more redeterminations of the expected completion time, e.g., in view of the load of the laboratory instrument and maintenance requirements of the laboratory instrument, the expected completion time for the potassium test may be determined to be 45 minutes. In some cases, after one or more further redeterminations of the expected completion time, e.g., in view of calibration requirements of the laboratory instrument and a level of impairment of one of the components (e.g., an aliquoter module) of the laboratory instrument, the expected completion time may be determined to be 60 minutes. If this the case, if, for example, the at least one warning condition of the one or more warning conditions consists of the condition that the expected completion time meets or exceeds a warning threshold of 50 minutes, a warning is displayed when the expected completion time is updated the second time, i.e. when the updated expected completion time is 60 minutes.

Accordingly, an event related to the internal functioning of the laboratory system may be that at least one warning condition on the expected completion time is met. More specifically, the event may be that the expected completion time meets or exceeds the warning threshold. The event may be automatically detected and may cause display of the warning, which may prompt the user to interact with the laboratory or the laboratory instrument.

The method may further comprise determining, before starting the clinical test, a plurality of expected durations, wherein each processing step of the plurality of processing steps has a respective expected duration of the plurality of expected durations. The method may further comprise determining, before starting the clinical test, the expected completion time for the clinical test using the plurality of expected durations. The method may further comprise displaying the expected completion time for the clinical test (i.e., the expected completion time of the clinical test).

In this case, the determination of the expected completion time is carried out by using the expected durations of all the processing steps of the plurality of processing steps, because said determinations is carried before starting the clinical test, i.e. when none of the plurality of processing steps has been completed.

Before starting the clinical test, the expected completion time for the clinical test may be determined according to the following formula: where E_t is the expected completion time for clinical test t having n processing steps and ED_t is the expected duration of processing step i.

The expected completion time for the clinical test may be displayed within the graphical user interface. Moreover, the expected completion time for the clinical test may be displayed near or in relation to other information regarding the clinical test. For example, the expected completion time of the clinical test may be displayed next to an identifier of the biological sample or a location of the biological sample.

Determining the expected completion time may comprise calculating a sum of the one or more expected durations and a sum of the one or more actual durations. For example, the expected completion time may be determined according to the following formula: where E_t is the expected completion time for clinical test t having p processing steps that have not been completed and q processing steps that have been completed, ED, is the expected duration of processing step i that has not yet been completed and ADi is the actual duration of processing step i that has been completed.

The at least one warning condition on the expected completion time may be a condition that the expected completion time meets or exceeds (i.e., is greater than or equal to) a warning threshold. The at least one warning condition on the expected completion time may depend on the expected completion time. In other words, the at least one warning condition may be triggered based on the expected completion time and/or other factors (i.e., values).

The warning threshold may be determined according to one of the following:

- a sum of expected completion durations of all the processing steps of the plurality of processing steps in addition to a first specified factor,

- a time limit for completing the clinical test minus a second specified factor, wherein, in particular, the time limit for completing the clinical test is determined based on one of the following:

- a health condition of a patient for whom the clinical test is carried out,

- one or more characteristics of the clinical test, and

- a user input.

For instance, the sum of expected durations of all the processing steps of the plurality of processing steps in addition to the first specified factor may be calculated as follows: where W_t is the warning threshold for clinical test t, clinical test t has n processing steps, ED, is the expected duration for processing step i and 9 is the first specified factor. The first specified factor may provide a safety buffer so that a result of the clinical test can be provided in time.

The time limit for completing the clinical test minus a second specified factor may be calculated as follows:

W_t = T_t - y where W_t is the warning threshold for clinical test t, T_t is the time limit for completing the clinical test t, and y is the second specified factor.

The health condition of the patient for whom the clinical test is carried out may affect the time limit for completing the clinical test by lowering the time limit. For example, if the health condition of the patient is critical then the time limit may be lower than if the health condition of the patient is stable or satisfactory.

The characteristics of the clinical test may include a purpose of the clinical test (e.g., confirming a specific health condition or regular check-up), and an intended use of a result of the clinical test. For example, the intended use of the result of the clinical test may be for a surgical procedure to be performed at a predetermined time or the intended use of the result of the clinical test may be for general diagnostics or to test for a health condition that is not severe or life threatening.

The second specified factor may also provide a safety buffer so that the result of the clinical test can be provided in time. The warning threshold may be determined according to a sum of a plurality of alert times. Each processing step of the plurality of processing steps may have a respective alert time of the plurality of alert times, wherein, for each processing step of the plurality of processing steps, the respective alert time may be greater than the expected duration of said each processing step.

For example, the warning threshold may be determined according to the following formula: where W_t is the warning threshold for clinical test t having n processing steps, and At is the alert time for step i. The alert time may be a user specified time giving an indication that there may be a problem with a respective processing step in view of an excessive period of time required to complete the respective processing step. In addition or alternatively, the alert time may be determined based on the historical duration data. More specifically, an alert time may be determined based on a percentile rank for a respective processing step of the plurality of processing steps. For example, a historical duration in the historical duration data occurring in at least the 90th percentile or at least the 95th percentile for the respective processing step may be used as a basis for the alert time or as the alert time.

The one or more warning conditions may comprise a condition that an actual duration of a processing step of the plurality of processing steps that has been completed meets or exceeds a first alert threshold, wherein the first alert threshold is the alert time of the processing step of the plurality of processing steps that has been completed.

In addition or alternatively, the one or more warning conditions may comprise a condition that a sum of the one or more actual durations meets or exceeds a second alert threshold, wherein the second alert threshold is a sum of alert times of the processing steps of the plurality of processing steps that have been completed.

In addition or alternatively, the one or more warning conditions may comprise a condition that a sum of the one or more actual durations meets or exceeds a third alert threshold, wherein the third alert threshold is a sum of expected durations for the processing steps of the plurality of processing steps that have been completed in addition to a specified factor.

The condition that the one or more warning conditions comprise a condition that an actual duration of a processing step of the plurality of processing steps that has been completed meets or exceeds a first alert threshold, wherein the first alert threshold is the alert time of the processing step of the plurality of processing steps that has been completed, may be formulated as follows:

AD, > A,-

The condition that a sum of the one or more actual durations meets or exceeds a second alert threshold, wherein the second alert threshold is a sum of alert times of the processing steps of the plurality of processing steps that have been completed, may be determined as follows: where AD, is the actual duration of processing step i in a clinical test in which q processing steps have been completed and A, is the alert time of processing step i in the clinical test.

The condition that a sum of the one or more actual durations meets or exceeds a third alert threshold, wherein the third alert threshold is a sum of expected durations for the processing steps of the plurality of processing steps that have been completed in addition to a specified factor, may be formulated as follows: where AD, is the actual duration of processing step i in a clinical test in which q processing steps have been completed, ED_t is the expected duration of processing step i in the clinical test and <x is the specified factor. The specified factor may be a safety buffer or other value determined in order to provide the state of the clinical test and/or potential problems when carrying out the clinical test.

The use of the second alert threshold and the third alert threshold is particularly advantageous because the formulation of said thresholds account for cross cancellation of delays among different processing steps. In other words, even assuming that one processing step of the plurality of processing steps is significantly delayed, another processing step of the plurality of processing steps may be completed faster than expected, such that the significant delay does not have a meaningful impact on the expected completion time.

Hence, the event related to the internal functioning of the laboratory system may be related to (e.g., triggered by) the one or more actual durations. More specifically, the event may be triggered based on the first alert threshold, the second alert threshold or the third alert threshold and may cause display of the warning. The display of the warning may provide an indication of a state prevailing in the laboratory or the laboratory instrument and may prompt the user to interact with the laboratory or the laboratory instrument.

The method may further comprise providing a graphical control element to display one or more of the following:

- an indication of at least one expected duration of the one or more expected durations, and

- an indication of at least one actual duration of the one or more actual durations.

The graphical control element may also be referred to as a graphical widget or a control. The graphical control element may be displayed in the graphical user interface as an element of interaction. The graphical control element may be implemented as part of a menu or a tab that can be interacted with using a pointing device (e.g., a mouse). The graphical control element may be displayed within a window or a panel of the graphical user interface.

In some cases, the state of the clinical test indicates a problem in at least one component of the laboratory instrument. The method may further comprise one or more of the following:

- recommending use of another laboratory instrument that is different from the laboratory instrument affected by the problem, and

- recommending use of another component of the laboratory instrument that is different from the component of the laboratory instrument affected by the problem.

For example, when recommending use of the other laboratory instrument that is different from the laboratory instrument affected by the problem, the other laboratory instrument may be of the same type as the laboratory instrument affected by the problem. More specifically, the laboratory instrument affected by the problem may be a pre-analysis laboratory instrument including a centrifuge and the other laboratory instrument may also be a pre-analysis laboratory instrument including a centrifuge. Alternatively, the laboratory instrument affected by the problem may be an analysis instrument, such as a chemistry analyzer, and the other laboratory instrument may also be a chemistry analyzer.

As another example, the other laboratory instrument may be designated as a backup for the laboratory instrument affected by the problem.

When recommending use of the other component of the laboratory instrument that is different from the component of the laboratory instrument affected by the problem, the other component may be of the same type as the component affected by the problem. For example, the component of the laboratory instrument affected by the problem may be a centrifuge and the different component of the laboratory instrument may also be a centrifuge.

Recommending use of the other laboratory instrument may comprise displaying an option to reroute a container including the biological sample (i.e., cause the container including the biological sample to be sent or transported) to the other laboratory instrument. Recommending use of the other component of the laboratory instrument may comprise displaying an option to reroute the container including the biological sample (i.e., cause the container including the biological sample to be sent or transported) to the other component of the laboratory instrument.

The problem may include a hindrance to (e.g., blocking or delaying of) transportation of the container including the biological sample involved in a respective processing step. The transportation of the container to the laboratory instrument and/or within the laboratory instrument may be hindered (e.g., blocked or delayed).

In addition or alternatively, the problem may include an overloading or an impairment of the laboratory instrument. The impairment of the laboratory instrument may occur when at least one module of the laboratory instrument is not functioning, at least one check carried out on the laboratory instrument indicates an error or the laboratory instrument can no longer supply a reagent.

The module may be a centrifuge or an aliquot unit. In addition or alternatively, the at least one check may be a quality control check. Accordingly, when the at least one service indicates the error, the indication may specify that a result of the laboratory instrument is not reliable. More specifically, when the quality control check fails, one or more processing steps may need to be carried out again, thereby affecting the expected completion time.

The method may further comprise recommending a user to initiate a rerouting of a container comprising the biological sample within the laboratory instrument, and in response to a request of the user to reroute the container, rerouting the container within the laboratory instrument.

The method may further comprise rerouting a container comprising the biological sample within the laboratory instrument. In particular, the recommendation for the user to initiate a rerouting of the container is a prompt for the user to interact with the laboratory in view of a state (e.g., impairment) of the laboratory instrument.

In particular, rerouting the container within the laboratory instrument may comprise generating a route plan for the container and instructing the laboratory instrument to route the container according to the route plan.

Indeed, the route plan for the container may identify one or more components of the laboratory instrument that are expected to carry out the processing steps of the clinical test and, if present, the processing steps of further clinical tests to be performed on the biological sample in the container. The route plan may further indicate a path through the plurality of components that the sample should follow. In other words, the route plan may specify an order according to which the sample should be handled by the different components of the laboratory instrument, e.g. a temporal sequence of processing steps and the components that shall carry out said 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 laboratory instrument should carry out. Generating a route plan may comprise associating one or more processing steps with a component of the laboratory instrument that is configured to carry out the one or more processing steps. The route plan may include processing steps involving transportation of the container, such as from an input module to a component of the laboratory instrument or from a component of the laboratory instrument to an output module. In particular, if the laboratory instrument is an automated laboratory system, generating the route plan comprises accessing layout data representing the spatial arrangement of the components of the automated laboratory instrument in order to determine processing steps involving transportation of the sample. Accordingly, the route plan may be generated also based on layout data.

For example, the laboratory instrument may be the automation component for moving containers from one pre-analysis, analysis or post-analysis laboratory instrument component to another pre-analysis, analysis or post-analysis laboratory instrument component. Accordingly, rerouting the container within the laboratory instrument may involve transporting the container from one centrifuge of the laboratory instrument to another centrifuge of the same laboratory instrument or to another centrifuge of a different laboratory instrument. Alternatively, rerouting the container within the laboratory instrument may involve transporting the container from one laboratory instrument in a depleted state (i.e., supply of a reagent has been depleted) to another laboratory instrument in an as expected state.

The example above may be applicable to rerouting of the container initiated by the user or rerouting the container that has not been initiated by the user. In addition or alternatively, one or more corrective actions may be taken, such as calibrating the laboratory instrument or resupplying the reagent.

The clinical test may be one of a plurality of clinical tests to be carried out on the biological sample. Accordingly, The method may further comprise determining an expected sample completion time for the plurality of clinical tests to be carried out on the biological sample. The expected sample completion time may be calculated as follows:

T_s= max {E_t} for all t of s where T, is the expected sample completion time for all clinical tests t of sample s and E_t is the expected completion time for clinical test t having p processing steps that have not been completed and q processing steps that have been completed. Hence, T_s may be determined from the longest (i.e., maximum) expected completion time of all clinical tests t of sample s.

The method may further comprise receiving input at a graphical control element after displaying the warning. In response to the input, displaying one or more of the following:

- the expected completion time for the clinical test,

- the actual duration of at least one processing step of the plurality of processing steps that has been completed, and - an indication of a location of a container including the biological sample within a laboratory including the laboratory instrument or within the laboratory instrument. The method may further comprise carrying out one or more of the following t 5 steps:

- displaying an indication for a user to remove the container from a component of the laboratory instrument and to manually reload the container to another component of the laboratory instrument,

- receiving an indication to stop routing further containers to the laboratory instrument, and

-receiving an indication to reroute the container to another laboratory instrument.

In particular, the display in response to the input described above is a prompt for the user to interact with the laboratory in view of a state (e.g., impairment) of the laboratory instrument. The subsequent steps carried out may be ways of resolving a problem with the laboratory in response to the prompt.

The indication of the location of the container including the biological sample may specify the laboratory instrument or a component of the laboratory instrument. For example, if the container is located in a chemistry analyzer or a chemistry analyzer having a specified identification number, the indication of the location of the container may specify the chemistry analyzer and/or the specified identification number of the chemistry analyzer.

When displaying the indication for the user to remove the container from the component of the laboratory instrument and to manually reload the container to the other component of the laboratory instrument, the container may be removed from an automated loading component of the laboratory instrument and reload the container to a manual loading component of the laboratory instrument.

The indication to stop routing further containers to the laboratory instrument may be received based on user input or based on a determination made by a computer. The indication to reroute the container to another laboratory instrument may be received based on user input or based on a determination made by the computer.

Exemplarily, in response to the input, the method may further comprise displaying:

- for each processing step of the plurality of processing steps that has been completed, the actual duration of said each processing step; and - for each processing step of the plurality of processing steps that has not been completed, the actual duration of said each processing step.

According to a second aspect, a computer program is provided. The computer program comprises instructions that, when the program is executed by a computer, cause the computer to carry out the method of the first aspect of the present invention. The computer program may be included in a computer program product.

According to a third aspect, a computer readable storage medium is provided. The computer readable storage medium may store the computer program according to the second aspect of the present invention. More specifically, the computer program may be tangibly embodied in the computer readable storage medium. The computer readable storage medium may be non-transitory.

According to a further aspect, a computer system for providing a state of a clinical test carried out on a biological sample via a laboratory instrument is provided, the clinical test comprises a plurality of processing steps, the system comprises a graphical user interface and at least one processor. The at least one processor is configured to determine, after starting the test, an expected completion time for the clinical test based on one or more expected durations and one or more actual durations, wherein each processing step of the plurality of processing steps that has not been completed has a respective expected duration of the one or more expected durations and each processing step of the plurality of processing steps that has been completed has a respective actual duration of the one or more actual durations. The at least one processor is further configured to display, on the graphical user interface, a warning when at least one warning condition of the one or more warning conditions is met, wherein the one or more warning conditions comprise at least one warning condition on the expected completion time.

The computer system may be configured to carry out any of the method steps of the method according to the first aspect of the present invention. In other words, the computer system may be configured to carry out subject matter of the method according to the first aspect.

The subject matter described in this disclosure can be implemented as a method or on a device, possibly in the form of one or more computer programs (e.g., computer program products). Such computer programs may cause a data processing apparatus to perform one or more operations described in the present disclosure.

The subject matter described in the present disclosure can be implemented in a data signal or on a machine readable medium, where the medium is embodied in one or more information carriers, such as a CD-ROM, a DVD-ROM, a semiconductor memory, or a hard disk. In particular, disclosed subject matter may be tangibly embodied in a non-transitory machine (computer) readable medium.

In addition, the subject matter described in the present disclosure can be implemented as a system including a processor, and a memory coupled to the processor. The memory may encode one or more programs to cause the processor to perform one or more of the methods described in the application. Further subject matter described in the present disclosure can be implemented using various machines.

Details of one or more implementations are set forth in the exemplary drawings and description that follow. Other features will be apparent from the description, the drawings, and from the concept.

Brief Description of the Figures

Figure 1 shows a schematic representation of a computer and a schematic representation of an automated laboratory system that may be used in some embodiments.

Figure 2 shows steps of a method for providing a state of a clinical test carried out on a biological sample via the laboratory instrument that may be performed in some embodiments.

Figure 3 shows steps of the method for providing the state of the clinical test that may be performed in some embodiments.

Figure 4 shows further steps of the method for providing the state of the clinical test that may be performed in some embodiments.

Figure 5 shows additional steps of the method for providing the state of the clinical test that may be performed in some embodiments.

Figures 6a and 6b show screenshots from a graphical user interface that may be used to provide the state of the clinical test. Detailed Description

In the following text, a detailed description of examples will be given with reference to the drawings. Various modifications to the examples may be made. In particular, one or more elements of one example may be combined and used in other examples to form new examples.

Figure 1 shows a computer 100 and an automated laboratory system (ALS) 200 that may be used in some embodiments. The computer 100 and the automated laboratory system 200 may be part of a laboratory. The ALS 200 may be a laboratory environment. The computer 100 may include an input/output (I/O) interface 111 , a processor 112, a memory 113, and a network interface controller 114. One or more peripheral (input or output) devices may be connectable to the input/output interface 111. The peripheral input devices may include one or more of the following: a computer keyboard and/or a pointing device, such as a mouse. The peripheral output devices may include one or more of the following: a terminal, a printer, a disk drive or other storage device, and a video monitor. The processor 112 may include a central processing unit (CPU) and/or a graphics processing unit (GPU), each having one or more processing cores. The memory 113 may include primary memory, such as random access memory (RAM), read-only memory (ROM) or flash memory, and/or secondary memory, such as a solid-state drive or a hard disk drive.

The network interface controller 114 may be connectable to a computer network 12. The ALS 200 may also be connectable to the computer network 12. In some cases, the computer 100 may be included in (i.e., may be part of) the ALS 200. The ALS 200 may also be referred to as a laboratory instrument or an automated laboratory instrument. The ALS 200 may include immunoassay laboratory instruments 210a, 210b as well as 220a and 220b. For instance, the immunoassay laboratory instruments 210a and 210b are immunoassay instruments of a first type and the immunoassay laboratory instruments 210a and 210b are immunoassay instruments of a second type. Exemplarily, the immunoassay laboratory instruments 210a and 210b may have a smaller footprint and have a lower throughput volume capability than the immunoassay laboratory instruments 220a and 220b.

The automated laboratory system 200 may include chemistry analyzer laboratory instruments 230a, 230b of a first type as well as chemistry analyzer laboratory instruments 240a, 240b and 240c of a second type. The automated laboratory system 200 may also include one or more post-analytics laboratory instruments 250, an automation component 260, and one or more pre-analytics laboratory instruments 270. The pre-analytics laboratory instrument 270 may comprise a loading area (not shown) for loading and identifying sample containers in the ALS 200, a centrifuge (not shown) for centrifuging sample containers and/or a decapper (not shown) for decapping sample containers.

Specifically, the automation component 260 includes a track, a belt and/or a tube carrier configured to move biological samples within the ALS 200. The automation component 260 is capable of transporting a container including a biological sample from one of the components 270, 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250 of the ALS 200 to another component 270, 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250 of the ALS 200. For instance, the automation component 260 is capable of transporting the container including the biological sample from the pre-analytics laboratory instruments 270 to one of the immunoassay laboratory instruments 210a, 210b, 220a, 220b. Accordingly, a processing step may be carried out via the pre-analytics laboratory instruments 270. For instance, said processing step may be the step of centrifuging the container including the biological sample. Another processing step may be carried out by automation component 260 and may be the step of transporting the container from the pre-analytics laboratory instruments 270 to the immunoassay laboratory instruments 210a, 210b, 220a, 220b. Moreover, yet another processing step may be carried out by one of the immunoassay laboratory instruments 210a, 210b, 220a, 220b and may be the step of identifying and detecting the concentration of one or more substances in the biological sample.

In addition or alternatively, a processing step may be carried out by the automation component 260 and may be the processing step of transporting the container to one of the chemistry analyzer laboratory instruments 230a, 230b, 240a, 240b. Accordingly, a further processing step may be carried out via the one of the chemistry analyzer laboratory instruments 230a, 230b, 240a, 240b and may be the processing step of providing an estimate of blood cell count. In addition or alternatively, a processing step may be carried out by the automation component 260 and may be the step of transporting the container to one of the post-analytics laboratory instruments 250. Accordingly, a further processing step may be carried out via the one of the post-analytics laboratory instruments 250.

Figure 2 shows flowchart comprising a plurality of steps 300. One or more of the steps 300 may be part of (i.e., comprised in) a method for providing a state of a clinical test carried out on a biological sample via the automated laboratory system 200. The clinical test comprises a plurality of processing steps. The steps 300 may be carried out after starting the clinical test.

The plurality of processing steps may include the following:

1 . Identifying the container in the ALS 200 via the pre-analysis component 270,

2. Transporting the container to a centrifuge and centrifuging the container,

3. Transporting the container to a decapper and decapping the container,

4. Transporting the container via the automation component 260 from the preanalysis component 270 to a chemistry analyzer for testing by the chemistry analyzer (e.g., the chemistry analyzer 230a shown in figure 1 ),

5. Uploading the result of the test in the Laboratory Information System (not shown).

The processing steps above are automated.

In some examples, further processing steps that may be carried out include sorting the container to a rack position of the laboratory system 200. The loading steps for the potassium test may then include loading a rack of containers on the analyzer.

Step 310 of the method may comprise, for each processing step that has not been completed, obtaining a respective expected duration. The expected durations may be obtained as an input provided by a user and/or can be read from a configuration file. Alternatively, each expected duration is determined based on historical duration data about the corresponding processing step. For example, historical duration data about the pre-analysis step (e.g., centrifuging) may indicate that the pre-analysis step takes from 9 to 15 minutes, with a mean of 12 minutes and a standard deviation of about 2. If this is the case, for example, the least one expected duration of the processing step of the plurality of processing steps that has not been completed may be determined to be 12 + 2 = 14 minutes.

For example, with reference to the processing steps 1 to 5 of the potassium test (hereafter also referred to as: “exemplary potassium test") and assuming that steps 1 to 3 have been completed while processing steps 4 and 5 are not completed, the expected durations obtained in step 310 may be the following:

Expected duration of processing step 4: ED4 = 20 minutes

- Expected duration of processing step 5: EDs = 2 minutes 30 seconds

Step 320 of the method may comprise, for each processing step that has been completed, obtaining a respective actual duration. The respective actual duration may only be applicable for processing steps that have been carried out to completion and may specify the amount of time that has been required to complete a processing step. For instance, the actual duration of a completed processing step may be stored in the memory 113 of the computer 100 when the processing step has been completed. Hence, in some examples, at step 320 the actual durations of the completed steps are obtained by retrieving them from the memory 113.

For example, with reference to the exemplary potassium test, the actual durations obtained in step 320 may be the following:

- Actual duration of processing step 1 : AD1 = 4 minutes

- Actual duration of processing step 2: AD2 = 4 minutes 50 seconds

- Actual duration of processing step 3: AD3 = 8 seconds

Step 330 of the method may comprise determining an expected completion time for the clinical test. The expected completion time may be determined based on the expected durations obtained at step 310 and the actual durations obtained at step 320. In particular, determining the expected completion time may comprise calculating the sum of the one or more expected durations and the sum of the one or more actual durations. For example, the expected completion time of the test may be the sum of the expected durations and the actual durations.

For example, with reference to the exemplary potassium test, the expected completion time of the test, EK, is given by:

EK = AD1 + AD2 + AD3 + ED4 + EDs = 31 minutes 28 seconds

The expected completion time may be displayed via a graphical user interface to provide a user with an indication of the state of the clinical test.

Step 340 of the method may comprise determining whether one or more warning conditions are met. For example, step 340 may be implemented by determining whether at least one warning condition on the expected completion time is met.

For example, the at least one warning condition on the expected completion time may consist of the condition that the expected completion time exceeds a warning threshold. In some examples, the warning threshold may be a sum of expected completion durations of all the processing steps of the plurality of processing steps in addition to a first specified factor. If this is the case, step 310 of the method may comprise, for each processing step that has been completed, obtaining a respective expected duration of said each processing step. Said respective expected durations may be obtained as an input provided by a user and/or can be read from a configuration file. Alternatively, each of said expected durations is determined based on historical duration data about the corresponding processing step. For example, with reference to the exemplary potassium test described above, the expected durations of the completed steps may be the following:

- Expected duration of processing step 1 : EDi = 3 minutes

- Expected duration of processing step 2: ED2 = 5 minutes

- Expected duration of processing step 3: ED3 = 8 seconds

Exemplarily, the warning threshold, WK, for the potassium test may be the following:

WK = ED1 + ED2 + AD3 + ED4 + EDs + 0 = 30 minutes 38 seconds + 0 wherein, for instance, 0 may be equal to 30 seconds or 1 minute.

When at least one of the one or more warning conditions is met, the method may comprise displaying a warning at step 360, e.g., via the graphical user interface. Alternatively, when none of the warning conditions is met, the method may return to step 310. For example, if the warning condition on the expected completion time is the condition that the expected completion time exceeds the warning threshold the warning is displayed if EK > WK.

With reference to the exemplary potassium test and if 0 - 30 seconds, the warning is displayed, as EK = 31 minutes 28 seconds and WK = 31 minutes 08 seconds. With reference to the exemplary potassium test and if 0 = 1 minute, the warning is not displayed, as EK = 31 minutes 28 seconds and WK = 31 minutes 38 seconds. In particular, the method may include periodically determining (or redetermining) the expected completion time for the clinical test according to steps 310 to 330 and determining (or redetermining) whether the one or more warning conditions are met according to step 340. In other words, the expected completion time for the clinical test may be determined after completion of a first one of the plurality of processing steps and redetermined after completion of a second one of the plurality of processing steps.

Redetermining the expected completion time may be carried out at follows. After carrying out processing step 4, step 310 may be carried out again. The actual duration of processing step 4 may be determined to be 22 minutes and 30 seconds, i.e., AD4 = 22 minutes and 30 seconds. Accordingly, the expected completion time for the clinical test may be redetermined as follows:

EK = ADi + AD2 + AD3 + AD4 + EDs = 33 minutes and 58 seconds

Hence, the expected duration ED4 of processing step 4 has been replaced by the actual duration of processing step 4 after completing processing step 4. Accordingly, the expected completion time for the clinical test has been updated to reflect the additional time required to complete processing step 4. Moreover, processing step 5 remains to be completed and therefore still has an expected duration rather than an actual duration.

In addition to displaying the warning at step 360, at least one further action may be taken when the one or more warning conditions are met. For example, the state of the clinical test may indicate a problem in a component (e.g., centrifuge, aliquoter, and the like) of the ALS 200 and/or in a check (e.g. a quality control check) of at least a component of the ALS 200, and/or a problem with the container or the laboratory. Accordingly, the method may further comprise recommending use of another laboratory instrument that is different from the laboratory instrument affected by the problem. In addition or alternatively, the method may further comprise recommending use of another component of the ALS 200 that is different from the component affected by the problem. For example, a graphical control element such as a window may be displayed in the graphical user interface and may contain a message recommending use of the other laboratory instrument. The message may specify an identifier and/or a location of the other laboratory instrument.

The problem of the laboratory instrument may be one of the following:

- an overload, lack of capacity or busy track of the laboratory instrument

- the laboratory instrument may be depleted of reagent,

- there may be planned maintenance or calibration of the laboratory instrument

- the container may arrive late (e.g., transportation may have been delayed)

- laboratory personnel may be overloaded or undertrained

- a quality control issue may arise, e.g., a volume of the biological sample in the container is too low to properly perform the clinical test.

The durations described above may be specified in seconds, minutes or seconds and minutes.

In some cases, a result of the clinical test may be reported within four hours of extracting the biological sample, in other cases, the result may be reported within one day.

Figure 3 shows a flowchart comprising a plurality of steps 400. One or more of the steps 400 of the flowchart may be part of the method for providing the state of the clinical test carried out on the biological sample via the automated laboratory system 200. Unless otherwise indicated, the steps 400 and corresponding details applicable to figure 2 are also applicable in the context of figure 3.

Step 405 of the method may comprise receiving an indication, - e.g., an instruction, (hereinafter also referred to as: “determination indication”) to determine the expected completion time for the clinical test. The determination indication may be provided via user input, the expiration of a specified time interval, or upon completion of a processing step. For example, the expiration of the specified time interval or the completion of the processing step may cause an instruction to determine the expected completion time to be provided.

For each processing step that, at the time at which the determination indication is received, has not been completed, step 410 of the method may comprise obtaining the respective expected duration. For each processing step that, at the time at which the determination indication is received, has been completed, step 415 of the method may comprise obtaining the respective actual duration. Step 420 of the method may comprise determining the expected completion time for the clinical test at the time at which the determination indication is received. Said expected completion time is determined based on the expected durations obtained at step 410 and the actual durations obtained at step 415. Step 425 of the method may comprise determining whether the one or more warning conditions are met. When at least one of the one or more warning conditions is met at step 430, step 435 of the method may comprise displaying a warning, for example, via the graphical user interface. Alternatively, at step 430, when none of the warning conditions is met, the method may return to step 405, e.g., after expiry of the specified time interval. In particular, as discussed in connection with figure 2, the method may include periodically determining, in response to receiving of a determination indication (step 405) the expected completion time for the clinical test according to steps 410 to 420 and determining whether the one or more warning conditions are met according to step 425.

Figure 4 shows a flowchart comprising a plurality of steps 500. One or more of said steps 500 may be part of the method for providing the state of the clinical test carried out on the biological sample via the ALS 200. Similar to figures 2 and 3, each processing step of the plurality of processing steps comprised in the clinical test may have a respective expected duration. Step 505 of the method may comprise, for each processing step, obtaining the respective expected duration. Hence, in this case, step 505 comprises obtaining the respective expected durations of all processing steps of the plurality of processing steps of the clinical test. Hence, for example, if the clinical test is a potassium test, step 505 of the method comprises obtaining, for each of the processing steps 1 to 5 described above, the respective expected duration. The expected durations of all processing steps may be obtained as discussed above for steps 310 and 410 (cf. figure 2 and figure 3, respectively). For instance, step 505 may be carried out before starting the clinical test.

Step 510 of the method may comprise determining the expected completion time using the expected durations. Step 515 of the method may comprise displaying the expected completion time. Steps 510 and 515 may be optional, as indicated via the dashed lines of their respective boxes. More specifically, steps 510 and 515 might only be carried out under one or more conditions, for example, when a configuration flag is set.

Step 405 of the method may comprise receiving an indication (hereinafter also referred to as: “determination indication”) to determine the expected completion time. For each processing step that, at the time at which the determination indication is received, has been completed, step 415 of the method may comprise obtaining the respective actual duration. Step 420 of the method may comprise determining the expected completion time for the clinical test at the time at which the determination indication is received. Step 425 of the method may comprise determining whether the one or more warning conditions are met. When the warning conditions are met at step 430, the method may further comprise displaying a warning at step 435. When the warning conditions are not met at step 430, the method may return to step 405, e.g., after expiry of the specified time interval.

Figure 5 shows a flowchart comprising a plurality of steps 600. One or more of said steps 600 may be part of the method for providing the state of the clinical test carried out on the biological sample via the automated laboratory system 200. Unless otherwise indicated, the considerations discussed in connection with figures 1 to 4 also apply in the context of figure 5. The steps 600 of the flowchart may be carried out when the clinical test is one of a plurality of clinical tests to be carried out on the biological sample. Accordingly, the quantity of clinical tests in the plurality of clinical tests may be N (i.e., there are N clinical tests to be carried out on the biological sample) and each clinical test in the plurality of clinical tests may be designated clinical test t.

Step 605 of the method may comprise receiving an indication (hereinafter also referred to as: “determination indication”) to determine the expected completion time of the clinical test.

Step 610 of the method may comprise setting a counter t to 0. Step 615 of the method may comprise incrementing the counter t. Step 620 of the method may comprise, for each processing step of the clinical test t that has not been completed, obtaining the respective expected duration. Step 620 of the method may correspond to step 410 as shown in figures 3 and 4. Step 625 of the method may comprise, for each processing step of the clinical test t that, at the time at which the determination indication is received, has been completed, obtaining the respective actual duration. Step 625 of the method may correspond to step 415 as shown in figures 3 and 4.

Step 630 of the method may comprise determining an expected completion time for the clinical test t at the time at which the determination indication is received. Step 630 of the method may correspond to step 420, as shown in figures 3 and 4. Step 635 of the method may comprise determining whether the one or more warning conditions for the clinical test t are met. When the one or more warning conditions are met at step 640 of the method, step 645 of the method may comprise displaying a warning for the clinical test t. When the one or more warning conditions are not met at step 640, step 650 of the method may comprise determining whether t = N . If t + N, then the method may continue at step 615. If t = N, then the method may return to 605, e.g., after expiry of the specified time limit.

Figure 6a and figure 6b show screenshots of displays from the graphical user interface. Figure 6a may be accessed by drilling down from another screen (e.g., interacting via the pointing device with a graphical control element of the other screen) of the graphical user interface. The display of figure 6b may be accessed by drilling down from the display of figure 6a. For example, an additional filter may be added to the display of figure 6a in order to arrive at the display of figure 6b. Alternatively, the user may interact with (e.g., use the pointing device to double click on) a clinical test in the leftmost column of figure 6a in order to call up the display of figure 6b.

The first column of figure 6a shows identifiers for a plurality of biological samples; one biological sample of the plurality of biological samples may be the biological sample described above. Upon receipt of input from the user, for example a click on an arrow via a pointing device, clinical tests corresponding to a respective biological sample of the plurality of biological samples may be displayed. For example, a clinical test for potassium (K), a clinical test for a low volume chemistry analyzer (AU) and a clinical test for a high volume chemistry analyzer (DxC) are shown in a first (leftmost) column of the display for the biological sample having identifier 1234562. A projected turnaround time (TAT) for each sample and each clinical test may be shown in a second column of the display. The projected turnaround time for a respective clinical test may correspond to the expected completion time for the clinical test. A third column of the display may show when the container containing the respective biological sample was received at the laboratory. Further columns of the display may show actual durations of processing steps that have been completed via respective laboratory instruments, where the laboratory instruments are identified in a header of the column. For example, a fifth column of the display may show actual durations of processing steps that have been completed via an immunoassay laboratory instrument ("Access 1"). In cases where an actual duration of one of the processing steps meets or exceeds a first alert threshold, an indication (e.g., a circular symbol) may be displayed to the left of the actual duration. The first alert threshold may be an alert time of the processing step that has been completed. The alert time may be greater than a respective expected duration of the processing step that has been completed.

Figure 6b shows a display for one of the clinical tests displayed in figure 6a. Specifically, figure 6b shows the display for a potassium (K) clinical test. Similar to figure 6a, the two leftmost columns of figure 6b show sample identifiers and projected turnaround times (TAT). However, in contrast to figure 6a, a third column of figure 6a shows a sample location. The sample location may indicate a laboratory instrument or a module of a laboratory instrument. Further columns shown in figure 6b have headers identifying processing steps or modules of laboratory instruments (e.g., input, centrifuge, decapper) that carry out corresponding processing steps. For instance, in the case of the potassium test: o “Input” indicates the pre-analysis component 270 that carries out processing step 1 mentioned above, i.e, the processing step of identifying the container in the ALS 200, o “Centrifuge” indicates the one or more components of ALS 200 that carry out processing step 2 mentioned above, o “Decapper” indicates the components of ALS 200 that carry out processing step 3 mentioned above, o “AU” indicates the components of ALS 200 that carry out processing step 4 mentioned above, and o “Result uploads” indicates processing step 5 mentioned above, i.e. the processing step of uploading the result of the test in the Laboratory Information System

Each of said further columns shown in figure 6b is hence associated with a respective processing step. Each entry of said further columns shown in figure 6b is associated with a respective biological sample (identified in the leftmost column) and indicates the actual duration of the respective completed processing step of the test carried out on the respective biological sample. If the respective processing step has started but has not been completed said each entry may display a window showing an ongoing duration (e.g., "Ongoing 1 m 23s").

Claims

Claims

1. A computer-implemented method for providing a state of a clinical test carried out on a biological sample via a laboratory instrument, wherein the clinical test comprises a plurality of processing steps, wherein the method comprises: determining, after starting the clinical test, an expected completion time for the clinical test based on one or more expected durations and one or more actual durations, wherein each processing step of the plurality of processing steps that has not been completed has a respective expected duration of the one or more expected durations and each processing step of the plurality of processing steps that has been completed has a respective actual duration of the one or more actual durations; and displaying a warning when at least one warning condition of one or more warning conditions is met, wherein the one or more warning conditions comprise at least one warning condition on the expected completion time.

2. The method of concept 1 , wherein the processing steps are carried out in series and/or the processing steps are carried out according to a specified order.

3. The method of any one of the preceding concepts, wherein the state of the clinical test reflects at least one of the following: a state of the laboratory instrument, a state of one or more laboratory instrument modules of the laboratory instrument, a load of the laboratory instrument, maintenance and/or calibration requirements of the laboratory instrument.

4. The method of any one of the preceding concepts, wherein the plurality of processing steps comprises one or more of the following: a processing step of collecting the biological sample in a container, wherein the container may be a tube; a processing step of transporting the container to a laboratory including the laboratory instrument; a processing step of acknowledging receipt of the container; a processing step of determining a tracking number for the biological sample; a processing step of transporting the container to the laboratory instrument for another processing step; a pre-analysis step to be performed via the laboratory instrument; a processing step of loading the container for testing; a processing step of testing the biological sample; a processing step of storing the container.

5. The method of any one of the preceding concepts, wherein at least one processing step of the plurality of processing steps comprises using the laboratory instrument to perform a task.

6. The method of any one of the preceding concepts, wherein the laboratory instrument is one of a laboratory analyzer and an automated laboratory system.

7. The method of any one of the preceding concepts, wherein the expected completion time for the clinical test is based on one or more of the following: a level of impairment of the laboratory instrument, a load or capacity level of the laboratory instrument, a supply of reagent contained by the laboratory instrument, and maintenance requirements of the laboratory instrument.

8. The method of any one of the preceding concepts, wherein at least one of the one or more expected durations is based on one or more of the following: a level of impairment of one or more components of the laboratory instrument, a load or capacity level of the one or more components of the laboratory instrument, a supply of reagent contained by the one or more components of the laboratory instrument, maintenance requirements of the one or more components of the laboratory instrument.

9. The method of any one of the preceding concepts, wherein at least one expected duration of a processing step of the plurality of processing steps that has not been completed is determined based on historical duration data about the processing step of the plurality of processing steps that has not been completed, wherein, optionally, the historical duration data includes statistical data, wherein, optionally, the historical duration data includes one or more of the following: a mean, a median, a mode, a standard deviation, a variance, a percentile rank.

10. The method of concept 9, wherein the expected duration of the processing step of the plurality of processing steps that has not been completed is determined based on the mean and/or the standard deviation.

11 . The method of any one of the preceding concepts, further comprising: before starting the clinical test, displaying at least one expected duration of a processing step of the plurality of processing steps; and prompting a user to accept or revise the expected duration of the processing step of the plurality of processing steps.

12. The method of any one of the preceding concepts, wherein the expected completion time for the clinical test is determined after completion of a first one of the plurality of processing steps, wherein the expected completion time for the clinical test is redetermined after completion of a second one of the plurality of processing steps, the completion of the second one of the plurality of processing steps taking place after the completion of the first one of the plurality of processing steps.

13. The method of any one of the preceding concepts, further comprising: determining, before starting the clinical test, a plurality of expected durations, wherein each processing step of the plurality of processing steps has a respective expected duration of the plurality of expected durations, determining, before starting the clinical test, the expected completion time for the clinical test using the plurality of expected durations; and displaying the expected completion time for the clinical test.

14. The method of any one of the preceding concepts, wherein determining the expected completion time comprises calculating a sum of the one or more expected durations and a sum of the one or more actual durations.

15. The method according to any one of the preceding concepts, wherein the at least one warning condition on the expected completion time is a condition that the expected completion time meets or exceeds a warning threshold.

16. The method of concept 15, wherein the warning threshold is determined according to one of the following: a sum of expected completion durations of all the processing steps of the plurality of processing steps in addition to a first specified factor; a time limit for completing the clinical test minus a second specified factor, wherein, in particular, the time limit for completing the clinical test is determined based on one or more of the following: a health condition of a patient for whom the clinical test is carried out, one or more characteristics of the clinical test, and a user input.

17. The method of concept 15, wherein the warning threshold is determined according to a sum of a plurality of alert times, wherein each processing step of the plurality of processing steps has a respective alert time of the plurality of alert times, wherein, for each processing step of the plurality of processing steps, the respective alert time is greater than the expected duration of said each processing step.

18. The method of concept 17, wherein the one or more warning conditions comprise a condition that an actual duration of a processing step of the plurality of processing steps that has been completed meets or exceeds a first alert threshold, wherein the first alert threshold is the alert time of the processing step of the plurality of processing steps that has been completed; and/or wherein the one or more warning conditions comprise a condition that a sum of the one or more actual durations meets or exceeds a second alert threshold, wherein the second alert threshold is a sum of alert times of the processing steps of the plurality of processing steps that have been completed; and/or wherein the one or more warning conditions comprise a condition that a sum of the one or more actual durations meets or exceeds a third alert threshold, wherein the third alert threshold is a sum of expected durations for the processing steps of the plurality of processing steps that have been completed in addition to a specified factor.

19. The method of any one of the preceding concept, further comprising: providing a graphical control element to display one or more of the following: an indication of the expected completion time, an indication of at least one expected duration of the one or more expected durations, and an indication of at least one actual duration of the one or more actual durations.

20. The method of any one of the preceding concept, wherein the state of the clinical test indicates a problem in at least one component of the laboratory instrument, wherein the method further comprises one or more of the following: recommending use of another laboratory instrument that is different from the laboratory instrument affected by the problem, and recommending use of another component of the laboratory instrument that is different from the component of the laboratory instrument affected by the problem.

21. The method of concept 20, wherein the problem includes a hinderance to transportation of the container including the biological sample involved in a respective processing step, wherein transportation of the container to the laboratory instrument and/or within the laboratory instrument is hindered.

22. The method of any one of the preceding concept, further comprising: recommending a user to initiate a rerouting of a container comprising the biological sample within the laboratory instrument, and in response to a request of the user to reroute the container, rerouting the container within the laboratory instrument.

23. The method of any one of the preceding concept, further comprising: rerouting a container comprising the biological sample within the laboratory instrument.

24. The method of any one of the preceding concept, wherein the clinical test is one of a plurality of clinical tests to be carried out on the biological sample.

25. The method of any one of the preceding concept, further comprising: receiving input at a graphical control element after displaying the warning; in response to the input, displaying one or more of the following: the expected completion time for the clinical test, actual durations for at least one processing step of the plurality of the processing steps that has been completed, and an indication of a location of a container including the biological sample within a laboratory including the laboratory instrument or within the laboratory instrument; carrying out one or more of the following steps: displaying an indication for a user to remove the container from a component of the laboratory instrument and to manually reload the container to another component of the laboratory instrument; receiving an indication to stop routing further containers to the laboratory instrument; and receiving an indication to reroute the container to another laboratory instrument.

26. A computer program comprising instructions that, when the program is executed by a computer, cause the computer to carry out the method of any one of the preceding concepts.

27. A computer-readable medium storing the computer program of concept 28.

28. A computer system for providing a state of a clinical test carried out on a biological sample via a laboratory instrument, wherein the clinical test comprises a plurality of processing steps, the system comprising: a graphical user interface; at least one processor configured to: determine, after starting the test, an expected completion time for the clinical test based on one or more expected durations and one or more actual durations, wherein each processing step of the plurality of processing steps that has not been completed has a respective expected duration of the one or more expected durations and each processing step of the plurality of processing steps that has been completed has a respective actual duration of the one or more actual durations; and display, on the graphical user interface, a warning when at least one warning condition of one or more warning conditions is met, wherein the one or more warning conditions comprise at least one warning condition on the expected completion time.