Method, computer program product, computing system, and laboratory automation system for labelling secondary sample containers
The method of generating unique indicia for secondary sample containers addresses labeling inconsistencies in laboratory automation systems, enhancing interoperability and efficiency in clinical testing by ensuring accurate data management and compatibility across different laboratories and analyzers.
Patent Information
- Application Number
- PCT/US2025/034572
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-07-03
- Filing Date
- 2025-06-20
- Publication Date
- 2026-01-08
AI Technical Summary
Laboratory automation systems face challenges in handling biological samples due to inconsistencies in labeling and data management when aliquoting samples across different laboratories or analyzers, leading to potential mistakes and inefficiencies in clinical testing.
A method involving a computing system that generates unique indicia, such as barcodes, for secondary sample containers based on laboratory data and templates, ensuring compatibility with various instruments and locations, and maintaining identification integrity across different LIS environments.
Enhances interoperability and efficiency in clinical testing by ensuring accurate labeling and data management of aliquoted samples, regardless of the laboratory or analyzer, reducing errors and improving sample handling processes.
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Figure US2025034572_08012026_PF_FP_ABST
Abstract
Description
METHOD, COMPUTER PROGRAM PRODUCT, COMPUTING SYSTEM, AND LABORATORY AUTOMATION SYSTEM FOR LABELLING SECONDARY SAMPLE CONTAINERS
[0001] The present invention generally relates to the field of handling biological samples, such as body fluid samples (e.g., blood samples) inside containers (such as tubes). Specifically, the present invention relates to a method, computer program product, computing system, and laboratory automation system in relation to handling a biological sample.
[0002] Various types of clinical tests related to patient diagnosis and therapy can be performed by analyzing biological samples of human or animal subjects by using laboratory automation systems (LAS), which may handle pre-analytical, analytical and / or post-analytical stage processing of the samples. Biological samples may for example be urine, blood, e.g., blood plasma and / or blood serum, interstitial liquid, cerebrospinal liquids, and similar. Blood cell analysis is one of the most performed clinical tests for providing an overview of a patient's health status. A blood sample can be drawn from a patient's body and stored in a container, e.g., a test tube, which for instance may contain an anticoagulant to prevent clotting.
[0003] Typically, the containers are manually labelled with one or more barcodes for handling by the LAS. The barcode label(s) may for example contain an accession number, test order, and / or other information, that may be correlated to demographic information that may be used for identification of the therein contained biological sample, the used container, etc. and entered into a hospital's laboratory information system (LIS). For example, an operator may introduce the barcode-labeled containers into the LAS, such as in a rack, and the LAS may automatically transport the containers for pre-analytical stage processing such as centrifugation, decapping, aliquot preparation, and the like. This pre-analytical stage processing may be carried out before the biological sample in the containers is clinically tested, in particular clinically analyzed or assayed by one or more analyzers, which may or may not be part of the LAS.
[0004] There are cases in which different clinical tests need to be carried out for the same biological sample. In some cases, a biological sample included in a sample in container (the so-called primary container) may be aliquoted into one or more secondary containers, each secondary container including a respective portion of the biological sample, the respective portion of the biological sample being, e.g., transferred from the primary container to that secondary container e.g., by an aliquoter of the LAS. Each portion of the same biological sample may be processed differently from and independently to one another, in particular analyzed by different analyzers. In those cases, aliquoting allows for carrying out the clinical tests assigned to the biological sample efficiently. For example, each one of the different analyzers may be capable of conducting a different clinical test, e.g., determining different characteristics, parameters or similar of the biological sample. For this purpose, one or more sub-samples (also referred to as: “aliquots”) are drawn from the biologicalsample contained in the primary container and transferred to the one or more secondary containers. In particular, aliquoting may also be performed to preserve the integrity of the biological sample.
[0005] Primary containers may be received by the LAS from different providers (e.g., hospitals, doctor’s practices, laboratories, and the like), wanting to make use of the LAS for clinical testing of biological samples. Each one of these providers may use a piece of software for managing the data relating to their biological samples, in particular their patient data. Said piece of software is typically not directly communicatively connected to the LAS carrying out the pre-analytical, analytical and / or post-analytical stage processing of the biological samples included in the primary containers. This piece of software is typically referred to as a Laboratory Information Service (LIS). The LIS may manage, for example, information about the patient, the identification information of the label on the first container, and further information such as what clinical test or tests are to be carried out on the biological sample.
[0006] There may be a further software, e.g., a middleware, between the LIS and an operating software of the LAS. The middleware and the LIS may be communicatively connected via a data interface for exchanging data with each other. Further, the middleware and the LAS operating software may also be communicatively connected via a data interface for exchanging data with each other. The middleware may receive test orders for the biological samples, the test orders specifying the clinical tests assigned to the biological samples inside the primary containers. Then, the middleware may transfer this order information to LAS operating software. The operating software of the LAS may then instruct the LAS to carry out one or more of the clinical tests assigned to the biological samples inside the primary container and any secondary containers, in case aliquoting is to be carried out.
[0007] There may be situations in which the LAS, or several LAS of the same laboratory, may not perform all clinical tests on the same biological sample or in which the LAS performing a clinical test is at least not connected to the same middleware. For example, certain analyzers may be unavailable, e.g., because they are defective or busy, not capable of conducting certain clinical tests as requested by the LIS, or similar. Hence, the LAS that is receiving the primary container may need to provide or send out said container or a secondary container to a different analyzer not connected to the LAS, to a different laboratory and / or to a different LAS, in particular not connected to or not using the same middleware (software). This analyzer, laboratory and / or LAS, and its operating software, as well as a potentially different middleware, may not know anything about the aliquoting and the different identification information of the second container or may not be able to read the barcodes generated by the LAS. This may lead to mistakes in the handling of the containers, in the processing of the biological samples, and / or in the transmission and / or recording of the test results.
[0008] The above problems are at least partially solved or alleviated by the subject matter of the independent claims of the present disclosure, wherein further examples are incorporated in the dependent claims.
[0009] According to a first aspect of the present disclosure, there is provided a method comprising:obtaining, by a computing system, aliquoting data, wherein the aliquoting data comprise instructions specifying that a portion of a biological sample included in a first sample container is to be aliquoted into a second sample container; obtaining, by the computing system, laboratory data, wherein the laboratory data comprises information indicative of one or more laboratory instruments which are to process the second sample container and / or one or more laboratory locations at which the second sample container is to be processed; determining, by the computing system, based on at least the laboratory data, indicium data, wherein the indicium data comprise information indicative of an indicium template (herein also referred to as: “second indicium template”) according to which an indicium (herein also referred to as: “second indicium”) is to be generated, wherein the indicium is to label the second sample container and comprises identification information for identifying the second sample container, and causing, by the computing system, the indicium to be generated according to the indicium template.
[0010] Exemplarily, determining the indicium data may comprise determining the indicium template among a plurality of indicium templates (herein also referred to as: “first plurality of indicium templates”).
[0011] Exemplarily, the method of this disclosure may provide an indicium to one or more aliquoted second sample containers. The indicium may in particular be comprised by or be in the form of a label affixed to the second sample container. The indicium is based on an indicium template. In particular the indicium data may indicate the indicium template. The indicium template may be determined based at least on laboratory data such that the laboratory instrument(s) and / or laboratory location(s) for processing the second sample container(s) are considered when determining the indicum data and, hence, the indicium template, and, ultimately and in particular, in the generation of the indicium. Hence, the indicium may be created such that it fits to and / or functions with the laboratory instrument(s) and / or the laboratory location(s). This way in particular the clinical testing of the biological sample may be optimally performed, including sample processing and clinical testing result processing. Generally, the indicium template may be specifying a format and / or a content of the identification information to be included in the indicium.
[0012] An indicium template is in particular a data item that comprises information specifying the way an indicium is to be generated. In particular, an indicium template may specify the type of information included in the indicium and the format of said information. For example, the second indicium template may specify that the indicium shall comprise the identification information for identifying the second sample container and that said information shall be comprised in an alphanumeric string. Moreover, an indicium template may specify the symbology used to create the indicium. If the indicium is a barcode, for example, the symbology may be the way bars and blanks are arranged with respect to one another. Generally, symbology may specify a set of rules, e.g., a “grammar”, according to which the indicium or identification information is written. In particular, the symbology of a barcode is a set of rules that allow to map the information comprised in the barcode with the arrangement of the symbols (e.g., parallel lines or colored pixels) constituting the barcodeand vice versa. For example, the symbology specified by the second indicium template may be code 128, code 93, or code 39.
[0013] In particular, the first sample container may be labelled by an indicium (herein also referred to as: “first indicium”) which comprises identification information (herein also referred to as: “first identification information”) for identifying the first sample container.
[0014] In a first example, the second indicium template may be configured to provide an indicium, in particular a barcode, with a symbiology that is different from the symbiology of an indicium of the first sample container. Exemplarily, different symbology between the indicium of the first sample container and the second sample container may be used in presence of offline laboratory instruments, e.g., analyzers that are not mechanically connected and / or not comprised in the LAS and that are not configured to read the symbology of the indicium of the first sample container. For example, the use of a different symbology for the indicium to label the second sample container is convenient when the second sample container shall be sent to another laboratory location and / or instrument that cannot read the symbology of the indicium of the first sample container. This is the case, for instance, when the biological sample must undergo some special clinical tests that cannot carried out on the LAS and shall be sent to dedicated laboratories. The functionality may improve interoperability between different laboratories.
[0015] Additionally, or alternatively, the indicium template may be configured to provide an indicium, in particular a barcode, such that the identification information comprised therein is different from the identification information comprised in the indicium labelling the first container. In particular, the second identification information may comprise information that is not comprised in the first identification information. Alternatively, or in addition, the second identification information may differ from the first identification information in that the former information does not comprise information included in the latter information. Exemplarily, the second identification information may be completely different from the first identification information. In particular, the indicium template may be used for creating a second indicium such that the second identification information differs from the first identification information in the presence of a suffix and / or a prefix and is otherwise identical to the first identification information. Such second indicium may be conveniently used to process the second sample container in an LIS / middleware environment that supports the possibility to aliquot the first sample container. In such environments, it may be convenient to link the second sample containers to the first sample containers and, at the same time, be able to distinguish among several second sample containers and the first sample container, e.g., to know which test is carried out on which sample container.
[0016] In particular, the second identification information may uniquely identify the second sample container. Alternatively, the second identification information may not uniquely identify the second sample container but may be the same as the first identification information.
[0017] Additionally, or alternatively, the indicium template may be configured to generate the second indicium such that the second indicium is identical to the first indicium. This way, the LIS may always correlate the results of the clinical tests carried out on the biological sample to the biological sample, independent of which LAS, analyzer or laboratory carries out the clinical test andwhich piece of software, e.g., middleware, provides the clinical test result. In particular, in this case, the LAS may aliquot the biological sample in the first sample container even if the LIS and / or the middleware do not support aliquotation, i.e., do not have the possibility to handle multiple sample containers containing portions of the same biological samples. This allows for further improving the efficiency of clinical testing, without the need for the LIS and / or the middleware to support the handling of secondary tubes.
[0018] For example, the first indicium and the second indicium may comprise the same identification information. In this case, for instance, the first identification information is acquired e.g., by reading the first indicium, copied, and included in the second indicium, thereby providing the second indicium with the same identification information of the first indicium, as, e.g., the second identification information is a copy of, and hence, identical to, the first identification information. For this purpose, for example, a camera unit of the LAS may take an image and / or a scanner unit of the LAS may scan the first indicium, and the LAS, in particular a computing system thereof, may access the first identification information comprised in the first indicium and provide it to a printer unit of the LAS for printing the second indicium, according to the indicium template, such that the second indicium comprises the identification information obtained from the first indicium. In particular, in some cases, the first indicium and the second indicium may be identical (e.g., equal) to one another. However, the first indicium and the second indicum are two distinct indicia, the former indicium being affixed to the first sample container and the second indicium being for the second sample container.
[0019] The method according to the first aspect of the present disclosure may be partially or fully computer-implemented, which means that one, several or all of the steps of the method may be executed by a computing system. The computing system may comprise one or more computing units or computers, which may be spatially distributed. Hence, different steps of the method may be carried out by the same or different computing unit or computer. In particular, the computing system may be comprised in the LAS.
[0020] Additionally, the method may comprise steps executed by different hardware than a computing system, e.g., a handling system for handling the sample containers, an aspiration system for aspirating a sample volume from the biological sample inside the first container, a dispensing system for dispensing at least part of the aspirated sample volume into the second sample container, and / or a labeling unit for labeling the second sample container with the indicium. For example, the labeling unit may comprise a printer unit for printing the indicium on a label and / or an affixing unit for affixing the label comprising the indicium to the second sample container.
[0021] For example, the method may be for handling a biological sample by a laboratory automation system, LAS. The method may, for example, further comprise one or more of the following steps: providing the first sample container, the first sample container being labeled with an indicium comprising identification information for identifying the first sample container; aspirating a sample volume from the biological sample inside the first sample container; dispensing at least part of the aspirated sample volume into the second sample container; labeling the second sample container with the indicium generated according to the indicium template.
[0022] The steps of aspirating the sample volume and dispensing at least part thereof into the second sample container may also be referred to herein as aliquoting. Also, it may be possible to repeat any one or both of the steps of the aliquoting for any number (e.g., two, three, four, or more than four) of further second sample containers. Hence, any reference to a single second sample container made herein includes the possibility that there may be several second sample containers and that the thereto related features, e.g., steps, may be repeated for each one of these second containers. For example, the step of causing the indicium to be generated according to the indicium template and / or the step of labeling the second sample container may be repeated for all of these further second sample containers.
[0023] In particular, in an example, the aliquoting data may comprise instructions specifying that a portion of a biological sample included in a first sample container is to be aliquoted into a plurality of second sample containers, wherein, in particular, the second sample container comprises the second sample container described above. Moreover, the laboratory data may comprise, for each second container of the plurality of second sample containers, information indicative of one or more respective laboratory instruments which are to process said each second sample container and / or one or more respective laboratory locations at which said each second sample container is to be processed. Exemplarily, indicium data may comprise, for each second container of the plurality of second sample containers, information indicative of a respective indicium template according to which a respective indicium is to be generated, wherein the respective indicium is to label said each second sample container and comprises respective identification information for identifying said each second sample container. In particular, the method according of the present disclosure may comprise, for each second container of the plurality of second sample containers, causing, by the computing system, the respective indicium to be generated according to the respective indicium template.
[0024] In particular, the method according to the present disclosure may comprise accessing the first identification information comprised in the first indicium. Moreover, the method of the present disclosure may comprise causing, by the computing system, the first indicium to be accessed, e.g., read, by the LAS, e.g., by a barcode reader of the LAS.
[0025] For instance, the first identification information may comprise the aliquoting data. In particular, obtaining the aliquoting data may be carried out by using the identification information comprised in the first indicium e.g., by querying the LIS by using said identification information to obtain the aliquoting data. Exemplarily, obtaining the laboratory data may be carried out by using the first identification information comprised in the first indicium e.g., by querying the LIS by using said identification information to obtain the laboratory data.
[0026] According to the present disclosure, obtaining data (e.g., obtaining aliquoting data, obtaining laboratory data) may comprise accessing the data. Alternatively, obtaining data may comprise generating the data, e.g. creating the data based on one or more inputs. In yet another example, obtaining data may comprise accessing a first portion of the data and generating a second portion of the data e.g. from the first portion of the data. According to the present disclosure, accessing data may comprise receiving the data, e.g. from a user or a computing system different from the computingsystem accessing the data. The two options are not mutually exclusive. For instance, accessing, data may comprise receiving the data, storing the data in the memory of the computer device accessing the data and retrieving the data by accessing said memory.
[0027] The method of the present disclosure may, for example, comprise taking an image of the first indicium, in particular by a camera unit of the LAS. Alternatively, or additionally, the method may, for example, comprise scanning the first indicium. In particular, when the first indicium is a barcode, scanning the first indicium may be carried out by a scanner unit, e.g., by a laser scanner unit. In particular, accessing the identification information comprised in the first indicium may, for example, comprise, reading, e.g., based on the image of the first indicium or the scan of the first indicium, the identification information included in the first indicium. In particular, reading said identification information may comprise receiving, by the computing system, the image of the first indicium and / or the scan of the first indicium, e.g., from the LAS. For instance, accessing the identification information comprised in the first indicium comprises analyzing the indicium depicted on the image taken by the camera unit or based on the scan of the indicium by the scanner unit.
[0028] Alternatively, or additionally, the aliquoting data and / or the laboratory data may be obtained from a piece of software and / or from information provided by a piece of software. In particular, the piece of software may be the middleware or the operating software of the LAS. For example, the piece of software may obtain the aliquoting data and / or the laboratory data from the LIS and transmitted to the piece of software.
[0029] Herein, providing data, a template and / or information e.g., to a computing system may be carried out by making said data, template and / or information available to said computing system or piece of software, e.g. by storing said data, template and / or information in a memory comprised in or accessible by said computing system and / or by granting said computing system access to said data, template and / or information, so that said computing device can retrieve, copy and / or access said data, template and / or information. For example, providing data, a template and / or information to a computing device may comprise sending, e.g. over a network, said data, template and / or information to said computing device. Providing data, template and / or information to a computing device may comprise sending, e.g. over a network, to said computing device a link to said data, template and / or information.
[0030] The LAS may be configured for at least partial or fully automated handling of biological samples for laboratory purposes such as sample analysis for clinical testing. In particular, an LAS may be an assembly comprising a plurality of components. The LAS may comprise a computing system operatively connected to these components and may be configured to control each component. A component of the LAS may be an analytic instrument, a pre-processing (e.g. pre- analytic) instrument, a post-processing (e.g. post-analytic) instrument, an input module, an output module, a transportation component (e.g., a track, a belt, a tube carrier and the like) configured to move a sample container. In the following, “processing component” and “instrument” may be used interchangeably.
[0031] In particular, the transportation components may allow for moving containers within the LAS, e.g., 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 components may includeone or more tracks, one or more belts and / or container carriers configured to move biological samples contained in sample containers.
[0032] An analytic instrument (hereinafter referred to also as “laboratory instrument”) may be configured to carry out at least a clinical test. An analytical instrument may be a laboratory analyzer. The analytical instrument may include one or more pre-analysis, analysis, and post-analysis components.
[0033] An analyzer may be, in particular, a laboratory instrument configured to carry out one or more analytic steps, such as measuring one or more characteristics of a biological sample, e.g., the concentration of an analyte. The laboratory analyzer may be an immunoassay analyzer, a chemistry analyzer, and identification and antibiotic susceptibility analyzer, a bacteriology analyzer, a molecular analyzer, a hematology analyzer, a urinalysis instrument, and the like.
[0034] A pre-analysis laboratory instrument may be configured to carry out one or more pre-analytic steps on a biological sample to prepare the biological sample for the analytic instrument(s). A preanalysis laboratory instrument may include a centrifuge, a decapper, an input module and / or an aliquoter.
[0035] A post-analysis laboratory instrument may be configured to carry out one or more postprocessing steps on the biological sample after the biological sample has been processed by one or more laboratory analyzers. A post-analysis laboratory instrument may include one or more of a recapper (e.g., for putting caps back on containers), a storage unit, in particular a refrigerated storage unit, and an output module.
[0036] A clinical test may comprise one or more procedures that, when carried out on the biological sample or on a component thereof, allow for estimating the value of a parameter, e.g. a clinical parameter. In particular, a clinical test may comprise physical, biological, optical, mechanical, immunological, and / or chemical procedures. In particular, the LAS may be configured for handling pre-analytical, analytical and / or post-analytical stage processing of biological samples.
[0037] A biological sample may be a sample of a bodily fluid of a human or animal subject. For example, the bodily fluid may be a physiological fluid, such as blood, saliva, urine, sweat, amniotic fluid, cerebrospinal fluid, ascites fluid, or the like. The biological sample may comprise one or more components that may potentially comprise analytes of interest for performing at least one clinical test. For instance, blood serum, blood cells and blood plasma are components of a blood sample. In an example, the biological sample may be a body fluid sample. Further, for example, the biological sample may be a blood sample.
[0038] Generally, after the biological sample is collected from a subject, it is put in a sample container. The container may be configured to receive and hold the biological sample. The sample container may be a sample tube for collecting the biological sample from a body, e.g., of a human or an animal subject. Typically, sample tubes comprise a closed tube end and an end opposite thereto. The latter end defines an opening for inserting the sample in the sample tube. The opening may be closeable, e.g. sealable, by a cap. In general, a sample container may be configured to receive and hold a biological sample. Accordingly, the sample container may comprise an opening for receiving the sample and a bottom as well as one or more walls to hold the sample, wherein the opening maybe configured to be releasably closed by a closing element, e.g. a cap. In particular, the sample container may have a substantially cylindrical shape (i.e. a cylindrical wall), with the opening at one base and the bottom at the opposite base. In particular, a sample tube, which may have a greater tube elongation than tube diameter.
[0039] In particular, according to the present disclosure, an indicium may be or comprise a barcode. The barcode may, for example, be one dimensional, e.g., comprise a plurality of parallel lines with varying widths, spacings and / or sizes. The barcode may be two dimensional, e.g., a matrix code such as a QR code. In particular, the barcode is machine-readable, e.g., a machine, i.e., a computer, may read the code based on an image or scan thereof, e.g., via image processing on the computer. In particular, the LAS, e.g., a barcode reader thereof, and / or the computing system may be configured to read an indicium and intelligibly access the identification information provided therein. In case the indicium of the first sample container and the second sample containers are different, the barcodes may be varying in dimension, or in the symbology. For example, according to the present disclosure, an indicium may be an RFID chip plus antenna affixed or to be affixed to a respective sample container.
[0040] For example, the identification information comprised in an indicium for a sample container may comprise information uniquely specifying the biological sample comprised in that sample container and / or information uniquely specifying that sample container. For example, the identification information comprises an alphanumeric string that, when provided to the middleware, to the LAS operating software and / or to the computing system, allows respectively the middleware, the LAS operating software, and the computing system to query a database and / or the LIS and obtain one or more of the aliquoting data and the laboratory data.Exemplarily, the identification information comprised in an indicium for a sample container may relate to at least one of: that sample container, the biological sample comprised in that sample container and the tests to be carried on the biological sample contained in that sample container. If the container is a secondary sample container (e.g., the second sample container), the identification information comprised in an indicium for that secondary sample container may further relate to one or more of: the primary sample container from which the biological sample is aliquoted, and the biological sample comprised in the primary sample container. For example, the identification information comprised in an indicium for a sample container may comprise or be associated with information specifying one or more clinical tests, e.g., all the clinical tests, to be performed on the biological sample in that sample container. In this case, for instance, the identification information comprised in the second indicium may comprise, for each clinical test of those one or more clinical tests, one or more of the following: an identifier (e.g., an alphanumeric string) of said each clinical test, and an identifier of one or more instruments for carrying out said each clinical tests test. The identification information comprised in an indicium for a sample container may comprise information uniquely identifying the subject to which the biological sample contained in that sample container belongs. Said information may be such that the patient identity is encrypted and / or obfuscated. Additionally, or alternatively, the identification information comprised in an indicium for a sample container may include for example one or more of the following: information specifying a type of thebiological sample comprised in that sample container (e.g., blood, urine, and the like), information specifying a phlebotomy time (i.e., the time at which the biological sample in that sample container was drawn from the subject), information specifying a clotting time, information specifying an expiration date (i.e., date at which the biological sample included in that sample container is considered degraded and may be disposed of), information specifying storage conditions (e.g., temperature) for that sample container and / or the biological sample contained therein, and information specifying a priority of the biological sample contained in that sample container (e.g., high priority, for STAT samples, medium priority, low priority and the like).
[0041] For example, causing the second indicium to be generated may comprise causing the second indicium to be printed, e.g., by a printing unit, according to the indicium template. In particular, the printing unit may a printer, e.g., a printer comprised in the LAS. The second indicum may be printed on a label. The label may have an adhesive surface and a printable surface opposite the adhesive surface. The adhesive surface may be attachable to the secondary sample container. Generally, the second indicium may be printed on the printable surface, the second indicium comprising the second identification information. In other examples, the second indicium may be an RFID chip plus antenna comprised in the label, e.g., between the adhesive surface and the printable surface. The label may be a sheet of material (or a composite of materials) that is suitable to be affixed to a container. In particular, the dimensions of the label and the characteristics of the material(s) may be chosen such that the label can be affixed to the second sample container. For instance, the label may be made of paper and / or plastics. Exemplarily, the label may be rectangular, and it may be affixed to the second sample container such that the long sides are in the direction of the length of the second container.
[0042] In an example, causing the second indicium to be generated may comprise instructing a device configured to generate indicia to generate the second indicium according to the indicium template. Such device may be a printing unit of the LAS, for example.
[0043] In an example, the method may further comprise accessing the indicium template, wherein causing the second indicium to be generated may comprise providing the indicium template to the device configured to generate indicia.
[0044] In particular, the method of the present invention may comprise generating, by the LAS, the second indicium according to the indicium template. In particular, generating the indicium may comprise printing, e.g., by a printing unit of the LAS, the label. The method of the present disclosure may further comprise affixing, e.g., by the LAS, the label to the second container.
[0045] In an example, obtaining the laboratory data may comprise obtaining a route plan for processing the second sample container within and / or outside the LAS and determining the laboratory data from the route plan. The route plan may be indicative of the routing of the second sample container. In particular, the route plan may include information specifying the instruments that are to process the second sample container and / or the portion of the biological sample contained therein. In particular the route plan may specify an ordered list of the laboratory instruments that are to process the second sample container and / or the portion of the biological sample contained therein. In particular, the ordering of the list reflects the chronological orderaccording to which the laboratory instruments shall process the second sample container. Hence, the ordered list may be a temporal list. In particular, the route plan may specify instruments that are comprised in the LAS, standalone instruments, and / or instruments comprised in further LASs. The standalone instruments and the further LASs may be comprised in the laboratory comprising the LAS or in another laboratory. In particular, the laboratory data may be comprised in or derived from the route plan. According to the present disclosure, an instrument that is comprised in the LAS is also referred as an “online instrument”. According to the present disclosure an instrument not comprised in the LAS may also be referred to as “offline instrument”.
[0046] In an example, the method may further comprise causing the portion of the biological sample included in the first sample container to be aliquoted in the second sample container. In particular, the method according to the present disclosure may comprise aliquoting, e.g., by an aliquoter, the portion of the biological sample in the second sample container. For instance, the aliquoter is comprised in the LAS.
[0047] In an example, determining the indicium data may be carried out by using a set of indicium rules, wherein the set of indicium rules indicates, depending on the one or more laboratory instruments to process the second sample container and / or the one or more locations at which the second sample container is to be processed, one or more indicium templates for generating the indicium for labelling the second sample container. The laboratory instruments may belong to a plurality of instruments in one or more laboratories. In particular, some instruments of the plurality of instruments may be comprised in the LAS, some instruments of the plurality of instruments may be comprised in further LASs located in a laboratory of the one or more laboratories. Alternatively, or in addition, the plurality of instruments may comprise one or more standalone instruments, each standalone instrument of the one or more standalone instruments being located in a respective laboratory of the one or more laboratories.
[0048] In particular, the set of rules may be defined, e.g., pre-defined, by a user. The set of rules may be stored in one or more computer-readable files. In particular, determining the indicium data may comprise accessing the one or more computer-readable files and apply each rule of the set of rules. For example, each rule of the set of rules may comprise one or more respective conditions, said conditions depending on at least a portion of the laboratory data. Alternatively, or additionally, each rule of the set of rules may be associated with a respective indicium template of the first plurality of indicium templates. For example, each rule of the set of rules indicates the respective indicium template if the one or more respective conditions are fulfilled.
[0049] Exemplarily, determining the indicium data may comprise determining if the one or more indicium templates comprise a plurality of indicium templates, and, in the positive, randomly selecting the indicium template from the one or more indicium templates.
[0050] In an example, determining the indicium data may comprise determining, by using the laboratory instrument data, the one or more indicium templates indicated by the set of indicium rules. The set of indicium rules may be defined, e.g., pre-configured, by a user, for example. In particular, the user may provide an input to the computing system for defining the set of indicium rulesaccording to the requirements or specifications of the one or more laboratory instruments and / or locations.
[0051] In an example, determining the indicium data may comprise determining if the one or more indicium templates comprise a plurality of indicium templates (herein also referred to as: “second plurality of indicium templates”), and, in the positive, determining, e.g., selecting, the indicium template from the one or more indicium templates by using one or more determination criteria. In particular, the determination criteria may depend on the laboratory data.
[0052] In an example, the one or more determination criteria comprises a determination criterion based on ranking data, the ranking data comprising information specifying a ranking among the one or more indicium templates, e.g., among the first plurality of indicium templates.
[0053] In particular, according to the present disclosure, a ranking among the elements of a set (e.g., the indicium templates of the one or more indicium templates) is a relationship between those elements, such that, for any two elements of the set, the first element is either "ranked higher than" or "ranked lower than" the second element. For example, a ranking among the elements of a set is a relationship between those elements, such that, for any two elements of the set, the first element is either "ranked higher than" or "ranked lower than" or "ranked equal to" the second element.
[0054] For instance, the ranking among the one or more indicium templates may specify a selection priority among the one or more indicium templates. For example, the selection priority may be specified such that an indicium template has a highest selection priority than another indicium template if the former indicium template is ranked higher than the latter indicium template.Exemplarily, the selection priority may be specified such that an indicium template has highest selection priority than another indicium template if the former indicium template is ranked lower than the latter indicium template.
[0055] In particular, the determination criterion may be defined so that the second indicium template is an indicium template of the one or more indicium templates with highest selection priority according to the ranking among the one or more indicium templates. Exemplarily, the determination criterion specifies that the second indicium template is an indicium template of the one or more indicium templates with highest rank according to the ranking among the one or more indicium templates. Alternatively, the determination criterion may specify that the second indicium template is an indicium template of the one or more indicium templates with lowest rank according to the ranking among the one or more indicium templates.
[0056] In an example, each indicium template of the one or more indicium templates is associated with a respective rule of the set of indicium rules, e.g., so that the respective rule, if fulfilled, indicates said each indicium template. In particular, the ranking among the one or more indicium templates corresponds to a ranking among the set of indicium rules.
[0057] For instance, the ranking among the one or more indicium templates corresponds to a ranking among the set of indicium rules in such a way that: (i) if a rule of the set of indicium rules is ranked higher than another rule of that set, the indicium template associated with the former rule is ranked higher than the indicium template associated with the latter rule: and (ii) if a rule of the set ofindicium rules is ranked lower than another rule of that set, the indicium template associated with the former rule is ranked lower than the indicium template associated with the latter rule.
[0058] For example, the ranking among the one or more indicium templates corresponds to a ranking among the set of indicium rules in such a way that: (i) if a rule of the set of indicium rules is ranked higher than another rule of that set, the indicium template associated with the former rule is ranked lower than the indicium template associated with the latter rule: and (ii) if a rule of the set of indicium rules is ranked lower than another rule of that set, the indicium template associated with the former rule is ranked higher than the indicium template associated with the latter rule.
[0059] For example, the ranking among the set of indicium rules is an order according to which rules of the set of indicium rules are listed in a computer-readable file collecting said set of rules. For instance, the ranking among the set of indicium rules is a temporal order according to which the rules of the set of indicium rules have been defined by the user. For instance, a rule of the set of indicium rules is ranked higher than another rule of the set of indicium rules if the former rule has been defined before the latter rule and a rule of the set of indicium rules is ranked lower than another rule of the set of indicium rules if the former rule has been defined after the latter rule. Alternatively, for example, a rule of the set of indicium rules is ranked higher than another rule of the set of indicium rules if the former rule has been defined after the latter rule and a rule of the set of indicium rules is ranked lower than another rule if the former ruled has been defined before the latter rule.
[0060] In an example, obtaining aliquoting data may comprise determining, by using a set of aliquoting rules, the aliquoting data, wherein the set of aliquoting rules indicate, depending on one or more processing steps to be carried out on the biological sample, whether the biological sample is to be aliquoted or not. The set of aliquoting rules may be defined, e.g., pre-configured, by a user. For instance, the user may define that for some particular tests, e.g., a cholesterol test on a blood sample, the biological sample is to be aliquoted for processing at a particular laboratory instrument and / or location.
[0061] In an example, the first sample container is to be processed within a laboratory automation system and comprises a further indicium (herein also referred to as: “first indicium”) which has been generated according to a further indicium template (herein also referred to as: “first indicium template”). In particular, determining the indicium data may comprise determining, by using the laboratory data, whether the second sample container is to be processed within the laboratory automation system or not and one or more of:- if the second sample container is to be processed within the laboratory automation system, the indicium template is determined to be different from the further indicium template; and- if the second sample container is not to be processed within the laboratory automation system, the indicium template is determined to be the further indicium template.
[0062] In an example, both the identification information comprised in the first indicium and the identification information comprised in the second indicium may be unique identifiers for identifying the first sample container and the second sample container, respectively. Thereby, it may be prevented that different sample containers or biological samples are confused with one another.
[0063] In some cases, the first and the second indicium are identical to one another. In this case, the first sample container and the second sample container(s) may be differentiated from one another by the LAS, as described below. For example, the method according to the present disclosure may comprise:- obtaining, e.g., by the computing system, first physical attribute information and second physical attribute information, wherein the first physical attribute information specifies a physical appearance of a physical attribute of the first sample container and the second physical attribute information specifies a physical appearance of the physical attribute of the second sample container, wherein the physical appearance of the physical attribute of the first sample container and the physical appearance of the physical attribute of the second sample container are different from one another; and- identifying, e.g., by the computing system, the first sample container and / or the second sample container based at least on the first physical attribute information and the second physical attribute information.In particular, the method may look or analyze the same physical attribute present on the first sample container and the second sample container. For example, an image may be taken by a camera unit of the LAS, and the image may be processed or analyzed, in particular by the computing system and / or by a computing system of the LAS, to identify the same physical attribute present in both or more of the containers. For example, the physical attribute may at least relate to a size, a shape and / or a color of at least a portion of the sample containers. For example, said portion may be a label, a cap and / or a body of the sample container. In particular the physical appearance of that physical attribute is different for both sample containers, i.e., the physical attribute appears differently in said both containers. For example, the first sample container and the second sample container may have different size, different shape and / or different color. The first and the second physical attribute information may be obtained before, at the time of and / or after aliquoting and may be stored by the LAS, in particular in a data storage thereof, and in particular in association with the identification information. In particular, when the LAS needs to identify whether a sample container is a first sample container or the second sample container, the LAS may access the data storage for retrieving the first and the second physical attribute information based on the read identification information associated therewith. Then, based on processing of an image of the sample container to be identified, the LAS may compare the physical appearance of the physical attribute of the sample container to be identified with the first and second physical attribute information.
[0064] In an example, the first physical attribute information and the second physical attribute information may be respectively obtained based on at least one image of the first sample container and / or of the second sample container. For this purpose, as described, the LAS may comprise one or more camera units for taking images of the sample containers. The at least one image may be showing both the first sample container and the second sample container. Hence, the camera unit may be configured to take an image of one or both of the first sample container and the second sample container. Alternatively, there may be more than one image. For example, there may be one image of the first sample container and one of the second sample container such that there are atleast two images, one showing the first container and the other one showing the second container, wherein said images may be taken by the same or different camera units of the LAS. Also, there may be more images, e.g., from different perspectives, of each one of the containers or both containers.
[0065] In an example, the second sample container may be identified based on the second physical attribute information after being send out from the laboratory automation system and being reintroduced into the laboratory automation system. For example, there may be cases in which the second sample container that is sent outside of the LAS, e.g., for clinical testing in another laboratory and / or by an analyzer not comprised in the LAS, may be, either accidentally or on purpose, reintroduced into the LAS. In this case, the method may advantageously detect that the second sample container has been reintroduced into the LAS and is not a new first sample container. Hence, it may be avoided that containers are lost, or clinical tests are not performed.
[0066] In an example, the method may further comprise routing, e.g., by the LAS, the second sample container to an error region of the laboratory automation system based on the physical attribute information. For this purpose, in particular before routing, the method may further comprise determining whether to route the second sample container to the error region or not. For example, the routing may be carried out or determined to be carried out after determining that the second container that previously has been sent outside of the LAS has been reintroduced in the LAS.
[0067] In an example, the second indicium may comprise the identification information comprised in the first indicium and additional identification information for distinguishing the second sample container from the first sample container e.g., when the laboratory information indicates that the biological sample comprised in the second sample container is processed inside the LAS. For example, the additional identification information, may be a suffix and / or a prefix that may be added to the first identification information to constitute the second identification information, i.e., the identification information comprised in the second indicium.
[0068] According to a second aspect of the present disclosure, there is provided a computer program product comprising instructions which, when executed by a computer system, causes the computer system to carry out the method of the first aspect of the present disclosure.
[0069] The computer program product may comprise a rule engine, the rule engine comprising instructions which, when executed by a computer system, cause the computer system to allow a user to define one or more rules, the one or more rules comprising a set of indicium rules, wherein the set of indicium rules indicates, depending on the one or more laboratory instruments which are to process the second sample container and / or the one or more laboratory locations at which the second sample container is to be processed, one or more indicium templates.
[0070] The computer program product may cause the computer system to carry out the method of the present disclosure, if the one or more rules have been defined.
[0071] In particular, a computer program product is provided, which comprises a rule engine, the rule engine comprising instructions which, when executed by a computer system, cause the computer system to allow a user to define one or more rules, the one or more rules comprising a set of indicium rules, wherein the set of indicium rules indicates, depending on one or more laboratoryinstruments which are to process a second sample container and / or one or more locations at which the second sample container is to be processed, one or more indicium templates, wherein the computer program product comprises instructions which, when executed by a computer system, causes, if the one or more rules have been defined, the computer system to carry out a method comprising: obtaining aliquoting data, wherein the aliquoting data comprise instructions specifying that a portion of a biological sample included in a first sample container is to be aliquoted in the second sample container; obtaining laboratory instrument data, wherein the laboratory data comprise information indicative of one or more laboratory instruments which are to process the second sample container and / or one or more laboratory locations at which the second sample container is to be processed; determining, by using the first set of indicium rules and the laboratory data, indicium data comprising information indicative of an indicium template according to which an indicium for labelling the second sample container is to be generated, wherein the indicium comprises identification information for identifying the second sample container; and causing the indicium to be generated according to the indicium template.
[0072] According to a third aspect of the present disclosure, there is provided a computing system configured to carry out the method according to the first aspect of the present disclosure. For example, the computing system may comprise one or more computing units or computers, in particular comprised in or connected to a laboratory automation system. The computing system may also comprise, e.g., stored in a memory comprised in the computing system, the computer program product of this disclosure.
[0073] The computing system may comprise a rule engine, the rule engine comprising instructions which, when executed by the computer system, cause the computer system to allow a user to define one or more rules, the one or more rules comprising a set of indicium rules, wherein the set of indicium rules indicates, depending on the one or more laboratory instruments which are to process the second sample container and / or the one or more laboratory locations at which the second sample container is to be processed, one or more indicium templates.
[0074] The computing system may be configured to carry out the method of this disclosure, if the one or more rules have been defined.
[0075] For example a computing system is provided, which comprises a rule engine, the rule engine being configured to allow a user to define one or more rules, the one or more rules comprising a set of indicium rules, wherein the set of indicium rules indicates, depending on one or more laboratory instruments which are to process a second sample container and / or one or more locations at which the second sample container is to be processed, one or more indicium templates, wherein, if the one or more rules have been defined, the computing device is configured to carry out a method comprising: obtaining aliquoting data, wherein the aliquoting data comprise instructions specifying that a portion of a biological sample included in a first sample container is to be aliquoted in the second sample container;obtaining laboratory instrument data, wherein the laboratory instrument data comprise information indicative of one or more laboratory instruments which are to process the second sample container and / or one or more locations at which the second sample container is to be processed; determining, by using the first set of indicium rules and the laboratory instrument data, indicium data comprising information indicative of a first indicium template according to which a first indicium for labelling the second sample container is to be generated, wherein the indicium comprises identification information for identifying the second sample container; and causing the first indicium to be generated according to the first indicium template.
[0076] According to a fourth aspect of the disclosure, there is provided a laboratory automation system comprising the computer program product according to the second aspect of the present disclosure and / or the computing system according to the third aspect of the present disclosure.
[0077] The laboratory automation system may be configured to handle the biological sample comprised in the first sample container; the first sample container being labeled with the first indicium. In particular, the first indicium comprises identification information for identifying the first sample container.
[0078] In particular, the laboratory automation system may comprise one or more of: an aliquoter configured to aspirate a portion or sample volume from the biological sample contained in a sample container (e.g., the first sample container), and configured for dispensing at least part of the aspirated sample volume into another sample container (e.g., the second sample container); and a labeling unit configured for labeling the second container with the second indicium.
[0079] In particular, the aliquoter may comprise a dispenser configured to aspirate a sample volume from a biological sample from a sample container and to dispense at least a portion of the aspirated sample volume in another sample container. In particular, the dispenser is configured to hold the aspirated portion of the biological sample before dispensing it.
[0080] Exemplarily, the dispenser may comprise a pipettor and a pipette tip. The pipettor may be configured to hold the pipette tip, wherein the pipette tip may be releasably mounted to the pipettor. The pipettor may comprise a pump configured to aspirate and / dispense portions of biological sample. The aliquoting unit may comprise a capacitive sensing component coupled to the dispenser. In particular, the capacitive sensing component uses capacitance for liquid level detection, i.e., as an indication of whether the pipette tip is outside of or within a biological sample in a sample container.
[0081] The biological sample contained in the first container has a total volume. The dispenser of the aliquoting unit may be configured to aspirate a sample volume from this total volume, wherein the sample volume is a sub-volume of (i.e. a fraction of) the total volume or coincides with the total volume. Exemplarily, the sub-volume may be a smaller volume than the total volume. The dispenser may be configured to dispense at least part of the aspirated sample volume to the second container. In particular, when the second container is initially loaded in the LAS, it does not contain any fraction of biological sample, e.g. it may be empty, or it may contain a reagent. The second container may be brought to the LAS by an automated mechanism, such as a conveyor or a robot, and / or by a human user. In particular, the LAS may comprise an input unit configured to receive second containers.
[0082] The sample volume aspirated by the dispenser from the first container is dispensed at least in part into the second container. The at least part of the sample volume that is dispensed to the second container may be referred to as aliquot of said second container. In some examples, the dispenser may dispense the whole sample volume to the second container. In other examples, the dispenser may dispense only a fraction of the sample volume to the second container. In particular, the dispenser may be configured to distribute the aspirated sample volume among a plurality of second containers, so that each second container receives a fraction of the sample volume. The dispenser may be configured to dispense a plurality of fractions of the sample volume, wherein the sum of the fractions substantially equals the sample volume, to a respective plurality of second containers in a temporal sequence, i.e., temporally one after the other.
[0083] The dispenser of the aliquoter may be configured to move between a first position and a second position, the first position being different from the second position. The first position is the position at which the dispenser aspirates the sample volume from a sample container (e.g., the first sample container). The second position is the position at which the dispenser dispenses at least part of the aspirated sample volume in another sample container (e.g., the second sample container).
[0084] In particular, the second indicium may be printed on a label. The labelling unit of the LAS may comprise fixing means for affixing the label to the second container, e.g., for bringing the adhesive surface of the label in contact with the second container. In particular, the labelling unit may be configured to affix the label to the second container such that the identification information for identifying the second sample container can be accessed via the label. In some cases, all points of the label may be affixed to the second container at the same time. In other cases, the label may be incrementally affixed to the second container, e.g., different parts of the label may be affixed to the second container in a temporal sequence, one after the other. For instance, the label may be provided on a substrate, e.g. in form of a roll, and may be detached from the substrate prior to or substantially at the time point at which the substrate comes into contact with the second container. The labelling unit may be configured to accommodate the second container when affixing the label on the second container. Furthermore, the labelling unit may be configured to accommodate the second container when the dispenser dispenses the at least part of the sample volume into the second container. Thus, the labelling unit may be configured to accommodate the second container both for being labelled and for receiving the aliquot. The labelling unit may be configured to accommodate only one second container or several second containers at the same time. In particular, the labelling unit may be comprised in the aliquoter of the LAS.
[0085] Exemplarily, the labelling unit may further comprise a printer unit configured to print on the label, e.g., to print the second indicium on the label. The printer unit may be configured to obtain the second identification information e.g., from the LIS, and the printer unit may be configured to create the second indicium to be printed on the label, the second indicium comprising the second identification information. The printer unit may comprise a processing unit. In particular, the printer unit may be configured to receive an empty label and print the second indicium on the label.
[0086] It is noted that the above aspects, examples, and features may be combined with each other irrespective of the aspect involved.
[0087] The above and other aspects of the present disclosure will become apparent from and elucidated with reference to the examples described hereinafter.
[0088] Exemplary embodiments will be further described with reference to the figures, wherein:
[0089] Figure 1 shows a schematic representation of a computing system and a schematic representation of a LAS.
[0090] Figure 2a and Figure 2b show a schematic representation of the first sample container and a schematic representation of the second sample container, respectively.
[0091] Figure 3 shows steps of a method for determining an indicium template.
[0092] Figure 4 shows steps of a method for determining indicium data.
[0093] The figures are schematic only and not true to scale. In principle, identical or like parts, elements and / or steps are provided with identical or like reference numerals in the figures.
[0094] Figure 1 shows a computing system 100 and a laboratory automation system (LAS) 200. The computing system 100 and the LAS 200 may be part of a laboratory. The computing system 100 may include an input / output (I / O) interface 111 , a processor 112, a memory 113, and a network interface controller (NIC) 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.
[0095] The computing system 100, e.g., the memory 113, may comprise a computer program product (not shown) comprising instructions which, when executed by the computer system 100, causes the computer system 100 to carry out the method of the first aspect of the present disclosure. In particular, computer program product comprises a rule engine (not shown), the rule engine comprising instructions which, when executed by a computer system, cause the computer system to allow a user to define one or more rules, the one or more rules comprising a set of indicium rules. The set of indicium rules indicates, depending on one or more laboratory instruments which are to process a second sample container and / or one or more locations at which the second sample container is to be processed, one or more indicium templates, wherein the computer program product comprises instructions which, when executed by a computer system, causes, if the one or more rules have been defined, the computer system to carry out the method comprising the following steps.• obtaining aliquoting data, wherein the aliquoting data comprise instructions specifying that a portion of a biological sample included in a first sample container is to be aliquoted in the second sample container;• obtaining laboratory instrument data, wherein the laboratory data comprise information is indicative of one or more laboratory instruments which are to process the second samplecontainer and / or one or more laboratory locations at which the second sample container is to be processed;• determining, by using the first set of indicium rules and the laboratory data, indicium data comprising information indicative of an indicium template according to which an indicium for labelling the second sample container is to be generated, wherein the indicium comprises identification information for identifying the second sample container; and• causing the indicium to be generated according to the indicium template.
[0096] The network interface controller 114 may be connectable to a computer network 12. The LAS 200 may also be connectable to the computer network 12. In some cases, the computing system 100 may be included in (i.e., may be part of) the LAS 200. The LAS 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.
[0097] The LAS 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 LAS 200 may also include one or more post-analytics laboratory instruments 250, an automation component 260, and one or more pre-analytics laboratory instruments. The one or more pre-analytics laboratory instruments comprise an aliquoter 270. The pre-analytics laboratory instrument may comprise a loading area (not shown) for loading and identifying sample containers in the LAS 200, a centrifuge (not shown) for centrifuging sample containers and / or a decapper (not shown) for decapping sample containers.
[0098] The aliquoter 270 is configured to aspirate a sample volume from the biological sample contained in a primary sample container (e.g., the first sample container 1 , as schematically shown in figure 2a), and to dispense at least part of the aspirated sample volume into a secondary sample container (e.g., the second sample container 2, as schematically shown in figure 2b). The aliquoter 270 may comprise a dispenser (not shown) and a labeling unit (not shown), wherein the labeling unit is configured to label the secondary containers with a label comprising an indicium, e.g., the second sample container 2 with a label 42 comprising the second indicium 52 (c.f., figure 2b). The dispenser (not shown) may comprise the features described above, e.g. the pipettor described above. The labeling unit (not shown) may comprise the features described above.
[0099] In particular, the aliquoter 270 may comprise a dispenser configured to aspirate a sample volume from the biological sample contained in the first sample container 1 , and to dispense at least part of the aspirated sample volume into a second sample container 2.
[0100] Specifically, the automation component 260 includes a track, a belt and / or a tube carrier configured to move sample containers comprising biological samples within the LAS 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 LAS 200 to another component 270, 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250 of the LAS 200. For instance, the automation component 260 is capable of transporting a sample containerincluding 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. For instance, said processing step may be the step of centrifuging that sample container.
[0101] Another processing step that may be carried out by automation component 260 may be the step of transporting a container from the pre-analytics laboratory instruments 270 to the immunoassay laboratory instruments 210a, 210b, 220a, 220b. Moreover, yet another processing step that may be carried out by one of the immunoassay laboratory instruments 210a, 210b, 220a, 220b may be the step of carrying out one or more immunoassay tests on the biological sample in the container.
[0102] In addition or alternatively, a processing step may be carried out by the automation component 260 and may be the processing step of transporting a 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 carrying out one or more clinical chemistry tests on the biological sample comprised in that container. In addition, or alternatively, a processing step may be carried out by the automation component 260 and may be the step of transporting a 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.
[0103] The loading area (not shown) of the LAS 200 may receive the first sample container 1 schematically shown in figure 2a. In particular, the first sample container 1 includes a biological sample 31 . The first container 1 is labeled with a label 41 , the label comprising the first indicium, e.g., a one-dimensional barcode 51 printed on the label 41 . The first indicium 51 comprises the first identification information for identifying the first sample container 1 . This label 4 may have been provided by the provider, such as a hospital, of the first sample container 1 at the time of drawing of the biological sample 3 from a subject. The first identification information comprised in the first indicium 51 may comprise information uniquely specifying the biological sample 31 comprised in the first sample container 1 and / or information uniquely specifying that sample container 1 . For example, said identification information comprises an alphanumeric string that, when provided to the middleware, to the LAS operating software and / or to the computing system 100, allows respectively the middleware, the LAS operating software, and the computing system 100 to query a database and / or the LIS and obtain one or more of the aliquoting data and the laboratory data.
[0104] Figure 3 shows steps of a method 400 for determining an indicium template. At step 410, a computing system, e.g., the computing system 100 schematically depicted in figure 1 and described above, obtains aliquoting data. The aliquoting data comprise instructions specifying that a portion of the biological sample 31 included in the first sample container 1 is to be aliquoted into the second sample container 2. In particular, step 410 may comprise obtaining a test order for the biological sample 31 . In particular, the test order comprises information specifying the clinical tests to be performed on the biological sample 31 and is received by the computing system 100 from the LIS (not shown) and / or the middleware (not shown). Moreover, step 410 may comprise determining thealiquoting data by using a set of aliquoting rules. The set of aliquoting rules indicate, depending on the clinical tests to be carried out on the biological sample 31 , whether the biological sample 31 is to be aliquoted or not. For instance, the set of aliquotation rules may comprise or consist of a rule specifying that a biological sample 31 is to be aliquoted if the test order contains a cholesterol test. For example, in this case, and if the test order contains the cholesterol test, the biological sample 31 is to be aliquoted.
[0105] If the biological sample 31 is to be aliquoted, at step 420, the computing system 100 obtains laboratory data. The laboratory data comprises information indicative of one or more laboratory instruments 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250, 270 which are to process the second sample container 2 and / or one or more laboratory locations at which the second sample container 2 is to be processed. In particular, the step 420 may comprise generating the route plan for the second sample container. In particular, the computing system 100 may generate the route plan by using (i) information indicative of the test orders to be carried out on the biological sample 32 included in the second sample container 2, (ii) information specifying the configuration of the LAS 200 and, if present, of other LASs (not shown) and standalone clinical instruments (not shown) and (iii) information specifying the availability and the workload of the instruments 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250, 270 comprised LAS 200 and, if present, of the instruments comprised in other LASs (not shown) and of the standalone clinical instruments (not shown). Alternatively, the computing system may obtain 420 the laboratory data by querying the LAS 200 for the route plan of the second sample container 2 and by receiving the route plan from the LAS 200.
[0106] At step 430, the computing system 100 determines indicium data. The indicium data comprise information indicative of the second indicium template, according to which the second indicium 52 is to be generated, wherein the indicium 52 is to label the second sample container 2 and comprises second identification information for identifying the second sample container 2. In particular, step 430 may comprise determining the second indicium template among a first plurality of indicium templates by using a set of indicium rules. The set of indicium rules indicates, depending on the one or more laboratory instruments 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250, 270 to process the second sample container 2 and / or the one or more locations at which the second sample container is to be processed, one or more indicium templates for generating the indicium 52 for labelling the second sample container 2. In particular, each indicium template of the first plurality of indicium templates is associated with at least a respective rule of the set of indicium rules, e.g., so that the respective rule, if fulfilled, indicates that indicium template. In particular, the indicium data are obtained by applying each rule of the set of indicium rules.
[0107] The first plurality of indicium templates may comprise a first exemplary indicium template that specifies a symbology that is different from the symbology of the indicium 51 on the label 41 affixed to the first sample container 1 . For instance, a rule of the set of rules may indicate the first exemplary indicium template if the second sample container 2 is to be processed by an instrument, e.g., a standalone instrument that is not configured to read indicia with the symbology of the indicium 51 of the first sample container 1 .
[0108] The first plurality of indicium templates may comprise a second exemplary indicium template, said template being such that the identification information comprised in an indicium generated according to the second exemplary indicium template is different from the identification information comprised in the indicium 51 on the label 41 affixed to the first sample container 1 . In particular, if the indicium 52 for the second sample container 2 is generated according to the second exemplary indicium template, the alphanumeric string encoding the second identification information in the indicium 52 on the label 42 affixed to the second sample container 2 comprises the alphanumeric string encoding the identification information in the indicium 51 on the label 41 affixed to the first sample container 1 , so that the second sample container 2 is linked to the first sample container 1 . The former alphanumeric string may further comprise a suffix that allows for distinguishing the first sample container 1 from the second sample container 2. For instance, a rule of the set of rules may indicate the second exemplary indicium template if the second sample container 2 is to be processed by an instrument of the LAS 200.
[0109] The first plurality of indicium templates may also comprise a third exemplary indicium template that allows for generating an indicium that is identical to the indicium 51 on the label 41 affixed to the first sample container 1 .
[0110] In some cases, if the set of indicium rules indicates a single indicium template, the indicium data specifies that single indicium template. In those cases, if the set of indicium rules indicates a plurality of indicium templates, step 430 may comprise selecting, e.g., randomly selecting, one indicium template of the plurality of indicium templates and the indicium data specifies the selected indicium template.
[0111] In some other cases, determining 430 the indicium data may comprise the steps schematically shown in figure 4 and described below. With reference to figure 4, the computing system 100 determines 431 whether the one or more indicium templates indicated by the set of indicium rules comprise a plurality of indicium templates. In the negative, the set of indicium rules indicates a single indicium template and the computing system 100 determines 432 the indicium data such that said data specify that single indicium template.
[0112] If the set of indicium rules indicates a plurality of indicium templates, the computing system 100 determines 433 the indicium template from the one or more indicium templates by using one or more determination criteria. In particular, the one or more determination criteria comprise, e.g., consist of, a ranking determination criterion based on ranking data, wherein the ranking data comprises information specifying a ranking among the first plurality of indicium templates. Exemplarily, the ranking among the first plurality of indicium templates corresponds to a ranking among the set of indicium rules, so that: (i) if a rule of the set of indicium rules is ranked higher than another rule of that set, the indicium template associated with the former rule is ranked higher than the indicium template associate with the latter rule: and (ii) if a rule of the set of indicium rules is ranked lower than another rule of that set, the indicium template associated with the former rule is ranked lower than the indicium template associate with the latter rule. For example, the ranking among the set of indicium rules is the order according to which rules of the set of indicium rules are listed in a computer-readable file collecting said set of rules. Hence, in particular, the informationspecifying the ranking among the first plurality of indicium templates is expressed in terms of the ranking among the set of indicium rules.
[0113] For instance, the ranking determination criterion may specify that the second indicium template is an indicium template of the one or more indicium templates associated with the rule with highest rank according to the ranking among the set of rules. For example, if the one or more determination criteria consist of the ranking determination criterion mentioned above, the computing system determines the indicium template by: (i) accessing information indicative of the ranking among the set of rules; (ii) determining the rules associated with the one or more indicium templates and among these rules, the one with highest rank; and (iii) determining the second indicium template as the indicium template associated with the rule with highest rank. At step 434, the computing system 100 determines the indicium data such that said data specify the indicium template associated with the rule with highest rank.
[0114] With reference to figure 3, at step 440, the computing system 100 causes the second indicium, e.g., the second barcode, 52 to be generated according to the indicium template specified in the indicium data. In particular, at step 440, the computing system instruct the LAS 200 to create an aliquot of the biological sample 31 contained in the first sample container 1 and to create the second indicium 52 for the sample container 2 that contains the aliquot of the biological sample 31 according to the indicium template specified in the indicium data.
[0115] At optional step 450, the LAS 200 aliquots the biological sample 31 contained in the first sample container 1 thereby creating the second indicium 52. In particular, the LAS 200 routes the first sample container 1 to the aliquoter 270 and, when the first sample container 1 is in the aliquoter 270, it instructs the aliquoter to aliquot the biological sample 31 . In particular, the dispenser of the aliquoter 270 aspirates a sample volume of the biological sample 31 and dispenses at least part of this aspirated sample volume in the second sample contained. The labelling unit of the aliquoter 270 prints the label 42 comprising the second indicium 52 and affixes the label 42 to the second sample container 2.
[0116] The second sample container 2 after the aliquoting of the biological sample 31 is schematically shown in figure 2b. In particular, the second sample container 2 includes a portion 32 of the biological sample 31 . The second container 2 is labelled with a label 42, the label 42 comprising the second indicium, e.g., a one-dimensional barcode 52 printed on the label 42. The second indicium 52 comprises identification information for identifying the second sample container.
[0117] The method of figure 3 may comprise the optional step of receiving 460, by the LAS 200, the first sample container 1 . Optional step 460 may be carried out before the step of obtaining aliquoting data 410. In particular, optional step 460 may be carried out before step 410. In particular, the loading area (not shown) of the LAS 200 receives the first sample container 1 . The loading area may comprise a barcode reader configured to read the first indicium 51 on the label 41 of the first sample container 2 and access the identification information comprised in the first indicium 51 . The LAS 200 may provide the identification information to the computing system 100 which e.g., may use this information to obtain the test order for the biological sample 31.
[0118] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art and practicing the claimed invention, from a study of the drawings, the disclosure, and the claims.
[0119] As used herein, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Further, as used herein, the phrase “at least one” or similar, e.g., “one or more of’, in reference to a list of one or more entities should be understood to mean at least one entity selected from any one or more of the entities in the list of entities, but not necessarily including at least one of each and every entity specifically listed within the list of entities and not excluding any combinations of entities in the list of entities. This definition also allows that such entities may optionally be present other than the entities specifically identified within the list of entities to which the phrase “at least one” or similar refers, whether related or unrelated to those entities specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B” or, equivalently “at least one of A and / or B” or, equivalently “one or more of A and B”, “one or more of A or B”, or “one or more of A and / or B”) may refer, in one example, to at least one, optionally including more than one, A, with no B present (and optionally including entities other than B); in another example, to at least one, optionally including more than one, B, with no A present (and optionally including entities other than A); in yet another example, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other entities). In other words, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” may mean A alone, B alone, C alone, A and B together, A and C together, B and C together, A, B, and C together, and optionally any of the above in combination with at least one other entity.
[0120] Further, as used herein, phrases such as “based on”, “related” or “relating”, “associated” and similar are not to be seen exclusively in terms of the entities, elements and / or steps to which they are referring, unless otherwise stated. Instead, these phrases are to be understood inclusively, unless otherwise stated, in that, for example, an entity, element or step referring by any of these phrases or similar, e.g., being “based on”, an or another entity, element or step, does not exclude that the respective entity, element or step may be further or also “based on” any other entity, element or step than the one to which it refers.
[0121] Any designation of methods and steps as first, second, etc. as provided herein is merely intended to make the methods and their steps referenceable and distinguishable from one another. By no means does the designation of methods and steps constitute a limitation of the scope of this disclosure. For example, when this disclosure describes a third step of a method, a first or second step of the method do not need to be present yet alone be performed before the third step unlessthey are explicitly referred to as being required per se or before the third step. Moreover, the presentation of methods or steps in a certain order is merely intended to facilitate one example of this disclosure and by no means constitutes a limitation of the scope of this disclosure. Generally, unless no explicitly required order is being mentioned, the methods and steps may be carried out in any feasible order. Specifically, the terms first, second, third or (a), (b), (c) and the like in the description and in the claims are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.
[0122] In the context of the present invention any numerical value indicated is typically associated with an interval of accuracy that the person skilled in the art will understand to still ensure the technical effect of the feature in question. As used herein, the deviation from the indicated numerical value is in the range of ± 10%, and preferably of ± 5%. The aforementioned deviation from the indicated numerical interval of ± 10%, and preferably of ± 5% is also indicated by the terms “about” and “approximately” used herein with respect to a numerical value.
[0123] Any reference signs in the claims should not be construed as limiting the scope.
Claims
Claims1 . A method (400) comprising:- obtaining, by a computing system (100), aliquoting data, wherein the aliquoting data comprise instructions specifying that a portion of a biological sample (31) included in a first sample container (1) is to be aliquoted into a second sample container (2);- obtaining, by the computing system (100), laboratory data, wherein the laboratory data comprises information indicative of one or more laboratory instruments (210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250, 270) which are to process the second sample container (2) and / or one or more laboratory locations at which the second sample container (2) is to be processed;- determining, by the computing system (100), based on at least the laboratory data, indicium data, wherein the indicium data comprise information indicative of an indicium template according to which an indicium (52) is to be generated, wherein the indicium (52) is to label the second sample container (2) and comprises identification information for identifying the second sample container (2); and- causing, by the computing system (100), the indicium (52) to be generated according to the indicium template.
2. The method (400) of claim 1 , wherein causing the indicium to be generated comprises instructing a device configured to generate indicia to generate the indicium (52) according to the indicium template.
3. The method (400) of claim 1 or 2, further comprising causing the portion of the biological sample (31) included in the first sample container (1) to be aliquoted in the second sample container (2).
4. The method (400) according to any one of the preceding claims, wherein determining the indicium data is carried out by using a set of indicium rules, wherein the set of indicium rules indicates, depending on the one or more laboratory instruments (210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250, 270) to process the second sample container (2) and / or the one or more locations at which the second sample container is to be processed, one or more indicium templates for generating the indicium (52) for labelling the second sample container (2).
5. The method (400) of claim 4, wherein determining the indicium data comprises determining if the one or more indicium templates comprise a plurality of indicium templates, and, in the positive, determining the indicium template from the one or more indicium templates by using one or more determination criteria.
6. The method (400) of claim 5, wherein the one or more determination criteria comprises a determination criterion based on ranking data, the ranking data comprising information specifying a ranking among the one or more indicium templates.
7. The method (400) of claim 6, wherein each indicium template of the one or more indicium templates is associated with a respective rule of the set of indicium rules and wherein the ranking among the one or more indicium templates corresponds to a ranking among the set of indicium rules.
8. The method (400) of any one of the preceding claims, wherein obtaining aliquoting data comprises determining, by using a set of aliquoting rules, the aliquoting data, wherein the set of aliquoting rules indicate, depending on one or more processing steps to be carried out on the biological sample (31), whether the biological sample (31) is to be aliquoted or not.
9. The method (400) of any one of the preceding claims, wherein the first sample container (1 ) is to be processed within a laboratory automation system and comprises a further indicium, wherein the further indicium has been generated according to a further indicium template, wherein determining the indicium data comprises determining, by using the laboratory data, whether the second sample container (2) is to be processed within the laboratory automation system or not and one or more of:- if the second sample container (2) is to be processed within the laboratory automation system, the indicium template is determined to be different from the further indicium template; and- if the second sample container (2) is not to be processed within the laboratory automation system, the indicium template is determined to be the further indicium template.
10. A computer program product comprising instructions which, when executed by a computer system (100), causes the computer to carry out the method (400) of any one of the previous claims.11 . The computer program product of claim 10, wherein the computer program product comprises a rule engine, the rule engine comprising instructions which, when executed by a computer system (100), cause the computer system (100) to allow a user to define one or more rules, the one or more rules comprising a set of indicium rules, wherein the set of indicium rules indicates, depending on the one or more laboratory instruments (210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250, 270) which are to process the second sample container (2) and / or the one or more laboratory locations at which the second sample container (2) is to be processed, one or more indicium templates.
12. The computer program product of claim 11 , wherein the computer program product causes the computer system (100) to carry out the method (400) of any one of claims 1 to 9, if the one or more rules have been defined.
13. A computing system (100) configured to carry out the method of any one of claims 1 to 9.
14. The computing system (100) of claim 13, wherein the computing system (100) comprises a rule engine, the rule engine comprising instructions which, when executed by the computer system (100), cause the computer system (100) to allow a user to define one or more rules, the one or more rules comprising a set of indicium rules, wherein the set of indicium rules indicates, depending on the one or more laboratory instruments (210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250, 270) which are to process the second sample container (2) and / or the one or more laboratory locations at which the second sample container (2) is to be processed, one or more indicium templates.
15. A laboratory automation system (200) comprising the computer program product of any one of claims 10 to 12 and / or the computing system of claim 13 or 14.
Citation Information
Patent Citations
Method and apparatus for printing on an object having a curved surface
WO2016065072A2