Laboratory automation system processing of follow up tests

Abstract

A laboratory automation system may perform tests on a biological sample. This may include performing a first test on a first testing portion contained in a first container. After the first test has been performed, the laboratory automation system may obtain an order to perform a follow up test, and may then make a container determination comprising determining a container from which a second testing portion should be extracted. Following this container determination, the follow up test may be performed on the second testing portion.

Description

LABORATORY AUTOMATION SYSTEM PROCESSING OFFOLLOW UP TESTSBACKGROUND

[0001] A variety of instruments exist for analyzing biological samples. For example, hematology analyzers such as described in U.S. patent 9,322,752, filed on March 17, 2014 for flowcell systems and methods for particle analysis in blood samples, which patent is incorporated herein by reference in its entirety, can be used to determine information such as the populations of various types of cells in a sample. Similarly, immunoassay analyzers such as described in application PCT / US 19 / 68650, filed December 27, 2019 for clinical analyzer automated system diagnostics, which application is incorporated herein by reference in its entirety, can be used to process a sample to determine the presence and amount(s) of various analytes. Other types of instruments (e.g., chemical analyzers) also exist and can be used in sample analysis in appropriate cases.

[0002] Often, obtaining appropriate information from a biological sample may require the use of a set of tests which cannot be determined until the results of at least some of the tests in the set are available. For example, if a first test provides a result indicating an elevated risk of a particular condition, a second test which would not have been appropriate at the outset may be necessary to confirm (or disconfirm) that condition. Similarly if a first test provides a result which is out of an expected range, a rerun of that test may be appropriate to confirm that the first result was not an anomaly. The need for sequential performance of tests along with sequential determination of whether (and how) those tests should be performed can significantly slow processing of biological samples, thereby (among other things) significantly reducing the throughput of laboratories which are used to perform sample analysis. Accordingly, there is a need for technology that can speed the processing of sequential tests on biological samples.SUMMARY

[0003] Aspects of the present disclosure may be applied in processing follow up tests using a laboratory automation system. For example, in some embodiments, a laboratory automation may perform acts comprising performing a primary test on the first testing portion in a first container. After the primary test has been performed, the laboratory automation system may obtain an order to perform a follow up test, and may then make a container determination comprising determining a container from which a second testing portion should be extracted. Following this container determination, the follow up test may be performed on the second testing portion.

[0004] Other aspects and implementations are described herein. Accordingly, the exemplary aspects described in this summary should be understood as being illustrative only, and should not be treated as limiting.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0006] FIG. 1 schematically illustrates a system comprising a laboratory automation system, a laboratory information system, and a middleware system.

[0007] FIG. 2 illustrates steps which may be performed in a method for performing tests on a biological sample.

[0008] FIG. 3 illustrates a process which could be used for container determination.

[0009] FIG. 4 illustrates a set of aliquoting tasks as well as potential subsequent activities.

[0010] FIG. 5 illustrates steps which may be performed in cases where a laboratory automation system applies error catching functionality to containers.

[0011] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.DETAILED DESCRIPTION

[0012] The present disclosure relates to articles, systems, and methods for performing tests on biological samples. In some aspects, the tests may comprise both a first test, which may be referred to as a primary test, and a second test, which may be referred to as a follow up test. Using some aspects of the disclosed technology, follow up tests may be efficiently processed, which may include automatically identifying a container from which a portion of a sample should be extracted for use in performing a follow up test. Specific exemplary embodiments which could be used and implemented based on this disclosure are described below. These embodiments may be used for purposes such as reducing contamination between tests, and / or keeping sample quality high and extending the period of time in which a sample can be used to provide reliable results.

[0013] Turning now to the figures, FIG. 1 schematically illustrates a system which may be implemented based on this disclosure. As shown in FIG. 1, such a system may include a laboratory information system 101, a laboratory automation system 102, and a middleware system 103 disposed on a network path between the laboratory information system 101 and the laboratory automation system 102. In an implementation such as shown in FIG. 1, the laboratory information system 101 can function as a central repository of information for a laboratory, and may include a database 104 with information such as patient sample identifications, tests ordered for individual samples, demographic information, test results, etc. A laboratory information system 101 may also include a computer 105 which may beconfigured to perform functions such as interfacing with a hospital information system (not shown in FIG. 1), generating orders for follow up tests based on the application of rules by a rules engine to data in the database 104, and / or presenting an interface on a display (not shown in FIG. 1) which a user (e.g., a doctor) can use to review test results and potentially manually create orders for follow up tests to be done. Other functions, such as encrypting information to ensure privacy of patient data during storage and / or transmission may also be performed by a laboratory information system 101 in some embodiments.

[0014] In addition to the laboratory automation system 101, the system of FIG. 1 also includes a laboratory automation system 102. This laboratory automation system 102 may be used to control and integrate the activities of a plurality of components in the physical transport and processing of biological samples (e.g., patient samples). To support this, a laboratory automation system 102 as shown in FIG. 1 may include one of more analytical instruments 108, and a conveyor track 106 which could be used to transport sample material (e.g., portions of patient samples contained in tubes) to appropriate devices or locations within a laboratory. It may also include a controller 110, which may be implemented as a computing device configured to control the aliquoting of the samples and / or control the lab automation system (e.g., generate the route plan of the tubes, control the routing of the tubes) and / or host and run the rules engine and / or act upon the outcome of the results of the rules engine.

[0015] When a sample is provided to the laboratory automation system 102, the laboratory automation system 102 may read a unique identifier of that sample (e.g., with a barcode reader), and a controller 110 may correlate that identifier with information stored in its memory (e.g., orders sent from the laboratory information system 101) to determine how the sample should be processed. Based on that determination, the laboratory automation system 102 may convey the sample along the conveyor track 106, transfer it from the track to an intake portion of the appropriate devices (e g., using a diversion arm) when it reached the positions of those devices along the conveyor track 106, and send instructions to those devices indicating how those devices should process the sample. The laboratory automation system 102 may also perform certain error checking activities to ensure that samples were processed properly. For example, if an order for a sample required activities which could not feasibly be performed for thatsample (e.g., the order required aliquoting a sample into multiple portions for multiple tests, but the sample did not have sufficient volume to be separated into multiple portions), the laboratory automation system may detect this condition (e.g., it may include a sample volume detector, such as a camera and an appropriate image analysis algorithm) and route the sample to the error region 109 (e.g., a drawer or a portion of a drawer) so that a user could appropriately react to the issue(s) which prevented the test(s).

[0016] The system of FIG. 1 also includes a middleware system 103, disposed on a network path between the laboratory information system 101 and the laboratory automation system 102. This middleware system 103 may serve a variety of purposes in different embodiments. For example, in some cases a middleware system 103 may host a rules engine and / or software which presents an interface which would allow a doctor to create new orders. This may be done, for example, if such a rules engine and or software was not present on the laboratory information system 101, or if they were present but had interfaces which made them difficult to use. A middleware system 103 may also facilitate communications between laboratory information and automation systems (e.g., translating an output format of a laboratory information system into an input format for a laboratory automation system), and / or with other systems not shown in FIG. 1 (e.g., a hospital information system).

[0017] As a concrete illustration of how a laboratory automation system 102 may integrate the operation of various devices needed to process a sample, consider a case where a sample was received at a laboratory automation system with an order for using it to run a complete blood count and a test for a metabolite for a commonly used recreational drug. In such a case, the controller 110 of the laboratory automation system 102 may determine that the sample would need to be separated into two portions, since a complete blood count would be run on a first instrument (i.e., a hematology analyzer) 108-1 from the one or more analytical instruments 108 comprised by the laboratory automation system 102, while the metabolite test would be performed by a second instrument (e.g., an immunoassay analyzer) 108-2 from the laboratory automation system’s one or more analytical instruments. Based on that determination, the laboratory automation system 102 may route the sample to an aliquoter 107, where a portion of the sample could be removed from the sample container and placed into a second container(e.g., a tube). The laboratory automation system may then apply a barcode with a unique identifier to the second container, and send a message to the middleware system 103 indicating the second container’s unique identifier, and informing the middleware system 103 that the sample in the second container was an aliquot of the original patient sample. The laboratory automation system 102 may also send instructions to the aliquoter 107 to separate out an additional portion of the sample and place it in a preservation container, which could then be routed to a refrigerated storage area (not shown in FIG. 1) to be stored for potential use in further tests.

[0018] After the sample had been aliquoted, the containers containing the sample could be routed to the appropriate analytical instruments, in this case a hematology analyzer 108-1 and an immunoassay analyzer 108-2. The controller 110 of the laboratory automation system could communicate with local controllers on each of these analyzers informing them what tests should be run on their respective sample portions. Those analyzers could then, when the containers with their sample portions arrived, extract testing portions from their containers, and perform the appropriate test(s) on their containers. For example, a hematology analyzer 108-1 could flow its testing portion through a flow cell and take measurements of cells as they move through the flow cell, while an immunoassay analyzer 108-2 could mix a testing portion with a reagent that would bind to the analyte of interest (in this case the drug metabolite) and could then allow the presence and concentration of that analyte of interest to be measured. The results of the tests would then be sent back to the controller 110, which could send them on to the middleware system 103. The middleware system 103 could then correlate the identifier for the second container with the original sample, and send both of the results to the laboratory information system 101 using the original sample’s identifier, thereby informing that system (and any of its users) that the ordered tests had been completed and that their results were ready.

[0019] As a further illustration of how a laboratory automation system may operate, consider FIG. 2, which illustrates steps which may be performed in a method for performing tests on a biological sample which includes the performance of both a primary test and a subsequent follow up test. In that method, initially, a first testing portion of a biological sample will beextracted 201 from a first container (e.g., a primary tube in which the sample was originally provided to the laboratory automation system, or a secondary tube obtained by removing an aliquot from a primary tube and placing it in a new tube). This may be done, for example, by routing the biological sample to one of the one or more analytical instruments 108, and sending instructions to that analytical instrument causing it to remove a portion of the biological sample that it would need to perform its test. For instance, a controller 110 of a laboratory automation system could route a blood sample to an immunoassay analyzer 108-2, and send instructions to that analyzer to test for a certain drug metabolite. The analyzer 108-2 would, in turn, perform a set of steps which could include extracting a portion of the biological sample (i.e., the testing portion) from the container using a pipettor, and placing that portion into a reaction vessel to be mixed with an appropriate reagent and otherwise processed to determine if the metabolite was present. Once the first testing portion has been extracted 201, a primary test can be performed 202 on the first testing portion. For example, in the case of using an immunoassay analyzer 108-2 to test for a drug metabolite, this may be done by mixing the testing portion in the reaction vessel with one or more reagents to bind the metabolite to a detectable marker, washing out the unbound material from the testing portion, and then detecting the markers which remained in order to determine the amount (if any) of the metabolite in the testing portion. Other types of testing activities are also possible, and may be performed depending on the nature of the test ordered for the sample (e g., flowing a testing portion through a flow cell, in the case of a test run using a hematology analyzer 108-1).

[0020] As shown in FIG. 2, a method for performing tests on a biological sample may also include preparing 203 a preservation container for the biological sample. This may be done by, for example, removing 204 liquid from the sample and placing 205 that liquid into a separate container (i.e., the preservation container). The preservation container may then be routed to a storage area where it could be maintained so that material would be available for later tests even if the remainder of the biological sample is unavailable.

[0021] Subsequently, after the primary test has been performed 202, the method of FIG. 2 continues with the laboratory automation system 102 obtaining 206 an order to perform a follow up test on the biological sample. For example, a rules engine in either the middleware system 103 orthe laboratory information system 101 or on the controller 110 of the laboratory automation system 102, or a physician using an interface presented by the laboratory information system 101 or the middleware system 103 or the laboratory automation system 102, may determine that, based on the result of the primary test, a follow up test needs to be run. This may be, for example, simply repeating the primary test (a rerun), which could be appropriate if the primary test provided a result outside of an expected range and repeating that test would increase the confidence that the result was correct rather than a reflection of an error or some other type of anomaly in the testing process. Alternatively, the follow up test may be a different test generated at a laboratory information system, a laboratory automation system, or a middleware system, either automatically by a rules engine (a reflex test), or ordered by a physician (an add on test), as may be the case where the result of the primary test indicated an elevated risk of a certain condition, and a follow up test was desired to confirm (or disconfirm) that the patient from whom the biological sample was obtained actually did have the condition in question. Once the test had been determined, the laboratory automation system 102 may obtain it through the system on which it was determined (e.g., the middleware system or the laboratory information system, if it wasn’t determined by the laboratory automation system itself) sending it to the laboratory automation system 102 and the laboratory automation system receiving it on a network connection and storing it in memory of the controller 110 where it could be processed. Alternatively, if the order for the follow up test was generated locally at the laboratory automation system, then “obtaining” the follow up test order may be performed by the follow up test order’s generation.

[0022] Turning now to that processing, once a follow up test order had been obtained 206, the laboratory automation system 102 may, based on the execution of instructions stored in a non- transitory computer readable medium such as the memory of its controller 110, make 207 a container determination comprising determining a container from which a portion of the biological sample to use in the follow up test (i.e., a second testing portion) should be extracted. To illustrate how this container determination may take place, consider FIG. 3, which depicts a process which could be used for that purpose. Initially, in the process of FIG. 3, a check 301 could be made of whether a first condition is satisfied, where the first condition is that the follow up test is a rerun of the primary test. If the first condition is satisfied, then the containerdetermination could comprise determining 302 that the second testing portion should be extracted from the first container. That is, if the first test had been performed on a portion of the biological sample extracted from the container in which the biological sample was originally provided, then a second portion should be extracted from the container in which the biological sample was originally provided, while if the first test had been performed on a portion of the biological sample extracted from a different container (e.g., a container in which it had been placed by an aliquoter), then the second testing portion should be extracted from the different container rather than the container in which the biological sample was originally provided to the laboratory automation system.

[0023] Continuing with the process of FIG. 3, if the follow up test is not a rerun, then a second check 303 could be made of whether a set of rules engine rules for a rules engine on the laboratory automation system (e.g., resident in the controller 110) specify the container from which the second testing portion should be extracted. For example, to reduce the risk that a low sensitivity test may contaminate subsequent higher sensitivity tests, a rule may be defined to create an aliquot when a low sensitivity test is ordered so that the low sensitivity test can be run on the aliquot and subsequent (potentially higher sensitivity tests) could be run on other tubes. An example of such a rule would be:IF (test type of test == chemistry) THEN aliquot.In such a case (and considering only the above rule), then if the follow up test was a chemistry test, then the second check 303 could be treated as being satisfied, while if the follow up test was not a chemistry test, then the second check 303 could be treated as not having been satisfied.

[0024] If the set of rules engine rules did specify the container from which the second testing portion should be extracted, then the container determination could comprise determining 304 that the second portion should be extracted from the container specified by the rules. Additionally, and depending on the rule in question, additional acts may be performed as well. For example, in the case of the rule stating that follow up immunoassay tests (other than reruns) should be performed on a separate aliquot, then the laboratory automation system 102 may also performa set of aliquoting tasks 401 as shown in FIG. 4. These tasks may include moving 402 (e.g., using an aliquoter 107) an aliquot of the biological sample from the first container (i.e., a container from which a testing portion had already been extracted, which may be, for example the primary container) to the second container (i.e., the container from which the second testing portion would be extracted). A label comprising a unique identifier for the second container (e.g., a numeric identifier encoded in a barcode) could then be added 403 to the second container, and a message correlating the unique identifier for the second container with a similar unique identifier for the first container (i.e., the container from which the biological sample would be moved into the second container) could be sent 404 to the middleware system. This may enable the laboratory automation system 102 to send 405 the result of the follow up test to the middleware system 103 using the unique identifier for the second container, as the middleware system 103 could correlate the unique identifier for the second container with the unique identifier for the first container and then send 406 the result of the follow up test to the laboratory information system 101 using the unique identifier of the first container.

[0025] Continuing with the discussion of FIG. 3, if the follow up test is not a rerun and the container from which the second testing portion should be extracted was not specified by rules engine rules, a further check 305 could be made of whether a preservation container had been created. If it had, then the container determination could comprise determining 306 that the second testing portion should be extracted from the preservation container. Otherwise, as a default, the container determination could comprise determining 307 that the second portion should be extracted from the primary container - i.e., the container in which the sample had originally been provided to the laboratory automation system.

[0026] Returning now to FIG. 2, after the container determination had been made 207, the second testing portion could be extracted 208 based on the container determination. For example, if the container determination indicated that the second testing portion should be extracted from a new container created after aliquoting the biological sample, then the new container could be routed to the analytical instrument which would perform the follow up test, and that instrument could then extract 208 the second testing portion for the test’s actual performance. Alternatively, if the container determination indicated that the second testing portion shouldbe extracted from the same container as the first testing portion, or from a preservation container, then that container could be routed to the appropriate analytical instrument (e.g., removed from storage and sent to via the track or, if it was already on the track, such as if it was a content preservation container and it was en route to storage, being redirected to the appropriate analytical instrument) so that that instrument could extract 208 and process the second testing portion. Finally, after the second testing portion had been extracted 208, then that testing portion could be used to perform 209 the follow up test.

[0027] Methods for performing tests on a biological sample where the tests include both primary and follow up tests may also vary from that shown in FIG. 1 and discussed above. For example, as noted above, a laboratory automation system 102 may include error detecting functionality, such as a camera or other volume detector which could determine that a biological sample in a container was not sufficient to perform an ordered test. In some cases, this functionality could be integrated in a method for performing tests which include primary and follow up tests. For example, as shown in FIG. 5, after a container determination is made 207, a laboratory automation system 102 may confirm 501 that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted (e.g., by testing the volume of material in such container, or, in a case where the container determination determined that the second testing portion should be extracted from a second container, confirming that there was even enough material available for the second container to be created). If it was confirmed that the follow up test could be performed with this material, then the second testing portion may be extracted 208 and the follow up test may be performed 209 on the second testing portion. Alternatively, if the follow up test could not be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, then the laboratory automation system may prevent 502 the follow up test from being performed with that material. For instance, it may send a command to the analytical instrument which would perform the follow up test instructing it not to extract 208 the second testing portion or otherwise proceed with the follow up test, it may simply not divert the container to the analytical instrument and / or not instruct the analytical instrument to proceed with thefollow up test. The laboratory automation system 102 may also route 503 the container from which the second testing portion would have been extracted to the error region.

[0028] Other variations are also possible, and will be immediately apparent to those of skill in the art in light of this disclosure. Accordingly, the above examples, figures, descriptions and variations should be understood as being illustrative only, and should not be treated as implying limitations on the protection provided by this document or any related document. To illustrate the potential for further variations, the following examples are provided of non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.

[0029] Example 1

[0030] A method for performing tests on a biological sample, the method comprising: a) performing a first test on a first testing portion of the biological sample, the first testing portion being contained in a first container; b) obtaining an order to perform a follow up test on the biological sample; c) making, based on the execution of a set of computer executable instructions stored on a non-transitory computer readable medium, a container determination, wherein making the container determination comprises determining a container from which a second testing portion of the biological sample should be extracted; and d) performing the follow up test on the second testing portion.

[0031] Example 2

[0032] The method of example 1, wherein making the container determination comprises, in the event that a first condition is satisfied, determining that the second testing portion should be extracted from the first container based on the first condition being satisfied, wherein the first condition is the follow up test is a rerun of the first test.

[0033] Example 3

[0034] The method of example 2, wherein making the container determination comprises, in the event that the first condition is not satisfied, determining whether a second condition is met, wherein the second condition is the set of rules engine rules specify the container from which the second testing portion should be extracted.

[0035] Example 4

[0036] The method of example 3, wherein a) the method comprises preparing a preservation container for the biological sample by performing acts comprising: i) removing liquid from the biological sample; and ii) placing the liquid removed from the biological sample in the preservation container; and b) making the container determination comprises, in the event that the first condition is not satisfied and the second condition is not satisfied, determining that the second testing portion should be extracted from the preservation container.

[0037] Example 5

[0038] The method of example 3, wherein making the container determination comprises, in the event that the first condition is not satisfied and the second condition is not satisfied and a third condition is not satisfied, determining that the second testing portion should be extracted from a primary container, and wherein the third condition is a preservation container has been prepared for the biological sample prior to making the container determination.

[0039] Example 6

[0040] The method of example 3, wherein: a) the set of rules engine rules comprise a rule requiring creation of an aliquot container for the second test; and b) the method comprises creating the aliquot container for the second test.

[0041] Example 7

[0042] The method of example 3, wherein: a) the acts of: i) performing the first test; ii) making the container determination; and iii) performing the follow up test; are all performed by a laboratory automation system; b) making the container determination comprises determining that the second testing portion should be extracted from a second container; and c) the method comprises: i) performing a set of aliquoting tasks comprising: A) moving an aliquot of the biological sample from the first container to the second container; B) adding a label to the second container, wherein the label comprises a unique identifier for the second container; and C) sending a message to a remotely located middleware system correlating the unique identifier for the second container and a unique identifier for the first container; and ii) the laboratory automation system sending a result of the follow up test to the remotely located middleware system using the unique identifier for the second container; and iii) the remotely located middleware system sending the result of the follow up test to a remotely located laboratory information system using the unique identifier for the first container.

[0043] Example 8

[0044] The method of example 7, wherein the set of aliquoting tasks are performed based on the container determination being the second testing portion should be extracted from the second container.

[0045] Example 9

[0046] The method of any of examples 7-8, wherein: a) determining that the second testing portion should be extracted from the second container is performed by evaluating the set of rules engine rules using a local rules engine comprised by the laboratory automation system; and b) the method comprises, prior to making the container determination, using a rules enginelocated remotely from the laboratory automation system, determining that the follow up test should be performed.

[0047] Example 10

[0048] The method of example 9, wherein: a) the method further comprises the laboratory automation system, after making the container determination, executing instructions to confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted; b) the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted.

[0049] Example 11

[0050] The method of example 10, wherein a) the instructions to confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted comprise instructions for confirming, in the event that the container determination determines that the second testing portion should be extracted from a second container after an aliquot has been moved to the second container, that: i) there is sufficient sample volume for the aliquot to be moved to the second container; and ii) for the second testing portion to be extracted from the aliquot in the second container; b) the instructions to prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted comprise instructions to, in the event that: i) the container determination determines that the second testing portion should be extracted from the second container after the aliquot has been moved from the first container to the second container; and ii) the laboratory automation system does not confirm that the first container contains sufficient sample volume for the aliquot to be moved from the first containerto the second container; preventing the aliquot from being moved from the first container to the second container.

[0051] Example 12

[0052] The method of example 10, wherein the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, route the container from which the container determination determined that the second testing portion should be extracted to an error region of the laboratory automation system.

[0053] Example 13

[0054] The method of any of examples 1-12, wherein: a) performing the first test on the first testing portion comprises extracting the first testing portion from the first container; and b) performing the follow up test on the second testing portion comprises extracting the second testing portion based on the container determination.

[0055] Example 14

[0056] The method of any of examples 1-13, wherein the method comprises, prior to performing the first test on the first testing portion of the biological sample, moving an aliquot of the biological sample from a primary container to the first container.

[0057] Example 15

[0058] A system comprising: a) a laboratory information system; b) a laboratory automation system located remotely from the laboratory information system and comprising an aliquoter and one or more analytical instruments; c) a middleware system disposed remotely from the laboratory automation system and the laboratory information system on a network path between the laboratory automation system and the laboratory information system; wherein the laboratory automation system is configured to perform a method for performing tests, the method comprising: A) performing a primary test on the first testing portion of the biological sample,the first testing portion being contained in a first container; B) obtaining an order to perform a follow up test on the biological sample; C) making a container determination, wherein making the container determination comprises determining a container from which a second testing portion should be extracted; and D) performing the follow up test on the second testing portion.

[0059] Example 16

[0060] The system of example 15, wherein making the container determination comprises, in the event that a first condition is satisfied, determining that the second testing portion should be extracted from the first container based on the first condition being satisfied, wherein the first condition is the follow up test is a rerun of the primary test.

[0061] Example 17

[0062] The system of example 16, wherein making the container determination comprises, in the event that the first condition is not satisfied, determining whether a second condition is met, wherein the second condition is a set of rules engine rules specify the container from which the second testing portion should be extracted.

[0063] Example 18

[0064] The system of example 17, wherein: a) the method for performing tests comprises preparing a preservation container for the biological sample by performing acts comprising: i) removing liquid from the biological sample; and ii) placing the liquid removed from the biological sample in the preservation container; and b) making the container determination comprises, in the event that the first condition is not satisfied and a second condition is not satisfied, determining that the second testing portion should be extracted from the preservation container.

[0065] Example 19

[0066] The system of example 17, wherein making the container determination comprises, in the event that the first condition is not satisfied and the second condition is not satisfied and a third condition is not satisfied, determining that the second testing portion should be extracted froma primary container, and wherein the third condition is a preservation container has been prepared for the biological sample prior to making the container determination.

[0067] Example 20

[0068] The system of example 17, wherein: a) the set of rules engine rules comprise a rule requiring creation of an aliquot container for the second test; and b) the method for performing tests comprises creating the aliquot container for the second test.

[0069] Example 21

[0070] The system of example 17, wherein: a) the laboratory automation system is configured to, in the event that making the container determination comprises determining that the second testing portion should be extracted from a second container: i) perform a set of aliquoting tasks comprising: A) moving an aliquot of the biological sample from the first container to the second container; B) adding a label to the second container, wherein the label comprises a unique identifier for the second container; and C) sending a message to the middleware system correlating the unique identifier for the second container and a unique identifier for the first container; ii) send a result of the follow up test to the middleware system using the unique identifier for the second container; and b) the middleware system is configured to, based on receiving the result of the follow up test sent using the unique identifier for the second container, send the result of the follow up test to the laboratory information system using the unique identifier for the first container.

[0071] Example 22

[0072] The system of any of examples 20-21, wherein: a) the laboratory automation system is configured to determine that the second testing portion should be extracted from the second container by evaluating the set of rules engine rules using a local rules engine comprised by the laboratory automation system; and b) the system comprises a remotely located rules engine configured with rules operable to determine whether the follow up test should be performed, wherein the remotely located rules engine is resident on the laboratory information system or the middleware system.

[0073] Example 23

[0074] The system of example 22, wherein: a) the laboratory automation system is configured to, after making the container determination, confirming that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted; b) the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted.

[0075] Example 24

[0076] The system of example 23, wherein: a) the instructions to confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted comprise instructions for confirming, in the event that the container determination determines that the second testing portion should be extracted from a second container after an aliquot has been moved to the second container, that: i) there is sufficient sample volume for the aliquot to be moved to the second container; and ii) for the second testing portion to be extracted from the aliquot in the second container; b) the instructions to prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted comprise instructions to, in the event that: i) the container determination determines that the second testing portion should be extracted from the second container after the aliquot has been moved from the first container to the second container; and ii) the laboratory automation system does not confirm that the first container contains sufficient sample volume for the aliquot to be moved from the first container to the second container; preventing the aliquot from being moved from the first container to the second container.

[0077] Example 25

[0078] The system of example 23, wherein the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, route the container from which the container determination determined that the second testing portion should be extracted to an error region of the laboratory automation system.

[0079] Example 26

[0080] The system of any of examples 15-25, wherein: a) performing the first test on the first testing portion comprises extracting the first testing portion from the first container; and b) performing the follow up test on the second testing portion comprises extracting the second testing portion based on the container determination.

[0081] Example 27

[0082] The system of any of examples 15-26, wherein the method for performing tests comprises, prior to performing the first test on the first testing portion of the biological sample, moving an aliquot of the biological sample from a primary container to the first container.

[0083] Each of the calculations or operations described herein may be performed using a computer or other processor having hardware, software, and / or firmware. The various method steps may be performed by modules, and the modules may comprise any of a wide variety of digital and / or analog data processing hardware and / or software arranged to perform the method steps described herein. The modules optionally comprising data processing hardware adapted to perform one or more of these steps by having appropriate machine programming code associated therewith, the modules for two or more steps (or portions of two or more steps) being integrated into a single processor board or separated into different processor boards in any of a wide variety of integrated and / or distributed processing architectures. These methods and systems will often employ a tangible media embodying machine-readable code with instructions for performing the method steps described above. Suitable tangible media may comprise a memory (including a volatile memory and / or a non-volatile memory), a storagemedia (such as a magnetic recording on a floppy disk, a hard disk, a tape, or the like; on an optical memory such as a CD, a CD-R / W, a CD-ROM, a DVD, or the like; or any other digital or analog storage media), or the like.

[0084] All patents, patent publications, patent applications, journal articles, books, technical references, and the like discussed in the instant disclosure are incorporated herein by reference in their entirety for all purposes.

[0085] Different arrangements of the components depicted in the drawings or described above, as well as components and steps not shown or described are possible. Similarly, some features and sub-combinations are useful and may be employed without reference to other features and subcombinations. Embodiments have been described for illustrative and not restrictive purposes, and alternative embodiments will become apparent to readers of this patent. In certain cases, method steps or operations may be performed or executed in differing order, or operations may be added, deleted or modified. It can be appreciated that, in certain aspects, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to provide an element or structure or to perform a given function or functions. Except where such substitution would not be operative to practice certain embodiments of the invention, such substitution is considered within the scope of the invention. Accordingly, the claims should not be treated as limited to the examples, drawings, embodiments and illustrations provided above, but instead should be understood as having the scope provided when their terms are given their broadest reasonable interpretation as provided by a general-purpose dictionary, except that when a term or phrase is indicated as having a particular meaning under the heading Explicit Definitions, it should be understood as having that meaning when used in the claims.

[0086] Explicit Definitions

[0087] It should be understood that, in the above examples and the claims, a statement that something is “based on” something else should be understood to mean that it is determined at least in part by the thing that it is indicated as being based on. To indicate that something must becompletely determined based on something else, it is described as being “based EXCLUSIVELY on” whatever it must be completely determined by.

[0088] It should be understood that, in the above examples and claims, the term “set” should be understood as one or more things which are grouped together.

[0089] It should be understood that adjectives such as “first,” “second,” “primary” and “secondary” are used for identification purposes only, and are not intended to imply substantive requirements. For example, a statement that something is a “first” test on a sample should not be understood as implying that there were no tests performed on that sample prior to the “first” test. Similarly, a statement that a test is a “second” test on a sample should not be understood as implying that no tests were performed between that test and a “first” test.

[0090] It should be understood that a statement that one component is “remotely located” from another means that the two components are at locations which are separated from each other by a wide area network. For example, a statement that a middleware system is remotely located from a laboratory automation system should be understood as meaning that the middleware system is at a different location than the laboratory automation system and communicates with the laboratory automation system over a wide area network. Similarly, a statement that a laboratory information system is remotely located from a middleware system should be understood as meaning that the middleware system is at a different location than the laboratory information system and communications with the laboratory information system over a wide area network.

Claims

What is claimed is:

1. A method for performing tests on a biological sample, the method comprising: a) performing a first test on a first testing portion of the biological sample, the first testing portion being contained in a first container; b) obtaining an order to perform a follow up test on the biological sample; c) making, based on the execution of a set of computer executable instructions stored on a non-transitory computer readable medium, a container determination, wherein making the container determination comprises determining a container from which a second testing portion of the biological sample should be extracted; and d) performing the follow up test on the second testing portion.

2. The method of claim 1, wherein making the container determination comprises, in the event that a first condition is satisfied, determining that the second testing portion should be extracted from the first container based on the first condition being satisfied, wherein the first condition is the follow up test is a rerun of the first test.

3. The method of claim 2, wherein making the container determination comprises, in the event that the first condition is not satisfied, determining whether a second condition is met, wherein the second condition is a set of rules engine rules specify the container from which the second testing portion should be extracted.

4. The method of claim 3, wherein: a) the method comprises preparing a preservation container for the biological sample by performing acts comprising: i) removing liquid from the biological sample; and ii) placing the liquid removed from the biological sample in the preservation container; andb) making the container determination comprises, in the event that the first condition is not satisfied and the second condition is not satisfied, determining that the second testing portion should be extracted from the preservation container.

5. The method of claim 3, wherein making the container determination comprises, in the event that the first condition is not satisfied and the second condition is not satisfied and a third condition is not satisfied, determining that the second testing portion should be extracted from a primary container, and wherein the third condition is a preservation container has been prepared for the biological sample prior to making the container determination.

6. The method of claim 3, wherein: a) the set of rules engine rules comprise a rule requiring creation of an aliquot container for the second test; and b) the method comprises creating the aliquot container for the second test.

7. The method of claim 3, wherein: a) the acts of: i) performing the first test; ii) making the container determination; and iii) performing the follow up test are all performed by a laboratory automation system; b) making the container determination comprises determining that the second testing portion should be extracted from a second container; and c) the method comprises: i) performing a set of aliquoting tasks comprising:A) moving an aliquot of the biological sample from the first container to the second container;B) adding a label to the second container, wherein the label comprises a unique identifier for the second container; andC) sending a message to a remotely located middleware system correlating the unique identifier for the second container and a unique identifier for the first container; and ii) the laboratory automation system sending a result of the follow up test to the remotely located middleware system using the unique identifier for the second container; and iii) the remotely located middleware system sending the result of the follow up test to a remotely located laboratory information system using the unique identifier for the first container.

8. The method of claim 7, wherein the set of aliquoting tasks are performed based on the container determination being the second testing portion should be extracted from the second container.

9. The method of claim 7, wherein: a) determining that the second testing portion should be extracted from the second container is performed by evaluating the set of rules engine rules using a local rules engine comprised by the laboratory automation system; and b) the method comprises, prior to making the container determination, using a rules engine located remotely from the laboratory automation system, determining that the follow up test should be performed.

10. The method of claim 9, wherein: a) the method further comprises the laboratory automation system, after making the container determination, executing instructions to confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted;b) the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted.

11. The method of claim 10, wherein: a) the instructions to confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted comprise instructions for confirming, in the event that the container determination determines that the second testing portion should be extracted from a second container after an aliquot has been moved to the second container, that: i) there is sufficient sample volume for the aliquot to be moved to the second container; and ii) for the second testing portion to be extracted from the aliquot in the second container; b) the instructions to prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted comprise instructions to, in the event that: i) the container determination determines that the second testing portion should be extracted from the second container after the aliquot has been moved from the first container to the second container; and ii) the laboratory automation system does not confirm that the first container contains sufficient sample volume for the aliquot to be moved from the first container to the second container;preventing the aliquot from being moved from the first container to the second container.

12. The method of claim 10, wherein the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, route the container from which the container determination determined that the second testing portion should be extracted to an error region of the laboratory automation system.

13. The method of claim 1, wherein: a) performing the first test on the first testing portion comprises extracting the first testing portion from the first container; and b) performing the follow up test on the second testing portion comprises extracting the second testing portion based on the container determination.

14. The method of example 1 , wherein the method comprises, prior to performing the first test on the first testing portion of the biological sample, moving an aliquot of the biological sample from a primary container to the first container.

15. A system comprising: a) a laboratory information system; b) a laboratory automation system located remotely from the laboratory information system and comprising an aliquoter and one or more analytical instruments; c) a middleware system disposed remotely from the laboratory automation system and the laboratory information system on a network path between the laboratory automation system and the laboratory information system; wherein the laboratory automation system is configured to perform a method for performing tests, the method comprising:A) performing a primary test on the first testing portion of the biological sample, the first testing portion being contained in a first container;B) obtaining an order to perform a follow up test on the biological sample;C) making a container determination, wherein making the container determination comprises determining a container from which a second testing portion should be extracted; andD) performing the follow up test on the second testing portion.

16. The system of claim 15, wherein making the container determination comprises, in the event that a first condition is satisfied, determining that the second testing portion should be extracted from the first container based on the first condition being satisfied, wherein the first condition is the follow up test is a rerun of the primary test.

17. The system of claim 16, wherein making the container determination comprises, in the event that the first condition is not satisfied, determining whether a second condition is met, wherein the second condition is a set of rules engine rules specify the container from which the second testing portion should be extracted.

18. The system of claim 17, wherein: a) the method for performing tests comprises preparing a preservation container for the biological sample by performing acts comprising: i) removing liquid from the biological sample; and ii) placing the liquid removed from the biological sample in the preservation container; and b) making the container determination comprises, in the event that the first condition is not satisfied and a second condition is not satisfied, determining that the second testing portion should be extracted from the preservation container.

19. The system of claim 17, wherein making the container determination comprises, in the event that the first condition is not satisfied and the second condition is not satisfied and a third condition is not satisfied, determining that the second testing portion should be extracted from a primary container, and wherein the third condition is a preservation container has been prepared for the biological sample prior to making the container determination.

20. The system of claim 17, wherein: a) the set of rules engine rules comprise a rule requiring creation of an aliquot container for the second test; and b) the method for performing tests comprises creating the aliquot container for the second test.

21. The system of claim 17, wherein: a) the laboratory automation system is configured to, in the event that making the container determination comprises determining that the second testing portion should be extracted from a second container: i) perform a set of aliquoting tasks comprising:A) moving an aliquot of the biological sample from the first container to the second container;B) adding a label to the second container, wherein the label comprises a unique identifier for the second container; andC) sending a message to the middleware system correlating the unique identifier for the second container and a unique identifier for the first container; ii) send a result of the follow up test to the middleware system using the unique identifier for the second container; and b) the middleware system is configured to, based on receiving the result of the follow up test sent using the unique identifier for the second container, send the result ofthe follow up test to the laboratory information system using the unique identifier for the first container.

22. The system of claim 21, wherein: a) the laboratory automation system is configured to determine that the second testing portion should be extracted from the second container by evaluating the set of rules engine rules using a local rules engine comprised by the laboratory automation system; and b) the system comprises a remotely located rules engine configured with rules operable to determine whether the follow up test should be performed, wherein the remotely located rules engine is resident on the laboratory information system or the middleware system.

23. The system of claim 22, wherein: a) the laboratory automation system is configured to, after making the container determination, confirming that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted; b) the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted.

24. The system of claim 23, wherein: a) the instructions to confirm that the follow up test can be performed using material extracted from the container from which the container determination determinedthat the second testing portion should be extracted comprise instructions for confirming, in the event that the container determination determines that the second testing portion should be extracted from a second container after an aliquot has been moved to the second container, that: i) there is sufficient sample volume for the aliquot to be moved to the second container; and ii) for the second testing portion to be extracted from the aliquot in the second container; b) the instructions to prevent the follow up test from being performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted comprise instructions to, in the event that: i) the container determination determines that the second testing portion should be extracted from the second container after the aliquot has been moved from the first container to the second container; and ii) the laboratory automation system does not confirm that the first container contains sufficient sample volume for the aliquot to be moved from the first container to the second container; preventing the aliquot from being moved from the first container to the second container.

25. The system of claim 23, wherein the laboratory automation system is configured with instructions operable to, in the event that it does not confirm that the follow up test can be performed using material extracted from the container from which the container determination determined that the second testing portion should be extracted, route the container from which the container determination determined that the second testing portion should be extracted to an error region of the laboratory automation system.

26. The system of claim 15, wherein:a) performing the first test on the first testing portion comprises extracting the first testing portion from the first container; and b) performing the follow up test on the second testing portion comprises extracting the second testing portion based on the container determination.

27. The system of claim 15, wherein the method for performing tests comprises, prior to performing the first test on the first testing portion of the biological sample, moving an aliquot of the biological sample from a primary container to the first container.

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