Laboratory Sample Delivery and Proxy Systems

Abstract

A method for delivering a medical sample and a digital laboratory request from an extraction site to a testing laboratory. The method includes checking the availability of a test to be performed on the medical sample at a first testing laboratory during a specific time period. If the test cannot be performed at the first testing laboratory during the specific time period, the laboratory properties available at multiple testing laboratories are checked by multiple laboratory proxy devices that are communicatively connected by a communication network. A suitable candidate testing laboratory can be identified from the multiple testing laboratories based on the laboratory properties of the suitable candidate testing laboratory. The identified suitable candidate testing laboratory communicates with the first testing laboratory about the feasibility of the suitable candidate testing laboratory performing the test on the medical sample. If it is feasible to perform the test at the suitable candidate testing laboratory, the medical sample and the digital laboratory request are delivered to the suitable candidate testing laboratory for testing.

Description

Technical Field

[0001] The present disclosure generally relates to a laboratory agent system for delivering medical samples to a testing laboratory. Background Art

[0002] Typically, after a medical sample is drawn from a patient at a general practitioner's office, a courier picks up the medical sample and delivers it to a centralized testing laboratory. The courier typically delivers the medical sample to the same centralized testing laboratory location using the same route. The courier typically does not attempt to optimize time and resources when delivering the medical sample to the centralized testing laboratory. As a result, the medical sample may not be delivered to the most appropriate laboratory or the laboratory with the highest availability for testing the medical sample.

[0003] Furthermore, if the required test cannot be performed on the medical sample at the centralized testing laboratory after the courier delivers the medical sample, the medical sample may have to wait for the required test to be available, and the test result may be delayed. Therefore, if it is a time- or temperature-sensitive test, the quality of the test result may be affected.

[0004] Therefore, when a courier picks up a medical sample from a medical institution, the medical sample needs to be transferred / delivered to the nearest, most available laboratory. Summary of the invention

[0005] The present disclosure proposes the use of a laboratory proxy component within a laboratory. This laboratory proxy component can be connected to other laboratory proxy components in a test laboratory network to share data, such as the number of orders to be tested for a specific test at a specific test laboratory, i.e., the availability of a specific test at a specific test laboratory. In one embodiment, the test laboratory network can be a private laboratory chain. Such private laboratory chains typically have test laboratories that are specialized in a specific area, and the test laboratories can be dispersed throughout a geographic area to cover as many areas as possible to reduce delivery costs. In another embodiment, the test laboratory network can be a public test laboratory in a public healthcare system. The laboratory proxy component can also take into account the number of laboratories available in a private laboratory chain or a public healthcare system.

[0006] If a particular test cannot be performed at a particular test lab, the lab proxy component may communicate with other lab proxy components at other test labs in the network to determine whether other test labs may have availability to perform the particular test that the original test lab cannot perform.

[0007] Other testing laboratories in the network that have availability to perform the test may publish key service characteristics of their laboratories to the original testing laboratory through the laboratory proxy component system. Such key service characteristics may be, for example, the geographical location of the testing laboratory, travel time to transport the sample to the testing laboratory, cost / price of the test at the testing laboratory, testing capacity of the testing laboratory (i.e., number of tests performed per day), turnaround time (TAT) to get test results from the laboratory, time to receive test results, type of quality control (QC) used, QC precision and accuracy versus QC precision and accuracy of other laboratories, inter-laboratory QC procedures, Six Sigma rating, pre-analytical instrument qualification, post-analytical instrument qualification, and / or validation type.

[0008] After a suitable candidate testing laboratory is identified, the corresponding lab agent components begin communicating with each other. If it is determined that it is feasible for the candidate testing laboratory to perform the required test, the test order and medical sample are sent to the candidate laboratory. Both the test request and the results are sent independently of the laboratory solution. The Integrated Healthcare Enterprise (IHE) Pathology and Laboratory Medicine (PaLM) domain can define inter-laboratory workflow (ILW) profiles that can be used for interaction.

[0009] Additionally, a lab agent component may use its own proprietary communication logic, which may be the same communication logic as all other lab agent components. The IHE Palm domain may define a laboratory-to-laboratory code set distribution (LSCD) profile that may be used to share common terminology, such as available test sets and test and observation codes, between different lab agent components involved in this communication logic.

[0010] The present disclosure also provides a method for delivering a medical sample with a digital laboratory request from an extraction site to a test laboratory. The method may include checking the availability of a test to be performed on a medical sample at a first test laboratory during a specific time period, that is, whether the test can be performed on the medical sample during the time period. If the test cannot be performed at the first test laboratory during the specific time period, the laboratory properties available at multiple test laboratories are checked by connecting multiple laboratory agent components located in different test laboratories by a communication network. Then, based on the laboratory properties of the suitable candidate test laboratory, a suitable candidate test laboratory can be identified in multiple test laboratories. The suitable candidate test laboratory and the first test laboratory communicate about the feasibility of the suitable candidate test laboratory to perform the test on the medical sample. If it is feasible to perform the test at the suitable candidate test laboratory, the medical sample and the digital laboratory request are delivered to the suitable candidate test laboratory for testing. After the suitable candidate test laboratory performs the test on the medical sample, the laboratory test result is transmitted to the extraction site in a digital manner.

[0011] However, if it is not feasible to perform the test at a suitable candidate test lab, lab properties available at remaining test labs among the plurality of test labs may be rechecked through a plurality of lab agent components located in the test labs in the network.

[0012] The multiple lab proxy components communicate using a shared common nomenclature and communication standards, such as HL7v2.5 Chapter 13: Clinical Laboratory Automation or HL7 FHIR Version 4: Diagnostic Medicine Module. The shared common nomenclature and communication standards use interoperability profiles defined in the IHE PaLM domain, such as Interlaboratory Workflow (ILW) or Laboratory Code Set Distribution (LCSD). ILW supports workflow of orders and results through subcontracted laboratories. LCSD distributes managed clinical laboratory code sets, such as test suites, tests, and observation codes. The multiple lab proxy components can also dynamically communicate with management and reimbursement systems associated with the testing of medical samples over the communication network.

[0013] When a medical sample is picked up from a drawing site, a portable lab agent component installed on a personal portable device (e.g., a smartphone or tablet) may be used in transit to check the availability of tests to be performed on the medical sample at a first testing laboratory during a specific time period.

[0014] The laboratory attributes of the testing laboratory may include at least one of the following: the geographic location of the testing laboratory, the time to travel to the testing laboratory, the cost / price of testing at the testing laboratory, the testing capacity of the testing laboratory (i.e., the number of tests performed per day), the time to receive test results, the type of quality control (QC) used, the QC precision and accuracy compared to the QC precision and accuracy of other laboratories, the inter-laboratory QC procedures, Six Sigma rating, pre-analytical instrument qualification, post-analytical instrument qualification, and / or the type of validation.

[0015] The feasibility of suitable candidate testing laboratories may also be based on future predicted capacity at suitable candidate testing laboratories.

[0016] The centralized testing laboratory may also medically verify the test results and / or provide medical advice based on the qualifications and authority of the centralized testing laboratory.

[0017] The present disclosure also provides a system for delivering a medical sample from a first location to a testing laboratory. The system includes a first laboratory proxy component and a plurality of laboratory proxy components. Each laboratory proxy component can be resident in the testing laboratory. The system also includes a communication network communicatively connected to the first laboratory proxy component and the plurality of laboratory proxy components. The first laboratory proxy component and the plurality of laboratory proxy components are configured to transmit laboratory attributes through the communication network to determine an available testing laboratory suitable for testing the medical sample.

[0018] The first lab agent component may be a mobile application installed on a portable smart device or tablet device.

[0019] The first laboratory agent component is portable and is positioned upon delivery of a medical sample.

[0020] In some embodiments, the first lab-agent component can operate fully automatically.

[0021] In other embodiments, the first laboratory component may be configured with pre-existing conditions required for the appropriate laboratory attributes. The pre-existing conditions are geographic location, type of quality control used, and / or quality control validation.

[0022] The first site may be a point of care (POC) setting, a laboratory, a medical clinic, or a physician's office.

[0023] The system further includes an external database connected to the plurality of lab agent components and configured to collect usage patterns of the plurality of lab agent components. The usage patterns include the number of tests performed and the number of reagents consumed at the test laboratory.

[0024] There are several advantages to using the lab proxy component system. The first advantage is that if the required test cannot be performed at the original testing laboratory for some reason, the lab proxy component can be used to find another testing laboratory, and the medical sample can be quickly transported by the courier to the appropriate testing laboratory and the required test results can be obtained.

[0025] Second, the lab proxy component system can be used to quickly find a testing laboratory that has specialized tests that can only be performed at a specific testing laboratory, thereby reducing shipping requirements and costs and making the testing of medical samples more efficient.

[0026] Third, based on the required tests and the workload of the original testing laboratory, some medical samples can be dynamically subcontracted to other testing laboratories in the network, thereby improving testing efficiency. In addition, the management and reimbursement associated with the testing of medical samples can also be dynamically allocated by the laboratory agent component system, which can also improve the efficiency of these allocations.

[0027] Fourth, if abnormal test results are returned from a specific testing instrument device in a testing laboratory, that is, if there is doubt about the quality of these test results, the medical sample can be delivered to another testing laboratory in the network, and the required tests can be run again to verify the original test results, thereby improving the accuracy and validity of the test results of the medical sample.

[0028] Fifth, by determining the most appropriate testing laboratory to run the required tests on the medical sample, the logistics of the delivery system can be optimized and unnecessary work such as unpacking, sorting, repackaging and re-shipping of medical samples can be avoided if the medical samples need to be delivered to more than one testing laboratory, thereby saving time and reducing costs.

[0029] Sixth, if a testing lab has technical difficulties (e.g., a power outage at the testing lab), the courier will be informed by the lab agent component to avoid the testing lab until the technical difficulties are resolved (e.g., the testing lab has power restored). In addition, the courier may also avoid the testing lab if it is predicted that the testing lab does not have the capacity to perform the required tests at the time the medical sample is delivered.

[0030] Finally, depending on the urgency of receiving the results of the tests required for the medical samples, the courier's delivery route can be changed, and the order in which the medical samples are sent to the testing laboratory can be changed to take into account the urgency of the tests.

[0031] In another embodiment, the laboratory agent can not only optimize the delivery of medical samples to the testing laboratory, but the laboratory agent can also facilitate the delivery of laboratory consumables required for the tests performed on the medical samples throughout the laboratory network to the testing laboratory. This laboratory consumable can be any consumable used by the testing laboratory. Examples of laboratory consumables can be reagents and calibrators and / or sample tubes, sample wells or pipette tips and / or even sample containers or shipping boxes, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The following detailed description of specific embodiments of the present disclosure may be best understood when read in conjunction with the following drawings, in which like structures are represented by like reference numerals, and in which:

[0033] FIG. 1 illustrates a lab agent system utilizing an external database for data collection according to an embodiment of the present disclosure.

[0034] FIG. 2 shows a laboratory agent system according to another embodiment of the present disclosure.

[0035] FIG3 illustrates a lab agent system with a portable lab agent according to an embodiment of the present disclosure.

[0036] FIG4 schematically illustrates a flow chart of a method for delivering a medical sample from a extraction site to a testing laboratory according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0037] In the following detailed description of the embodiments, reference is made to the accompanying drawings which form a part thereof, and in which are shown, by way of illustration and not limitation, specific embodiments in which the present disclosure may be practiced. It should be understood that other embodiments may be utilized and that logical, mechanical, and electrical changes may be made without departing from the spirit and scope of the present disclosure.

[0038] Certain terms will be used in this patent application, and their expressions should not be interpreted as limited to the specific terms selected but rather as related to the general concept behind the specific terms.

[0039] "A" or "an" is used to describe the elements and components of the embodiments described herein. This is done only for convenience and to provide a general understanding of the concept of the present invention. The explanation should be understood to include one or at least one, and the singular includes the plural unless it is obvious that it has other meanings.

[0040] The terms "sample", "patient sample" and "biological sample" may refer to one or more materials that may contain a target analyte. Patient samples may be derived from any biological source, such as physiological fluids, including blood, saliva, ocular lens fluid, cerebrospinal fluid, sweat, urine, feces, semen, milk, ascites fluid, mucus, synovial fluid, peritoneal fluid, amniotic fluid, tissue, cultured cells, etc. Patient samples may be pretreated before use, such as preparing plasma from blood, diluting viscous fluids, lysing, etc. Processing methods may include filtration, distillation, concentration, inactivation of interfering components and addition of reagents. Patient samples can be used directly when obtained from the source, or can be used after pretreatment to change the characteristics of the sample. In some embodiments, the initial solid or semi-solid biological material can be made liquid by dissolving or suspending in a suitable liquid medium. In some embodiments, the sample may be suspected of containing a specific antigen or nucleic acid.

[0041] The term "analyte" may refer to a component of a medical sample to be analyzed, such as molecules of various sizes, ions, proteins, metabolites, etc. The information collected about the analyte can be used to evaluate the effects of drug administration on an organism or a specific tissue or to perform a diagnosis. Thus, "analyte" may refer to a general term for a substance about which information about its presence and / or concentration is intended to be obtained. Examples of analytes include glucose, coagulation parameters, endogenous proteins (e.g., proteins released by the myocardium), metabolites, nucleic acids, etc.

[0042] As used herein, the term "laboratory instrument" may include any device or device component operable to perform and / or cause to be performed one or more processing steps / workflow steps on one or more biological specimens and / or one or more reagents. Thus, the term "processing step" may refer to a physically performed processing step, such as centrifugation, aliquoting, sample analysis, etc. The term "instrument" may encompass pre-analytical instruments, post-analytical instruments, analytical instruments, and laboratory middleware.

[0043] As used herein, the term "post-analytical device" may include any device or device component that can be configured to perform one or more post-analytical processing steps / workflow steps, including but not limited to sample unloading, transport, re-capping, de-capping, temporary storage / buffering, archiving (whether refrigerated or not), retrieval and / or disposal.

[0044] As used herein, the term "pre-analytical instrument" may include any device or device component that can be configured to perform one or more pre-analytical processing steps / workflow steps, including but not limited to centrifugation, resuspension (e.g., by mixing or vortexing), capping, decapping, recapping, sorting, tube type identification, sample quality determination, and / or aliquoting steps. Such processing steps may also include adding chemicals or buffers to the sample, concentrating the sample, incubating the sample, etc.

[0045] As used herein, the term "analyzer" / "analytical instrument" may include any device or device assembly configured to obtain a measurement value. The analyzer may be operable to determine the parameter value of a sample or its components via various chemical, biological, physical, optical or other technical procedures. The analyzer may be operable to measure the parameters of a sample or at least one analyte and return the obtained measurement value. The possible analysis result list returned by the analyzer includes, but is not limited to: the concentration of the analyte in the sample, the digital (yes or no) result indicating the presence of the analyte in the sample (corresponding to the concentration above the detection level), optical parameters, DNA or RNA sequences, data obtained by mass spectrometry of proteins or metabolites, and various types of physical or chemical parameters. The analytical instrument may include a unit that helps to pipette, feed and mix samples and / or reagents. The analyzer may include a reagent holding unit that holds reagents used to perform the assay. Reagents may, for example, be arranged in the form of a container or box containing individual reagents or a group of reagents, placed in a suitable receptacle or position in a storage room or conveyor belt. It may include a consumables feeding unit. The analyzer may include a processing and detection system, and its workflow may be optimized for certain types of analysis. Examples of such analyzers are clinical chemistry analyzers, coagulation chemistry analyzers, immunochemistry analyzers, urine analyzers, nucleic acid analyzers, used to detect the results of a chemical or biological reaction or to monitor the progress of a chemical or biological reaction.

[0046] As used herein, the term "analysis" or "analytical test" may include laboratory procedures to produce parameters that characterize a biological / medical sample for the qualitative assessment or quantitative measurement of the presence or amount or functional activity of an analyte.

[0047] As used herein, the term "reagent" may refer to materials necessary for performing an analyte analysis, including reagents for sample preparation, control reagents, reagents for reacting with an analyte to obtain a detectable signal, and / or reagents necessary for testing an analyte. Such reagents may include reagents for separating an analyte and / or reagents for processing a sample and / or reagents for reacting with an analyte to obtain a detectable signal and / or washing reagents and / or diluents.

[0048] The terms "sample container", "sample rack" and "sample tube" may refer to any single container for storing, transporting and / or processing medical samples. Specifically, the term refers to a piece of laboratory glass or plastics, optionally including a cover at its upper end. The container includes an opening for dispensing liquid into / from the vessel. The opening can be closed in a liquid-tight manner by a cover, a frangible seal or a similar suitable device. Sample tubes (e.g., sample tubes for collecting blood) typically contain other substances, such as clot activators or anticoagulants, which have an impact on the processing of the sample. Therefore, different tube types can generally be suitable for pre-analytical requirements and analytical requirements of specific analyses (e.g., clinical chemistry analysis, blood analysis or coagulation analysis). Confusing sample tube types may make samples unusable for analysis. To prevent errors during sample collection and operation, sample covers of many tube manufacturers are coded according to fixed and uniform color schemes. Some sample tube types are additionally or alternatively characterized by specific tube sizes, cover sizes and / or tube colors. The dimensions of a tube include, for example, its height, its size and / or other characteristic shape properties.

[0049] A "data storage unit" or "database" may be a computing unit for storing and managing data, such as a memory, a hard disk or a cloud storage. This may relate to data about biological / medical samples processed by an automated system. The data management unit may be connected to an LIS (Laboratory Information System) and / or an HIS (Hospital Information System). The data management unit may be a unit within a laboratory instrument or a unit co-located with a laboratory instrument. It may be part of a laboratory middleware. Alternatively, the database may be a remotely located unit. For example, it may be embodied in a computer connected via a communication network.

[0050] The term 'communication network' as used herein may include any type of wireless network (such as WiFi™, GSM™, UMTS or other wireless digital networks) or a cable-based network (such as Ethernet™, etc.). In particular, the communication network may implement the Internet Protocol (IP). For example, the communication network may include a combination of a cable-based network and a wireless network.

[0051] As used herein, the term "remote system" or "server" may include any physical or virtual machine with a physical or virtual processor capable of receiving, processing, and sending data. A server may run on any computer, including a dedicated computer, which may also be generally referred to as a "server" alone or as a shared resource such as a virtual server. In many cases, a computer may provide several services and have several servers running. Thus, the term server may encompass any computerized device that shares resources with one or more client processes. In addition, the term "remote system" or "server" may include data transmission and processing systems distributed over a data network, such as a cloud environment.

[0052] First, referring to FIG. 1 , a lab agent system (10) is shown. The lab agent system (10) includes a plurality of test labs (100, 120, 140). Each of the plurality of test labs includes a lab agent component (110, 125). Each lab agent component (110, 125) communicates with each other via a communication network (115).

[0053] In one embodiment, a medical sample is drawn from a patient and delivered to a first testing laboratory within a plurality of testing laboratories (100, 120, 140), i.e., a centralized testing laboratory (100). For example, the extraction site (not shown) may be a doctor's office or a medical clinic. In another embodiment, the medical sample is drawn from the patient at the centralized testing laboratory (100) itself. Upon receiving the medical sample, the centralized testing laboratory (100) may determine whether the centralized testing laboratory (100) has the capacity or ability to complete the test order for the received medical sample within the time required to obtain accurate test results.

[0054] If it is determined that the test cannot be performed at the centralized test laboratory (100) during the specific time period, lab properties available at the plurality of test laboratories (120, 140) are checked by a plurality of lab proxy components (125) of the lab proxy component (110) communicatively connected to the centralized test laboratory (100) by a communication network (115).

[0055] The laboratory attributes checked by the laboratory agent component (110) include at least one of the following: geographic location of the testing laboratory, time to travel to the testing laboratory, available transportation to the laboratory, testing cost / price, testing capacity of the testing laboratory (i.e., number of tests per day), turnaround time (TAT) to get test results from the laboratory, time to receive test results at the testing laboratory, type of quality control (QC) used, QC precision and accuracy compared to QC precision and accuracy of other laboratories, inter-laboratory QC procedures, Six Sigma rating, pre-analytical instrument qualification, post-analytical instrument qualification, and / or validation type.

[0056] A suitable candidate testing laboratory (140) can then be identified among the plurality of testing laboratories (120, 140) based on the specific laboratory attributes of the suitable candidate testing laboratory (140). For example, each of the plurality of testing laboratories (120, 140) can be ranked based on the specific laboratory attributes possessed by each testing laboratory, i.e., the testing laboratory possessing the most laboratory attributes will be ranked highest. The suitable candidate testing laboratory (140) and the centralized testing laboratory (100) can then communicate via the communication network (115) regarding the feasibility of the suitable candidate testing laboratory (140) to perform the test on the medical sample within the desired time.

[0057] If it is feasible to perform the test at the appropriate candidate testing laboratory (140), the medical sample and the digital lab request are delivered to the appropriate candidate testing laboratory (140) for testing. The medical sample and the digital lab request may be delivered to the appropriate candidate testing laboratory 140 by delivery or any other known shipping delivery service. After the test is performed on the medical sample at the appropriate candidate testing laboratory 140, the lab test results may be digitally transmitted to the centralized testing laboratory (100) or the original extraction site via the communication network (115).

[0058] However, if it is determined that performing the required testing at a suitable candidate test laboratory (140) is not feasible at all, then the laboratory properties available at the remaining test laboratories (120) in the plurality of test laboratories (120) are re-examined by the plurality of lab proxy components (110, 125) until another potentially suitable test laboratory is identified. Alternatively, the second highest ranked test laboratory may be contacted until a suitable candidate test laboratory (140) is identified.

[0059] The multiple laboratory proxy components (110, 125) communicate over a communication network (115) using a shared common nomenclature and communication standard, such as HL7 v2.5 Chapter 13: Clinical Laboratory Automation or HL7 FHIR Version 4: Diagnostic Medicine Module. The shared common nomenclature and communication standard uses interoperability profiles defined in the IHE PaLM domain, such as Inter-Laboratory Workflow (ILW) or Laboratory Code Set Distribution (LCSD). ILW supports workflow of orders and results through subcontracted laboratories. LCSD distributes managed clinical laboratory code sets, such as test suites, test, and observation codes. The multiple laboratory proxy components (110, 125) can also dynamically communicate with management and reimbursement systems for testing of medical samples over the communication network (115).

[0060] In one embodiment, the centralized testing laboratory (100) or a suitable candidate testing laboratory (140) may medically verify the test results and / or provide medical advice based on the qualifications and authority of the centralized testing laboratory (100).

[0061] In one embodiment, the lab proxy component (110, 125) may be fully automated. In another embodiment, the lab proxy component (110, 125) may be configured with some pre-existing restrictions on which test labs (120) may be considered by the lab proxy component (125). For example, some pre-existing restrictions may be the geographic location of the test lab, the type of quality control used by the test lab, and the type of validation used by the test lab.

[0062] In one embodiment, the external database 130 may be connected to all lab agent components (110, 125) to collect information about the tests performed and statistics related to the tests performed from all test labs (100, 120) in the communication network (115). The collected information may then be used, for example, for learning purposes, such as test usage and reagent consumption at the test labs and / or the development of new commercial offers.

[0063] Figure 2 shows an embodiment where the extraction site (230) can be a point of care (POC) device, a laboratory, or any type of extraction site for a medical sample from a patient. In this embodiment, the extraction site (230) refers to the first site that handles a sample tube containing a medical sample.

[0064] The extraction site (230) may not be a testing laboratory in the traditional sense. Instead, the extraction site (230) may be a location such as a doctor's office (e.g., a general practitioner's office, an emergency room), a POC device (e.g., a glucose meter), or any type of extraction site where a medical sample can be extracted from a patient. At the extraction site (230), some basic tests can be performed on the medical sample, and therefore, in some cases, it may not be necessary to transport the medical sample to a testing laboratory (200, 220) for further testing.

[0065] However, in this embodiment, if the medical sample extracted from the patient at the extraction site (230) requires other tests, the medical sample can be transported to the centralized testing laboratory (200) by a courier or any other medical sample transport method. In one embodiment, the extraction site (230) can have its own laboratory agent component (235), which can be used to communicate with the laboratory agent components (110, 225) housed in the testing laboratories (200, 220) in the network through the communication network (115). Alternatively, the extraction site (230) may not have its own laboratory agent component (235). In this case, the laboratory agent component (110) at the centralized testing laboratory (200), after receiving the medical sample from the extraction site (230), can be used to communicate with multiple laboratory agent components (225) at multiple testing laboratories (220) to find a suitable testing laboratory.

[0066] After stopping the testing of the medical sample at the extraction site (230), the laboratory agent component (235) at the extraction site (230) may begin looking for other laboratory agent components (110, 225) at different laboratories (200, 220) based on specific criteria defined at the extraction site (230), or the medical sample may be shipped to the centralized testing laboratory (200) and the laboratory agent component (110) may communicate with other laboratory agent components (225) at different laboratories (220). In either case, the specific criteria may be, for example, time to receive results from the testing laboratory, testing capacity of the testing laboratory, maximum testing price at the testing laboratory, pre-analysis instrument qualification and post-analysis instrument qualification, specific or national regulations, QC accuracy and six sigma results of the testing laboratory, reliability of the medical sample, etc.

[0067] In this embodiment, the external database (240) may also be connected to all lab agent components (110, 225, 235) to collect information and data from multiple testing labs (200, 220) connected to the communication network (115), as described above in FIG. 1.

[0068] Another embodiment of the lab agent component system is shown in FIG3 . In this embodiment, the lab agent component (110) may not be linked to / housed at a testing laboratory or extraction site at all. Instead, in this embodiment, the lab agent component (110) may be installed on a personal portable device (340), such as a smartphone or tablet of a deliverer. In other words, the portable lab component (110) may be an application downloaded and installed on the deliverer's personal portable device. The portable lab agent component (110) may be carried by the deliverer who is responsible for transporting the medical sample to the appropriate testing laboratory.

[0069] The delivery person may use the portable lab agent component (110) during the transportation of the medical sample from the extraction site (330) (e.g., a doctor's office) to the appropriate testing laboratory (320). For example, once the delivery person picks up the medical sample from the extraction site (330), the delivery person may use the portable lab agent component (110) to connect to all the testing laboratories (320) in the network via the communication network (115) in order to find the most appropriate testing laboratory for performing the desired test on the medical sample.

[0070] In this embodiment, the portable lab agent component (110) can assign a final testing laboratory destination to a recently collected medical sample during medical sample shipment without first shipping the medical sample to a centralized testing laboratory location for distribution. Thus, the appropriate testing laboratory can be assigned in real time.

[0071] In one embodiment, the portable lab agent component (110) can be used to check to see which testing laboratory in the network of laboratories (320) is most suitable, i.e., most suitable (e.g., by comparing the workload, capacity, etc. of the testing laboratories) for each medical sample collected at a future delivery time (e.g., 5 p.m.). Thus, the decision on the delivery location can be based on the future predicted laboratory capacity at each laboratory in the network.

[0072] Also in this embodiment, the external database 350 can be connected to all lab agent components (110, 325) to collect information and data from multiple testing laboratories (330, 320) through the communication network (115), as described above. Figure 1 as described.

[0073] FIG4 schematically illustrates an overall method for delivering a medical sample from an extraction site (230, 330) to a testing laboratory (120, 220, 320). Once the medical sample is collected at the extraction site (230, 330) at step 410, the availability of a test to be performed on the medical sample needs to be evaluated at a first testing laboratory (100, 200) at step 420. If the first testing laboratory (100, 200) is able to perform the test, then the medical sample and the digital lab request are shipped to the first testing laboratory at step 430. On the other hand, if the first testing laboratory (100, 200) is unable to perform the test within the necessary testing parameters, then at step 440, important laboratory test attributes available at multiple testing laboratories (120, 220, 320) are checked via multiple lab proxy components (110, 125, 225, 325) over a communications network (115). At step 450, a suitable candidate test laboratory is identified among the plurality of test laboratories (120, 220, 320) based on the laboratory attributes of the suitable candidate test laboratory. At step 460, the feasibility of the suitable candidate test laboratory to perform the test on the medical sample is determined through communication between the suitable candidate test laboratory and the first test laboratory (100, 200). If it is determined that it is feasible to perform the test at the suitable candidate test laboratory, the medical sample and the digital laboratory request are transmitted to the suitable candidate test laboratory for testing at step 470. However, if it is not feasible to perform the test at the suitable candidate test laboratory, the laboratory attributes available at the remaining test laboratories in the plurality of test laboratories (120, 220, 330) are rechecked through the plurality of laboratory proxy components (110, 125, 225, 325) at step 440. After the test is performed at the first test laboratory (100, 200) or at the suitable candidate test laboratory, the laboratory test results are digitally transmitted back to the extraction site (230, 330) at step 480.

[0074] It should be noted that terms such as "preferably," "generally," and "typically" are not used herein to limit the scope of the claimed embodiments or to imply that certain features are critical, essential, or even important to the structure or function of the claimed embodiments. Instead, these terms are merely intended to highlight alternative or additional features that may or may not be used in a particular embodiment of the present disclosure.

[0075] The present disclosure has been described in detail with reference to specific embodiments of the present disclosure, and it will be apparent that modifications and variations may be made without departing from the scope of the present disclosure as defined in the appended claims. More specifically, although some aspects of the present disclosure are identified herein as preferred or particularly advantageous, it is contemplated that the present disclosure is not necessarily limited to these preferred aspects of the present disclosure.

Claims

1. A method for a laboratory proxy system to transfer a medical sample together with a digital laboratory test request from a sampling site (230, 330) to a testing laboratory (120, 220, 320), the laboratory proxy system comprising: a first test laboratory, comprising a first laboratory agent component (110); and a plurality of test labs, comprising a plurality of lab agent components (125, 225, 325), wherein each lab agent component resides in the test lab, the method comprising: checking the availability of a test to be performed on a medical sample at a first testing laboratory (100, 200) during a specific time period; If the test cannot be performed at the first test laboratory (100, 200) during the specific time period, checking laboratory properties available at a plurality of test laboratories (120, 220, 320) by a plurality of lab agent components (110, 125, 225, 325) communicatively connected by a communication network (115); identifying the suitable candidate testing laboratory among the plurality of testing laboratories (120, 220, 320) based on the laboratory attributes of the suitable candidate testing laboratory; communicating between the suitable candidate testing laboratory and the first testing laboratory (100, 200) regarding the feasibility of the suitable candidate testing laboratory to perform the test on the medical sample; If it is feasible to perform the test at the suitable candidate testing laboratory, communicating the medical sample and the digital lab request to the suitable candidate testing laboratory for testing; and After the test is performed at the appropriate candidate testing laboratory, the laboratory test results are digitally transmitted to the extraction site (230, 330).

2. The method according to claim 1, further comprising If it is not feasible to perform the test at the suitable candidate test lab, lab properties available at remaining test labs among the plurality of test labs (120, 220, 330) are rechecked by a plurality of lab proxy components (110, 125, 225, 325).

3. The method of claim 1 or 2, wherein the plurality of lab agent components (110, 125, 225, 325) communicate using a shared common nomenclature and communication standards.

4. The method of claim 1 or 2, wherein the shared common nomenclature and communication standards use interoperability profiles defined in the integrated healthcare enterprise pathology and laboratory medicine domains.

5. The method according to claim 1 or 2, wherein checking the availability of the test to be performed on the medical sample at the first testing laboratory (200) during the specific time period occurs in transit when the medical sample is removed from the extraction site (230).

6. The method of claim 1 or 2, wherein the laboratory attributes include at least one of: geographic location of the testing laboratory, time to travel to the testing laboratory, cost / price of the test, testing capacity of the testing laboratory, time to receive test results, type of quality control (QC) used at the testing laboratory, QC precision and accuracy versus QC precision and accuracy of other laboratories, inter-laboratory QC procedures, Six Sigma rating, pre-analytical instrument qualification, post-analytical instrument qualification, and / or validation type.

7. The method of claim 1 or 2, wherein the feasibility of the suitable candidate testing laboratory is based on future predicted capacity at the suitable candidate testing laboratory.

8. The method of claim 6, wherein the testing capacity of the testing laboratory is the number of tests per day.

9. A laboratory agent system for transferring a medical sample from a first location to a testing laboratory, the laboratory agent system comprising: a first test laboratory, comprising a first laboratory agent component (110); A plurality of test labs, comprising a plurality of lab agent components (125, 225, 325), wherein each lab agent component resides in a test lab (100, 120, 220, 320); as well as A communication network (115) communicatively coupled to the first laboratory proxy component (110) and the plurality of laboratory proxy components (125, 225, 325), wherein the first laboratory proxy component (110) and the plurality of laboratory proxy components (125, 225, 325) are configured to communicate laboratory attributes via the communication network (115) to determine an available testing laboratory suitable for testing the medical sample.

10. The system of claim 9, wherein the first lab agent component (110) is a mobile application installed on a portable smart device (340).

11. The system according to claim 9 or 10, wherein the first laboratory agent component (110) is portable and is located on a delivery transport device of the medical sample.

12. The system according to claim 9 or 10, wherein the first lab agent component (110) is configured with pre-existing conditions of suitable lab attributes.

13. The system of claim 9 or 10, wherein the pre-existing condition is the geographical location of the testing laboratory, the type of quality control used at the testing laboratory and / or the quality control verification of the testing laboratory.

14. The system of claim 9 or 10, wherein the first location (230, 330) is a point-of-care device, a testing laboratory, or a physician's office.

15. The system according to claim 9 or 10, further comprising An external database (130) connected to the plurality of lab agent components (110, 125, 225, 325) is configured to collect usage patterns of the test laboratories (100, 120, 220, 320) from the plurality of lab agent components (110, 125, 225, 325).

16. The system of claim 15, wherein the usage pattern comprises a number of tests performed and a number of reagents consumed at the testing laboratory.

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