Method and apparatus for preventing patient-to-sample mismatch during diagnostic testing

Abstract

In some embodiments, a method of operating multiple diagnostic engines is provided. The operating method includes receiving, via an instrument data manager (IDM) that communicates with the multiple diagnostic engines, a selection of one of the multiple diagnostic engines for testing a patient sample; disabling, using the IDM, at least one of the multiple diagnostic engines that was not selected; requiring input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and enabling, using the IDM, any of the disabled diagnostic engines after receiving the input of patient information or sample information. Many other embodiments are provided.

Description

[Technical Field]

[0001] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 63 / 485,957, filed February 20, 2023. The entire contents of the above-referenced patent application are expressly incorporated herein by reference.

[0002] FIELD OF THE INVENTION This application relates to diagnostic testing, and more particularly to methods and devices for preventing patient-to-sample mismatches during diagnostic testing. [Background technology]

[0003] Point-of-care testing can be defined as medical diagnostic testing performed at the location where care or other treatment is provided. Point-of-care testing is also sometimes referred to as bedside testing, remote testing, satellite testing, and rapid diagnostic testing. Point-of-care test results are made available relatively quickly so that they can be acted upon without delay. This increases the likelihood that patients, physicians, and care teams will receive test results more quickly, allowing for better and more rapid clinical management decisions to be made. Summary of the Invention [Problem to be solved by the invention]

[0004] To be useful, test results must be accurately associated with the correct patient. Thus, there is a need for methods and devices that prevent patient-to-sample mismatches during diagnostic testing. [Means for solving the problem]

[0005] In some embodiments, a method for operating multiple diagnostic engines is provided. The method includes receiving, via an instrument data manager (IDM) that communicates with the multiple diagnostic engines, a selection of one of the multiple diagnostic engines for testing a patient sample; disabling, using the IDM, at least one of the multiple diagnostic engines that was not selected; requiring input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and enabling, using the IDM, any disabled diagnostic engines after receiving the input of patient information or sample information. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the operations of the method.

[0006] In some embodiments, a point-of-care system is provided that includes an IDM configured to communicate with a plurality of diagnostic engines and configured to: receive a selection of one of the plurality of diagnostic engines for testing a patient sample; disable at least one diagnostic engine that was not selected; require input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and enable any disabled diagnostic engines after receiving the input of patient information or sample information. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the operations of the system.

[0007] In some embodiments, a system is provided that includes a plurality of diagnostic engines; and an IDM configured to control the operation of the plurality of diagnostic engines, the IDM including: a display; a processor coupled to the display; and a memory coupled to the processor, the memory having a plurality of stored computer-executable instructions that, when executed by the processor, cause the IDM to: receive a selection of one of the plurality of diagnostic engines for testing a patient sample; disable at least one of the plurality of diagnostic engines that was not selected; require input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and enable any disabled diagnostic engines after receiving the input of patient information or sample information. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the operations of the system.

[0008] One or more computer systems are configured to perform particular operations or behaviors by having software, firmware, hardware, or a combination thereof installed on the system that, when in operation, causes the system to perform the actions. One or more computer programs are configured to perform particular operations or behaviors by containing instructions that, when executed by a data processing device, cause the device to perform the actions.

[0009] Other features and aspects of the present invention will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings. [Brief explanation of the drawings]

[0010] [Figure 1A] FIG. 1 illustrates an exemplary point-of-care system provided by an embodiment of the present disclosure. [Figure 1B] FIG. 1 illustrates an exemplary diagnostic engine provided by an embodiment of the present disclosure. [Figure 2A] FIG. 1 illustrates an exemplary data structure for patient information, according to an embodiment of the present disclosure. [Figure 2B] FIG. 10 illustrates an exemplary data structure for diagnostic consumable information, according to an embodiment of the present disclosure. [Figure 2C] FIG. 1 illustrates an exemplary data structure in which patient identification (ID) information is linked to diagnostic consumable ID information, according to an embodiment of the present disclosure. [Figure 3A] FIG. 1 illustrates an exemplary method for collecting patient ID information and diagnostic consumable ID information and linking the patient ID information and the diagnostic consumable ID information according to embodiments disclosed herein. [Figure 3B] FIG. 1 illustrates an exemplary method for ensuring patient ID information and diagnostic consumable ID information are linked before enabling testing using a diagnostic engine, according to embodiments disclosed herein. [Figure 4A] 1 is a schematic diagram of a point-of-care (POC) system including a combination of a Patient ID Sample ID (PIDSID)-unaware diagnostic engine and a PIDSID-aware / validated diagnostic engine, according to embodiments provided herein. [Figure 4B] 1 is a schematic diagram of a POC system including a combination of a PIDSID-unenabled diagnostic engine and a PIDSID-enabled / disabled diagnostic engine, according to embodiments provided herein. [Figure 4C] FIG. 1 is a schematic diagram of a POC system including only a PIDSID-uncompliant diagnostic engine, according to embodiments provided herein. [Figure 4D] 1 is a schematic diagram of a POC system including a combination of a PIDSID non-compliant diagnostic engine, a PIDSID enabled / disabled diagnostic engine, and a PIDSID enabled / enabled diagnostic engine according to embodiments provided herein. [Figure 5A]1A-1C illustrate exemplary display screen layouts for configuring an equipment data manager, according to embodiments provided herein. [Figure 5B] 1A-1C illustrate exemplary display screen layouts for configuring an equipment data manager, according to embodiments provided herein. [Figure 5C] 1A-1C illustrate exemplary display screen layouts for configuring an equipment data manager, according to embodiments provided herein. [Figure 6A] FIG. 1 illustrates an exemplary method for preventing patient-to-sample mismatch during diagnostic testing, according to embodiments provided herein. [Figure 6B] FIG. 1 illustrates an exemplary method for preventing patient-to-sample mismatch during diagnostic testing, according to embodiments provided herein. [Figure 6C] FIG. 1 illustrates an exemplary method for preventing patient-to-sample mismatch during diagnostic testing, according to embodiments provided herein. [Figure 7] FIG. 1 illustrates an exemplary method for operating multiple diagnostic engines according to embodiments provided herein. DETAILED DESCRIPTION OF THE INVENTION

[0011] Regardless of grammatical usage of the term, individuals of male, female, or other gender identities are included within the term.

[0012] As described above, point-of-care systems enable patients, physicians, and care teams to quickly receive test results, allowing better and more rapid clinical management decisions to be made. However, to be useful, test results must be accurately associated with the correct patient. This becomes more difficult in busy clinical settings where many tests are performed on a large number of patients. Embodiments provided herein help ensure that test results performed during point-of-care testing are associated with the correct patient.

[0013] Point-of-care testing can be defined as medical diagnostic testing performed at the location where care or other treatment is provided. Point-of-care systems or devices can be located, for example, in hospitals, nursing homes, clinics, or individual patient homes. Point-of-care testing may also be referred to herein as bedside testing, remote testing, satellite testing, and / or rapid diagnostic testing.

[0014] During point-of-care testing, a patient sample is collected and analyzed using a testing device, referred to herein as a diagnostic engine. Exemplary patient samples can include urine, blood, plasma, saliva, cerebrospinal fluid, pleural fluid, nasopharyngeal fluid, etc. Patient samples are collected using diagnostic consumables, which can include, for example, a sample cartridge or other sample container in which blood or another bodily fluid is stored, a urine cup, test strips such as urine strips or lateral flow strips, etc. Such diagnostic consumables are typically, but need not be, disposable consumables.

[0015] According to embodiments provided herein, the diagnostic engines used for testing are controlled by a central interface unit called an Instrument Data Manager (IDM). For example, U.S. Patent Application Publication No. 2020 / 0286621(A1), published September 10, 2020, entitled "User Interface for Managing a Multiple Diagnostic Engine Environment," which is incorporated herein by reference in its entirety for all purposes, describes a point-of-care system including multiple diagnostic engines and an IDM in electronic communication with each of the diagnostic engines. Each of the diagnostic engines can perform tests on samples received from patients and collected using diagnostic consumables. The IDM is configured to communicate with each of the diagnostic engines so that multiple tests can be performed on multiple different samples substantially simultaneously. Multiple users can use the diagnostic engines. The IDM can present a single user interface for managing tests by the multiple diagnostic engines and for receiving measurement results of the tests performed by each of the diagnostic engines.

[0016] PCT Publication WO 2020 / 163214(A1), published August 13, 2020, entitled "Patient ID and Sample ID Workflow Methods and Apparatus for Facilitating Diagnostic Testing," which is incorporated herein by reference in its entirety for all purposes, describes a point-of-care system that can include one or more diagnostic engines controlled by and / or interfaced with an IDM. The IDM is used to obtain identification (ID) information for the patient on whom the test is to be performed. The IDM is also used to obtain ID information for diagnostic consumables used to collect and / or store samples from the patient. In some embodiments, the IDM can use a scanner to image a barcode on a patient wristband to obtain the patient ID information and / or to image a barcode on a diagnostic consumable to obtain the diagnostic consumable ID information. The IDM then links the patient ID information to the diagnostic consumable ID information. For example, the patient ID information and the diagnostic consumable ID information are linked to each other in a memory and / or a database (or other data structure) within the IDM. Each patient tested using the diagnostic engine can have one or more diagnostic consumables linked to the patient. In some embodiments, the patient ID information and diagnostic consumable ID information are linked immediately prior to sample collection.

[0017] After sample collection and before performing a test on a patient sample using a diagnostic engine in a point-of-care system, the ID information of the diagnostic consumable (having the sample to be tested) is scanned in the diagnostic engine. For example, a barcode scanner in or near the diagnostic engine can be used to obtain the diagnostic consumable ID information. This diagnostic consumable ID information is provided to the IDM, which determines whether the diagnostic consumable is linked to a patient (e.g., whether the scanned diagnostic consumable ID information is linked to patient ID information in the IDM). If the diagnostic consumable ID information is linked to patient ID information in the IDM, the IDM allows the diagnostic engine to perform the test on the sample collected using the diagnostic consumable. If the diagnostic consumable ID information is not linked to patient ID information in the IDM, the IDM prevents the diagnostic engine from performing the test.

[0018] By linking patient ID information with diagnostic consumable ID information at the time the sample is taken (or shortly thereafter), and then verifying that any diagnostic consumables with samples to be tested are linked to a patient in the IDM before testing with the diagnostic engine, it is known that the test results are associated with the correct patient.

[0019] A diagnostic engine configured to require linking (e.g., matching) of patient ID information and sample ID information (e.g., via diagnostic consumable ID information) prior to testing is referred to herein as patient ID and sample ID (PIDSID)-enabled. (Alternatively, such a diagnostic engine is referred to as patient ID and reagent ID (PIDRID)-enabled.) If a diagnostic engine is PIDSID-enabled and this capability is enabled, the diagnostic engine is referred to as PIDSID-enabled / enabled. If a diagnostic engine is PIDSID-enabled and this capability is disabled, the diagnostic engine is referred to as PIDSID-enabled / disabled. A diagnostic engine that is not PIDSID-enabled is referred to herein as PIDSID-unaware. In summary, as summarized below in Table 1 (DE stands for diagnostic engine), a diagnostic engine can be PIDSID-unaware or PIDSID-enabled, and a PIDSID-enabled diagnostic engine can be PIDSID-enabled / enabled or PIDSID-enabled / disabled.

[0020] [Table 1]

[0021] While a PIDSID-enabled / enabled Diagnostic Engine ensures that test results are associated with the correct patient, there are instances where PIDSID-enabled / disabled Diagnostic Engines and / or PIDSID-non-enabled Diagnostic Engines are used alone, together, or with one or more PIDSID-enabled / enabled Diagnostic Engines under the control of the same IDM. In such cases, the link between patient information and sample information is not necessarily confirmed prior to testing (in the case of a PIDSID-non-enabled Diagnostic Engine or a PIDSID-enabled / disabled Diagnostic Engine), and therefore the possibility exists that test results may be associated with the wrong patient (e.g., due to operator error, loss of identifying information on diagnostic consumables, etc.).

[0022] The embodiments described herein provide methods and apparatus for preventing patient-to-sample mismatches in environments such as those described above (e.g., where an IDM is interfaced with or communicatively connected to one or more PIDSID-incapable and / or PIDSID-enabled / invalidated diagnostic engines).

[0023] As a first example, an IDM can interface with and control one or more PIDSID-enabled / enabled diagnostic engines and one or more PIDSID-unenabled diagnostic engines. According to embodiments provided herein, when an operator selects a PIDSID-unenabled diagnostic engine for a test using the IDM, or when an operator attempts to perform a test using such a diagnostic engine, the IDM can disable all other PIDSID-unenabled diagnostic engines controlled by the IDM. These PIDSID-unenabled diagnostic engines can remain disabled until the operator enters information requested by the IDM for the selected diagnostic engine (e.g., patient information, sample information, other demographic information, other test parameters, etc.). For example, the IDM can require that information about the sample and / or the patient who provided the sample be provided so that test results from the selected diagnostic engine can be associated with the correct patient. Once the requested information for the selected diagnostic engine is entered, the disabled diagnostic engine is re-enabled. In some embodiments, the selected diagnostic engine can perform a test on the sample before the operator enters the information requested by the IDM. However, test results from the selected diagnostic engine will not be displayed until the requested information is entered. In other embodiments, the selected diagnostic engine is prevented from testing until the requested information is entered.

[0024] A similar process is used when the IDM interfaces with and controls a combination of PIDSID-enabled / disabled and PIDSID-unenabled diagnostic engines. That is, when the IDM is used to select a PIDSID-enabled / disabled or PIDSID-unenabled diagnostic engine for a test, or when an operator attempts to perform a test using such a diagnostic engine, the IDM can disable all other PIDSID-enabled / disabled and PIDSID-unenabled diagnostic engines controlled by the IDM. These diagnostic engines remain disabled until the operator enters the information required by the IDM for the selected diagnostic engine, as described above. Such a process is similarly used when only PIDSID-unenabled or only PIDSID-enabled / disabled diagnostic engines are used, or when any combination of PIDSID-enabled / enabled, PIDSID-enabled / disabled, and PIDSID-unenabled diagnostic engines is used.

[0025] These and other embodiments provided herein are described below with reference to Figures 1A-7.

[0026] 1A illustrates an exemplary point-of-care (POC) system 100 provided in accordance with an embodiment of the present disclosure. Referring to FIG. 1A, the POC system 100 may include an instrument data manager (IDM) 102 in communication with one or more diagnostic engines 104a-z. Any number of diagnostic engines may be used (e.g., 1, 2, 3, 5, 10, etc.).

[0027] In some embodiments, the IDM 102 may include a processor 106 connected to a memory 108, a scanner 110, and a display 111 having a user interface 112. The processor 106 may be a computing resource such as, but not limited to, a microprocessor, a microcontroller, an embedded microcontroller, a digital signal processor (DSP), a field programmable gate array (FPGA) configured to function as a microcontroller, etc. The IDM 102 may include any suitable computing device such as a tablet computer, a laptop computer, a desktop computer, a personal digital assistant, etc.

[0028] The memory 108 may be any suitable type of memory, such as, but not limited to, one or more of volatile and / or nonvolatile memory. The memory 108 may have a plurality of stored instructions that, when executed by the processor 106, cause the processor 106 to perform various operations specified by one or more of the stored instructions. These computer program instructions are provided to the processor 106 to perform operational acts according to the present systems and methods, as specified in the flowchart and / or block diagram block or blocks herein. A processor 106 configured in this manner is a specialized machine particularly suited to perform according to the present systems and methods. These computer program instructions are stored in a computer-readable medium, such as the memory 108, that can direct the processor 106 to function in a particular manner. The term "memory," as used herein, can refer to both non-transitory and transitory memory.

[0029] Scanner 110 may include any suitable imaging device capable of capturing an image of a barcode or other identifying information on a patient name tag (e.g., a wristband), diagnostic consumables, etc., as described further below. In some embodiments, scanner 110 may be a barcode reader in communication with IDM 102. For example, scanner 110 may be a wireless (e.g., Bluetooth, WIFI, or other wireless communication protocol) barcode reader. In some embodiments, scanner 110 may include a camera.

[0030] The user interface 112 may include, for example, one or more of a display screen or touch panel and / or touch screen, an audio speaker, and a microphone. The user interface 112 is controlled by the IDM 102, and the functionality of the user interface 112 is implemented at least in part by computer-executable instructions (e.g., program code or software) stored in memory 108 and / or executed by the processor 106 of the IDM 102. In some embodiments, the IDM 102 may receive one or more measurement results from one or more diagnostic engines 104a-z, process the measurement results to generate calculation results, and present the calculation results and / or other information, such as patient information, via the user interface 112.

[0031] In some embodiments, the user interface 112 can be diagnostic engine agnostic, meaning that it can present results associated with any number of diagnostic engines and any type of diagnostic engine. The user interface 112 allows multiple diagnostic engines to operate simultaneously using the same interface. In one or more embodiments, a user of the user interface 112 can start a test, enter or view patient information, enter login credentials, view the time remaining for a particular test, and / or view calculation results based on tests performed by a given diagnostic engine 104a-z. Additionally, the user interface 112 can display the status or calculation results of multiple tests simultaneously.

[0032] The user interface 112 provides common screens and elements across different types of diagnostic engines, allowing users of the user interface 112 to learn only a single interface, thereby improving the efficiency of the POC system 100. The common elements are presented in the user interface 112. For example, if a user is administering a urine test to a first patient and a blood test to a second patient, the user can view one or more of the status or test results of the urine test and the blood test on a single screen. In one example, the user interface 112 is configured to simultaneously display test results associated with two different users of the user interface 112.

[0033] The diagnostic engines 104a-z may perform one or more tests. For example, the diagnostic engines 104a-z may perform one or more tests to determine one or more characteristics of a sample, such as a bodily fluid sample. In some embodiments, the one or more diagnostic engines 104a-z may be a diabetes diagnostic engine configured to determine one or more characteristics of a blood sample, such as an HbA1c level associated with the blood sample, or a urinalysis diagnostic engine configured to determine one or more characteristics of a urine sample, such as the presence of one or more metabolites in the urine sample. Other diagnostic engines may also be used.

[0034] Each diagnostic engine 104a-z may include a processor 114 connected to a memory 116. Optionally, a scanner 118 (e.g., a camera, a barcode reader, etc.) may also be connected to the processor 114. Other exemplary components that may be included in one or more of the diagnostic engines 104a-z (e.g., a radio circuit 120, a heating element 122, a mixing means 124, an optical sensor 126, a pump 128, reagents 130, and / or the like) are shown in the diagnostic engine 104 of FIG. 1B . It is understood that a given one of the diagnostic engines 104a-z may optionally include any number or combination of these elements. It is further understood that the diagnostic engines 104a-z may include other components not shown in the figures or described herein, such as a separation means or any other component as would be understood by one of ordinary skill in the art. Additionally, a first type of diagnostic engine (e.g., a diabetes diagnostic engine) may include a different number and / or combination of components than a second type of diagnostic engine (e.g., a urinalysis diagnostic engine).

[0035] The processor 114 may be a computer resource such as, but not limited to, a microprocessor, a microcontroller, an embedded microcontroller, a DSP, an FPGA configured to function as a microcontroller, etc. The memory 116 may be any suitable type of memory such as, but not limited to, one or more of a volatile memory and / or a non-volatile memory. The memory 116 may have a plurality of instructions stored thereon that, when executed by the processor 114, cause the processor 114 to perform various operations specified by one or more of the stored instructions.

[0036] The processor 114 is configured to enable processing of a sample. For example, the processor 114 is configured to receive instructions from a user to perform a test on a sample inserted into the diagnostic engines 104a-z (e.g., on or contained in a diagnostic consumable) and output one or more values ​​representing measurement results of the test on the sample. In one embodiment, the processor 114 can be a real-time processor configured to generate one or more measurements within a given period of time, such as 10 seconds. The processor 114 can additionally or alternatively be a non-real-time processor configured to generate a measurement result based on measurements from the test sample. In one example, one or more of the diagnostic engines 104a-z can include multiple processors, such as a real-time processor configured to obtain measurements in real time and a non-real-time processor configured to process the measurements and generate a measurement result.

[0037] The processor 114 may control and receive feedback from various components of the diagnostic engines 104a-z (e.g., heating element 122, mixing means 124, optical sensor 126, pump 128, reagents 130, etc.) and may adjust (in real time) one or more characteristics of the diagnostic engines 104a-z accordingly to keep the diagnostic engines 104a-z within suitable operating conditions and may obtain measurement results of tests performed by the diagnostic engines 104a-z.

[0038] 1A, the memory 116 of the diagnostic engines 104a-z is configured to store information received or generated by the diagnostic engine, such as one or more values ​​representing measurement results of tests performed by the diagnostic engines 104a-z.

[0039] Wireless circuitry 120 (FIG. 1B) enables diagnostic engines 104a-z to communicate with one or more other components of POC system 100. For example, wireless circuitry 120 enables diagnostic engines 104a-z to communicate measurement results via a Bluetooth® or WiFi connection with IDM 102 (which may also include wireless circuitry, not separately shown).

[0040] Each diagnostic engine 104a-z is configured to receive a sample in the form of a diagnostic consumable (e.g., a sample cartridge containing blood or another bodily fluid, a test strip such as a urine strip or a lateral flow strip, etc.). The diagnostic engine is configured to directly contact the sample during testing. Examples of these types of diagnostic engines include so-called "benchtop" blood gas analyzers (e.g., the RapidPoint500 sold by Siemens Healthcare Diagnostics Inc. of Tarrytown, NY) and automated urine chemistry analyzers (e.g., the Clinitek Novus sold by Siemens Healthcare Diagnostics Inc. of Tarrytown, NY). Alternatively, the diagnostic engines 104a-z and their physical components can indirectly (e.g., optically) contact the sample rather than directly.

[0041] Sample can be obtained from patient by any one or combination of methods known in the art.For example, to obtain blood sample, can use syringe to draw blood from patient's vein.In addition or alternatively, blood sample can be separated (for example, by centrifugation) to obtain serum sample.In addition or alternatively, blood sample can be obtained by lightly pricking one of subject's fingers (for example, with a sterile needle), and then collecting desired amount of blood.

[0042] Following sample collection, the sample is placed in a sample container or other consumable, collectively referred to herein as a diagnostic consumable, configured to be received by a given one of the diagnostic engines 104a-z. For example, a diagnostic consumable can be a plastic or glass container configured to receive a specific volume of sample, or can be a test strip configured to receive a small volume of sample.

[0043] In some embodiments, the diagnostic consumables can be cartridges or containers that hold a sample, and the cartridges or containers are placed directly into the diagnostic engines 104a-z. Alternatively, the diagnostic consumables can simply hold a sample before the sample is analyzed by the diagnostic engine. For example, a first diagnostic consumable can be a urine cup that holds a sample before application of a second diagnostic consumable, such as a urine strip. The urine strip is then analyzed by the diagnostic engines 104a-z.

[0044] The POC system 100 can include any number of diagnostic engines 104a-z for testing any number of different types and combinations of samples. Exemplary diagnostic engines 104a-z include, but are not limited to, a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, a urinalysis diagnostic engine, and a blood pressure diagnostic engine.

[0045] Each diagnostic engine 104a-z is configured to receive a test sample, perform a test on the sample, and transmit measurement results from the test to the IDM 102. Each diagnostic engine 104a-z is also configured to store one or more measurement results in the diagnostic engine's memory 116.

[0046] The IDM 102 is configured to receive one or more measurement results from one or more of the diagnostic engines 104a-z. The measurement results are received, for example, via a communication connection 132 between the one or more diagnostic engines 104a-z and the IDM 102. In one embodiment, the connection 132 may include a wireless connection or a wired connection. For example, the connection 132 may include a Bluetooth® connection. Other communication protocols may also be used. The measurement results may include one or more values ​​representing measurement results of a test performed by the diagnostic engine 104a-z. For example, the IDM 102 may receive a single value representing the HbA1c value of a blood sample from a diabetes diagnostic engine, or may receive multiple values ​​corresponding to the total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels of a blood sample from a cardiac diagnostic engine.

[0047] The IDM 102 is configured to communicate information to any diagnostic engines 104a-z, such as instructions to initiate or enable or disable a test, software updates, or changes to the diagnostic engine protocol used by the processor 114 of the diagnostic engine 104a-z in generating one or more test results. Control of the diagnostic engines 104a-z themselves is performed by the processor 114 associated with the diagnostic engine 104a-z and / or by instructions received at the diagnostic engine 104a-z from one or more users.

[0048] In some embodiments, the processor 106 of the IDM 102 is configured to receive measurement results from the diagnostic engines 104a-z, process the measurement results, and thereby present a calculation result to a user of the POC system 100. For example, the IDM 102 can receive one or more values ​​(e.g., measurement results) from the diagnostic engines 104a-z. The processor 106 can be configured to determine which values ​​correspond to particular health markers and determine how to present those values ​​(e.g., as test results) to a user of the POC system 100. The processor 106 is configured to generate a calculation result by comparing the received value with one or more other stored or received values, and is configured to calculate a ratio of one value to another, such as the ratio of triglycerides to HDL cholesterol in a blood sample, to generate the calculation result.

[0049] The memory 108 of the IDM 102 is configured to store measurement results received from any of the diagnostic engines 104a-z and / or one or more calculation results generated by the IDM 102. The memory 108 may further store information associated with one or more patients. For example, the memory 108 may store patient information such as an identifier associated with the patient, the patient's last name, the patient's first name, the patient's gender, and the patient's date of birth.

[0050] 2A illustrates an exemplary data structure 200, such as a database or lookup table, of patient information stored in memory 108. Referring to FIG. 2A, data structure 200 may associate patient information, such as the patient's last name, the patient's first name, the patient's date of birth, and the patient's address, with a patient ID. In some embodiments, memory 108 may store the patient's test results (not shown) along with the patient information so that they can be retrieved at a later date.

[0051] As previously mentioned, in some embodiments, a diagnostic engine may be PIDSID-aware or PIDSID-unaware. For a PIDSID-enabled diagnostic engine with PIDSID functionality enabled, memory 108 of IDM 102 may store diagnostic consumable information and link patient ID information to the diagnostic consumable ID information. For example, FIG. 2B illustrates an exemplary data structure 202, such as a database or lookup table, of diagnostic consumable information. Exemplary diagnostic consumable information stored in memory 108 may include diagnostic consumable IDs, tests performed at / by the diagnostic consumable, etc. FIG. 2C illustrates an exemplary data structure 204, such as a database or lookup table, in which patient ID information is linked to diagnostic consumable ID information that is stored in memory 108 (e.g., prior to sample collection).

[0052] Exemplary operations of the PIDSID enabled / enabled diagnostic engine will be described with reference to Figures 1A-3B. Exemplary operations of the PIDSID enabled / disabled diagnostic engine and the PIDSID disabled diagnostic engine will be described with reference to Figures 4A-7.

[0053] 3A , a method 300 for operating a PIDSID-enabled / enabled diagnostic engine is performed by the POC system 100 and includes obtaining patient ID information (block 302), obtaining diagnostic consumable ID information (block 304), and linking the patient ID information to the diagnostic consumable ID information (block 306). In some embodiments, the method 300 is performed immediately before a sample is collected from a patient (e.g., before a blood draw, fingerstick draw, urine draw, etc.).

[0054] Patient ID information is entered into the IDM 102 and stored in memory 108. In some embodiments, the patient ID information is entered manually via a user interface 112 of the IDM 102. In other embodiments, a scanner 110 of the IDM 102 can scan the patient ID information into the IDM 102 for storage in memory 108, such as by scanning a barcode on paperwork or a wristband associated with the patient. In one or more embodiments, the barcode is scanned and used to retrieve previously stored patient information on a server (e.g., for storage in memory 108 of the IDM 102). An exemplary wristband 134 including a barcode 136 with encoded patient ID information is shown in FIG. 1A . In some embodiments, the barcode 136 on the wristband 134 is scanned by a scanner 110 or another imaging device to obtain the patient ID information for storage in memory 108 of the IDM 102.

[0055] Exemplary patient identification information may include a patient ID number, patient name, date of birth, gender, address, email address, allergies, medical history, etc. Exemplary patient information stored in a database or lookup table in memory 108 is shown in FIG. 2A.

[0056] Diagnostic consumable ID information is similarly entered into IDM 102 and stored in memory 108. In some embodiments, diagnostic consumable ID information is manually entered via a user interface 112 of IDM 102. In other embodiments, a scanner 110 of IDM 102 can scan the diagnostic consumable ID information for storage in memory 108, such as by scanning a barcode on a sample cartridge, urine (specimen) cup, test strip, or other diagnostic consumable. An exemplary diagnostic consumable 138 including a barcode 140 encoded with diagnostic consumable ID information is shown in FIG. 1A.

[0057] Exemplary diagnostic consumable ID information includes the diagnostic consumable ID number, the type of test performed on the diagnostic consumable, the time the diagnostic consumable ID was scanned, calibration information, expiration date, lot number, etc. Exemplary diagnostic consumable information stored in a database or lookup table in memory 108 is shown in FIG. 2B.

[0058] When PIDSID is enabled for a PIDSID-enabled diagnostic engine, patient ID information and diagnostic consumable ID information are linked within IDM 102. For example, both patient ID information and diagnostic consumable ID information are stored in memory 108, such as in a database or lookup table (e.g., as shown in FIG. 2C). Patient ID information and diagnostic consumable ID information can also be linked in other ways.

[0059] Referring to FIG. 3B , a method 310 is performed by the POC system 100 and a PIDSID-enabled / enabled diagnostic engine 104a-z when a sample test is performed. Once a sample is collected using a diagnostic consumable, the method 310 includes obtaining ID information for the diagnostic consumable (block 312) and verifying that the diagnostic consumable is valid (block 314). For example, a barcode scanner, such as the scanner 118 of one of the diagnostic engines 104a-z of FIG. 1A , can be used to scan a barcode on the diagnostic consumable to determine its diagnostic consumable ID information. In some embodiments, inserting the diagnostic consumable into a PIDSID-enabled / enabled diagnostic engine for testing can cause the barcode on the diagnostic consumable to be scanned. Alternatively, a barcode scanner separate from the diagnostic engine can be used to obtain the diagnostic consumable ID information. The PIDSID-enabled / enabled diagnostic engine can then provide the scanned diagnostic consumable ID information to the IDM 102.

[0060] When the IDM 102 receives the diagnostic consumable ID information, the IDM 102 can determine whether the diagnostic consumable is valid. For example, the IDM 102 can determine whether the diagnostic consumable ID number is a valid ID number, whether it corresponds to the appropriate type of diagnostic consumable for the diagnostic engine being used, etc. If not valid, the method 310 ends (block 316); otherwise, the method 310 includes determining whether the diagnostic consumable ID information is linked to patient ID information in the IDM 102 (block 318). For example, the IDM 102 can access memory 108 to determine whether the diagnostic consumable ID information is linked to patient ID information. If not, the diagnostic engine ceases (or is otherwise restricted or limited) from testing samples collected with that diagnostic consumable, and method 310 ends (block 316); otherwise, if the diagnostic consumable ID information is linked or otherwise associated with patient ID information, IDM 102 enables the PIDSID-enabled / enabled diagnostic engine to perform tests on samples collected with that diagnostic consumable (block 320). For example, IDM 102 can issue a command to the diagnostic engine indicating that the diagnostic engine should begin testing. Following the testing, test results from the diagnostic engine are communicated to IDM 102 and / or stored (e.g., in memory 108 of IDM 102) along with the patient ID information.

[0061] In some embodiments, when the method 310 ends at block 316 due to either the detection of an invalid diagnostic consumable or the diagnostic consumable not being linked to a patient in the IDM 102, the diagnostic engine is discontinued or otherwise restricted from performing any tests on samples collected with that diagnostic consumable. For example, the IDM 102 can use the user interface 112 to alert the operator that an error has occurred or to flag the invalid or unlinked diagnostic consumable.

[0062] When a PIDSID-unaware diagnostic engine or a PIDSID-enabled / invalidated diagnostic engine is used, the link between the patient and sample information is not confirmed prior to testing, and therefore the possibility exists that test results will be associated with the wrong patient (e.g., due to operator error, loss of identifying information for diagnostic consumables, etc.) Embodiments described herein provide methods and apparatus for preventing patient-to-sample mismatch in circumstances such as these, as described below with reference to Figures 4A-7.

[0063] Figure 4A is a schematic diagram of a point-of-care (POC) system 400a that includes a combination of a PIDSID unsupported diagnostic engine and a PIDSID enabled / enabled diagnostic engine. Referring to Figure 4A, the POC system 400a includes an IDM 102 that interfaces with and controls three PIDSID unsupported diagnostic engines 104a-104c and two PIDSID enabled / enabled diagnostic engines 104d-104e. Figure 4B is a schematic diagram of a similar POC system 400b that includes PIDSID unsupported diagnostic engines 104f-104h and PIDSID enabled / disabled diagnostic engines 104i-104j. Figure 4C is a schematic diagram of a POC system 400c that includes only PIDSID-unenabled diagnostic engines 104k-104o; Figure 4D is a schematic diagram of a POC system 400d that includes PIDSID-enabled / disabled diagnostic engines 104p-104q, a PIDSID-unenabled diagnostic engine 104r, and a PIDSID-enabled / enabled diagnostic engines 104s-104t. Other diagnostic engine types and / or configurations may also be used.

[0064] 4A-4D, the IDM 102 can be used to select a diagnostic engine for testing. For example, in the POC system 400a of FIG. 4A, the IDM 102 can be used to select diagnostic engine 104a (Engine 1 in FIG. 4A) to test a sample contained in a diagnostic consumable collected from a patient. Because diagnostic engine 104a is PIDSID-unaware, there is no requirement to link a patient ID with a sample ID (e.g., a diagnostic consumable ID) before initiating testing using diagnostic engine 104a. Similarly, diagnostic engines 104b and 104c of FIG. 4A, diagnostic engines 104f-104j of FIG. 4B, diagnostic engines 104k-104o of FIG. 4C, and diagnostic engines 104p-104r of FIG. 4D are PIDSID-unaware or PIDSID-enabled / disabled diagnostic engines that do not use linking between a patient ID and a sample ID before testing. An embodiment for preventing patient-to-sample mismatch in such situations is described below with reference to Figures 5A-6C.

[0065] 5A-5C illustrate exemplary display screen layouts for configuring the IDM 102, according to embodiments provided herein. Referring to FIG. 5A, in the main menu, an administrator can use the selectable patient test demographics field 502 to configure whether entry of patient test demographic information is enabled, disabled, required, or optional during a test. Similarly, an administrator can use the selectable test parameters field 504 to configure whether entry of test parameters is enabled, disabled, required, or optional during a test. Finally, an administrator can use the patient ID sample ID linking field 506 to enable or disable patient ID sample ID linking requirements for any PIDSID-enabled diagnostic engines controlled by the IDM 102. In some embodiments, the only option may be to enable or disable the PIDSID linking functionality for all PIDSID-enabled diagnostic engines controlled by the IDM 102. In other embodiments, the PIDSID linking functionality is enabled or disabled for individual PIDSID-enabled diagnostic engines. Less, more, or different information may be designated as being disabled, enabled, required, or optional.

[0066] FIG. 5B shows exemplary patient test demographic information that, when the patient test demographics field 502 is enabled, can be set by an administrator to be disabled, enabled, required, or optional for input before viewing test results from the diagnostic engine. Exemplary selectable patient test demographic information includes patient ID, patient name prefix, patient first name, patient last name, date of birth, etc. FIG. 5C shows exemplary test parameter information that, when the test parameters field 504 is enabled, can be set by an administrator to be disabled, enabled, required, or optional for input before viewing test results from the diagnostic engine. Exemplary selectable test parameter information includes patient age, patient race, patient temperature, sample container, sample color, sample clarity, etc. Less, more, or different information can be designated as disabled, enabled, required, or optional.

[0067] 6A-6C illustrate an exemplary method 600 for preventing patient-to-sample mismatches during diagnostic testing within a POC system (such as POC systems 100, 400a, 400b, 400c, and / or 400d) according to embodiments provided herein. Referring to FIG. 6A, at block 602, an IDM receives an administrator's selection regarding enabling PIDSID linking functionality for PIDSID-enabled diagnostic engines controlled by the IDM. Additionally, patient demographic information requests and test parameter information requests are selected (e.g., enabled, disabled, required, optional, etc.). Exemplary patient demographic information and exemplary test parameters are described above with reference to FIGS. 5A-5C. In some examples, an administrator can set up the IDM 102 with desired PIDSID requests, patient demographic information requests, and test parameter information requests prior to use by medical staff. As described above, in one or more embodiments, all PIDSID-enabled diagnostic engines are placed in either a PIDSID-enabled / enabled state, in which the patient ID and sample ID must be linked within the IDM 102 prior to testing, or a PIDSID-enabled / disabled state, in which there is no requirement that the patient ID and sample ID be linked within the IDM 102. In other embodiments, individual PIDSID-enabled diagnostic engines are placed in either a PIDSID-enabled / enabled state or a PIDSID-enabled / disabled state.

[0068] During subsequent use following IDM setup, a determination is made (e.g., by the IDM 102) in block 604 whether there is a request to enter patient demographic information or test parameter information for use by the diagnostic engines controlled by the IDM. For example, the settings of the patient test demographics field 502 and the test parameter field 504 are examined. If there is no request to enter either patient demographic information or test parameter information, in block 606, all diagnostic engines are operated independently and without any further preventative steps (other than those normally applied in clinical practice) to reduce patient-to-sample mismatches. Thus, unless only PIDSID-enabled diagnostic engines (that are PIDSID-enabled / enabled) are used, there remains a risk of patient-to-sample mismatches.

[0069] If, at block 604, it is determined that the IDM requires patient demographic information or test parameter information to be entered (e.g., via patient test demographic fields 502 or test parameter fields 504), method 600 proceeds to block 608. If, at block 608, the IDM interfaces with one or more PIDSID-enabled diagnostic engines that are PIDSID-enabled / enabled diagnostic engines, method 600 proceeds to block 610 (FIG. 6B); otherwise, method 600 proceeds to block 630 (FIG. 6C). Thus, FIGS. 6B-6C illustrate how a POC system (e.g., POC system 100, 400a, 400b, 400c, and / or 400d) responds to the selection of a diagnostic engine for a test depending on how the IDM is configured at block 602 and whether a PIDSID-enabled / enabled diagnostic engine is used with the POC system.

[0070] 6B, when an operator is ready to perform a test on a sample, the operator can select a diagnostic engine for use. For example, the operator can select a diagnostic engine from the user interface 112 of the IDM 102, or the operator can attempt to start a test in the diagnostic engine, such as by inserting a diagnostic consumable into the diagnostic engine. Upon receiving the diagnostic consumable, the diagnostic engine can send a signal or other communication to the IDM 102 informing the IDM 102 that the diagnostic consumable has been inserted into the diagnostic engine and / or that a test has been started in the diagnostic engine.

[0071] In block 610, it is determined whether a PIDSID-enabled / enabled diagnostic engine is selected. If a PIDSID-enabled / enabled diagnostic engine is selected, in block 612, the operator is requested to provide a sample ID (e.g., by scanning a barcode on a diagnostic consumable in the diagnostic engine or, for example, by using a scanner in the IDM 102). In block 614, it is determined whether the sample ID (e.g., diagnostic consumable ID) is linked to a patient (and whether the sample ID is valid, as described above). For example, the IDM 102 can determine whether the patient is linked to the sample ID, as in data structure 204 of FIG. 2C. If the patient and sample are linked (deeming the sample ID valid), in block 616, the sample is processed in the selected PIDSID-enabled / enabled diagnostic engine; if not, in block 618, the operator is alerted that the sample ID is not linked to a patient or is invalid, and the test is not allowed to proceed in the diagnostic engine (as described above with reference to block 316 of FIG. 3B). For example, a selected diagnostic engine may be prevented or otherwise restricted from performing any tests on samples collected with the diagnostic consumable or from presenting the results of any tests already performed due to either the detection of an invalid diagnostic consumable or the diagnostic consumable not being linked to a patient within the IDM 102. The user interface 112 of the IDM 102 may alert the operator that an error has occurred and may flag the invalid or unlinked diagnostic consumable.

[0072] Returning to block 610, if it is determined that no PIDSID-capable / enabled engine has been selected, then in block 620, all other PIDSID-non-capable (or PIDSID-enabled / disabled) diagnostic engines controlled by the IDM are disabled. For example, the IDM 102 may place these diagnostic engines in a “not ready” state that prevents the diagnostic engines from accepting or performing tests on diagnostic consumables. In some embodiments, disabled diagnostic engines are grayed out or otherwise unavailable for selection in the interface 112 of the IDM 102. In block 622, an operator who selects a PIDSID-non-capable (or PIDSID-enabled / disabled) diagnostic engine for a test is prompted to collect a patient sample and start the test on that diagnostic engine (if the test has not already been started on the selected diagnostic engine). Thereafter, in block 624, the operator is prompted to enter patient and / or sample information (e.g., patient demographic information, test parameter information, etc.). For example, the user interface 112 of the IDM 102 may prompt the operator to enter a patient ID, the patient's first and last name, the patient's date of birth, other demographic information, test parameters, such as the patient's age, the patient's race, the patient's temperature, the sample container, the sample color, the sample clarity, etc., associated with or related to the sample to be tested in the selected diagnostic engine. Depending on the settings within the IDM 102 (from block 602), the entry of such information may be required, optional, enabled, or disabled. In some embodiments, the operator must at least manually skip certain screens or data requests before proceeding. Based on the received demographic and / or test parameter information, the IDM 102 may identify the patient associated with the test results generated by the selected diagnostic engine. In this manner, the possibility of mismatches between patients and test results is significantly reduced.

[0073] Once the required patient demographic information and / or test parameter information has been entered by the operator, the test results from the selected diagnostic engine are displayed or otherwise presented (e.g., via the user interface 112 of the display 111 of the IDM 102) in block 626. Before, after, or simultaneously with displaying the test results from the selected diagnostic engine, any previously disabled diagnostic engines are re-enabled in block 628. In particular, the IDM 102 may enable diagnostic engines that it disabled in block 620. In some embodiments, diagnostic engines are disabled when not within range of the IDM 102. For example, each diagnostic engine controlled by the IDM may have computer program code that disables tests in the diagnostic engine when the diagnostic engine is not within range of or not communicating with the IDM (e.g., out of Bluetooth range or other wireless protocol range). Such a configuration further reduces the possibility of patient-to-sample mismatch, since the operator cannot use any diagnostic engine that does not provide the information required by the IDM to initiate a test or view test results in the diagnostic engine (e.g., patient demographic information and / or test parameter information, as described above).

[0074] Returning to block 608 of FIG. 6A , as previously described, if the IDM does not interface with one or more PIDSID-enabled / enabled diagnostic engines, method 600 proceeds to block 630 ( FIG. 6C ). In block 630 ( FIG. 6C ), the IDM receives a selection of a diagnostic engine for testing (e.g., via interface 112 of IDM 102 or an operator loading a sample into the diagnostic engine). Thereafter, in block 632, the IDM disables all other diagnostic engines controlled by the IDM (e.g., any other PIDSID-non-enabled or PIDSID-enabled / disabled diagnostic engines). For example, the IDM 102 can place these diagnostic engines in a “not ready” state, which prevents the diagnostic engines from accepting diagnostic consumables or performing tests on diagnostic consumables. In block 634, an operator who selects a PIDSID-incapable (or PIDSID-enabled / disabled) diagnostic engine for testing is prompted to collect a patient sample and start the test on that diagnostic engine (if the test has not already been started on the selected diagnostic engine).

[0075] In block 636, the operator, having selected a diagnostic engine for testing, is prompted to enter information for the selected diagnostic engine. For example, the user interface 112 of the IDM 102 may prompt the operator to enter a patient ID, the patient's first and last name, the patient's date of birth, other demographic information, test parameters, etc., associated with the sample to be tested in the selected diagnostic engine. Depending on the settings within the IDM 102 (from block 602), entry of such information may be required, optional, enabled, or disabled. Based on the received demographic and / or test parameter information, the IDM 102 may identify the patient associated with the test results generated by the selected diagnostic engine. Thus, the possibility of mismatches between patients and test results is significantly reduced.

[0076] Once the required demographic and / or test parameter information has been entered by the operator, the test results from the selected diagnostic engine are displayed or otherwise presented to the operator (e.g., via the user interface 112 of the IDM 102) in block 638. Before, after, or simultaneously with displaying the test results from the selected diagnostic engine, any previously disabled diagnostic engines are re-enabled in block 640. In particular, the IDM 102 may enable any diagnostic engines that it disabled in block 632.

[0077] FIG. 7 illustrates an example method 700 of operating multiple diagnostic engines according to embodiments provided herein, which advantageously reduces the risk of discrepancies between patient and test results, as described above. Referring to FIG. 7 , at block 702, an IDM in communication with multiple diagnostic engines receives a selection of one of the diagnostic engines to be used to test a patient sample. For example, the IDM 102 may receive the selection of the diagnostic engine to be used to test the sample. In some embodiments, an operator may select the diagnostic engine via the user interface 112 of the IDM 102. Alternatively, the operator may insert a diagnostic consumable into the selected diagnostic engine or start a test on the selected diagnostic engine, and the diagnostic engine may notify the IDM 102 of this. At block 704, in response to the selection 702, at least one diagnostic engine that was not selected is disabled. In some embodiments, if the selected diagnostic engine is a PIDSID-incapable or PIDSID-enabled / disabled diagnostic engine, the IDM may disable any other diagnostic engines controlled by the IDM that are not PIDSID-enabled / enabled (e.g., any diagnostic engines that are not configured to link patient identification information to diagnostic consumable identification information prior to testing in the diagnostic engine). At block 706, before displaying test results from the selected diagnostic engine for a patient sample, the IDM may request input of patient and / or sample information. For example, the IDM 102 may request input of patient demographic information and / or test parameter information associated with the sample to be tested in the selected diagnostic engine (e.g., via the patient test demographics field 502 and / or the test parameter field 504). In some embodiments, requesting input of patient information and / or sample information may include requesting the scanning of a barcode (e.g., by a scanner or camera located on or near the IDM 102 or the selected diagnostic engine).In other embodiments, requesting input of at least one of patient information and sample information may include requesting manual input of the information in IDM 102 (e.g., via user interface 112).

[0078] In block 708, after or in response to receiving input of patient or sample information, the IDM may (re)enable any of the disabled diagnostic engines. In some embodiments, any of the diagnostic engines within the IDM 102 that were disabled in block 704 are enabled (e.g., placed in a ready state and able to perform diagnostic tests). In block 710, test results from the selected diagnostic engines are provided to the operator (e.g., via the interface 112 of the IDM 102). The test results from the selected diagnostic engines are displayed in response to providing the requested patient or sample information and at any time thereafter (e.g., before, during, or after any disabled diagnostic engines are re-enabled).

[0079] Computer program code or executable instructions for implementing the described display screen layouts or similar screen layouts and / or for performing methods 300, 310, 600 and / or 700 are stored in memory 108 of IDM 102 and / or memory 116 of diagnostic engines 104a-z and executed by processor 106 of IDM 102 and / or processor 114 of diagnostic engines 104a-z.

[0080] In some embodiments, if the PIDSID feature is enabled for a PIDSID-enabled diagnostic engine, patient ID information must be entered before testing or before viewing test results, otherwise the test will be blocked.

[0081] In some embodiments, a POC system includes multiple diagnostic engines (e.g., diagnostic engines 104a-z) and an IDM (e.g., IDM 102) configured to control the operation of the multiple diagnostic engines. The IDM can include a display, a processor coupled to the display, and memory coupled to the processor (e.g., display 111, processor 106, and memory 108). The memory can have multiple computer-executable instructions stored thereon that, when executed by the processor, cause the IDM to (a) receive a selection of one of the multiple diagnostic engines for testing a patient sample; (b) disable at least one of the multiple diagnostic engines that was not selected; (c) require input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and (d) enable any disabled diagnostic engines after receiving the input of patient information or sample information. For example, memory 108 of IDM 102 can include computer-executable instructions for performing method 700. Similarly, memory 108 of IDM 102 can include computer-executable instructions that cause the IDM to display test results from a selected diagnostic engine on a display of the IDM after receiving input of patient or sample information. Additionally, memory 108 of IDM 102 can include computer-executable instructions that cause the IDM to disable any diagnostic engines that are not configured to link patient identification information to diagnostic consumable ID information before testing in a selected diagnostic engine. In some embodiments, each diagnostic engine 104a-z can include computer-executable instructions (e.g., stored in memory 116 and executable by processor 114) that cause each diagnostic engine to prevent testing in the diagnostic engine if the diagnostic engine is out of range of IDM 102.

[0082] The following is a list of non-limiting exemplary embodiments disclosed herein:

[0083] Exemplary Embodiment 1. A method of operating multiple diagnostic engines, the method comprising: receiving, via an Instrument Data Manager (IDM) in communication with the multiple diagnostic engines, a selection of one of the multiple diagnostic engines for testing a patient sample; disabling, using the IDM, at least one of the multiple diagnostic engines that was not selected; requiring input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and enabling, using the IDM, any of the disabled diagnostic engines after receiving the input of the patient information or sample information.

[0084] Exemplary Embodiment 2. The method of exemplary embodiment 1, further comprising, after receiving input of patient or sample information, using the IDM to display test results from a selected diagnostic engine.

[0085] Exemplary Embodiment 3. The method of exemplary embodiment 1 or 2, wherein receiving a selection of one of the plurality of diagnostic engines includes receiving the selection via an interface of the IDM.

[0086] Exemplary Embodiment 4. The method of any one of Exemplary Embodiments 1-3, wherein receiving a selection of one of the plurality of diagnostic engines includes receiving, at the IDM, a communication from the selected diagnostic engine that a sample has been loaded into the selected diagnostic engine or that a test has started on the selected diagnostic engine.

[0087] Exemplary Embodiment 5. The method of any one of Exemplary Embodiments 1-4, wherein the patient information includes patient identification (ID) information and the sample information includes diagnostic consumable ID information.

[0088] Exemplary Embodiment 6. The method of any one of Exemplary Embodiments 1-5, wherein using the IDM to disable at least one diagnostic engine includes using the IDM to disable any non-selected diagnostic engines that are not configured to link patient identification information to diagnostic consumable identification information prior to testing in the diagnostic engine.

[0089] Exemplary Embodiment 7. The method of any one of Exemplary Embodiments 1-6, wherein disabling at least one diagnostic engine using the IDM includes preventing testing using the at least one diagnostic engine using the IDM.

[0090] Exemplary Embodiment 8. The method of any one of exemplary embodiments 1-7, wherein disabling, using the IDM, at least one diagnostic engine that was not selected includes disabling, using the IDM, all diagnostic engines except for the selected diagnostic engine.

[0091] Exemplary Embodiment 9. The method of any one of exemplary embodiments 1-8, wherein prompting for input of at least one of patient information and sample information includes prompting for scanning of a barcode.

[0092] Exemplary embodiment 10. The method of any one of exemplary embodiments 1-9, wherein requesting input of at least one of patient information and sample information includes requesting manual input of the information in the IDM.

[0093] Exemplary embodiment 11. A point-of-care system including: an IDM configured to communicate with a plurality of diagnostic engines; receive a selection of one of the plurality of diagnostic engines for testing a patient sample; disable at least one diagnostic engine that was not selected; require input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and enable any of the disabled diagnostic engines after receiving the input of the patient information or the sample information.

[0094] Exemplary Embodiment 12. The point-of-care system of any one of the preceding exemplary embodiments, wherein the IDM is configured to display test results from a selected diagnostic engine after receiving input of patient or sample information.

[0095] Exemplary Embodiment 13. The point-of-care system of any one of the preceding exemplary embodiments, wherein the IDM is configured to receive a selection of one of a plurality of diagnostic engines via an interface of the IDM.

[0096] Exemplary Embodiment 14. The point-of-care system of any one of the preceding exemplary embodiments, wherein the IDM is configured to receive a selection of one of the plurality of diagnostic engines by receiving, at the IDM, a communication from the selected diagnostic engine that a sample has been loaded into the selected diagnostic engine or a communication that a test has started at the selected diagnostic engine.

[0097] Exemplary Embodiment 15. The point-of-care system of any one of the preceding exemplary embodiments, wherein the patient information includes patient ID information and the sample information includes diagnostic consumable ID information.

[0098] Exemplary Embodiment 16. The point-of-care system of any one of the preceding exemplary embodiments, wherein the IDM is configured to disable any non-selected diagnostic engines that are not configured to link patient identification information to diagnostic consumable identification information prior to testing in the diagnostic engines.

[0099] Exemplary Embodiment 17. The point-of-care system of any one of the preceding exemplary embodiments, wherein the IDM is configured to request input of at least one of patient information and sample information by requesting the scanning of a barcode.

[0100] Exemplary Embodiment 18. The point-of-care system of any one of the preceding exemplary embodiments, wherein each diagnostic engine is configured to prevent testing at the diagnostic engine if the diagnostic engine is outside of the range of the IDM.

[0101] Exemplary Embodiment 19. The point-of-care system of any one of the preceding exemplary embodiments, wherein the IDM is configured to communicate with each diagnostic engine via wireless communication.

[0102] Exemplary Embodiment 20. The point-of-care system of any one of the preceding exemplary embodiments, wherein the plurality of diagnostic engines includes at least one of a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, and a urinalysis diagnostic engine.

[0103] Exemplary Embodiment 21. The point-of-care system of any one of the preceding exemplary embodiments, wherein the IDM is configured to prompt for input of patient or sample information by requiring an operator to at least manually skip screens or data requests.

[0104] Exemplary Embodiment 22. A system comprising: a plurality of diagnostic engines; and an IDM configured to control operation of the plurality of diagnostic engines, the IDM including: a display; a processor coupled to the display; and a non-transitory memory coupled to the processor, the non-transitory memory having a plurality of computer-executable instructions stored therein that, when executed by the processor, cause the IDM to: receive a selection of one of the plurality of diagnostic engines for testing a patient sample; disable at least one of the plurality of diagnostic engines that was not selected; require input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; and enable any of the disabled diagnostic engines after receiving the input of patient information or sample information.

[0105] Exemplary Embodiment 23. The system of any one of the preceding exemplary embodiments, wherein the non-transitory memory includes computer-executable instructions that, when executed by the processor, cause the IDM to display test results from a selected diagnostic engine on a display of the IDM after receiving input of patient information or sample information.

[0106] Exemplary Embodiment 24. The system of any one of the preceding exemplary embodiments, wherein the non-transitory memory includes computer-executable instructions that, when executed by the processor, cause the IDM to disable any diagnostic engines that are not configured to link patient identification information to diagnostic consumable ID information prior to checking in the diagnostic engine.

[0107] Exemplary Embodiment 25. The system of any one of the preceding exemplary embodiments, wherein each diagnostic engine is configured to prevent testing at the diagnostic engine if the diagnostic engine is outside of the range of the IDM.

[0108] The foregoing description discloses merely exemplary embodiments of the invention; modifications of the above-disclosed apparatus and methods which fall within the scope of the invention will be readily apparent to those of ordinary skill in the art. Accordingly, while the invention has been disclosed with respect to exemplary embodiments thereof, it should be understood that other embodiments may be within the spirit and scope of the invention, as defined by the following claims.

Claims

1. 1. A method of operating multiple diagnostic engines, comprising: receiving a selection of one of a plurality of diagnostic engines for testing the patient sample via an instrument data manager (IDM) in communication with the plurality of diagnostic engines; Disabling at least one of the plurality of diagnostic engines that was not selected using the IDM; requiring input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; After receiving input of patient or sample information, the IDM may be used to enable any disabled diagnostic engines. The method comprising:

2. 10. The method of claim 1, further comprising using the IDM to display test results from a selected diagnostic engine after receiving input of patient or sample information.

3. The method of claim 1 , wherein receiving a selection of one of a plurality of diagnostic engines comprises receiving the selection via an interface of an IDM.

4. 10. The method of claim 1, wherein receiving a selection of one of the plurality of diagnostic engines comprises receiving, at the IDM, a communication from the selected diagnostic engine that a sample has been loaded into the selected diagnostic engine or a communication that a test has started on the selected diagnostic engine.

5. The method of claim 1 , wherein the patient information includes patient identification (ID) information and the sample information includes diagnostic consumable ID information.

6. 10. The method of claim 1, wherein using the IDM to disable at least one diagnostic engine includes using the IDM to disable any non-selected diagnostic engines that are not configured to link patient identification information to diagnostic consumable identification information prior to testing in the diagnostic engine.

7. The method of claim 1 , wherein disabling at least one diagnostic engine using the IDM comprises preventing testing using the at least one diagnostic engine using the IDM.

8. 2. The method of claim 1, wherein disabling at least one non-selected diagnostic engine using the IDM comprises disabling all diagnostic engines other than the selected diagnostic engine using the IDM.

9. The method of claim 1 , wherein prompting for input of at least one of patient information and sample information comprises prompting for scanning of a barcode.

10. The method of claim 1 , wherein requesting entry of at least one of patient information and sample information comprises requesting manual entry of the information in the IDM.

11. 1. A point-of-care system comprising: An equipment data manager (IDM) configured to communicate with a plurality of diagnostic engines: receiving a selection of one of a plurality of diagnostic engines for testing the patient sample; Disabling at least one diagnostic engine that was not selected; requiring input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for the patient sample; Enabling any disabled diagnostic engines after receiving patient or specimen information input The point-of-care system includes an IDM configured as follows:

12. 12. The point-of-care system of claim 11, wherein the IDM is configured to display test results from a selected diagnostic engine after receiving input of patient or sample information.

13. 12. The point-of-care system of claim 11, wherein the IDM is configured to receive a selection of one of a plurality of diagnostic engines via an interface of the IDM.

14. 12. The point-of-care system of claim 11, wherein the IDM is configured to receive a selection of one of the plurality of diagnostic engines by receiving a communication from the selected diagnostic engine at the IDM that a sample has been loaded into the selected diagnostic engine or that a test has started on the selected diagnostic engine.

15. 12. The point-of-care system of claim 11, wherein the patient information includes patient identification (ID) information and the sample information includes diagnostic consumable ID information.

16. 12. The point-of-care system of claim 11, wherein the IDM is configured to disable any non-selected diagnostic engines that are not configured to link patient ID information to diagnostic consumable ID information prior to testing in the diagnostic engine.

17. 17. The point-of-care system of claim 16, wherein the IDM is configured to request input of at least one of patient information and sample information by requesting the scanning of a barcode.

18. 17. The point-of-care system of claim 16, wherein each diagnostic engine is configured to prevent testing at the diagnostic engine if the diagnostic engine is outside of the IDM range.

19. The point-of-care system of claim 11 , wherein the IDM is configured to communicate with each diagnostic engine via wireless communication.

20. 12. The point-of-care system of claim 11, wherein the plurality of diagnostic engines includes at least one of a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, and a urinalysis diagnostic engine.

21. 12. The point-of-care system of claim 11, wherein the IDM is configured to prompt for input of patient or sample information by requiring an operator to at least manually skip screens or data requests.

22. 1. A system comprising: a plurality of diagnostic engines; An equipment data manager (IDM) configured to control the operation of a plurality of diagnostic engines, the IDM comprising: a display; a processor connected to a display; a non-transitory memory coupled to the processor, the non-transitory memory having stored thereon a plurality of computer-executable instructions that, when executed by the processor, cause the IDM to: receiving a selection of one of a plurality of diagnostic engines for testing the patient sample; Disabling at least one of the plurality of diagnostic engines that is not selected; requiring input of at least one of patient information and sample information before displaying test results from the selected diagnostic engine for a patient sample; enabling any disabled diagnostic engines after receiving input of patient information or sample information; a non-transitory memory having a plurality of computer-executable instructions stored thereon; Including IDM and The system comprising:

23. 23. The system of claim 22, wherein the non-transitory memory includes computer-executable instructions that, when executed by the processor, cause the IDM to display test results from a selected diagnostic engine on a display of the IDM after receiving input of patient or sample information.

24. 23. The system of claim 22, wherein the non-transitory memory includes computer-executable instructions that, when executed by the processor, cause the IDM to disable any diagnostic engine that is not configured to link patient ID information to diagnostic consumable ID information before checking in the diagnostic engine.

25. 23. The system of claim 22, wherein each diagnostic engine is configured to prevent testing at the diagnostic engine if the diagnostic engine is outside the scope of the IDM.

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