EP4670172A1 - METHOD AND DEVICE FOR AVOIDING PATIENT AND SAMPLE MISCATCHES DURING DIAGNOSTIC TESTS - Google Patents

Abstract

In some embodiments, a method of operating a plurality of diagnostic engines is provided. The method of operating includes receiving, via an instrument data manager (IDM) in communication with a plurality of diagnostic engines, a selection of one of the plurality of diagnostic engines for testing a sample of a patient; employing the IDM to disable at least one of the plurality of diagnostic engines that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, requiring entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, employing the IDM to enable any disabled diagnostic engine. Numerous other embodiments are provided.

Description

METHODS AND APPARATUS FOR PREVENTING PATIENT AND SAMPLE MISMATCH DURING DIAGNOSTIC TESTING

[0001] This application claims benefit under 35 USC § 119(e) of US Provisional Application No. 63/485,957, filed February 20, 2023. The entire contents of the abovereferenced patent application(s) are hereby expressly incorporated herein by reference.

FIELD

[0002] The present application relates to diagnostic testing, and more particularly to methods and apparatus for preventing patient and sample mismatch during diagnostic testing.

BACKGROUND

[0003] Point of care testing may be defined as medical diagnostic testing that is performed at a location where care or other treatment is provided. Point of care testing may also be referred to as near-patient testing, remote testing, satellite testing, and rapid diagnostics testing. Point of care test results may be made available relatively quickly so that they can be acted upon without delay. This increases the likelihood that the patient, physician, and care team will receive test results quicker, which allows for better and more immediate clinical management decisions to be made.

[0004] To be beneficial, test results must be accurately associated with the correct patient. Accordingly, there is a need for methods and apparatus that prevent patient and sample mismatch during diagnostic testing.

SUMMARY

[0005] In some embodiments, a method of operating a plurality of diagnostic engines is provided. The method of operating includes receiving, via an instrument data manager (IDM) in communication with a plurality of diagnostic engines, a selection of one of the plurality of diagnostic engines for testing a sample of a patient; employing the IDM to disable at least one of the plurality of diagnostic engines that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, requiring entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, employing the IDM to enable any disabled diagnostic engine. 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 actions 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 to: receive a selection of one of the plurality of diagnostic engines for testing a sample of a patient; disable at least one diagnostic engine that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, require entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, enable any disabled diagnostic engine. 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 actions of the system.

[0007] In some embodiments, a system is provided that includes 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 memory coupled to the processor, the memory having stored therein a plurality of 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 sample of a patient; disable at least one of the plurality of diagnostic engines that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, require entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, enable any disabled diagnostic engine. 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 actions of the system.

[0008] A system of one or more computers may be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs may be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus 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 DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1A illustrates an example point of care system provided in accordance with embodiments of the disclosure.

[0011] FIG. 1 B illustrates an example diagnostic engine provided in accordance with embodiments of the disclosure.

[0012] FIG. 2A illustrates an example data structure of patient information in accordance with embodiments of the disclosure.

[0013] FIG. 2B illustrates an example data structure of diagnostic consumable information in accordance with embodiments of the disclosure.

[0014] FIG. 2C illustrates an example data structure in which patient identification (ID) information may be linked with diagnostic consumable ID information in accordance with embodiments of the disclosure.

[0015] FIG. 3A illustrates an example method for collecting patient ID information and diagnostic consumable ID information, and linking patient ID information and diagnostic consumable ID information in accordance with embodiments disclosed herein.

[0016] FIG. 3B illustrates an example method for ensuring patient ID information and diagnostic consumable ID information are linked before allowing testing with a diagnostic engine in accordance with embodiments disclosed herein.

[0017] FIG. 4A is a schematic diagram of a point-of-care (POC) system that includes a combination of Patient ID Sample ID (PIDSID) incapable and PIDSID- capable/enabled diagnostics engines in accordance with embodiments provided herein.

[0018] FIG. 4B is a schematic diagram of a POC system that includes a combination of PIDSID-incapable and PIDSID-capable/disabled diagnostic engines in accordance with embodiments provided herein. [0019] FIG. 4C is a schematic diagram of a POC system that includes only PIDSID- incapable diagnostic engines in accordance with embodiments provided herein.

[0020] FIG. 4D is a schematic diagram of a POC system that includes a combination of PIDSID-incapable, PIDSID-capable/disabled, and PIDSID-capable/enabled diagnostic engines in accordance with embodiments provided herein.

[0021] FIGS. 5A-5C illustrate example display screen layouts for configuring an Instrument Data Manager in accordance with embodiments provided herein.

[0022] FIGS. 6A-6C illustrate an example method for preventing patient and sample mismatch during diagnostic testing in accordance with embodiments provided herein.

[0023] FIG. 7 illustrates an example method of operating a plurality of diagnostic engines in accordance with embodiments provided herein.

DETAILED DESCRIPTION

[0024] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.

[0025] As stated above, point of care systems allow patients, physicians, and care teams to receive test results quickly, which allows for better and more immediate clinical management decisions to be made. However, to be beneficial, test results must be accurately associated with the correct patient. This becomes more difficult in a busy clinical setting in which numerous tests are performed on many patients. Embodiments provided herein help ensure that test results performed during point of care testing are associated with the correct patient(s).

[0026] Point of care testing may be defined as medical diagnostic testing that is performed at a location where care or other treatment is provided. A point of care system or device may be located, for example, in a hospital, nursing home, clinic, or in the home of an individual patient. Point of care testing may also be referred to herein as near-patient testing, remote testing, satellite testing, and/or rapid diagnostics testing.

[0027] During point of care testing, a patient sample is collected and analyzed using a testing device referred to herein as a diagnostic engine. Example patient samples may include urine, blood, plasma, saliva, cerebrospinal fluid, pleural fluid, nasopharyngeal fluid, or the like. Patient samples are collected using a diagnostic consumable which may include, for example, a sample cartridge or other sample container in which blood or another bodily fluid is stored, a urine cup, a test strip such as a urine or lateral flow strip, etc. Such diagnostic consumables are typically, but need not be, one-time-use consumables.

[0028] In accordance with embodiments provided herein, diagnostic engines used for testing may be controlled by a central interface unit, referred to as an instrument data manager (IDM). For example, U.S. Patent Application Publication No.

US2020/0286621A1 , published September 10, 2020, titled “User Interface for Managing a Multiple Diagnostic Engine Environment,” and which is hereby incorporated by reference herein in its entirety for all purposes, describes a point of care system which includes a plurality of diagnostic engines and an IDM in electronic communication with each of the diagnostic engines. Each of the diagnostic engines may perform testing on a sample received from a patient and collected with a diagnostic consumable. The IDM may be configured to communicate with each of the diagnostic engines to enable a plurality of tests to be performed on multiple different samples substantially simultaneously. A plurality of users may use the diagnostic engines. The IDM may present a single user interface for managing testing by the plurality of diagnostic engines and for receiving measured results of tests performed by each of the diagnostic engines.

[0029] PCT Application Publication No. WO2020/163214A1 , published August 13, 2020, titled “Patient ID and Sample ID Workflow Methods and Apparatus for Facilitating Diagnostic Testing,” and which is hereby incorporated by reference herein in its entirety for all purposes, describes a point of care system that may include one or more diagnostic engines controlled and/or interfaced with an IDM. The IDM may be employed to obtain identification (ID) information of a patient for which a test is to be performed. The IDM also may be used to obtain ID information of a diagnostic consumable to be used to collect and/or store a sample from the patient. In some embodiments, the IDM may use a scanner to image a barcode on a patient wrist band to obtain patient ID information and/or to image a barcode on a diagnostic consumable to obtain diagnostic consumable ID information. The IDM then links the patient ID information with the diagnostic consumable ID information. For example, the patient ID information and diagnostic consumable ID information may be linked together in a memory and/or database (or other data structure) within the I DM. Each patient to be tested using diagnostic engines may have one or more diagnostic consumables linked with the patient. In some embodiments, patient ID information and diagnostic consumable ID information may be linked just prior to sample collection.

[0030] After sample collection and prior to performing a test on a patient’s sample using a diagnostic engine within the point of care system, ID information of the diagnostic consumable (with the sample to be tested) is scanned at the diagnostic engine. For example, a barcode scanner within or near the diagnostic engine may 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 with a patient (e.g., whether the scanned diagnostic consumable ID information is linked with patient ID information within the IDM). If the diagnostic consumable ID information is linked with patient ID information within the IDM, the IDM allows the diagnostic engine to perform a test on the sample collected with the diagnostic consumable. If the diagnostic consumable ID information is not linked with patient ID information within the IDM, the IDM prevents the diagnostic engine from performing the test.

[0031] By linking patient ID information and diagnostic consumable ID information at (or near) the time a sample is taken, and then confirming that any diagnostic consumable having a sample to be tested is linked with a patient within the IDM prior to testing with a diagnostic engine, test results are known to be associated with the correct patient(s).

[0032] Diagnostic engines 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 are referred to herein as being patient ID and sample ID (PIDSID) capable. (Alternatively, such diagnostic engines may be referred to as being patient ID and reagent ID (PIDRID) capable). When a diagnostic engine is PIDSID capable and has this feature enabled, the diagnostic engine is referred to as being PIDSID- capable/enabled. When a diagnostic engine is PIDSID capable and has this feature disabled, the diagnostic engine is referred to as being PIDSID-capable/disabled. Diagnostic engines that are not PIDSID capable are referred to herein as being PIDSID incapable. In summary, diagnostic engines may be PIDSID incapable or PIDSID capable, and PIDSID capable diagnostic engines may be PIDSID-capable/enabled or PIDSID-capable/disabled as summarized below in Table 1 (wherein DE stands for diagnostic engine).

Table 1 : Diagnostic Engine (DE) descriptions.

[0033] While PIDSID-capable/enabled diagnostic engines ensure that test results are associated with the correct patients, there may be instances in which PIDSID- capable/disabled and/or PIDSID-incapable diagnostic engines are used alone or together, or with one or more PIDSID-capable/enabled diagnostic engines under control of the same IDM. In such cases, because the linking of patient and sample information is not always confirmed prior to testing (for the PIDSID-incapable or PIDSID- capable/disabled diagnostic engines), there exists a chance that test results may be associated with incorrect patients (e.g., due to operator error, loss of identifying information on the diagnostic consumable, etc.).

[0034] Embodiments described herein provide methods and apparatus for preventing patient and sample mismatch in environments such as those described above (e.g., when an IDM interfaces with or is communicatively coupled to one or more PIDSID- incapable and/or PIDSID-capable/disabled diagnostic engines).

[0035] As a first example, an IDM may interface with and control one or more PIDSID- capable/enabled diagnostic engines and one or more PIDSID-incapable diagnostic engines. In accordance with embodiments provided herein, when the IDM is used to select a PIDSID-incapable diagnostic engine for testing, or when an operator attempts to perform a test using such a diagnostic engine, the IDM may disable all other PIDSID- incapable diagnostic engines controlled by the IDM. These PIDSID-incapable diagnostic engines may remain disabled until an operator enters information required by the IDM for the selected diagnostic engine (e.g., patient information, sample information, other demographic information, other test parameters, or the like). For example, the IDM may require that information be provided about a sample and/or a patient who supplied the sample so that test results from the selected diagnostic engine are associated with the correct patient. Once the required information is entered for the selected diagnostic engine, the disabled diagnostic engines may be re-enabled. In some embodiments, the selected diagnostic engine may perform testing on the sample prior to the operator entering the information required by the IDM. However, test results from the selected diagnostic engine will not be displayed until the required information has been entered. In other embodiments, the selected diagnostic engine may be prevented from testing until the required information has been entered.

[0036] A similar process may be employed if an IDM interfaces with and controls a combination of PIDSID-capable/disabled and PIDSID incapable diagnostic engines. That is, when the IDM is used to select a PIDSID-capable/disabled diagnostic engine or a PIDSID-incapable diagnostic engine for testing, or when an operator attempts to perform a test using such a diagnostic engine, the IDM may disable all other PIDSID- capable/disabled and PIDSID-incapable diagnostic engines controlled by the IDM. These diagnostic engines may remain disabled until an operator enters information required by the IDM for the selected diagnostic engine as described above. Such a process may be similarly employed when only PIDSID-incapable diagnostic engines or only PIDSID-capable/disabled diagnostic engines are used, or when any combination of PIDSID-capable/enabled, PIDSID-capable/disabled, and PIDSID-incapable diagnostic engines are used.

[0037] These and other embodiments provided herein are described below with reference to FIGS. 1A-7.

[0038] FIG. 1A illustrates an example point-of-care (POC) system 100 provided in accordance with embodiments of the disclosure. With reference to FIG. 1A, 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 employed (e.g., 1 , 2, 3, 5, 10, etc.).

[0039] In some embodiments, IDM 102 may include a processer 106 coupled to a memory 108, a scanner 110 and a display 111 having a user interface 112. Processor 106 may be a computational 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 perform as a microcontroller, or the like. IDM 102 may comprise any suitable computing device, such as a tablet computer, laptop computer, desktop computer, personal digital assistant, or the like.

[0040] Memory 108 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. Memory 108 may have a plurality of instructions stored therein that, when executed by processor 106, cause processor 106 to perform various actions specified by one or more of the stored instructions. These computer program instructions may be provided to processor 106 to perform operation acts in accordance with the present system and methods specified in the flow chart and/or block diagram block or blocks herein. The processor 106 so configured becomes a special purpose machine particularly suited for performing in accordance with the present system and methods. These computer program instructions may be stored in a computer readable medium, such as 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.

[0041] Scanner 110 may include any suitable imaging device capable of imaging a barcode or other identifying information of a patient name tag (e.g., a wrist band), a diagnostic consumable, 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 communications protocol) barcode reader. In some embodiments, scanner 110 may include a camera.

[0042] User interface 112 may include one or more of a display screen or a touch panel and/or screen, an audio speaker, and a microphone, for example. User interface 112 may be controlled by the IDM 102, and functionality of user interface 112 may be implemented, at least in part, by computer-executable instructions (e.g., program code or software) stored in memory 108 and/or executed by processor 106 of IDM 102. In some embodiments, IDM 102 may receive one or more measured results from one or more diagnostic engines 104a-z, process the measured results to generate calculated results, and present the calculated results and/or other information, such as patient information, via user interface 112.

[0043] In some embodiments, user interface 112 may be diagnostic engine agnostic, meaning that it may present results associated with any number of diagnostic engines and any type of diagnostic engine. User interface 112 may allow multiple diagnostic engines to be operated at the same time and using the same interface. In one or more embodiments, a user of user interface 112 may be able to begin a test, enter or view patient information, enter login credentials, view the time remaining on a particular test, and/or view the calculated results based on a test performed by a given diagnostic engine 104a-z. Further, user interface 112 may display the status or calculated results of multiple tests simultaneously.

[0044] User interface 112 may allow for common screens and elements between different types of diagnostic engines, improving efficiency of POC system 100 as a user of user interface 112 may only need to learn a single interface. Common elements may be presented on user interface 112. For example, if a user is running a urine test on a first patient and a blood test on a second patient, the user may be able to view one or more of the status or the test results of the urine test and the blood test on a single screen. In one example, user interface 112 may be configured to simultaneously display test results associated with two different users of user interface 112.

[0045] Diagnostic engines 104a-z may perform one or more tests. For example, 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, 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 that urine sample. Other diagnostic engines may be used.

[0046] Each diagnostic engine 104a-z may include a processor 114 coupled to a memory 116. Optionally a scanner 118 (e.g., a camera, a barcode reader, etc.) also may be coupled to the processor 114. Other example components, that may be included in one or more of diagnostic engines 104a-z are illustrated in diagnostic engine 104 of FIG. 1 B (e.g., wireless circuitry 120, heating element 122, mixing means 124, optical sensor 126, pump 128, reagents 130 and/or the like). It is understood that a given one of diagnostic engines 104a-z may optionally comprise any number or any combination of these elements. It is further understood that a diagnostic engine 104a-z may comprise other components not shown in the figures or described herein, such as a separation means or any other components as would be understood by a person skilled in the art. In addition, a first type of diagnostic engine (e.g., a diabetes diagnostic engine) may comprise a different number and/or a different combination of components than a second type of diagnostic engine (e.g., a urinalysis diagnostic engine).

[0047] Processor 114 may be a computational resource such as, but not limited to, a microprocessor, a microcontroller, an embedded microcontroller, a DSP, a FPGA configured to perform as a microcontroller, or the like. 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. Memory 116 may have a plurality of instructions stored therein that, when executed by processor 114, cause processor 114 to perform various actions specified by one or more of the stored instructions.

[0048] Processor 114 may be configured to allow processing of a sample. For example, processor 114 may be configured to receive an instruction from a user to perform a test on a sample (e.g., contained on or in a diagnostic consumable) inserted into a diagnostic engine 104a-z and to output one or more values representing a measured result of the test on that sample. In one embodiment, processor 114 may be a real-time processor configured to generate one or more measurements within a given time period, such as ten seconds. Processor 114 may additionally or alternatively be a non-real time processor configured to generate measured results based on the measurements from the test samples. In one example, one or more of diagnostic engines 104a-z may comprise 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 to generate measured results.

[0049] Processor 114 may control the various components of a diagnostic engine 104a-z (e.g., heating elements 122, mixing means 124, optical sensors 126, pumps 128, reagents 130, etc.,) and may receive feedback from those components. Processor 114 may adjust one or more characteristics of a diagnostic engine 104a-z accordingly (in real-time) to keep the diagnostic engine 104a-z within the proper operating conditions and may obtain the measured results of a test performed by the diagnostic engine 104a-z.

[0050] Referring again to FIG. 1A, memory 116 of a diagnostic engine 104a-z may be configured to store information received or generated by that diagnostic engine. For example, memory 116 may be configured to store one or more values representing a measured result of a test performed by a diagnostic engines 104a-z.

[0051] Wireless circuitry 120 (FIG. 1 B) may enable a diagnostic engine 104a-z to communicate with one or more other components of POC system 100. For example, wireless circuitry 120 may enable a diagnostic engine 104a-z to communicate measured results over a Bluetooth® or WiFi connection to IDM 102 (which may also include wireless circuitry, not separately shown).

[0052] Each diagnostic engine 104a-z may be configured to receive a sample in the form of a diagnostic consumable (e.g., a sample cartridge in which blood or another bodily fluid is stored, a test strip such as a urine or lateral flow strip, etc.). A diagnostic engine may be configured to come into direct contact with the sample during the test. Examples of these types of diagnostic engines include so called “bench top” blood gas analyzers (such as the RapidPoint 500, sold by Siemens Healthcare Diagnostics Inc. of Tarrytown, NY) and automated urine chemistry analyzers (such as the Clinitek Novus, sold by Siemens Healthcare Diagnostics Inc. of Tarrytown, NY). Alternatively, a diagnostic engine 104a-z, and physical components thereof, may not come into contact with the sample directly, but rather indirectly (e.g., optically).

[0053] A sample may be obtained from a patient using any one or a combination of methods known in the art. For example, in order to obtain a blood sample, a syringe may be used to withdraw blood from a vein of a patient. Additionally or alternatively, the blood sample can be separated (e.g., by centrifugation) to isolate and obtain a serum sample. A blood sample can additionally or optionally be obtained by lightly pricking one of the subject's fingers (e.g., with a sterile needle) and then collecting a desired volume of blood.

[0054] Following collection of a sample, the sample may be 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 diagnostic engines 104a-z. For example, a diagnostic consumable may be a plastic or glass container configured to receive a certain volume of the sample, or may be a test strip configured to receive a minor amount of the sample.

[0055] In some embodiments, a diagnostic consumable may be a cartridge or container which holds a sample and which is placed directly into a diagnostic engine 104a-z. Alternatively, a diagnostic consumable may merely hold a sample prior to the sample being analyzed by a diagnostic engine. For example, a first diagnostic consumable may be a urine cup which holds a sample prior to application of a second diagnostic consumable such as a urine strip. The urine strip may then be analyzed by a diagnostic engine 104a-z.

[0056] POC system 100 may comprise any number of diagnostic engines 104a-z for testing any number of different types and combinations of samples. Example diagnostic engines 104a-z include but are not limited to blood gas diagnostic engines, cardiac diagnostic engines, coagulation diagnostic engines, diabetes diagnostic engines, urinalysis diagnostic engines, and blood pressure diagnostic engines.

[0057] Each diagnostic engine 104a-z may be configured to receive a test sample, perform a test on the sample, and send a measured result of that test to IDM 102. Each diagnostic engine 104a-z may also be configured to store one or more measured results in memory 116 of the diagnostic engine.

[0058] IDM 102 may be configured to receive one or more measured results from one or more of diagnostic engines 104a-z. The measured results may be received, for example, over a communications connection 132 between the one or more diagnostic engines 104a-z and IDM 102. In one embodiment, connection 132 may comprise a wireless or wired connection. For example, connection 132 may comprise a Bluetooth® connection. Other communication protocols may be used. A measured result may comprise one or more values that represent a measured result of a test performed by a diagnostic engine 104a-z. For example, IDM 102 may receive a single value from a diabetes diagnostic engine representing an HbA1c value of a blood sample or may receive multiple values from a cardiac diagnostic engine corresponding to total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels of the blood sample.

[0059] IDM 102 may be configured to communicate information to any diagnostic engines 104a-z, such as an instruction to initiate a test or enable or disable testing, software updates, or changes to the diagnostic engine protocol that may be used by processor 114 of a diagnostic engine 104a-z in generating one or more test results. Control of diagnostic engines 104a-z themselves may be performed by the processors 114 associated with the diagnostic engines 104a-z and/or instructions received from one or more users at diagnostic engines 104a-z.

[0060] In some embodiments, processor 106 of IDM 102, upon receiving a measured result from a diagnostic engine 104a-z, may be configured to process the measured result so that a calculated result may be presented to a user of POC system 100. For example, IDM 102 may receive one or more values (e.g., measured results) from a diagnostic engine 104a-z. Processor 106 may be configured to determine which values correspond to certain health markers and may determine how to present those values to a user of POC system 100 (e.g., as test results). Processor 106 may be configured to generated calculated results by comparing a received value to one or more other stored or received values and may be configured to compute a ratio of one value to another, such as a triglyceride to HDL cholesterol ratio of a blood sample, in order to generate calculated results.

[0061] Memory 108 of IDM 102 may be configured to store a measured result received from any of diagnostic engines 104a-z and/or one or more calculated results generated by IDM 102. Memory 108 may further store information associated with one or more patients. For example, memory 108 may store patient information such as an identifier associated with the patient, patient last name, patient first name, patient gender, and patient date of birth.

[0062] FIG. 2A illustrates an example data structure 200, such as a database or lookup table, of patient information that may be stored in memory 108. With reference to FIG. 2A, data structure 200 may associate patient information such as patient last name, patient first name, patient date of birth, patient address, etc., with a patient ID. In some embodiments, memory 108 may store patient test results (not shown) along with the patient information so that they may be retrieved at a later date.

[0063] As described previously, in some embodiments, diagnostic engines may be PIDSID capable or PIDSID incapable. For a PIDSID-capable diagnostic engine in which the PIDSID feature is enabled, memory 108 of IDM 102 may store diagnostic consumable information, and may link patient ID information with diagnostic consumable ID information. For example, FIG. 2B illustrates an example data structure 202, such as a database or lookup table, of diagnostic consumable information.

Example diagnostic consumable information that may be stored in memory 108 may include diagnostic consumable ID, the test to be performed on/with the diagnostic consumable, etc. FIG. 2C illustrates an example data structure 204, such as a database or lookup table, in which patient ID information is linked with diagnostic consumable ID information, and that may be stored in memory 108 (e.g., prior to sample collection). [0064] Example operation of a PIDSID-capable/enabled diagnostic engine is described with reference to FIGS. 1A-3B. Example operation of PIDSID- capable/disabled and PIDSID-incapable diagnostic engines is described with reference to FIGS. 4A-7.

[0065] Referring to FIG. 3A, a method 300 for operating a PIDSID-capable/enabled diagnostic engine may be performed by POC system 100 and includes obtaining ID information for a patient (Block 302), obtaining ID information for a diagnostic consumable (Block 304), and linking patient ID information with diagnostic consumable ID information (Block 306). In some embodiments, method 300 may be performed immediately prior to a sample being collected from a patient (e.g., prior to a blood draw, finger prick, urine collection, etc.). [0066] Patient ID information may be entered into IDM 102 and stored in memory 108. In some embodiments, patient ID information may be entered manually through user interface 112 of IDM 102. In other embodiments, scanner 110 of IDM 102 may scan patient ID information into IDM 102 for storage into memory 108, such as by scanning a barcode on paperwork or a wrist band associated with the patient. In one or more embodiments, a barcode may be scanned and used to lookup patient information previously stored on a server (e.g., for storage into memory 108 of IDM 102). An example wrist band 134 is shown in FIG. 1 A that includes a barcode 136 with encoded patient ID information. In some embodiments, the barcode 136 of wrist band 134 may be scanned by scanner 110 or another imaging device to obtain patient ID information for storage in memory 108 of IDM 102.

[0067] Example patient ID information may include a patient ID number, patient’s name, date of birth, gender, mailing address, email address, allergies, medical history or the like. Example patient information, stored in a database or lookup table in memory 108, is shown in FIG. 2A.

[0068] Diagnostic consumable ID information similarly may be entered into IDM 102 and stored in memory 108. In some embodiments, diagnostic consumable ID information may be entered manually through user interface 112 of IDM 102. In other embodiments, scanner 110 of IDM 102 may scan diagnostic consumable ID information for storage into memory 108, such as by scanning a barcode on a sample cartridge, urine (sample) cup, test strip or other diagnostic consumable. An example diagnostic consumable 138 is shown in FIG. 1A that includes a barcode 140 encoded with diagnostic consumable ID information.

[0069] Example diagnostic consumable ID information includes a diagnostic consumable ID number, the type of test to be performed on the diagnostic consumable, the time the diagnostic consumable ID was scanned, calibration information, expiration date, lot number, or the like. Example diagnostic consumable information, stored in a database or lookup table in memory 108, is shown in FIG. 2B.

[0070] When PIDSID is enabled for a PIDSID-capable diagnostic engine, within IDM 102, patient ID information and diagnostic consumable ID information are linked. For example, patient ID information and diagnostic consumable ID information may be stored together 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 may be otherwise linked.

[0071] With reference to FIG. 3B, method 310 may be performed by POC system 100 and a diagnostic engine 104a-z that is PIDSID-capable/enabled when sample testing is to be performed. Once a sample has been collected using a diagnostic consumable, method 310 includes obtaining ID information for the diagnostic consumable (Block 312), and confirming the diagnostic consumable is valid (Block 314). For example, a barcode scanner, such as scanner 118 of one of diagnostic engines 104a-z of FIG. 1A, may be used to scan a barcode on the diagnostic consumable to determine its diagnostic consumable ID information. In some embodiments, inserting a diagnostic consumable into a PIDSID-capable/enabled diagnostic engine for testing may cause a barcode on the diagnostic consumable to be scanned. Alternatively, a barcode scanner that is separate from the diagnostic engine may be used to obtain diagnostic consumable ID information. The PIDSID-capable/enabled diagnostic engine may then provide the scanned diagnostic consumable ID information to IDM 102.

[0072] Once IDM 102 receives ID information for a diagnostic consumable, IDM 102 may determine if the diagnostic consumable is valid. For example, IDM 102 may determine if the ID number for the diagnostic consumable is a valid ID number, corresponds to a proper type of diagnostic consumable for the diagnostic engine being used, etc. If not, method 310 ends (Block 316); otherwise method 310 includes determining if the diagnostic consumable ID information is linked with patient ID information within IDM 102 (Block 318). For example, IDM 102 may access memory 108 to determine if the diagnostic consumable ID information is linked with patient ID information. If not, the diagnostic engine may be prevented (or otherwise restricted or limited) from testing the sample collected with the 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 allows the PIDSID- capable/enabled diagnostic engine to perform testing on the sample collected with the diagnostic consumable (Block 320). For example, IDM 102 may issue an instruction to the diagnostic engine indicating that the diagnostic engine should commence testing. Following testing, test results from the diagnostic engine may be communicated to IDM 102 and/or stored with patient ID information (e.g., in memory 108 of IDM 102).

[0073] In some embodiments, when method 310 ends at block 316, either due to an invalid diagnostic consumable being detected or a diagnostic consumable not being linked with a patient in IDM 102, the diagnostic engine is prevented or otherwise restricted from performing any testing on the sample collected with the diagnostic consumable. For example, IDM 102 may employ user interface 112 to alert an operator that an error has occurred, to flag the invalid or unlinked diagnostic consumable, etc. [0074] In cases in which PIDSID-incapable or PIDSID-capable/disabled diagnostic engines are employed, because the linking of patient and sample information is not confirmed prior to testing, there exists a chance that test results may be associated with incorrect patients (e.g., due to operator error, loss of identifying information on the diagnostic consumable, etc.). Embodiments described herein provide methods and apparatus for preventing patient and sample mismatch in environments such as these, as described below with reference to FIGS. 4A-7.

[0075] FIG. 4A is a schematic diagram of a point-of-care (POC) system 400a that includes a combination of PIDSID-incapable and PIDSID-capable/enabled diagnostics engines. With reference to FIG. 4A, POC system 400a includes IDM 102 that interfaces and controls three PIDSID-incapable diagnostic engines 104a-104c and two PIDSID- capable/enabled diagnostic engines 104d-104e. FIG. 4B is a schematic diagram of a similar POC system 400b that includes PIDSID-incapable diagnostic engines 104f-104h and PIDSID-capable/disabled diagnostic engines 104i-104j. FIG. 4C is a schematic diagram of a POC system 400c that includes only PIDSID-incapable diagnostic engines 104k-104o; and FIG. 4D is a schematic diagram of a POC system 400d that includes PIDSID-capable/disabled diagnostic engines 104p-104q, PIDSID-incapable diagnostic engine 104r, and PIDSID-capable/enabled diagnostic engines 104s-104t. Other diagnostic engine types and/or configurations may be employed.

[0076] With reference to FIGS. 4A-4D, IDM 102 may be used to select a diagnostic engine for testing. For example, in the POC system 400a of FIG. 4A, IDM 102 may 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 incapable, there is no requirement to link patient ID and sample ID (e.g., diagnostic consumable ID) prior to commencing testing with diagnostic engine 104a. Likewise, 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-incapable or PIDSID-capable/disabled diagnostic engines that do not employ the linking of patient ID and sample ID prior to testing. Embodiments for preventing patient and sample mismatch in such situations are described below with reference to FIGS. 5A-6C.

[0077] FIGS. 5A-5C illustrate example display screen layouts for configuring IDM 102 in accordance with embodiments provided herein. With reference to FIG. 5A, in a main menu, an administrator may set whether entry of patient test demographic information during testing is enabled, disabled, required, or optional using a selectable Patient Test Demographics field 502. Likewise, an administrator may set whether entry of test parameters during testing is enabled, disabled, required, or optional using a selectable Test Parameters field 504. Finally, an administrator may enable or disable the patient ID sample ID linking requirement of any PIDSID-capable diagnostic engines controlled by IDM 102 using Patient ID Sample ID Link field 506. In some embodiments, the only option may be to enable or disable the P I DS ID-linking feature of all PIDSID-capable diagnostic engines controlled by IDM 102. In other embodiments, the PIDSID-linking feature of individual PIDSID-capable diagnostic engines may be enabled or disabled. Fewer, more, or different information may be specified as being disabled, enabled, required, or optional.

[0078] FIG. 5B illustrates example patient test demographic information that may be set to disabled, enabled, required, or optional by an administrator for entry prior to viewing test results from a diagnostic engine when Patient Test Demographics field 502 is enabled. Example selectable patient test demographic information includes patient ID, Patient Name prefix, Patient First Name, Patient Last name, date of birth, etc. FIG. 5C illustrates example test parameter information that may be set to disabled, enabled, required, or optional by an administrator for entry prior to viewing test results from a diagnostic engine when Test Parameters field 504 is enabled. Example selectable test parameter information includes patient age, patient race, patient temperature, sample container, sample color, sample clarity or the like. Fewer, more, or different information may be specified as being disabled, enabled, required, or optional.

[0079] FIGS. 6A-6C illustrate an example method 600 for preventing patient and sample mismatch during diagnostic testing within a POC system (such as POC system 100, 400a, 400b, 400c and/or 400d) in accordance with embodiments provided herein. With reference to FIG. 6A, in Block 602, an IDM receives an administrator’s selection regarding enabling the PIDSID-linking feature of PIDSID-capable diagnostic engines controlled by the IDM. Additionally, patient demographic and test parameter information requirements may be selected (e.g., enabled, disabled, required, optional, etc.). Example patient demographic information and example test parameters are described above with reference to FIGS. 5A-5C. In some embodiments, an administrator may setup IDM 102 with the desired PIDSID, patient demographic information, and test parameter information requirements prior to use by medical staff. As mentioned, in one or more embodiments, all PIDSID-capable diagnostic engines are either placed in a PIDSID-capable/enabled state in which patient ID and sample ID must be linked within the IDM 102 prior to testing or in a PIDSID-capable/disabled state in which there is no requirement for patient ID and sample ID to be linked within the IDM 102. In other embodiments, individual PIDSID-capable diagnostic engines may be placed in a PIDSID-capable/enabled or PIDSID-capable/disabled state.

[0080] During subsequent use following IDM setup, in Block 604, a determination is made (e.g., by IDM 102) whether there are any requirements to enter patient demographic information or test parameter information for use of the diagnostic engines controlled by the IDM. For example, the settings for Patient Test Demographics field 502 and Test Parameters field 504 may be examined. If there are no requirements to enter either patient demographic information or test parameter information, in Block 606, all diagnostic engines may be operated independently and without any additional preventative steps to reduce patient and sample mismatch (other than the processes normally applied in a clinical setting). As such, the risk of patient and sample mismatch remains unless only PIDSID-capable diagnostic engines (that are PIDSID- capable/enabled) are employed. [0081] If, in Block 604, it is determined that the IDM requires patient demographic or test parameter information to be entered (e.g., via Patient Test Demographics field 502 or Test Parameters field 504), method 600 proceeds to Block 608. In Block 608, if the IDM interfaces with one or more PIDSID-capable diagnostic engines that are PIDSID- capable/enabled, method 600 proceeds to Block 610 (FIG. 6B); otherwise, method 600 proceeds to Block 630 (FIG. 6C). FIGS. 6B-6C thus represent how the POC system (e.g., POC system 100, 400a, 400b, 400c, and/or 400d) will respond to selection of a diagnostic engine for testing, with the method of operation being dependent on how the IDM is configured in Block 602 and whether PIDSID-capable/enabled diagnostic engines are used with the POC system.

[0082] Referring to FIG. 6B, when an operator is ready to perform a test on a sample, the operator may select a diagnostic engine to use. For example, an operator may select a diagnostic engine from user interface 112 of IDM 102, or an operator may attempt to commence testing at a diagnostic engine, such as by inserting a diagnostic consumable into the diagnostic engine. The diagnostic engine receiving the diagnostic consumable may send a signal or other communication to IDM 102 informing IDM 102 that a diagnostic consumable has been inserted into the diagnostic engine and/or that testing has been started at the diagnostic engine.

[0083] In Block 610, it is determined whether a PIDSID-capable/enabled diagnostic engine has been selected. If a PIDSID-capable/enabled diagnostic engine has been selected, in Block 612, an operator is required to provide a sample ID (e.g., by scanning a barcode on a diagnostic consumable at the diagnostic engine or using a scanner of the IDM 102, for example). In Block 614, it is determined whether the sample ID (e.g., diagnostic consumable ID) is linked to a patient (and if the sample ID is valid as previously described). For example, IDM 102 may determine whether the patient is linked to the sample ID, such as in data structure 204 of FIG. 2C. If the patient and sample are linked (assuming the sample ID is valid), in Block 616, the sample is processed at the selected PIDSID-capable/enabled diagnostic engine; otherwise, at Block 618, an operator is alerted that the sample ID is not linked to a patient or is invalid and testing is not allowed to proceed at the diagnostic engine (as described previously with reference to Block 316 of FIG. 3B). For example, either due to an invalid diagnostic consumable being detected or a diagnostic consumable not being linked with a patient in IDM 102, the selected diagnostic engine may be prevented or otherwise restricted from performing any testing on the sample collected with the diagnostic consumable or from presenting results of any testing already done. User interface 112 of IDM 102 may alert an operator that an error has occurred, to flag the invalid or unlinked diagnostic consumable, etc.

[0084] Returning to Block 610, if it is determined that a PIDSID-capable/enabled engine is not selected, in Block 620, all other PIDSID-incapable (or PIDSID- capable/disabled) diagnostic engines controlled by the IDM are disabled. For example, IDM 102 may place these diagnostic engines in a “Not Ready” state that prevents the diagnostic engines from accepting a diagnostic consumable or performing a test on a diagnostic consumable. In some embodiments, the disabled diagnostic engines may be greyed out or otherwise non-selectable on interface 112 of IDM 102. In Block 622, the operator who selected the PIDSID-incapable (or PIDSID-capable/disabled) diagnostic engine for testing is prompted to collect a patient sample and start testing at the selected diagnostic engine (if testing has not already started at the diagnostic engine). Thereafter, in Block 624, the operator is prompted to enter patient information and/or sample information (e.g., patient demographic information, test parameter information, etc.). For example, user interface 112 of IDM 102 may prompt the operator to enter a patient ID, a patient first and last name, a patient date of birth, other demographic information, a test parameter such as patient age, patient race, patient temperature, sample container, sample color, sample clarity, or the like associated with or relevant to a sample being tested at 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. In some embodiments, an operator must at least manually skip a particular screen or data request before proceeding. Based on the received demographic and/or test parameter information, IDM 102 may identify the patient associated with the test results generated by the selected diagnostic engine. In this manner, the chance of a mismatch between a patient and test results is significantly reduced. [0085] Once the required patient demographic and/or test parameter information is entered by the operator, in Block 626, the test results from the selected diagnostic engine may be displayed or otherwise presented (e.g., via user interface 112 of display 111 of IDM 102). Before, after, or concurrently with displaying test results from the selected diagnostic engine, in Block 628, previously disabled diagnostic engines are reenabled. Specifically, IDM 102 may enable the diagnostic engines it disabled in block 620. In some embodiments, diagnostic engines may be disabled if they are not within range of IDM 102. For example, each diagnostic engine controlled by an IDM may have computer program code that disables testing at the diagnostic engine if the diagnostic engine is not in range of or in communication with the IDM (e.g., out of Bluetooth® or other wireless protocol range). Such a feature further reduces the likelihood of patient and sample mismatch because an operator cannot use any diagnostic engine that is not communicating information required by the IDM to initiate testing or view test results at the diagnostic engine (e.g., patient demographic and/or test parameter information as described above).

[0086] Returning to block 608 of FIG. 6A, as stated previously, if the IDM does not interface with one or more PIDSID-capable/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., through the interface 112 of IDM 102 or an operator loading a sample into a diagnostic engine). Thereafter, in Block 632, the IDM disables all other diagnostic engines controlled by the IDM (e.g., any other PIDSID- incapable or PIDSID-capable/disabled diagnostic engines). For example, IDM 102 may place these diagnostic engines in a “Not Ready” state that prevents the diagnostic engines from accepting a diagnostic consumable or performing a test on a diagnostic consumable. In Block 634, the operator who selected the PIDSID-incapable (or PIDSID- capable/disabled) diagnostic engine for testing is prompted to collect a patient sample and start testing at the selected diagnostic engine (if testing has not already started at the diagnostic engine).

[0087] In Block 636, the operator who selected the diagnostic engine for testing is prompted to enter information for the selected diagnostic engine. For example, user interface 112 of IDM 102 may prompt the operator to enter a patient ID, a patient first and last name, a patient date of birth, other demographic information, a test parameter, or the like associated with the sample being tested at 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, IDM 102 may identify the patient associated with the test results generated by the selected diagnostic engine. As such, the chance of a mismatch between a patient and test results is significantly reduced. [0088] Once the required demographic and/or test parameter information is entered by the operator, in Block 638, the test results from the selected diagnostic engine may be displayed or otherwise presented to the operator (e.g., via user interface 112 of IDM 102). Before, after, or concurrently with displaying test results from the selected diagnostic engine, in Block 640, previously disabled diagnostic engines are re-enabled. Specifically, IDM 102 may enable the diagnostic engines it disabled in Block 632. [0089] FIG. 7 illustrates an example method 700 of operating a plurality of diagnostic engines in accordance with embodiments provided herein which, as explained above, advantageously reduce the risk of mismatch between a patient and test results. With reference to FIG. 7, in Block 702, an IDM in communication with a plurality of diagnostic engines receives a selection of one of the diagnostic engines to be used for testing a sample of a patient. For example, IDM 102 may receive a selection of a diagnostic engine to be used to test a sample. In some embodiments, an operator may select a diagnostic engine via user interface 112 of IDM 102. Alternatively, an operator may insert a diagnostic consumable into the selected diagnostic engine or begin testing at the selected diagnostic engine and the diagnostic engine may communicate the same to the IDM 102. In 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 a PIDSID-capable/disabled diagnostic engine, the IDM may disable any other diagnostic engine controlled by the IDM that is not PIDSID-capable/enabled (e.g., any diagnostic engine that is not configured to link patient ID information with diagnostic consumable ID information prior to testing at the diagnostic engine). In Block 706, prior to displaying a test result from the selected diagnostic engine for the sample of the patient, the IDM may require entry of patient information and/or sample information. For example, IDM 102 may require entry of patient demographic and/or test parameter information related to the sample to be tested on the selected diagnostic engine (e.g., via Patient Test Demographics field 502 and/or Test Parameters field 504). In some embodiments, requiring entry of at least one of patient information and sample information may include requiring scanning of a barcode (e.g., by a scanner or camera located at or near the IDM 102 or the selected diagnostic engine). In other embodiments, requiring entry of at least one of patient information and sample information may include requiring manual entry of information at the IDM 102 (e.g., via user interface 112).

[0090] In Block 708, after or in response to receiving entry of the patient or sample information, the IDM may (re)enable any disabled diagnostic engine. In some embodiments, any diagnostic engine disabled in Block 704 that is within range of IDM 102 may be enabled (e.g., placed in a Ready state and capable of performing diagnostic testing). In Block 710, test results from the selected diagnostic engine are provided to the operator (e.g., via interface 112 of IDM 102). Test results from the selected diagnostic engine may be displayed in response to and any time after the requested patient or sample information is provided (e.g., before, during or after any disabled diagnostic engines are re-enabled).

[0091] Computer program code or executable instructions for implementing the described display screen layouts or similar screen layouts, and/or for carrying out the methods 300, 310, 600 and/or 700 may be 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.

[0092] In some embodiments, when the PIDSID feature is enabled for PIDSID- capable diagnostic engines, patient ID information must be entered prior to testing or viewing test results. Otherwise, testing is prevented.

[0093] In some embodiments, a POC system includes a plurality of diagnostic engines (e.g., diagnostic engines 104a-z) and an IDM (e.g., IDM 102) configured to control operation of the plurality of diagnostic engines. The IDM may include a display, a processor coupled to the display, and a memory coupled to the processor (e.g., display 111 , processor 106, and memory 108). The memory may have stored therein a plurality of computer executable instructions that, when executed by the processor, cause the IDM to (a) receive a selection of one of the plurality of diagnostic engines for testing a sample of a patient; (b) disable at least one of the plurality of diagnostic engines that was not selected; (c) prior to displaying a test result from the selected diagnostic engine for the sample of the patient, require entry of at least one of patient information and sample information; and (d) after receiving entry of the patient information or sample information, enable any disabled diagnostic engine. For example, memory 108 of IDM 102 may include computer executable instructions for carrying out method 700. Likewise, memory 108 of IDM 102 may include computer executable instructions that cause the IDM to, after receiving entry of the patient information or sample information, display the test result(s) from the selected diagnostic engine on the display of the IDM. Furthermore, memory 108 of IDM 102 may include computer executable instructions that cause the IDM to disable any diagnostic engine that is not configured to link patient ID information with diagnostic consumable ID information prior to testing at the selected diagnostic engine. In some embodiments, each diagnostic engine 104a-z may include computer executable instructions (e.g., stored in memory 116 and executable by processor 114) that cause each diagnostic engine to prevent testing at the diagnostic engine if the diagnostic engine is out of range of the IDM 102.

[0094] The following is a list of non-limiting illustrative embodiments disclosed herein: [0095] Illustrative embodiment 1 . A method of operating a plurality of diagnostic engines, comprising: receiving, via an instrument data manager (IDM) in communication with a plurality of diagnostic engines, a selection of one of the plurality of diagnostic engines for testing a sample of a patient; employing the IDM to disable at least one of the plurality of diagnostic engines that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, requiring entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, employing the IDM to enable any disabled diagnostic engine.

[0096] Illustrative embodiment 2. The method of illustrative embodiment 1 further comprising, after receiving entry of the patient information or sample information, employing the IDM to display the test result from the selected diagnostic engine. [0097] Illustrative embodiment 3. The method of any one of the preceding illustrative embodiments wherein receiving the selection of one of the plurality of diagnostic engines comprises receiving the selection via an interface of the IDM.

[0098] Illustrative embodiment 4. The method of any one of the preceding illustrative embodiments wherein receiving the selection of one of the plurality of diagnostic engines comprises receiving at the IDM a communication from the selected diagnostic engine that the sample has been loaded into the selected diagnostic engine or that testing has begun at the selected diagnostic engine.

[0099] Illustrative embodiment 5. The method of any one of the preceding illustrative embodiments wherein the patient information comprises patient identification (ID) information and the sample information comprises diagnostic consumable ID information.

[0100] Illustrative embodiment 6. The method of any one of the preceding illustrative embodiments wherein employing the IDM to disable at least one diagnostic engine comprises employing the IDM to disable any non-selected diagnostic engine that is not configured to link patient ID information with diagnostic consumable ID information prior to testing at the diagnostic engine.

[0101] Illustrative embodiment 7. The method of any one of the preceding illustrative embodiments wherein employing the IDM to disable at least one diagnostic engine comprises employing the IDM to prevent testing using the at least one diagnostic engine.

[0102] Illustrative embodiment 8. The method of any one of the preceding illustrative embodiments wherein employing the IDM to disable at least one diagnostic engine that was not selected comprises employing the IDM to disable all diagnostic engines other than the selected diagnostic engine.

[0103] Illustrative embodiment 9. The method of any one of the preceding illustrative embodiments wherein requiring entry of at least one of patient information and sample information comprises requiring scanning of a barcode.

[0104] Illustrative embodiment 10. The method of any one of the preceding illustrative embodiments wherein requiring entry of at least one of patient information and sample information comprises requiring manual entry of information at the IDM. [0105] Illustrative embodiment 11 . A point of care system comprising: an IDM configured to communicate with a plurality of diagnostic engines and to: receive a selection of one of the plurality of diagnostic engines for testing a sample of a patient; disable at least one diagnostic engine that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, require entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, enable any disabled diagnostic engine. [0106] Illustrative embodiment 12. The point of care system of any one of the preceding illustrative embodiments, wherein the IDM is configured to, after receiving entry of the patient information or sample information, display the test result from the selected diagnostic engine.

[0107] Illustrative embodiment 13. The point of care system of one any of the preceding illustrative embodiments, wherein the IDM is configured to receive the selection of one of the plurality of diagnostic engines via an interface of the IDM. [0108] Illustrative embodiment 14. The point of care system of any one of the preceding illustrative embodiments, wherein the IDM is configured to receive the selection of one of the plurality of diagnostic engines by receiving at the IDM a communication from the selected diagnostic engine that the sample has been loaded into the selected diagnostic engine or that testing has begun at the selected diagnostic engine.

[0109] Illustrative embodiment 15. The point of care system of any one of the preceding illustrative embodiments, wherein the patient information comprises patient ID information and the sample information comprises diagnostic consumable ID information.

[0110] Illustrative embodiment 16. The point of care system of any one of the preceding illustrative embodiments, wherein the IDM is configured to disable any nonselected diagnostic engine that is not configured to link patient ID information with diagnostic consumable ID information prior to testing at the diagnostic engine.

[0111] Illustrative embodiment 17. The point of care system of any one of the preceding illustrative embodiments, wherein the IDM is configured to require entry of at least one of patient information and sample information by requiring scanning of a barcode.

[0112] Illustrative embodiment 18. The point of care system of any one of the preceding illustrative embodiments, wherein each diagnostic engine is configured to prevent testing at the diagnostic engine if the diagnostic engine is out of range of the IDM.

[0113] Illustrative embodiment 19. The point of care system of any one of the preceding illustrative embodiments, wherein the IDM is configured to communicate with each diagnostic engine via wireless communications.

[0114] Illustrative embodiment 20. The point of care system of any one of the preceding illustrative embodiments, wherein the plurality of diagnostic engines comprise 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. [0115] Illustrative embodiment 21. The point of care system of any one of the preceding illustrative embodiments, wherein the IDM is configured to require entry of patient information or sample information by requiring an operator to at least manually skip a screen or data request.

[0116] Illustrative 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 stored therein a plurality of 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 sample of a patient; disable at least one of the plurality of diagnostic engines that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, require entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, enable any disabled diagnostic engine.

[0117] Illustrative embodiment 23. The system of any one of the preceding illustrative embodiments wherein the non-transitory memory includes computer executable instructions that, when executed by the processor, cause the IDM to, after receiving entry of the patient information or sample information, display the test result from the selected diagnostic engine on the display of the IDM.

[0118] Illustrative embodiment 24. The system of any of one the preceding illustrative embodiments 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 with diagnostic consumable ID information prior to testing at the diagnostic engine.

[0119] Illustrative embodiment 25. The system of any of one the preceding illustrative embodiments wherein each diagnostic engine is configured to prevent testing at the diagnostic engine if the diagnostic engine is out of range of the IDM.

[0120] The foregoing description discloses only example 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 present invention has been disclosed in connection with the example embodiments thereof, it should be understood that other embodiments may fall within the spirit and scope of the invention, as defined by the following claims.

Claims

WHAT IS CLAIMED IS:

1 . A method of operating a plurality of diagnostic engines, comprising: receiving, via an instrument data manager (IDM) in communication with a plurality of diagnostic engines, a selection of one of the plurality of diagnostic engines for testing a sample of a patient; employing the IDM to disable at least one of the plurality of diagnostic engines that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, requiring entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, employing the IDM to enable any disabled diagnostic engine.

2. The method of claim 1 further comprising, after receiving entry of the patient information or sample information, employing the IDM to display the test result from the selected diagnostic engine.

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

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

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

6. The method of claim 1 wherein employing the IDM to disable at least one diagnostic engine comprises employing the IDM to disable any non-selected diagnostic engine that is not configured to link patient ID information with diagnostic consumable ID information prior to testing at the diagnostic engine.

7. The method of claim 1 wherein employing the IDM to disable at least one diagnostic engine comprises employing the IDM to prevent testing using the at least one diagnostic engine.

8. The method of claim 1 wherein employing the IDM to disable at least one diagnostic engine that was not selected comprises employing the IDM to disable all diagnostic engines other than the selected diagnostic engine.

9. The method of claim 1 wherein requiring entry of at least one of patient information and sample information comprises requiring scanning of a barcode.

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

11. A point of care system comprising: an instrument data manager (IDM) configured to communicate with a plurality of diagnostic engines and to: receive a selection of one of the plurality of diagnostic engines for testing a sample of a patient; disable at least one diagnostic engine that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, require entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, enable any disabled diagnostic engine.

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

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

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

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

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

17. The point of care system of claim 16, wherein the IDM is configured to require entry of at least one of patient information and sample information by requiring scanning of a barcode.

18. 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 out of range of the IDM.

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

20. The point of care system of claim 11 , wherein the plurality of diagnostic engines comprise 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 . The point of care system of claim 11 , wherein the I DM is configured to require entry of patient information or sample information by requiring an operator to at least manually skip a screen or data request.

22. A system comprising: a plurality of diagnostic engines; and an instrument data manager (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 stored therein a plurality of 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 sample of a patient; disable at least one of the plurality of diagnostic engines that was not selected; prior to displaying a test result from the selected diagnostic engine for the sample of the patient, require entry of at least one of patient information and sample information; and after receiving entry of the patient information or sample information, enable any disabled diagnostic engine.

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, after receiving entry of the patient information or sample information, display the test result from the selected diagnostic engine on the display of the IDM.

24. 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 with diagnostic consumable ID information prior to testing at the diagnostic engine.

25. The system of claim 22 wherein each diagnostic engine is configured to prevent testing at the diagnostic engine if the diagnostic engine is out of range of the IDM.