Method and apparatus for facilitating maintenance of medical analyzer devices - Patent Application 20070122999

Abstract

A computer-implemented method for facilitating maintenance of a medical analyzer device is disclosed. The method includes obtaining a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a plurality of predefined QC samples by a plurality of medical analyzer devices. Each QC sample is associated with a predefined target range, and each medical analyzer device is associated with a peer group of medical analyzer devices. The method further includes evaluating, for each medical analyzer device, the obtained measurement results against the measurement results of the associated peer group to identify a deviation of at least one QC measurement parameter. Then, if a deviation above a predefined threshold is identified, the method further includes obtaining an action log for the medical analyzer device. The action log includes data indicative of any previously transmitted maintenance actions associated with the medical analyzer device. Furthermore, the method includes obtaining at least one suggested maintenance action for the medical analyzer device associated with the identified deviation based on a type of QC measurement parameter associated with the identified deviation. The method further includes selecting a maintenance action for the medical analyzer device associated with the identified deviation from the at least one suggested maintenance action based on the obtained action log. Further, the method includes transmitting data to a device for managing the medical analyzer device associated with the identified deviation, data indicative of instructions for performing a selected maintenance action for the medical analyzer device.

Description

Technical Field

[0001] The present disclosure generally relates to the field of clinical analysis and devices configured to analyze biological samples. In particular, the present disclosure relates to quality control (QC) processes for such devices.

Background Art

[0002] In the field of clinical analysis, a wide variety of electronic medical analysis devices are known that enable medical practitioners to obtain test results and / or measurement results or to separately analyze test substances such as samples of body fluids. These analyses include, for example, in vitro measurements on individual samples of whole blood, serum, plasma, and urine, tissue samples, or other types of samples obtained from patients. Further, the analyses include in vivo measurements on a sample stream, such as, for example, transcutaneous measurements of the partial pressures of oxygen (pO2) and / or carbon dioxide (pCO2), and also pulse oximetry measurements. Generally, a medical analysis device is a device configured to perform chemical analysis, optical analysis, physical analysis, or similar analysis on a test substance, for example, on an individual sample or a sample stream. Such medical analysis devices include analysis devices for performing various forms of clinical tests and / or analyses, such as the measurement of a patient's physiological parameters.

[0003] In modern clinical settings, medical analysis devices are widely used and there is a growing trend to move more and more tests from central laboratories to the actual point of care (POC). This has a number of advantages but also a number of challenges. For example, the operating environment in which a POC medical analysis device operates is less controllable than the central laboratory environment, for example, with respect to controlling the person operating the device.

[0004] Furthermore, modern medical analyzers require regular quality control (QC), which can be understood as a process used to monitor and evaluate the analysis process that yields patient results. There are numerous techniques for testing the functionality of medical analyzers for QC purposes. However, the convention is to perform periodic QC tests, where measurements are made on a set of known standard samples, also referred to as control substances, QC test items, or QC samples, each of which has predetermined characteristics to verify that the measurement results fall within a predefined range of acceptable values for each QC sample. These predefined ranges are often referred to as control ranges.

[0005] Generally, there is one or more dedicated individuals, often referred to as point-of-care coordinators (POCCs), who are tasked with analyzing the QC results to identify potential problems or future maintenance needs. More specifically, often the POCC manually analyzes the measurement results obtained from the QC program, identifies urgent or impending problems, and then attempts to find a suitable solution by reviewing the manual or set of instructions associated with the particular analyzer. Furthermore, in some cases, for a given problem (e.g., measurements related to a particular parameter that drifts over time), the first POCC may attempt to solve the problem by replacing the suspected faulty hardware component according to the relevant instruction manual. And at a later point when the same problem is identified by a second POCC (who is unaware of the device's maintenance history), the same hardware component may be replaced again unnecessarily. Thus, the prior art maintenance procedures are not only prone to drawbacks in terms of time efficiency but can also result in unnecessary disposal of components, which increases device waste and associated costs. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] Therefore, there is a need in the art for a new solution that promotes the maintenance of a medical analysis device, which solves or at least mitigates at least some of the problems discussed above.

Means for Solving the Problem

[0007] The term "comprising" (which may be replaced by "including") as used herein is taken to specify the presence of the stated features, integers, steps, or components, but does not preclude the presence or addition of one or more other features, integers, steps, components, or groups thereof. As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise.

[0008] Generally, when an apparatus is referred to herein, it is to be understood as a physical product, e.g., a device. The physical product may comprise one or more components, such as one or more controllers, one or more processors, or a control circuit in the form of the like.

[0009] The object of some embodiments is to solve, mitigate, alleviate, or eliminate at least some of the above or other drawbacks. A first aspect is a computer-implemented method for promoting the maintenance of a medical analysis device. The method includes obtaining a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a plurality of predefined QC samples by a plurality of medical analysis devices. Each QC sample is associated with a predefined target range, and each medical analysis device is associated with a peer group of medical analysis devices. The method further includes, for each medical analysis device, evaluating the obtained measurement results against the measurement results of the associated peer group to identify a deviation of at least one QC measurement parameter.

[0010] Next, if a deviation exceeding a predefined threshold is identified, the method further includes obtaining an action log of the medical analysis device. The action log includes data indicating any previously transmitted maintenance actions associated with the medical analysis device. Further, the method includes obtaining at least one proposed maintenance action for the medical analysis device associated with the identified deviation, based on the type of QC measurement parameter associated with the identified deviation. The method further includes selecting a maintenance action for the medical analysis device associated with the identified deviation from the at least one proposed maintenance action, based on the obtained action log. Further, the method includes transmitting, to a device for managing the medical analysis device associated with the identified deviation, data indicating an instruction to execute the selected maintenance action for the medical analysis device.

[0011] In some embodiments, the step of obtaining at least one maintenance action for the medical analysis device associated with the identified deviation includes identifying a parameter group of the type of QC measurement parameter associated with the identified deviation, and obtaining at least one proposed maintenance action based on the identified parameter group.

[0012] Further, in some embodiments, each QC measurement parameter is associated with one of a set of predefined parameter groups. The set of predefined parameter groups is formed based on one or more hardware and / or software components of the medical analysis device associated with the performance of the QC measurement.

[0013] Still further, in some embodiments, at least one proposed maintenance action includes a plurality of proposed maintenance actions arranged in order, and the selected maintenance action is the first maintenance action according to the order. Thus, the method further includes checking the obtained action log to identify an entry into the action log corresponding to the transmission of the first maintenance action when a deviation exceeding a predetermined threshold is identified. Then, when an entry into the action log corresponding to the transmission of the first maintenance action is identified and a deviation exceeding the predetermined threshold is identified at a time point after the entry into the action log corresponding to the transmission of the first maintenance action, the method further includes transmitting data indicating an instruction to execute a second maintenance action of the plurality of proposed maintenance actions for the medical analysis device to a device for managing the medical analysis device associated with the identified deviation. The second action is a subsequent maintenance action with respect to the first maintenance action according to the order.

[0014] In some embodiments, the method further includes obtaining a maintenance log for the medical analysis device. The maintenance log includes data indicating past maintenance actions performed on the medical analysis device prior to a time point defined by the timing of the obtained measurement results of the medical analysis device. Further, after the step of transmitting data indicating the selected maintenance action for the medical analysis device, the method further includes checking the obtained maintenance log to identify an entry into the maintenance log corresponding to the execution of the selected maintenance action. Then, when an entry into the maintenance log corresponding to the execution of the selected maintenance action is not identified within a predetermined period, the method further includes transmitting data indicating a reminder of the selected maintenance action for the medical analysis device to a device for managing the medical analysis device associated with the identified deviation.

[0015] In some embodiments, the measurement results of the peer group include information regarding the average measurement value for each QC measurement associated with the peer group. Thus, in some embodiments, the method further includes updating the average measurement value for each QC measurement of the peer group based on at least a portion of the plurality of acquired measurements.

[0016] In some embodiments, the predefined threshold includes a first predefined threshold, and the step of evaluating the acquired measurement results includes comparing the acquired measurement results with the average measurement value for each QC measurement of the associated peer group, and determining that a deviation has been identified if the comparison shows a difference exceeding the first predefined threshold.

[0017] Furthermore, in some embodiments, the acquired measurement results include information regarding the change over time of the measurement results for each of the plurality of medical analysis device devices, and the predefined threshold includes a second predefined threshold. Thus, in some embodiments, the step of evaluating the acquired measurement results includes comparing the measurement results for each QC measurement parameter over a recent period with the change over time of the average measurement value for each corresponding QC measurement of the associated peer group during the recent period, and determining that a deviation has been identified if the comparison shows a difference exceeding the second predefined threshold during the recent period.

[0018] Further, in some embodiments, the acquired measurement results include information regarding the change over time of the measurement results for the plurality of medical analysis device devices. Thus, in some embodiments, the step of evaluating the acquired measurement results includes comparing the measurement results for each QC measurement parameter over a recent period with the change over time of the average measurement value for each corresponding QC measurement during the recent period, and determining that a deviation has been identified if the comparison shows a difference that increases over time during the recent period.

[0019] A second aspect is a (non-transitory) computer-readable storage medium storing one or more programs configured to be executed by one or more processors of a processing system, the one or more programs including instructions for implementing the method of the first aspect according to any one of the embodiments disclosed herein. In this aspect, there are advantages and preferred features similar to those in the previously discussed first aspect.

[0020] As used herein, the term "non-transitory" is intended to describe a computer-readable storage medium (or "memory") excluding propagating electromagnetic signals, but is not intended to otherwise limit the type of physical computer-readable storage device encompassed by the phrase computer-readable medium or memory. For example, the term "non-transitory computer-readable medium" or "tangible memory" is intended to include types of storage devices that do not necessarily store information permanently, such as random access memory (RAM). Program instructions and data stored in a tangible computer-accessible storage medium in non-transitory form can further be transmitted by a transmission medium or signal, such as electrical, electromagnetic, or digital signals that can be transmitted via a communication medium such as a network and / or a wireless link. Thus, as used herein, the term "non-transitory" is a limitation of the medium itself (i.e., tangible and not a signal) as opposed to a limitation on data storage persistence (e.g., RAM versus ROM).

[0021] A third aspect is an apparatus for facilitating maintenance of a medical analysis device. The apparatus includes a control circuit configured to obtain a plurality of measurement results associated with a plurality of QC measurements performed on a plurality of predetermined QC samples by a plurality of medical analysis devices. Each QC sample is associated with a predetermined target range, and each medical analysis device is associated with a peer group of medical analysis devices. Further, the control circuit is configured to evaluate the obtained measurement results against the measurement results of the associated peer group for each medical analysis device to identify a deviation of at least one QC measurement parameter.

[0022] Then, if a deviation exceeding a predetermined threshold is identified, the control circuit is further configured to obtain an action log of the medical analysis device, the action log including data indicating any previously transmitted maintenance actions associated with the medical analysis device, and the control circuit is further configured to obtain at least one proposed maintenance action for the medical analysis device associated with the identified deviation based on the type of the QC measurement parameter associated with the identified deviation. Further, the control circuit is configured to select a maintenance action for the medical analysis device associated with the identified deviation from the at least one proposed maintenance action based on the obtained action log, and transmit data indicating an instruction to execute the selected maintenance action for the medical analysis device to a device for managing the medical analysis device associated with the identified deviation. In this aspect, there are advantages and preferred features similar to those in the previously discussed aspects, and vice versa.

[0023] In some embodiments, the device for managing the medical analysis device is configured to monitor and control one or more medical analysis devices connected to the device.

[0024] In some embodiments, a device for managing a medical analysis device is associated with a geographical location that includes one or more medical analysis devices. Further, in some embodiments, the control circuit is configured to identify a group of parameters of a type of QC measurement parameter associated with a specified deviation and to obtain at least one proposed maintenance action based on the identified group of parameters.

[0025] Further, in some embodiments, the at least one proposed maintenance action includes a plurality of proposed maintenance actions arranged in order, and the selected maintenance action is the first maintenance action according to the order. Thus, in some embodiments, the control circuit is configured to check the obtained action log to identify an entry into the action log corresponding to the transmission of the first maintenance action when a deviation exceeding a predetermined threshold is identified. Then, when an entry into the action log corresponding to the transmission of the first maintenance action is identified and a deviation exceeding the predetermined threshold is identified at a time after the entry into the action log corresponding to the transmission of the first maintenance action, the control circuit is further configured to transmit to a device for managing a medical analysis device associated with the identified deviation data indicating an instruction to execute a second maintenance action of a plurality of proposed maintenance actions for the medical analysis device. The second action is a subsequent maintenance action with respect to the first maintenance action according to the order.

[0026] Still further, in some embodiments, the control circuit is configured to obtain a maintenance log of the medical analysis device. The maintenance log includes data indicating past maintenance actions performed on the medical analysis device prior to a point in time defined by the timing of the measurement results obtained by the medical analysis device. After transmitting data indicating a selected maintenance action for the medical analysis device, the control circuit is further configured to check the obtained maintenance log to identify an entry into the maintenance log corresponding to the execution of the selected maintenance action. Thus, if an entry into the maintenance log corresponding to the execution of the selected maintenance action is not identified within a predetermined period, the control circuit is configured to transmit data indicating a reminder of the selected maintenance action for the medical analysis device to a device for managing the medical analysis device associated with the identified deviation.

[0027] Still further, in some embodiments, the measurement results of the peer group include information regarding the average measurement value for each QC measurement associated with the peer group. Thus, in some embodiments, the control circuit is configured to update the average measurement value for each QC measurement of the peer group based on at least a portion of the plurality of measurements obtained.

[0028] In some embodiments, the predetermined threshold includes a first predetermined threshold, and the control circuit is configured to evaluate the obtained measurement results by comparing the obtained measurement results with the average measurement value for each QC measurement of the associated peer group. Thus, the control circuit may be configured to determine that a deviation has been identified if the comparison indicates a difference that exceeds the first predetermined threshold.

[0029] In some embodiments, the acquired measurement results include information regarding the change over time of the measurement results for each of a plurality of medical analysis device devices, and the predetermined threshold includes a second predetermined threshold. Thus, in some embodiments, the control circuit is configured to evaluate the acquired measurement results by comparing the measurement results for each QC measurement parameter over a recent period with the change over time of the average measurement values for each corresponding QC measurement during the recent period. Therefore, the control circuit can be configured to determine that a deviation has been identified if the comparison shows a difference that exceeds the second predetermined threshold during the recent period.

[0030] Furthermore, in some embodiments, the acquired measurement results include information regarding the change over time of the measurement results for a plurality of medical analysis device devices. Thus, in some embodiments, the control circuit is configured to evaluate the acquired measurement results by comparing the measurement results for each QC measurement parameter over a recent period with the change over time of the average measurement values for each corresponding QC measurement during the recent period. Therefore, the control circuit can be configured to determine that a deviation has been identified if the comparison shows a difference that increases over time during the recent period.

[0031] A fourth aspect is a remote server comprising the apparatus of the third aspect according to any one of the embodiments disclosed herein. In this aspect, there are advantages and preferred features similar to those in the aspects discussed previously, and vice versa.

[0032] A fifth aspect is a cloud environment comprising one or more remote servers of the fourth aspect according to any one of the embodiments disclosed herein. In this aspect, there are advantages and preferred features similar to those in the aspects discussed previously, and vice versa.

[0033] The advantages of some embodiments are that the maintenance of the medical analysis device is facilitated. More specifically, by utilizing a centralized solution for evaluating QC measurements as disclosed herein, the need for maintenance can be identified in a more accurate and timely manner, thus resulting in a time-efficient maintenance solution.

[0034] The advantages of some embodiments are that the risk of accidentally replacing functional components is reduced, thereby reducing the operating costs associated with the medical analysis device. The advantages of some embodiments are that a given parameter group is formed based on one or more hardware and / or software components of the medical analysis device, enabling an efficient and accurate identification of specific components that may be malfunctioning.

[0035] The advantages of some embodiments are that the downtime of the medical analysis device is reduced because the maintenance of the medical analysis device is facilitated. The advantages of some embodiments are that the need for on-site service engineers for maintenance is reduced.

[0036] These and other features and advantages of the embodiments described herein will be made more apparent hereinafter with reference to the embodiments to be described. Further objects, features, and advantages of some embodiments will become apparent from the following embodiments for carrying out the invention with reference to the accompanying drawings.

Brief Description of the Drawings

[0037]

Figure 1

Figure 2

Figure 3

Figure 4

[0038] Those skilled in the art will understand that the steps, services, and functions described herein can be implemented using individual hardware circuits, using software operating in conjunction with a programmed microprocessor or general-purpose computer, using one or more application-specific integrated circuits (ASICs), and / or using one or more digital signal processors (DSPs). When an embodiment is described with respect to a method, it is also to be understood that it can also be embodied in one or more processors and in one or more memories coupled to the one or more processors, where the one or more memories store one or more programs that implement the steps, services, and functions disclosed herein when executed by the one or more processors.

[0039] Embodiments of the present disclosure will be described and illustrated more fully hereinafter with reference to the accompanying drawings. However, the solutions disclosed herein can be implemented in many different forms and should not be construed as limited to the embodiments set forth herein.

[0040] In the following, embodiments are described in the context of using peer group measurements to identify potential problems in associated medical analysis devices or potential negative trends in medical devices so that appropriate maintenance actions can be taken to facilitate the maintenance of one or more medical analysis devices.

[0041] Generally, when a medical analysis device is referred to within this specification, it can be understood as a device configured to perform chemical analysis, optical analysis, physical analysis, or similar analysis on a test object, for example, on an individual sample or a sample stream. Such a medical analysis device includes analysis devices for performing various forms of clinical trials and / or analysis, such as the measurement of a patient's physiological parameters.

[0042] Generally, when a "device for managing one or more medical analysis devices" is referred to within this specification, it can be understood as a device associated with a hospital or facility that includes one or more medical analysis devices. However, one or more medical analysis devices can be distributed across several geographical locations, and thus, a "device for managing one or more medical analysis devices" can also be associated with multiple hospitals or facilities that each include another medical analysis device. A "device for managing one or more medical analysis devices" is configured to maintain an overview of one or more medical analysis devices or to monitor the status and operation of one or more medical analysis devices. Furthermore, a "device for managing one or more medical analysis devices" is configured to transmit data (e.g., instructions) to the medical analysis devices associated with it.

[0043] FIG. 1 is a schematic flowchart diagram of a computer-implemented method S100 for facilitating the maintenance of a medical analysis device according to some embodiments. The purpose of such a method can be to determine suitable actions and transmit indicators for predictive maintenance of the medical analysis device.

[0044] Method S100 includes step S101 of obtaining a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a plurality of predetermined QC samples (which may also be referred to as control substances, QC test items, or QC samples) by a plurality of medical analysis device devices. More specifically, a QC sample is a measurable property that is carefully controlled such that when a medical analysis device device performs a measurement on the QC sample to verify its operational accuracy, the measurement results within the results must fall within a relevant target range (e.g., target value ± tolerance value) in order to meet the relevant quality requirements. The target range can be set, for example, by the manufacturer or vendor of the QC sample. The term "obtaining" should be interpreted broadly herein and includes receiving, acquiring, collecting, obtaining, determining, deriving, etc.

[0045] Furthermore, each medical analysis device device is associated with a peer group of medical analysis device devices. Generally, a peer group of medical analysis device devices, when referred to within this specification, can be understood as a group of medical analysis device devices that share some specific common characteristics. For example, a peer group of medical analysis device devices can be defined as medical analysis device devices of the same type (e.g., the same model), and / or medical analysis device devices having the same QC product type (i.e., using QC samples originating from the same source). Furthermore, the peer group can further include geographical constraints - for example, even if medical analysis device devices are of the same type, if they are associated with different countries (e.g., located in different countries), they do not necessarily have to belong to the same peer group.

[0046] Further, method S100 includes step S102 of evaluating the obtained measurement results (see S101) against the measurement results of the associated peer group for each medical analysis device device in order to identify a deviation of at least one QC measurement parameter. Some examples of the evaluation process as in S102, as well as some examples of what the term "deviating" can include, are provided below with reference to FIG. 3.

[0047] Generally, "measurement results of associated peer groups" can be understood as previously obtained measurement results from associated peer groups, i.e., one or more previously obtained measurement results. In some embodiments, "measurement results of associated peer groups" include the average measurement results for each QC measurement of the associated peer groups. Further, in some embodiments, "measurement results of associated peer groups" include the moving average measurement results for each QC measurement of the associated peer groups.

[0048] Subsequently, it is determined whether a deviation is detected, for example, whether a deviation exceeding a predetermined threshold is identified. If a deviation is detected, method S100 further includes step S103 of obtaining an action log of the (deviating) medical analysis device. The action log includes data indicating any previously transmitted maintenance actions associated with the medical analysis device.

[0049] Furthermore, at least one proposed maintenance action for the medical analysis device associated with the identified deviation is obtained in S104. The obtained proposed maintenance action in S104 is based on the type of QC measurement parameter associated with the identified deviation. For example, different proposed maintenance actions can be obtained depending on whether the deviating parameter is the concentration of hydrogen (e.g., the concentration of hydrogen ions in blood, cH + ) as compared to the case where the deviating measurement parameter is the potassium concentration (e.g., the concentration of potassium ions in plasma, cK + ).

[0050] Other QC measurement parameters include, but are not limited to, pH (a measure of the acidity or alkalinity of a sample), pCO2 (the partial pressure (or tension) of carbon dioxide in the blood), pO2 (the partial pressure (or tension) of oxygen in the blood), ctHb (the concentration of total hemoglobin in the blood), sO2 (oxygen saturation), FO2Hb (the proportion of oxyhemoglobin in total hemoglobin in the blood), FCOHb (the proportion of carboxyhemoglobin in total hemoglobin in the blood), FMetHb (the proportion of methemoglobin in total hemoglobin in the blood), cNa + (the concentration of sodium ions in the plasma), cGlu (the concentration of D - glucose in the plasma). This list should not be construed as exhaustive and may include additional measurement parameters readily understood by those skilled in the art.

[0051] Furthermore, each QC measurement parameter can be associated with one of a set of predefined parameter groups. The set of predefined parameter groups can be formed based on one or more hardware and / or software components of a medical analysis device associated with the performance of QC measurements. For example, the software and / or hardware components involved in performing the concentration measurement of sodium ions (cNa + ) in the plasma may also be involved in performing the concentration measurement of calcium ions (cCa2 + ) in the plasma. And these QC measurement parameters (i.e., cNa + and cCa2 + ) can be associated with the same parameter group.

[0052] Accordingly, in some embodiments, method S100 further includes step S108 of identifying a parameter group of the type of QC measurement parameter associated with a specified deviation, and step S109 of obtaining at least one proposed maintenance action based on the identified parameter group.

[0053] Since a given parameter group can be formed based on one or more hardware and / or software components of a medical analysis device, it enables an efficient and accurate identification of specific components that may be malfunctioning. Further, method S100 includes step S105 of selecting, from one or more proposed maintenance actions, a maintenance action for a medical analysis device associated with the identified deviation, based on the acquired action log. As described, the action log indicates any previously transmitted maintenance actions for the medical analysis device associated with the identified deviation. Thus, the action log may indicate, for example, that a first action (e.g., cleaning of membrane X) has been previously transmitted. However, seeing that this first action did not solve the problem, a second (subsequent) action (e.g., replacement of membrane X) may then be selected instead.

[0054] Finally, method S100 includes step S106 of transmitting, to a device for managing a medical analysis device associated with the identified deviation, data indicating an instruction to execute the selected maintenance action for the medical analysis device. As described above, the "device for managing one or more medical analysis devices" can be understood as a device configured to keep an overview of one or more medical analysis devices, or to monitor the state and operation of one or more medical analysis devices, and further to receive data from one or more medical analysis devices and transmit instructions to one or more medical analysis devices.

[0055] As described, the measurement results of the associated peer group may include information regarding the average measurement value of each QC measurement for that peer group. Thus, method S100 may further include step S107 of updating the average measurement value for each QC measurement of the peer group based on at least a portion of the plurality of acquired measurements.

[0056] Furthermore, the S101 measurement results obtained by each medical analysis device may be in the form of, for example, average measurement values for each QC sample. More specifically, the average measurement value for each QC sample may be, for example, an average value based on the past 10 measurements for each QC sample. However, in some embodiments, method S100 includes obtaining the most recent N measurement results (N≥2) associated with a plurality of QC measurements performed by a plurality of medical analysis devices, and averaging the obtained most recent N measurement values to determine an average measurement value for each QC sample for each medical analysis device. Furthermore, method S100 may further include filtering the most recent N measurements obtained before determining the average measurement value to remove any clearly incorrect measurements from the formed average value. The advantages in filtering and averaging the QC measurement results of each medical analysis device are that the risk of issuing unnecessary maintenance actions is reduced. Another advantage in filtering and averaging the QC measurements of each medical analysis device is that the risk of including statistical outliers (i.e., clearly incorrect inputs) in the peer group data is reduced.

[0057] Furthermore, in some embodiments, each medical analysis device is associated with a maintenance log. Thus, method S100 may further include step S118 of obtaining the maintenance log of the medical analysis device. The maintenance log includes data indicating past maintenance actions performed on the (deviating) medical analysis device prior to a point in time defined by the timing of the measurement results obtained by the (deviating) medical analysis device. The maintenance log is preferably used to monitor the maintenance actions performed on the medical analysis device in order to issue a reminder if a transmitted maintenance action has not been carried out. Some exemplary embodiments regarding use cases using the action log and the maintenance log are illustrated in FIG. 2.

[0058] Therefore, turning to FIG. 2, a schematic flowchart diagram of a computer-implemented method S200 for facilitating the maintenance of a medical analysis device is illustrated according to some embodiments. As shown in FIG. 2, some of the steps correspond to steps similar to those in FIG. 1 and, for the sake of brevity and conciseness, are not described in any further detail.

[0059] Accordingly, method S200 includes step S101 of obtaining or collecting QC measurement results from a plurality of medical analysis device devices, and step S102 of evaluating the collected S101 measurement results against the measurement results of an associated peer group. The evaluation in S102 is performed to detect any potentially malfunctioning or misbehaving medical analysis device based on a comparison of the QC measurement results of each medical analysis device, taking into account the measurement results of the associated peer group.

[0060] Next, in step S103, if at least one QC measurement parameter deviates from a threshold value from the measurement results of the peer group, the action logs of those deviating medical analysis devices are obtained. As described above, in some embodiments, there are a plurality of proposed maintenance actions that can be selected for a particular / detected deviation. These proposed maintenance actions can be arranged in order, i.e., the first maintenance action, the second maintenance action, etc.

[0061] Therefore, in some embodiments, method S200 may further include step S121 of checking the obtained S103 action log of the deviating medical analysis device to identify an input to the obtained S103 action log corresponding to the transmission of the first maintenance action. If there is no input corresponding to the first proposed maintenance, method S200 further includes step S105' of selecting the first maintenance action and step S106' of transmitting data indicating an instruction to execute the first maintenance action to a device for managing the medical analysis device associated with the identified deviation.

[0062] However, in some cases, the check S121 of the action log may indicate an entry into the action log corresponding to the transmission of the first maintenance action. Assuming that a deviation exceeding a predetermined threshold is identified at a point in time after the entry into the action log corresponding to the transmission of the first maintenance action, the method S200 may further include step S105'' of selecting a second / next maintenance action from a plurality of proposed maintenance actions. Next, data indicating an instruction to execute a second maintenance action among the plurality of proposed maintenance actions for the medical analysis device is transmitted to a device for managing the medical analysis device associated with the identified deviation S106''. Thus, the second action can be understood as a subsequent maintenance action with respect to the first maintenance action in accordance with the order.

[0063] In other words, the action log can be understood as a log including a maintenance process for the deviating medical analysis device, and further indicating at which step the associated medical analysis device is currently in that maintenance process. Thus, the maintenance processes for a number of medical analysis devices can be grasped, reducing the risk of issuing inappropriate maintenance action instructions.

[0064] Furthermore, in some embodiments, each of the medical analysis devices is associated with a maintenance log including data indicating past maintenance actions performed on the medical analysis device prior to a point in time defined by the timing of the measurement results obtained by the medical analysis device.

[0065] Accordingly, in some embodiments, method S200 includes step S118 of obtaining a maintenance log of a deviating medical analysis device, and step S123 of checking the obtained maintenance log to identify an entry into the maintenance log corresponding to the execution of the selected and transmitted maintenance action. If there is no entry into the maintenance log corresponding to the execution of the transmitted and selected maintenance action, method S200 may further include step S124 of transmitting data indicating a reminder of the selected maintenance action for the medical analysis device to a device for managing the medical analysis device associated with the identified deviation.

[0066] However, if there is an entry into the maintenance log corresponding to the execution of the transmitted and selected maintenance action, and if there is no second / next maintenance action in the action log, method S200 may further include step S125 of transmitting data indicating a defective medical analysis device to a device for managing the medical analysis device associated with the identified deviation. This may be interpreted, for example, as indicating that the medical analysis device should be considered non-functional and that a dedicated service person, e.g., a field service engineer, should be contacted to repair the defective medical analysis device.

[0067] Although step S102 of evaluating the obtained measurement results against the measurement results of an associated peer group may be included according to some embodiments, some examples are provided hereinbelow with reference to FIG. 3. More specifically, FIG. 3 shows some flowcharts of the evaluation S102 process according to some embodiments.

[0068] As previously mentioned, the measurement results of the peer group may be in the form of an average measurement value (e.g., a six-month moving average) for each QC measurement. Accordingly, in some embodiments, step S102 of evaluating the obtained measurement results includes comparing the obtained measurement results (X i,meas ) to each QC measurement parameter (X i,avgincludes a step S131 of comparing with an average measurement value for 2+ ). Here, "I" represents the type of the QC sample. In other words, for example, calcium ions (cCa 2+ ) in plasma as measured by a medical analysis device, the obtained measurement results are compared with the peer average of the concentration of calcium ions (cCa i,meas -X i,avg | > threshold 1), the method further includes a step S134 of determining that a deviation is identified / present. When the comparison S131 shows a difference (|X i,meas -X i,avg | ≤ threshold 1), it is concluded in S135 that there is no deviation.

[0069] Furthermore, in some embodiments, the obtained measurement results include information regarding the change over time of the measurement results for each of a plurality of medical analysis device devices, and the predetermined threshold includes a second predetermined threshold. Thus, in some embodiments, a step of evaluating the obtained measurement results, the obtained measurement results (X i,meas ) for each QC measurement parameter over a most recent period are compared with the change over time of the average measurement values (X i,avg ) for each corresponding QC measurement of the associated peer group during the most recent period in step S132. In other words, the measurement results (X i,meas ) for each QC measurement parameter are compared with the associated peer average (X i,avg ) over N consecutive samples in S132. Then, for a specific QC measurement parameter, when the comparison S131 shows a difference (|X i,meas -X i,avg | > threshold 2) that exceeds the second predetermined threshold for that specific QC measurement parameter during the most recent period, the method further includes a step S134 of determining that a deviation is identified / present. When the comparison S131 shows a difference (|X i,meas -Xi,avg When showing ≤ threshold 2), it is concluded in S135 that there is no deviation.

[0070] Still further, in some embodiments, the acquired measurement results include information regarding the change over time of measurement results for a plurality of medical analysis device devices. Thus, in some embodiments, the step of evaluating the acquired measurement results, the acquired measurement results (X i,meas ) for each QC measurement parameter over the most recent period are compared in step S133 with the change over time of the average measurement value (X i,avg ) for each corresponding QC measurement of the associated peer group during the most recent period. In other words, the measurement results (X i,meas ) for each QC measurement parameter are compared in S133 with the associated peer average (X i,avg ) over N consecutive samples. The method then further includes in step S134 determining that a deviation is identified / exists for a particular QC measurement parameter if the comparison S131 shows a difference that increases over time for that particular QC measurement parameter during the most recent period. If the comparison S131 does not show a difference that increases over time for that particular QC measurement parameter during the most recent period, it is concluded in S135 that there is no deviation.

[0071] The executable instructions for performing these functions and steps are optionally included in a non - transitory computer - readable storage medium or other computer program product configured for execution by one or more processors.

[0072] Figure 4 is a schematic block diagram of a system 10 comprising an apparatus 201 for facilitating the maintenance of a medical analysis device 110, according to some embodiments. The apparatus 201 comprises a control circuit CTRL202 configured to obtain a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a plurality of predetermined QC samples by a plurality of medical analysis devices. Each QC sample is associated with a predetermined target range, and each medical analysis device 110 is associated with a peer group 301 of medical analysis devices.

[0073] Further, for each medical analysis device 110, the control circuit 202 is configured to evaluate the obtained measurement results against the measurement results of the associated peer group to identify a deviation of at least one QC measurement parameter. Then, if a deviation exceeding a predetermined threshold is identified, the control circuit 202 is further configured to obtain an action log of the deviating medical analysis device 110. The action log includes data indicating any previously transmitted maintenance actions associated with the medical analysis device 110.

[0074] The control circuit 202 is further configured to obtain at least one proposed maintenance action for the deviating medical analysis device 110, i.e., for the medical analysis device associated with the identified deviation. The one or more obtained proposed maintenance actions are based on the type of the QC measurement parameter associated with the identified deviation.

[0075] Further, the control circuit 202 is configured to select, based on the obtained action log, a maintenance action for the medical analysis device associated with the identified deviation from the one or more proposed maintenance actions. Then, the control circuit 202 is configured to transmit data indicating an instruction to execute the selected maintenance action for the medical analysis device to a device 101 for managing the medical analysis device 110 associated with the identified deviation.

[0076] In some embodiments, the device 101 for managing medical analysis device(s) has a control circuit 202 configured to monitor and control one or more medical analysis devices connected to the device 101. Thus, the device 101 for managing medical analysis device(s) can be part of a Hospital Information System (HIS) and / or a Laboratory Information System (LIS) involved in monitoring and controlling a plurality of medical analysis devices associated therewith. Thus, in some embodiments, the device 101 for managing medical analysis device(s) is associated with a geographical location including one or more medical analysis devices. Nevertheless, in some embodiments, the device can be in the form of a cloud service (a cloud computing system provided by a cloud environment, e.g., a cloud computing system comprising one or more remote servers, e.g., distributed cloud computing resources) communicatively connected to one or more medical analysis devices (e.g., can be implemented as such).

[0077] In some embodiments, the device 101 for managing a plurality of medical analysis devices 110 has a control circuit 102 configured to obtain a plurality of measurement results associated with a plurality of QC measurements performed on a set of predefined QC samples by one or more of the plurality of medical analysis devices 110. The plurality of medical analysis devices and the device 101 can be associated with, for example, the same facility (e.g., a hospital or a laboratory).

[0078] Further, the control circuit 102 is configured to transmit data indicating the obtained plurality of measurement results to a central agent 201 (e.g., the device described above). The control circuit 102 can be further configured to transmit data indicating the analyzer type and the QC product type of each medical analysis device of the plurality of medical analysis devices.

[0079] In some embodiments, the control circuit 102 is further configured to receive, from the central agent 201, data indicative of instructions to perform selected maintenance actions for one or more associated medical analysis device devices 110.

[0080] However, in some embodiments, the control circuit 202 may be configured to directly transmit data indicative of instructions to perform selected maintenance actions to each medical analysis device device 110. Thus, each medical analysis device device 110 may include a control circuit configured to transmit (individually or independently) data indicative of a plurality of acquired measurement results to the central agent 201. In other words, in some embodiments, the device 101 for managing the medical analysis device devices may be an internal control unit or control circuit of the medical analysis device devices 110.

[0081] Embodiments other than those described above are possible and are within the scope of the claims. Method steps different from those described above, implemented by hardware or software, may be provided within the scope of the embodiments disclosed herein. Thus, according to an exemplary embodiment, a non-transitory computer-readable storage medium storing one or more programs configured to be executed by one or more processors of a processing system is provided, the one or more programs including instructions to perform a method according to any one of the embodiments discussed above. Alternatively, according to another exemplary embodiment, a cloud computing system may be configured to perform any of the methods presented herein. The cloud computing system may comprise distributed cloud computing resources for jointly performing the methods presented herein under the control of one or more computer program products.

[0082] Generally speaking, a computer-accessible medium can include any tangible or non-transitory storage or memory medium, such as an electronic, magnetic, or optical medium, e.g., a disk or a CD / DVD-ROM coupled to a computer system via a bus. The terms "tangible" and "non-transitory" as used herein are intended to describe a computer-readable storage medium (or "memory") excluding propagating electromagnetic signals, but are not intended to otherwise limit the types of physical computer-readable storage devices encompassed by the phrase computer-readable medium or memory. For example, the term "non-transitory computer-readable medium" or "tangible memory" is intended to include types of storage devices that do not necessarily store information permanently, such as random access memory (RAM). Program instructions and data stored in a tangible computer-accessible storage medium in non-transitory form can further be transmitted by a transmission medium or signal, such as electrical, electromagnetic, or digital signals that can be transmitted via a communication medium such as a network and / or a wireless link.

[0083] Processors 102, 202 (associated with apparatuses and devices 101, 201) can be or include any number of hardware components for performing data or signal processing or for executing computer code stored in memories 103, 203. Apparatuses and devices 101, 201 have associated memories 103, 203, which can be one or more devices for storing data and / or computer code for completing or facilitating the various methods described in this description. The memory can include volatile memory or non-volatile memory. Memories 103, 203 can include database components, object code components, script components, or any other type of information structure for supporting the various activities of this description. According to an exemplary embodiment, any distributed or local memory device can be used with the apparatuses and methods of this description. According to an exemplary embodiment, memories 103, 203 are communicatively connected to processors 102, 202 (e.g., via circuitry, or any other wired, wireless, or network connection) and include computer code for executing one or more of the processes described herein.

[0084] Communication interfaces 104, 105, 204 can provide the possibility of transmitting outputs to a remote location (e.g., a remote operator or control center) using suitable communication devices. Communication interfaces 104, 105, 204 can be arranged to communicate with other functional components and can thus also be regarded as control interfaces, although a separate control interface (not shown) may be provided. Local communication within facility 100 can also be of the wireless type using protocols such as WiFi, LoRa, Zigbee, Bluetooth, or similar medium / short-range technologies.

[0085] Therefore, it should be understood that some of the described solutions can be implemented either on one remote server, or on multiple remote servers, for example, multiple servers that are in communication with each other, so-called cloud solutions. Different features and steps of the embodiments can be combined in combinations other than those described.

[0086] Generally, all terms used herein shall be interpreted according to their ordinary meaning in the relevant technical field, unless a different meaning is expressly given and / or suggested by the context in which they are used.

[0087] It should be noted that the word "comprising" does not exclude the existence of elements or steps other than those listed, and the words "a" or "an" preceding an element do not exclude the existence of a plurality of such elements. Also, any reference signs do not limit the scope of the claims, embodiments can be implemented at least in part using both hardware and software, and further note that some "control circuits", "means", or "units" can be represented by the same item of hardware.

[0088] The figures may show method steps in a particular order, but the order of the steps may be different from that depicted. Additionally, two or more steps may be performed simultaneously or in partial concurrence. Such variations depend on the software and hardware systems selected, as well as the designer's choices. All such variations are within the scope of the disclosed embodiments. Similarly, software implementations may be achieved by standard programming techniques using rule-based logic and other logics to accomplish various connection steps, processing steps, comparison steps, and decision steps. The embodiments described above are given merely as examples and are not limitations on the present disclosure. Thus, it should be understood that the details of the described embodiments are merely examples proposed for illustrative purposes only and that all variations falling within the scope of the claims are intended to be incorporated therein.

Claims

1. A computer-implemented method (S100, S200) for facilitating the maintenance of medical analysis device devices, comprising: Obtaining (S101) a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a plurality of predetermined QC samples by a plurality of medical analysis device devices, wherein each QC sample is associated with a predetermined target range, and each medical analysis device device is associated with a peer group of medical analysis device devices; For each medical analysis device device, Evaluating (S102) the obtained measurement results against the measurement results of the associated peer group to identify a deviation of at least one QC measurement parameter; If a deviation exceeding a predetermined threshold is identified, Obtaining (S103) an action log of the medical analysis device device, the action log including data indicating any previously transmitted maintenance actions associated with the medical analysis device device; Obtaining (S104) at least one proposed maintenance action for the medical analysis device device associated with the identified deviation, based on the type of QC measurement parameter associated with the identified deviation, the step of obtaining (S104) the at least one proposed maintenance action further including identifying (S108) a parameter group of the type of QC measurement parameter associated with the identified deviation, and obtaining (S109) at least one proposed maintenance action based on the identified parameter group; Selecting (S105, S105’, S105’’) a maintenance action for the medical analysis device device associated with the identified deviation from the at least one proposed maintenance action, based on the obtained action log; Transmitting (S106, S106’, S106’’) data indicating an instruction to execute the selected maintenance action for the medical analysis device device to a device for managing the medical analysis device device associated with the identified deviation. Each QC measurement parameter is associated with one of a set of predefined parameter groups, and the set of predefined parameter groups is formed based on the commonality of one or more hardware and / or software components of the plurality of medical analysis device devices involved in the performance of QC measurements, method (S100, S200).

2. The at least one proposed maintenance action includes a plurality of proposed maintenance actions arranged in order, the selected maintenance action is the first maintenance action according to the order, and the method (S100) includes when a deviation exceeding the predefined threshold is identified, step (S121) of checking the obtained action log to identify an entry into the action log corresponding to the transmission of the first maintenance action, when the entry into the action log corresponding to the transmission of the first maintenance action is identified, and when a deviation exceeding the predefined threshold is identified at a time after the entry into the action log corresponding to the transmission of the first maintenance action, step (S106'') of transmitting, to the device for managing the medical analysis device device associated with the identified deviation, data indicating an instruction to execute a second maintenance action of the plurality of proposed maintenance actions for the medical analysis device device, wherein the second maintenance action is a subsequent maintenance action to the first maintenance action according to the order, step (S106''), further included in the method (S100, S200) according to claim 1.

3. step (S118) of obtaining a maintenance log of the medical analysis device device, the maintenance log including data indicating past maintenance actions performed on the medical analysis device device prior to a time defined by the timing of the obtained measurement results of the medical analysis device device, step (S118), after step (S106, 106', 106'') of transmitting data indicating the selected maintenance action for the medical analysis device device, step (S123) of checking the obtained maintenance log to identify an entry into the maintenance log corresponding to the execution of the selected maintenance action If the input to the maintenance log corresponding to the execution of the selected maintenance action is not identified within a predetermined period, The method (S100, S200) according to claim 1, further comprising: transmitting, to the device for managing the medical analysis device device associated with the identified deviation, data indicating a reminder of the selected maintenance action for the medical analysis device device (S124).

4. The measurement results of the peer group include information regarding an average measurement value for each QC measurement associated with the peer group, and the method (S100) The method (S100, S200) according to claim 1, further comprising: updating the average measurement value for each QC measurement of the peer group based on at least a portion of the plurality of acquired measurements (S107).

5. The predetermined threshold includes a first predetermined threshold, and the step (S102) of evaluating the acquired measurement results Comparing the acquired measurement results with the average measurement value for each QC measurement of the associated peer group (S131); The method (S100, S200) according to claim 4, comprising: determining that a deviation has been identified if the comparison indicates a difference exceeding the first predetermined threshold (S134).

6. The acquired measurement results include information regarding the change over time of the measurement results for each of the plurality of medical analysis device devices, the predetermined threshold includes a second predetermined threshold, and the step (S102) of evaluating the acquired measurement results Comparing the measurement results for each QC measurement parameter over a recent period with the change over time of the average measurement value for each corresponding QC measurement of the associated peer group during the recent period (S132); The method (S100, S200) according to claim 4, comprising: determining that a deviation has been identified if the comparison indicates a difference exceeding the second predetermined threshold during the recent period (S134).

7. The acquired measurement results include information regarding the change over time of the measurement results for the plurality of medical analysis device devices, and the step (S102) of evaluating the acquired measurement results comparing the measurement results for each QC measurement parameter over a recent period with the temporal change of the average measurement value for each corresponding QC measurement during the recent period (step S133); determining that a deviation has been identified if the comparison indicates a difference that increases over time during the recent period (step S134), the method (S100, S200) according to claim 4. **Claim 8** A computer-readable storage medium storing one or more programs configured to be executed by one or more processors of a processing system, the one or more programs including instructions for implementing the method (S100, S200) according to any one of claims 1 to 7. **Claim 9** An apparatus (201) for facilitating the maintenance of a medical analysis device, the apparatus comprising a control circuit (202), the control circuit (202) obtaining a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a plurality of predetermined QC samples by a plurality of medical analysis devices (110), each QC sample being associated with a predetermined target range, and each medical analysis device (110) being associated with a peer group of medical analysis devices; for each medical analysis device (110), evaluating the obtained measurement results against the measurement results of the associated peer group to identify a deviation in at least one QC measurement parameter; if a deviation exceeding a predetermined threshold is identified, obtaining an action log of the medical analysis device (110), the action log including data indicating any previously transmitted maintenance actions associated with the medical analysis device; obtaining at least one proposed maintenance action for the medical analysis device (110) associated with the identified deviation based on the type of QC measurement parameter associated with the identified deviation, the control circuit being further configured to identify a parameter group of the type of QC measurement parameter associated with the identified deviation and obtain at least one proposed maintenance action based on the identified parameter group. Based on the obtained action log, selecting a maintenance action for the medical analysis device (110) associated with the identified deviation from the at least one proposed maintenance action; Transmitting data indicating an instruction to execute the selected maintenance action for the medical analysis device to a device (101) for managing the medical analysis device (110) associated with the identified deviation; configured to do; Each QC measurement parameter is associated with one parameter group of a set of predefined parameter groups, and the set of predefined parameter groups is formed based on the commonality of one or more hardware and / or software components of the plurality of medical analysis devices involved in the implementation of the QC measurement, device (201).

10. The device for managing the medical analysis device is configured to monitor and control one or more medical analysis devices connected to the device, the device according to claim 9.

11. The device for managing the medical analysis device is associated with a geographical location including one or more medical analysis devices, the device according to claim 9.

12. A remote server comprising the device according to any one of claims 9 to 11.

13. A cloud environment comprising one or more remote servers according to claim 12.

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