Control range for devices for biological sample analysis

Abstract

A computer-implemented method performed by a central system for establishing a control range for a plurality of remote medical analyzer devices is disclosed. The method includes acquiring a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a set 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, for each peer group of the plurality of peer groups, determining a peer control range for each predefined QC sample by processing the plurality of measurement results of the peer group taking into account the associated target range. Furthermore, the method includes, for each medical analyzer device, determining a control range for each predefined QC sample based on the determined peer control range of the associated peer group. The method further includes transmitting data indicative of the determined control range for the set of predefined QC samples for the at least one medical analyzer device to a device for managing the at least one medical analyzer device.

Description

[Technical Field]

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

[0002] In the field of clinical analysis, a wide variety of electronic medical analyzers are known that enable medical personnel to obtain test results and / or measurements or to separately analyze specimens, such as samples of bodily 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. Furthermore, analyses include in vivo measurements on sample streams, such as transcutaneous measurements of partial pressure of oxygen (pO2) and / or carbon dioxide (pCO2), as well as pulse oximetry measurements. Generally, a medical analyzer is a device configured to perform chemical, optical, physical, or similar analyses on specimens, e.g., individual samples or sample streams. Such medical analyzers include analyzers for performing various forms of clinical testing and / or analysis, such as measuring patient physiological parameters. In modern clinical environments, medical analyzers are widely used, and there is a trend toward moving more and more testing from central laboratories to the actual point-of-care (POC).

[0003] Furthermore, modern medical analyzers require periodic quality control (QC), which may be understood as a process used to monitor and evaluate the analytical process that results in patient results. Many techniques exist for testing the functionality of medical analyzers for QC purposes. However, the common practice is to implement a periodic QC program / process in which measurements are performed on a set of known reference standards (which may also be referred to as control materials, QC specimens, 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.

[0004] Currently, these control ranges are obtained either from the manufacturer (often referred to as manufacturer ranges) or from periodic internal testing. The problem with manufacturer ranges is that they are often relatively broad, and therefore, QC programs / processes for testing device accuracy based on manufacturer ranges may have questionable reliability. Therefore, many facilities employ internal testing as part of their QC programs to set control ranges to obtain ranges narrower than the manufacturer ranges mentioned above.

[0005] However, the problem with control limits established by internal testing as part of each laboratory's QC program is that these processes are time-consuming and procedurally inefficient. More specifically, such internal testing processes for establishing control limits not only require valuable time from laboratory or medical personnel, but also result in the analytical equipment being taken out of service during that time. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, there is a need in the art for a new solution for establishing control ranges for medical analytical devices that solves or at least mitigates at least some of the problems discussed above. [Means for solving the problem]

[0007] It is emphasized that the term "comprises" (which can be interchanged with "includes"), when used herein, is taken to specify the presence of stated features, integers, steps, or components, but does not exclude 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 indicates otherwise.

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

[0009] It is an object of some embodiments to solve or mitigate, alleviate or eliminate at least some of the above or other disadvantages. A first aspect is a computer-implemented method performed by a central system for establishing control ranges for a plurality of remote medical analyzer devices. The method includes acquiring a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a set of predetermined QC samples by a plurality of medical analyzer devices. Each QC sample is associated with a predetermined target range, and each medical analyzer device is associated with a peer group of medical analyzer devices. The method further includes, for each peer group of the plurality of peer groups, determining a peer control range for each predetermined QC sample by processing the plurality of measurement results of the peer group taking into account the associated target range. Furthermore, the method includes, for each medical analyzer device, determining a control range for each predetermined QC sample based on the determined peer control range of the associated peer group. The method further includes transmitting data indicating the determined control range for the set of predetermined QC samples for the at least one medical analyzer device to a device for managing the at least one medical analyzer device.

[0010] In some embodiments, processing the plurality of measurements taking into account the associated target ranges includes discarding any measurements having difference values ​​above a threshold to form a filtered set of measurements, the difference values ​​defining the difference between the measurements and the corresponding predefined target ranges.

[0011] In some embodiments, processing the plurality of measurements taking into account the associated target range further includes determining, for each peer group, a peer control range based on a statistical function of the filtered set of measurements.

[0012] In some embodiments, the step of determining, for each peer group, a peer control range based on a statistical function of the filtered set of measurement results includes: determining, for each peer group, an average measurement value for each QC sample of a predetermined set of QC samples; and determining, for each peer group, a peer control range for each QC sample based on the determined average measurement value and at least one standard deviation value.

[0013] In some embodiments, determining the average measurement value for each peer group comprises determining, for each peer group, a running average value for each QC sample over a recent period of a defined length.

[0014] In some embodiments, the method further includes determining, for each medical analyzer device, an associated peer group of the plurality of peer groups based on the analyzer type and QC product type of each medical analyzer device, such that medical analyzer devices having a corresponding analyzer type and a corresponding QC product type belong to the same peer group.

[0015] In some embodiments, for each medical analyzer device, determining a control range for each predetermined QC sample includes calculating each control range based on each corresponding peer control range, the number of measurement samples used to determine the corresponding peer control range, and the number of medical analyzer devices included in the associated peer group.

[0016] Furthermore, 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 performing a method according to any one of the embodiments disclosed herein. In this aspect, similar advantages and preferred features exist as in the first aspect discussed previously.

[0017] The term "non-transitory," as used herein, is intended to describe computer-readable storage media (or "memory") excluding propagating electromagnetic signals, but is not intended to otherwise limit the type of physical computer-readable storage device encompassed by the phrases computer-readable medium or memory. For example, the term "non-transitory computer-readable medium" or "tangible memory" is intended to encompass types of storage devices that do not necessarily store information permanently, including, for example, random access memory (RAM). Program instructions and data stored in a tangible computer-accessible storage medium in non-transitory form may further be transmitted by a transmission medium or signal, such as an electrical, electromagnetic, or digital signal that may be transmitted over a communication medium such as a network and / or wireless link. Thus, the term "non-transitory," as used herein, is a limitation of the medium itself (i.e., tangible, not a signal), as opposed to a limitation on data storage persistence (e.g., RAM vs. ROM).

[0018] A third embodiment is an apparatus for establishing control ranges for a plurality of remote medical analyzer devices, the device comprising: a control circuit configured to acquire a plurality of measurement results associated with a plurality of measurements performed on a set of predetermined QC samples by the plurality of medical analyzer devices. Each QC sample is associated with a predetermined target range, and each medical analyzer device is associated with a peer group of medical analyzer devices. The control circuit is further configured to, for each peer group, determine a peer control range for each predetermined QC sample by processing the plurality of measurement results of the peer group taking into account the associated target range. Furthermore, the control circuit is configured to, for each medical analyzer device, determine a control range for each predetermined QC sample based on the determined peer control range of the associated peer group. The control circuit is further configured to transmit data indicating the determined control range for the set of predetermined QC samples for the at least one medical analyzer device to a device for managing the at least one medical analyzer device. Similar advantages and preferred features exist in this embodiment as in the previously discussed embodiment, and vice versa.

[0019] In some embodiments, a device for managing medical analyzer devices is configured to monitor and control one or more medical analyzer devices connected to the device.

[0020] In some embodiments, a device for managing medical analyzer devices is associated with a geographic location that includes one or more medical analyzer devices. In some embodiments, the control circuitry is further configured to discard any measurements having difference values ​​above a threshold to form a filtered set of measurements, the difference values ​​defining the difference between the measurements and the corresponding predetermined target ranges.

[0021] In some embodiments, the control circuitry is further configured to determine, for each peer group, a peer control range based on a statistical function of the filtered set of measurements.

[0022] In some embodiments, the control circuitry is further configured to determine, for each peer group, an average measurement value for each QC sample of a predetermined set of QC samples, and to determine, for each peer group, a peer control range for each QC sample based on the determined average measurement value and at least one standard deviation value.

[0023] In some embodiments, the control circuitry is further configured to determine, for each peer group, a running average value for each QC sample over a recent period of a defined length. In some embodiments, the control circuitry is further configured to determine, for each medical analyzer device, an associated peer group of the plurality of peer groups based on the analyzer type and QC product type of each medical analyzer device, such that medical analyzer devices having a corresponding analyzer type and a corresponding QC product type belong to the same peer group.

[0024] In some embodiments, the control circuitry is further configured to calculate each control range based on each corresponding peer control range, the number of measurement samples used to determine the corresponding peer control range, and the number of medical analyzer devices included in the associated peer group.

[0025] A fourth aspect is a remote server comprising an apparatus according to any one of the embodiments of the third aspect disclosed herein. In this aspect, similar advantages and preferred features exist as in the previously discussed aspects, and vice versa.

[0026] A fifth aspect is a cloud environment comprising one or more remote servers according to any one of the embodiments of the fourth aspect disclosed herein. In this aspect, similar advantages and preferred features exist as in the previously discussed aspects, and vice versa.

[0027] A sixth aspect is a device for managing a plurality of medical analyzer devices. The device comprises a control circuit configured to acquire a plurality of measurement results associated with a plurality of QC measurements performed on a set of predefined QC samples by the 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 control circuit is further configured to transmit data indicative of the acquired plurality of measurement results to a central agent (e.g., an apparatus according to the sixth aspect). Furthermore, the control circuit is configured to receive data from the central agent indicative of a set of control ranges for the set of predefined QC samples for one or more peer groups associated with the plurality of medical analyzer devices. The control circuit is further configured to configure, for each medical analyzer device, a control range for the set of predefined QC samples based on the received set of control ranges.

[0028] A seventh aspect is a system for establishing control ranges for a plurality of medical analyzer devices, the system comprising an apparatus according to any one of the embodiments of the third aspect and a device according to any one of the embodiments of the sixth aspect.

[0029] An advantage of some embodiments is that medical analyzer devices can be provided with narrow and precise control ranges in a more time- and resource-efficient manner. An advantage of some embodiments is that detection of an aberrant medical analyzer device is facilitated.

[0030] An advantage of some embodiments is that the initialization / installation of new medical analyzer devices is expedited, as an effective control range may be made immediately available. A further advantage of some embodiments is that they facilitate monitoring of control ranges within a group of medical analyzer devices.

[0031] A further advantage of some embodiments is that monitoring control ranges within a group of medical analyzer devices facilitates the detection of even slightly deviating medical analyzer devices. A further advantage of some embodiments is that monitoring control ranges within a group of medical analyzer devices facilitates providing narrow and precise control ranges.

[0032] These and other features and advantages of the embodiments described herein will be apparent from the following description with reference to the embodiments described hereinafter. Further objects, features, and advantages of some embodiments will become apparent from the following detailed description, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0033] [Figure 1] FIG. 1 is a schematic flow chart diagram of a computer-implemented method performed by a central system for establishing a range of control for multiple remote medical analyzer devices, according to some embodiments. [Figure 2] 1 is a schematic block diagram of a system having an apparatus for establishing a range of control for multiple remote medical analyzer devices, according to some embodiments. [Figure 3] 1 is a schematic block diagram of a system having an apparatus for establishing a range of control for multiple remote medical analyzer devices, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0034] Those skilled in the art will understand that the steps, services, and functions described herein may be implemented using discrete hardware circuits, using software working 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). It should also be understood that when an embodiment is described with respect to a method, it may also be embodied in one or more processors and one or more memories coupled to the one or more processors, the one or more memories storing one or more programs that, when executed by the one or more processors, perform the steps, services, and functions disclosed herein.

[0035] Embodiments of the present disclosure will be more fully described and illustrated hereinafter with reference to the accompanying drawings, in which: The solutions disclosed herein may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein;

[0036] In the following, embodiments are described for establishing narrow and efficient control ranges for multiple distributed medical analyzer devices by utilizing peer group data to calculate preferred control ranges.

[0037] Generally, when a medical analyzer device is referred to herein, it may be understood to be a device configured to perform chemical, optical, physical, or similar analysis on a specimen, e.g., on an individual sample or sample stream. Such medical analyzer devices include analytical instruments for performing various forms of clinical testing and / or analysis, such as measuring physiological parameters of a patient.

[0038] Generally, when a "device for managing one or more medical analyzer devices" is referred to herein, it can be understood as a device associated with a hospital or facility that includes one or more medical analyzer devices. However, one or more medical analyzer devices may be distributed across several geographic locations, and thus a "device for managing one or more medical analyzer devices" may also be associated with multiple hospitals or facilities that include another medical analyzer device. A "device for managing one or more medical analyzer devices" is configured to keep an overview of one or more medical analyzer devices or monitor the status and operation of one or more medical analyzer devices. Furthermore, a "device for managing one or more medical analyzer devices" is configured to transmit data (e.g., instructions) to the medical analyzer devices associated therewith.

[0039] 1 is a schematic flow chart diagram of a computer-implemented method S100 performed by a central system (central agent) for establishing control ranges for multiple remote medical analyzer devices. A control range may be understood as a range within which a quality control (QC) parameter should fall. A control range is specific to a particular QC measurement parameter, and each measurement parameter is associated with a particular QC sample (which may also be known as a QC specimen or QC liquid).

[0040] Some examples of QC measurement parameters include pH (a measure of the alkalinity of a sample), pCO2 (partial pressure (or tension) of carbon dioxide in the blood), pO2 (partial pressure (or tension) of oxygen in the blood), ctHb (concentration of total hemoglobin in the blood), sO2 (oxygen saturation), FO2Hb (percentage of oxyhemoglobin in total hemoglobin in the blood), FCOHb (percentage of carboxyhemoglobin in total hemoglobin in the blood), FMetHb (percentage of methemoglobin in total hemoglobin in the blood), cNa +(concentration of sodium ions in plasma), cGlu (concentration of D-glucose in plasma). This list should not be construed as exhaustive and may include additional measurement parameters that will be readily understood by those skilled in the art.

[0041] The method then includes step S101 of acquiring a plurality of measurement results associated with a plurality of QC measurements performed on a predetermined set of QC samples by a plurality of medical analyzer devices. Each QC sample is associated with a predetermined target range, and each medical analyzer device is associated with a peer group of medical analyzer devices. More specifically, a QC sample may be understood as a substance or sample having a measurable property that is carefully controlled so that when a medical analyzer device performs a measurement on the QC sample to verify its operational accuracy, there is an associated target range (e.g., target value ± tolerance value) within which the resulting measurement must fall to meet the associated quality requirement. The target range may be set, for example, by a manufacturer or distributor of the QC sample. The term acquiring, as used herein, should be interpreted broadly and encompasses receiving, acquiring, collecting, obtaining, determining, deriving, and the like.

[0042] The method further includes determining, for each peer group among the plurality of peer groups, a peer control range for each predetermined QC sample by processing S106 the plurality of measurement results obtained S101 of the peer group taking into account the associated target range.

[0043] In general, a peer group of medical analyzer devices, as referred to herein, can be understood as a group of medical analyzer devices that share some specific common characteristics. For example, a peer group of medical analyzer devices can be defined as medical analyzer devices of the same type (e.g., same model) and / or medical analyzer devices that have the same QC product type (i.e., use QC samples originating from the same source). Furthermore, a peer group can further include geographical constraints—for example, even if medical analyzer devices are of the same type, if they are associated with (e.g., located in) different countries, they do not necessarily have to belong to the same peer group.

[0044] Thus, in some embodiments, method S100 may further include acquiring data indicative of a medical analyzer type and / or a QC product type from each of the plurality of medical analyzer devices. The data may be transmitted, for example, as metadata along with the measurement results. Thus, in some embodiments, method S100 further includes determining, for each medical analyzer device, an associated peer group of the plurality of peer groups based on the analyzer type and QC product type of each medical analyzer device, such that medical analyzer devices having a corresponding analyzer type and a corresponding QC product type belong to the same peer group.

[0045] In general, "peer group measurements" may be understood as previously acquired measurements from a peer group, i.e., one or more previously acquired measurements. In some embodiments, "peer group measurements" include average measurements for each QC measurement of the associated peer group. Furthermore, in some embodiments, "associated peer group measurements" include running average measurements for each QC measurement of the peer group.

[0046] Further, referring to the processing of measurement results S106, in some embodiments, the processing of acquired measurement results S106 includes discarding / filtering any measurement results having a difference value above a threshold S107 to form a filtered set of measurement results, where the difference value defines the difference between the measurement result and the corresponding predetermined target range, such that statistical outliers in the measurement results can be removed and the reliability of the determined control range can be increased.

[0047] Furthermore, in some embodiments, processing S106 the plurality of measurements further includes determining, for each peer group, a peer control range based on at least one statistical function of the filtered set of measurements. The at least one statistical function may include, for example, a "mean function" of the measurements, i.e., a function whose output is the average value (which may also be referred to as the mean) of the measurements. The statistical function may include a "median function," i.e., a function whose output is the median of the measurements. The statistical function may include a "standard deviation function," i.e., a function whose output is the standard deviation of the measurements.

[0048] Thus, in some embodiments, the step of determining, for each peer group, a peer control range based on a statistical function of the filtered set of measurement results includes, for each peer group, determining S108 an average measurement value for each QC sample of a predetermined set of QC samples, and, for each peer group, determining S110 a peer control range for each QC sample based on the determined average measurement value and at least one standard deviation value.

[0049] Further, in some embodiments, determining the average measurement value for each peer group includes determining S109, for each peer group, a moving average value for each QC sample over a recent period of a specified length (e.g., 2-12 months). In other words, the average measurement value can be a moving average value, such as a 6-month moving average, a 5-month moving average, or any other suitable length.

[0050] Subsequently, once the peer control ranges have been determined S102, the method S100 further includes determining S103, for each medical analyzer device, a control range for each predetermined QC sample based on the peer control range determined S102. More specifically, determining S103 the control ranges may include calculating S103 each control range based on each corresponding peer control range, the number of measured samples used to determine the corresponding peer control range, and the number of medical analyzer devices included in the associated peer group.

[0051] Thus, the calculated control range in S103 is a customized control range that is narrower and more efficient than the manufacturer range. Further, method S100 includes a step S104 of transmitting data indicating the determined S103 control range for the set of predetermined QC samples for the at least one medical analyzer device to a device for managing the at least one medical analyzer device. Thus, each medical analyzer device is provided with a centrally calculated control range that is based on the peer control ranges of its associated peer group of medical analyzer devices.

[0052] Thus, the medical analyzer device is provided with a desirable narrow control range without requiring the medical analyzer device to perform time-consuming internal testing as part of a QC program. Furthermore, the control ranges as provided herein are based on peer control ranges (based on measurements from several "peer" devices) that provide redundancy and reliability to the calculated control range.

[0053] Alternatively or additionally, the control ranges as provided herein are based on a self-learning model and data obtained from the analytical device and measurements, and data from the analytical device and measurements can be continually added to the model and the model trained so that customized control ranges can be calculated.

[0054] Thus, the control ranges can be continually re-established and customized based on self-learning models and data acquired from the analytical device and measurement results, and thus can be dynamically determined as opposed to static control ranges such as manufacturer ranges.

[0055] Executable instructions for implementing these functions are optionally contained on a non-transitory computer-readable storage medium or other computer program product configured for execution by one or more processors.

[0056] 2 is a schematic block diagram of a system 10 comprising an apparatus 201 for establishing control ranges for a plurality of remote medical analyzer devices 110, according to some embodiments. The apparatus 201 comprises a control circuit CTRL 202 configured to acquire a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a plurality of predefined QC samples by the plurality of medical analyzer devices. Each QC sample is associated with a predefined target range, and each medical analyzer device 110 is associated with a peer group 301 of medical analyzer devices.

[0057] Additionally, the control circuit CTRL202 is configured to determine, for each peer group (e.g., a peer group of medical analyzer devices as indicated by dashed circle 301 in FIGS. 2 and 3), a peer control range for each pre-defined QC sample by processing the plurality of acquired measurement results of the peer group taking into account the associated target range. The control circuit 202 is further configured to determine, for each medical analyzer device of the plurality of medical analyzer devices, a control range for each pre-defined QC sample based on the determined peer control range of the associated peer group.

[0058] The control circuitry 202 may further be configured to acquire data (e.g., metadata associated with the measurement results) indicative of the analyzer type and QC product type of each medical analyzer device. This data (e.g., metadata) may then be used to determine, for each medical analyzer device, an associated peer group of the plurality of peer groups based on the analyzer type and QC product type of each medical analyzer device, such that medical analyzer devices having corresponding analyzer types and corresponding QC product types belong to the same peer group.

[0059] Still further, the control circuitry 202 is configured to transmit data indicative of the determined control ranges for a set of predetermined QC samples for the at least one medical analyzer device to the device 101 for managing the at least one medical analyzer device 110. In other words, the control circuitry 202 determines a set of control ranges for each medical analyzer device 110 based on the peer control ranges of the associated peer group, and subsequently pushes the determined set of control ranges to the medical analyzer device 110.

[0060] In some embodiments, the device 101 for managing medical analyzer devices has a control circuit 202 configured to monitor and control one or more medical analyzer devices connected to the device. Thus, the device 101 for managing medical analyzer devices may be part of a Hospital Information System (HIS) and / or Laboratory Information System (LIS), which is responsible for monitoring and controlling the multiple medical analyzer devices associated therewith. Thus, in some embodiments, the device 101 for managing medical analyzer devices is associated with a geographic location that includes one or more medical analyzer devices. Nevertheless, in some embodiments, the device may be in the form of (e.g., implemented as) a cloud service (e.g., a cloud computing system including one or more remote servers, provided by a cloud environment, e.g., distributed cloud computing resources) communicatively connected to one or more medical analyzer devices.

[0061] However, in some embodiments, the control circuit 202 may be configured to transmit data indicative of the determined control ranges for a given set of QC samples directly to each medical analyzer device 110. Thus, in some embodiments, the device 101 for managing the medical analyzer devices may be, for example, an internal control unit or control circuit CTRL112 of the medical analyzer device 110, as depicted in FIG. 3, which is a schematic block diagram of a system comprising an apparatus 201 for establishing control ranges for multiple remote medical analyzer devices 110.

[0062] 2, a device 101 for managing multiple medical analyzer devices 110 has a control circuit 102 configured to acquire multiple measurement results associated with multiple QC measurements performed on a predetermined set of QC samples by the multiple medical analyzer devices 110. The multiple medical analyzers and devices 101 may be associated, for example, with the same facility (e.g., a hospital or laboratory). Furthermore, each QC sample is associated with a predetermined target range, and each medical analyzer device is associated with a peer group of medical analyzer devices.

[0063] Additionally, the control circuitry 102 is configured to transmit data indicative of the plurality of acquired measurement results to a central agent 201 (e.g., an apparatus described above). As noted, the control circuitry 102 may be further configured to transmit data indicative of the analyzer type and QC product type of each medical analyzer device of the plurality of medical analyzer devices.

[0064] The control circuitry 102 is further configured to receive data from the central agent 201 indicating a set of control ranges for a pre-defined set of QC samples for one or more peer groups associated with the plurality of medical analyzer devices 110. The control circuitry is further configured to configure, for each medical analyzer device of the plurality of medical analyzer devices, a control range for the pre-defined set of QC samples based on the received set of control ranges.

[0065] Embodiments other than those described above are possible and within the scope of the claims. Method steps different from those described above, implementing the method 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 for implementing 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 implement any of the methods presented herein. The cloud computing system may comprise distributed cloud computing resources that jointly implement the methods presented herein under the control of one or more computer program products.

[0066] Generally speaking, a computer-accessible medium may include any tangible or non-transitory storage or memory medium, such as electronic, magnetic, or optical media, e.g., a disk or CD / DVD-ROM coupled to a computer system via a bus. The terms “tangible” and “non-transitory,” as used herein, are intended to describe computer-readable storage media (or “memory”) excluding propagating electromagnetic signals, but are not intended to otherwise limit the types of physical computer-readable storage devices encompassed by the phrases computer-readable medium or memory. For example, the terms “non-transitory computer-readable medium” or “tangible memory” are intended to encompass types of storage devices that do not necessarily store information permanently, including, for example, random access memory (RAM). Program instructions and data stored in a tangible computer-accessible storage medium in non-transitory form may further be transmitted by a transmission medium or signal, such as an electrical, electromagnetic, or digital signal, which may be transmitted over a communication medium, such as a network and / or a wireless link.

[0067] The processors 102, 112, 202 (associated with the devices and apparatuses 101, 110, 201) may be or include any number of hardware components for performing data or signal processing or for executing computer code stored in memory 103, 113, 203. The devices and apparatuses 101, 110, 201 have associated memory 103, 113, 203, which may be one or more devices for storing data and / or computer code for completing or facilitating the various methods described herein. The memory may include volatile or non-volatile memory. The memory 103, 113, 203 may include database components, object code components, script components, or any other type of information structure for supporting the various activities of the present description. According to an exemplary embodiment, any distributed or local memory device may be utilized with the apparatus and methods of the present description. According to an exemplary embodiment, memory 103, 113, 203 is communicatively connected to processor 102, 112, 202 (e.g., via circuitry or any other wired, wireless, or network connection) and includes computer code for executing one or more processes described herein.

[0068] The communication interfaces 104, 105, 114, 204 may provide the possibility to transmit the output to a remote location (e.g., a remote operator or control center) using a suitable communication device. The communication interfaces 104, 105, 114, 204 may be arranged to communicate with other functional components and may therefore also be seen as control interfaces, although a separate control interface (not shown) may also be provided. Local communication within the facility 100 may also be of the wireless type, using protocols such as WiFi, LoRa, Zigbee, Bluetooth, or similar medium / short range technologies.

[0069] It should therefore be understood that some of the described solutions may be implemented either on one remote server or on multiple remote servers, e.g., multiple servers in communication with each other, a so-called cloud solution. Different features and steps of the embodiments may be combined in combinations other than those described.

[0070] Generally, all terms used herein are to be construed in accordance with their ordinary meaning in the relevant art unless a different meaning is expressly given and / or implied by the context in which they are used.

[0071] It should be noted that the word "comprising" does not exclude the presence of elements or steps other than those listed, and the words "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. It should be further noted that any reference signs do not limit the scope of the claims, that the embodiments may be implemented at least in part by means of both hardware and software, and that several "control circuits," "means," or "units" may be represented by the same item of hardware.

[0072] While a diagram may show method steps in a particular order, the order of the steps may differ from that depicted. Additionally, two or more steps may be performed simultaneously or with partial concurrency. Such variations depend on the software and hardware systems selected and the designer's choice. All such variations are within the scope of the disclosed embodiments. Similarly, software implementations may be achieved through standard programming techniques using rule-based logic and other logic to accomplish the various connection, processing, comparison, and decision steps. The embodiments described above are given by way of example only and are not limitations on the present disclosure. Therefore, it should be understood that the details of the described embodiments are merely examples proposed for illustrative purposes, and that all variations that fall within the scope of the claims are intended to be incorporated therein.

Claims

1. 1. A computer-implemented method (S100) performed by a central system for establishing a range of control for a plurality of remote medical analyzer devices, comprising: (S101) acquiring a plurality of measurement results associated with a plurality of quality control (QC) measurements performed on a set of predetermined QC samples by a plurality of medical analyzer devices, each QC sample being associated with a predetermined target range, and each medical analyzer device being associated with a peer group of medical analyzer devices; determining (S102) a peer control range for each given QC sample by processing (S106) the plurality of measurements of the peer group taking into account the associated target range for each peer group of a plurality of peer groups; For each medical analyzer device, determining (S103) a control range for each predetermined QC sample based on the determined (S102) peer control range of the associated peer group; and transmitting (S104) data indicative of the determined (S103) control range for the predetermined set of QC samples for the at least one medical analyzer device to a device for managing the at least one medical analyzer device, The step of determining the control range for each predetermined QC sample for each medical analyzer device (S103) comprises: The method (S100) includes a step (S103) of calculating each control range based on each corresponding peer control range, the number of measurement samples used to determine the corresponding peer control range, and the number of medical analyzer devices included in the associated peer group.

2. The step of processing the plurality of measurements taking into account the associated target ranges (S106) comprises:

2. The method (S100) of claim 1, comprising a step (S107) of discarding any measurement results having a difference value above a threshold to form a filtered set of measurement results, the difference value defining a difference between the measurement result and a corresponding predetermined target range.

3. The step of processing the plurality of measurements taking into account the associated target values ​​(S106) comprises:

3. The method of claim 2, further comprising the step of determining, for each peer group, the peer control scope based on a statistical function of the filtered set of measurements. ００）。

4. determining, for each peer group, the peer control scope based on a statistical function of the filtered set of measurements, For each peer group, determining an average measurement value for each QC sample in the set of predefined QC samples (S108); and for each peer group, determining the peer control range for each QC sample based on the determined mean measurement value and at least one standard deviation value.

5. The step of determining the average measure for each peer group comprises:

5. The method (S100) of claim 4, comprising the step of determining (S109) for each peer group a moving average value for each QC sample over a recent period of a defined length.

6. 2. The method (S100) of claim 1, further comprising: determining, for each medical analyzer device, an associated peer group among the plurality of peer groups based on the analytical equipment type and QC product type of each medical analyzer device, such that the medical analyzer devices having a corresponding analytical equipment type and a corresponding QC product type belong to the same peer group.

7. 10. 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 performing the method of any one of claims 1 to 6.

8. An apparatus (201) for establishing a control range for a plurality of remote medical analyzer devices (110), said apparatus (201) comprising a control circuit (202), said control circuit (202) comprising: acquiring a plurality of measurement results associated with a plurality of measurements performed on a predetermined set of QC samples by a plurality of medical analyzer devices (110), each QC sample being associated with a predetermined target range, and each medical analyzer device being associated with a peer group of medical analyzer devices; for each peer group, determining a peer control range for each given QC sample by processing the plurality of measurements of the peer group taking into account the associated target range; For each medical analyzer device, determining a control range for each predetermined QC sample based on the determined peer control range of the associated peer group; transmitting data indicative of the determined control ranges for the predetermined set of QC samples for at least one medical analyzer device to a device for managing the at least one medical analyzer device; configured to Determining the control range for each predetermined QC sample for each medical analyzer device includes: and calculating each control range based on each corresponding peer control range, the number of measurement samples used to determine the corresponding peer control range, and the number of medical analyzer devices included in the associated peer group.

9. The device for managing the medical analyzer device is connected to the device.

10. The apparatus of claim 8, configured to monitor and control one or more medical analyzer devices.

10. The apparatus of claim 8 , wherein the device for managing the medical analyzer devices is associated with a geographic location that includes one or more medical analyzer devices.

11. A remote server comprising an apparatus according to any one of claims 8 to 10.

12. A cloud environment comprising one or more remote servers according to claim 11, communicatively connected to the remote medical analyzer device (110).

13. A system (10) for establishing control ranges for a plurality of medical analyzer devices (110), comprising: A device (201) according to any one of claims 8 to 10, A device (101) for managing a plurality of medical analyzer devices (110), comprising: The device (101) comprises a control circuit (102), the control circuit (102) acquiring a plurality of measurement results associated with a plurality of QC measurements performed on a predetermined set of QC samples by the plurality of medical analyzer devices (110), each QC sample being associated with a predetermined target range, and each medical analyzer device being associated with a peer group of medical analyzer devices; transmitting data indicative of said acquired measurements to a central agent (201); receiving data from the central agent (201) indicating a set of control ranges for the predetermined set of QC samples for one or more peer groups associated with the plurality of medical analyzer devices (110); for each medical analyzer device (110), configuring control ranges for the predetermined set of QC samples based on the received set of control ranges; A system (10) comprising: a device (101) configured to:

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