Patent Description:
Embodiments of this disclosure relate to apparatus and methods adapted to provide quality control in diagnostic analyzers.

In medical testing and processing, diagnostic analyzers (immunoassay instruments, clinical diagnostic analyzers, in vitro analyzers, and the like) may be used to test for concentrations of one or more constituents (e.g., one or more analytes or other component(s)) contained within a biological specimen, such as, e.g., blood or a component thereof such as serum or plasma, urine, sputum, saliva, cerebrospinal liquids, and the like. Such diagnostic analyzers may be complex and may perform hundreds or even thousands of diagnostic tests (hereinafter "specimen tests") on specimens each day. In order to ensure that the results of the specimen tests produced by a diagnostic analyzer are valid, typically a series of replicate quality control tests (hereinafter "replicate QC tests") may be performed thereon using quality control samples that are carefully prepared to produce an expected result.

If one of the replicate QC tests produces an unexpected result, the diagnostic analyzer may be considered to be "out of control. " That is, the diagnostic analyzer is operating unacceptably and all of the specimen test results produced by that diagnostic analyzer since the last successful replicate QC tests may be questionable and thus may have to be discarded or possibly rerun.

<CIT> discloses a system comprising a controller that includes programmable commands for performing a point-of-service service at a designated location. The system includes a plurality of modules, and each individual modules of the plurality of modules is in wireless communication with the controller of the system. The controller is configured to provide one or more instructions to said module or individual modules of said plurality of modules to facilitate performance of the at least one sample preparation procedure or the at least one type of assay.

<CIT> discloses systems and methods configured to guide and manage laboratory analytical process control operations. The application illustrates a network arrangement for executing a shared application and/or communicating data and commands between multiple computing systems and devices. LAN interconnects multiple devices to a client system. The client computer system provides the required data (e.g., patient test results/data, and other information from a local database and local instruments and devices) for processing by server, which would then provide processing results back to client system.

Accordingly, apparatus and methods that can improve quality control in diagnostic analyzers are sought.

According to a first aspect, a quality control method for a diagnostic analyzer according to claim <NUM> is provided. The quality control method includes performing a quality control test or a plurality of specimen tests; determining, with a controller, that a quality control test result or a plurality of specimen test results is outside of a threshold; monitoring one or more mechanical devices of the diagnostic analyzer with the controller; and initiating a calibration procedure in response to the quality control test result or the plurality of specimen test results being outside of the threshold and receiving the error code. The method is characterised by receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices, wherein one or more mechanical devices includes one or more motors and wherein the error code indicates an error in one or more motors.

According to a second aspect, a diagnostic analyzer according to claim <NUM> is provided. The diagnostic analyzer includes a controller configured to perform a quality control test or a plurality of specimen tests; determine that a quality control test result or a plurality of specimen test results is outside of a threshold; monitor one or more mechanical devices of the diagnostic analyzer; and initiate a calibration procedure in response to the quality control test result or the plurality of specimen test results being outside of the threshold and receiving the error code. The diagnostic analyzer is characterised in that the controller is configured to receive an error code indicating an error in a mechanical device of the one or more mechanical devices, wherein one or more mechanical devices includes one or more motors and wherein the error code indicates an error in one or more motors.

According to a third aspect, a quality control method is provided. The quality control method includes performing a quality control test; determining, with a controller, that a variance in the quality control tests is outside of a threshold; monitoring one or more mechanical devices of the diagnostic analyzer with the controller; receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices; and initiating a calibration procedure by the controller in response to the variance in the quality control tests being outside of the threshold and receiving the error code.

Still other aspects, features, and advantages of the disclosure may be readily apparent from the following detailed description illustrating a number of example embodiments. This disclosure may also be capable of different embodiments, and its several details may be modified in various respects. Accordingly, this disclosure covers all modifications, equivalents, and alternatives falling within the scope of claims.

Diagnostic analyzers may rely on quality control (QC) tests to ensure that diagnostic test results produced by the diagnostic analyzers are valid. A QC test may involve testing a QC sample in the diagnostic analyzer and comparing the QC sample test result with an expected result for that QC sample. In some embodiments, a QC test may include performing a plurality of tests using a replicate QC sample. A QC sample may contain a specific concentration of a chemical (e.g., an analyte) being tested and will cause the diagnostic analyzer to output an expected test result if the diagnostic analyzer is operating properly. If a diagnostic analyzer does not produce the expected test result in response to a QC test, the diagnostic analyzer may be considered to be "out of control" and all of the test results produced by that diagnostic analyzer since the last successful QC test may be called into question. For example, if there is a high variance in the QC tests, then the diagnostic analyzer may be considered to be out of control. Conventional methods of operating diagnostic analyzers provide for calling a service agent into a laboratory to fix a diagnostic analyzer when a determination is made that the diagnostic analyzer is out of control.

Reference is now made to <FIG>, which illustrates a flowchart of a prior art method <NUM> of operating a diagnostic analyzer. First, in block <NUM>, an operator of the diagnostic analyzer detects a variance of QC tests outside a threshold. For example, the diagnostic analyzer may periodically perform QC tests (e.g., replicate QC tests) to assure the integrity of the diagnostic analyzer and a variance of these QC tests may be outside the threshold. In block <NUM>, the operator may perform a new QC test on the diagnostic analyzer in response to the variance of the QC tests of block <NUM> being outside the threshold. The new QC test may be of the same type of QC test that was performed to reach the result in block <NUM>.

If the variance of the QC tests is within a threshold after performing the new QC test in block <NUM>, processing proceeds to block <NUM> where the issue with the diagnostic analyzer is resolved. For example, when the variance in QC tests is within the threshold after the new QC test is performed, the operator of the diagnostic analyzer may be confident that the diagnostic analyzer is operating properly. If running the new QC test in block <NUM> results in the variance of QC tests remaining outside a threshold, processing proceeds to block <NUM> where the issue with the diagnostic analyzer is not resolved. In block <NUM>, the diagnostic analyzer may be out of control.

With the variance in the QC being outside the threshold after running the new QC test in block <NUM>, the user contacts a service agent as described in block <NUM>. The service agent may be a representative of the manufacturer of the diagnostic analyzer, for example. In block <NUM>, the service agent visits the location of the diagnostic analyzer to service the diagnostic analyzer and assesses and possibly realigns and/or recalibrates the diagnostic analyzer. A subsequent QC test is performed on the diagnostic analyzer in block <NUM>. The subsequent QC test may be of the same type of QC test performed in block <NUM>.

In block <NUM>, the issue with the diagnostic analyzer is resolved. For example, after the subsequent QC test is performed, the variance of the QC tests is within a threshold. Thus, the alignment and/or recalibration performed by the service agent resolved the issue with the diagnostic analyzer. If the variance of the QC tests remains outside a threshold after the subsequent QC test is run in block <NUM>, processing proceeds to block <NUM> where the issue with the diagnostic analyzer is not resolved. Other contributors may be assessed by the service agent to determine whether the other contributors are causing the issue with the diagnostic analyzer.

In the method <NUM> of <FIG>, the service agent visits the site of the diagnostic analyzer to perform the above-described realignment and/or recalibration of the diagnostic analyzer. During the time that the service agent is in transit and at the site of the diagnostic analyzer, the diagnostic analyzer may not be able to operate properly and may not be able to perform one or more diagnostic tests. Thus, diagnostic testing may become significantly delayed. The delay may result in test specimens having to be sent to other diagnostic analyzers, which is time consuming and costly.

In view of the foregoing, one or more embodiments of the disclosure provide quality control methods and apparatus configured and operable to detect when a diagnostic analyzer is not operating properly. The methods and apparatus may initiate alignment and/or calibration procedures that may be performed without a service agent present at the diagnostic analyzer. The methods and apparatus may analyze specimen test results and/or QC test results (e.g., replicate QC test results) performed by the diagnostic analyzer. For example, the methods and apparatus may compare test results from specimen tests with expected test results to determine if the diagnostic analyzer is operating properly. In other embodiments, a variance in QC tests may be analyzed to determine if the variance in QC tests is outside a threshold. The analysis of the specimen test results and/or the variance in QC tests may indicate that the diagnostic analyzer is not operating properly or that the diagnostic analyzer is out of control.

In accordance with one or more embodiments of the disclosure, a controller of the diagnostic analyzer, once it has determined an error exists, may automatically prompt the operator of the diagnostic analyzer to perform one or more calibration procedures. In some embodiments, the one or more calibration procedures may include one or more automated calibration procedures. In other embodiments, the one or more calibration procedures may be performed by the user of the diagnostic analyzer. Thus, the controller may prompt the user to initiate one or more calibration procedures, which can be undertaken without a service agent present at the diagnostic analyzer. Accordingly, the one or more calibration procedures save time and reduce costs.

These and other aspects and features of embodiments of the disclosure will be described with reference to <FIG>.

Reference is now made to <FIG>, which illustrates a block diagram of a diagnostic analyzer <NUM> according to one or more embodiments. The diagnostic analyzer <NUM> may include a controller <NUM>, a testing apparatus <NUM>, and a user interface <NUM>. The diagnostic analyzer <NUM> may be configured to perform one or more diagnostic tests and/or analyses on biological specimens as described herein.

The controller <NUM> may include a memory <NUM> (e.g., RAM, ROM, or other devices) configured to store programming instructions, test results, and/or other information/data. In some embodiments, the controller <NUM> may be separate from the testing apparatus <NUM>. For example, the controller <NUM> may be integrated into a laboratory information system (LIS). The controller <NUM> may include a processor <NUM> that is configured to run programming instructions stored in the memory <NUM>. The processor <NUM> may also be configured to communicate with one or more devices within the diagnostic analyzer <NUM>. In some embodiments, the processor <NUM> may be configured to communicate with devices (not shown) that are external to the diagnostic analyzer, such as computer servers, computer workstations, and an LIS. The processor <NUM> may be or may include a central processing unit (CPU), a microprocessor, and/or the like.

The memory <NUM> may store an error detection module <NUM> that may be programming instructions that, when executed by the processor <NUM>, cause the processor <NUM> to monitor the testing apparatus <NUM>. The error detection module <NUM> may also cause the processor <NUM> or programs executed by the processor <NUM> to identify errors, such as errors with components of the testing apparatus <NUM>. Other programming instructions stored in the memory <NUM> may cause the processor <NUM> to operate the diagnostic analyzer <NUM>, including the testing apparatus <NUM>, as described herein.

The testing apparatus <NUM> may be configured to perform analyses on different specimen types, such as patient specimens and QC samples. The testing apparatus <NUM> may be controlled by instructions transmitted by the processor <NUM>. In addition, test results from the analyses may be transmitted from the testing apparatus <NUM> to the processor <NUM>. Programs executing by the processor <NUM> may analyze the test results, which may be used to determine the operational status of the diagnostic analyzer <NUM> as described herein.

The testing apparatus <NUM> may include one or more sensors <NUM> that may monitor one or more devices within the testing apparatus <NUM>. For example, the one or more sensors <NUM> may monitor electronic devices, mechanical devices, and other devices within the testing apparatus <NUM>. The one or more sensors <NUM> and/or the processor <NUM> may generate an error code identifying an error with a component, such as a defective motor, or an error with a process performed by the testing apparatus <NUM>. The one or more sensors <NUM> and/or the processor <NUM> may identify a reason for an error, such as a misaligned component caused by crash of the component within the testing apparatus <NUM>.

In some embodiments, the one or more mechanical devices may include one or more encoders that may be configured to monitor positions of one or more mechanical devices and/or moveable devices. For example, the one or more encoders may generate data identifying the position of one or more movable devices and/or mechanical devices within the testing apparatus <NUM>. The one or more sensors <NUM>, in conjunction with the controller <NUM>, may generate data, such as an error code, indicating an error with a position of an encoder and/or alignment of a movable device. In some embodiments, one or more mechanical devices or electrical devices may include one or more hall-effect sensors. In some embodiments, the one or more hall-effect sensors may be configured to monitor positions of one or more moveable devices and/or the one or more mechanical devices. The one or more sensors <NUM>, in conjunction with the controller <NUM>, may detect an error with a hall-effect sensor.

In some embodiments, one or more mechanical devices or electrical devices may include one or more motors within the testing apparatus <NUM> that may move one or more movable devices. The one or more sensors <NUM>, in conjunction with the controller <NUM>, may generate data, such as an error code, indicating an error with a motor. An error code associated with a motor detected by the one or more sensors <NUM> may indicate a short circuit associated with the motor and/or an undervoltage condition associated with the motor.

In some embodiments, the one or more sensors <NUM>, in conjunction with the controller <NUM>, may generate data, such as an error code, indicating an error with a movable device. In some embodiments, the error code may indicate a crash of a movable device. In some embodiments, a movable device may be a pipette and an error code may indicate a crash of the pipette as described herein.

In some embodiments, one or more mechanical devices may include an aspiration device. The one or more sensors <NUM>, in conjunction with the controller <NUM>, may generate data, such as an error code, indicating an error with the aspiration device. An error code may indicate a pressure associated with the aspiration device being outside a threshold or an average pressure associated with the aspiration device being outside a threshold.

The one or more sensors <NUM> may also include thermometers, bar code readers, barometers, and/or other sensors. The one or more sensors <NUM> may be internal and/or external to the testing apparatus <NUM> and may be configured to provide various measurements related to the operation of diagnostic analyzer <NUM>. These measurements may include, but are not be limited to, internal temperature of the testing apparatus <NUM>, level of internal vibrations of the testing apparatus <NUM>, humidity level, and atmospheric pressure. Other measurements/data related to the operation of diagnostic analyzer <NUM> may be provided.

The error detection module <NUM> may be configured to analyze data generated by the one or more sensors <NUM> as described above. In addition, the error detection module <NUM> may analyze results of tests performed by the testing apparatus <NUM>. For example, the error detection module <NUM> may determine whether the one or more sensors <NUM> have detected an error. The error detection module <NUM> may also analyze patient sample test results and/or variance of QC tests to determine whether the diagnostic analyzer <NUM> is operating properly. If the diagnostic analyzer <NUM> is not operating properly, the controller <NUM> may initiate processes to correct the operation of the diagnostic analyzer <NUM> as described herein.

The diagnostic analyzer <NUM> may also include an imaging device <NUM> that may capture images of items being tested by the testing apparatus <NUM>. For example, the imaging device <NUM> may capture images of specimens, specimen containers, and/or bar code labels affixed to specimen containers. The imaging device <NUM> may capture images of other items.

The user interface <NUM> may include one or more devices that enable a user of the diagnostic analyzer <NUM> to input data to the diagnostic analyzer <NUM>, such as to the processor <NUM>. The user interface <NUM> may also enable the diagnostic analyzer <NUM> to convey data and information to the user. In some embodiments, the user interface <NUM> may include a monitor 206A, such as a computer monitor, a keyboard 206B, and/or a computer mouse 206C.

Additional reference is made to <FIG>, which illustrates a block diagram of a more detailed embodiment of the diagnostic analyzer <NUM>. The diagnostic analyzer <NUM> may analyze specimens, such as specimen <NUM>, located within a specimen container <NUM>. In some embodiments, the specimen <NUM> may be a QC sample that has a precise and known concentration of an analyte that may be used to calibrate the diagnostic analyzer <NUM>. In some embodiments, the specimen <NUM> may be a specimen (e.g., a biological sample) from a patient, wherein the diagnostic analyzer <NUM> determines a concentration of one or more analytes located in the specimen <NUM>.

The diagnostic analyzer <NUM> may include a driver <NUM> that is electrically coupled between the controller <NUM> and various components of the testing apparatus <NUM>. The driver <NUM> may receive signals from the processor <NUM> instructing various components within the testing apparatus <NUM> to move to certain locations, for example. The driver <NUM> may also transmit signals from the testing apparatus <NUM> to the controller <NUM> that indicate one or more operating conditions of the testing apparatus <NUM>. In some embodiments, the driver <NUM> or components thereof may be implemented in the controller <NUM>.

The driver <NUM> may include an aspiration control module <NUM> and a position control module <NUM>. The driver <NUM> may include other modules and components. The aspiration control module <NUM> may control one or more aspiration processes performed by the testing apparatus <NUM>. In some embodiments, the aspiration control module <NUM> may receive data generated by one or more sensors that monitor aspiration processes. The position control module <NUM> may control one or more motors that move one or more movable devices within the testing apparatus <NUM>. In some embodiments, the position control module <NUM> may receive data generated by one or more sensors that monitor the movements of the one or more movable devices. The one or more sensors may include a hall-effect sensor and a position encoder. Other sensors may be included in the testing apparatus <NUM>.

The testing apparatus <NUM> may include a pipette <NUM> having a removable pipette tip 328T attached thereto. The testing apparatus <NUM> may operate to move the pipette tip 328T and the specimen container <NUM> proximate each other. The testing apparatus <NUM> may then move the pipette tip 328T into the specimen container <NUM> to aspirate the specimen <NUM>. The pipette <NUM> may also be used in a similar manner to dispense a liquid into the specimen container <NUM>.

The testing apparatus <NUM> may include one or more motors that move the pipette <NUM> to specific locations such as proximate the specimen container <NUM>. The motors may also be used to move other moveable devices within the testing apparatus <NUM>. In the embodiment depicted in <FIG>, the testing apparatus <NUM> includes a motor <NUM> that is configured to move the pipette <NUM> in a plane defined by an x-axis and a y-axis, wherein the y-axis is into the paper. In some embodiments, the motor <NUM> may move a movable member <NUM> that is coupled between the motor <NUM> and the pipette <NUM>. The testing apparatus <NUM> may also include a z-motor 330Z that is configured to move the pipette <NUM> in a z-direction, such as into and out of the specimen container <NUM>. The motor <NUM> and the z-motor 330Z may receive signals from the position control module <NUM> that cause the motor <NUM> and the z-motor 330Z to move the pipette <NUM> to specific locations.

The testing apparatus <NUM> may include a pump <NUM> operated by a motor <NUM>, wherein the motor <NUM> may be operational by instructions provided by the aspiration control module <NUM>. During aspiration and dispensing, the pump <NUM> may cause a pressure in a conduit <NUM> between the pump <NUM> and the pipette <NUM>. In some embodiments, the pump <NUM> may be used to aspirate and dispense liquids out of and into the specimen container <NUM>.

The testing apparatus <NUM> may include one or more sensors that provide status of the testing apparatus <NUM>. For example, the one or more sensors may provide data to the processor <NUM> indicating the status of one or more mechanical and/or electrical components associated with the one or more sensors. In some embodiments, one or more sensor may include one or more encoders. In some embodiments, the one or more encoders monitor position of the one or more mechanical devices in the testing apparatus <NUM>. In the embodiment depicted in <FIG>, the testing apparatus <NUM> includes a first encoder 344A and a second encoder 344B. The first encoder 344A may provide data regarding the vertical position of the pipette <NUM> (e.g., along a z-axis). The second encoder 344B may provide data regarding the position of the pipette <NUM> in the X-Y plane. The first encoder 344A may include a sensor that provides data indicating that an error may be present with the first encoder 344A. The second encoder 344B may also include a sensor that provides data indicating that an error may be present with the second encoder 344B. For example, the sensors may indicate that the first encoder 344A and the second encoder 344B are not positioned correctly or that data provided by the first encoder 344A and the second encoder 344B is not correct.

The first encoder 344A and the second encoder 344B are sensors that, in conjunction with the controller <NUM> or other devices, diagnose errors with the motor <NUM> and/or the z-motor 330Z. For example, the first encoder 344A and the second encoder 344B may provide position data of the pipette <NUM>. This position data may be compared to expected position data, such a data stored or provided by the position control module <NUM>, to determine whether the motor <NUM> and/or the z-motor 330Z are misaligned. For example, the position control module <NUM> may move the pipette <NUM> to a known location within the testing apparatus <NUM>. If the pipette <NUM>, the first encoder 344A, and the second encoder 344B are aligned properly and operating properly, data provided by the first encoder 344A and the second encoder 344B should match the known location in the testing apparatus <NUM>.

The diagnostic analyzer <NUM> may include a motor sensor 346A that senses one or more parameters of the z-motor 330Z and transmits a signal indicating the one or more parameters. In some embodiments, the signal is an error code. The motor sensor 346A may measure current into the z-motor and/or voltage at the z-motor. If no current flow is measured into the z-motor by the motor sensor 346A, then the motor sensor 346A may generate a signal (e.g., an error code) indicating that the z-motor has an open circuit error. In some embodiments, the motor sensor 346A may transmit a signal indicative of the current to the error detection module <NUM> (or other device), wherein the error detection module <NUM> determines that an open circuit condition or a high current condition exists with the z-motor 330Z. If voltage below a predetermined threshold is measured at the z-motor by the motor sensor 346A, the motor sensor 346A may generate a signal indicating a short circuit or an undervoltage condition within the z-motor 330Z. In some embodiments, the motor sensor 346A may generate an error code that identifies a specific error detected by the motor sensor 346A. In other embodiments, the error code may be generated by the error detection module <NUM>. A motor sensor 346B may detect similar error(s) and/or parameters with the motor <NUM>. The motor sensor 346B may be similar or identical to the motor sensor 346A. The motor sensor 346A and the motor sensor 346B may detect other errors with the motors.

The diagnostic analyzer <NUM> may include one or more hall-effect sensors that may be configured to sense positions of one or more movable devices, such as the pipette <NUM>. An embodiment of the hall-effect sensor <NUM> includes a coil that may be attached to a location within the diagnostic analyzer. A moveable device may have a magnet located thereon. As the magnet passes close to the hall-effect sensor <NUM>, the interaction of the magnet and the coil generates a current that may be detected by a detector, such as a detector within the position control module <NUM>. Thus, the hall-effect sensor <NUM> provides data regarding the position of a moving device located within the testing apparatus <NUM>.

The hall-effect sensor <NUM> may have an error sensor <NUM> associated therewith. The error sensor <NUM>, in conjunction with the controller <NUM>, may detect one or more errors with the hall-effect sensor <NUM> and may generate one or more error codes in response to detection of an error. In some embodiments, the error sensor <NUM> may detect an open circuit in the coil within the hall-effect sensor <NUM>. In some embodiments, the error sensor <NUM> may detect a short circuit in the coil. In some embodiments, the position control module <NUM> may cause the pipette <NUM> to move proximate the hall-effect sensor <NUM> to cause the hall-effect sensor <NUM> to generate a signal indicating that the pipette <NUM> is proximate the hall-effect sensor <NUM>. In the event that the hall-effect sensor <NUM> does not generate such a signal, the diagnostic analyzer <NUM> may flag an error with the hall-effect sensor <NUM>. Other error detection devices and methods may be used. The hall-effect sensor <NUM> or other hall-effect sensors may be in other locations within the testing apparatus <NUM> to detect the positions of other movable devices.

The testing apparatus <NUM> may include an aspiration device, which in the embodiment depicted in <FIG> includes the pump <NUM> and the conduit <NUM>. The testing apparatus <NUM> may include a pressure sensor <NUM> configured to measure pressure in the conduit <NUM>, which may indicate the operating status of the aspiration device. For example, during aspiration and/or dispensing, the pressure sensor <NUM> may measure the pressure in the conduit <NUM>. The pressure sensor <NUM> may transmit a signal indicating that the pressure in the conduit <NUM> is above a predetermined pressure, below a predetermined pressure, and/or outside a predetermined pressure range. In some embodiments, an error may be detected in response to an average pressure measured in the conduit <NUM> being above a predetermined pressure, below a predetermined pressure, and/or outside a predetermined pressure range. For example, low pressure in the conduit <NUM> may be indicative of a leak between the pump <NUM> and the pipette <NUM>. High pressure in the conduit <NUM> may be indicative of blockage in the conduit <NUM> and/or the pipette <NUM>.

The monitor 206A may display the status of the diagnostic analyzer <NUM>. For example, during operation of the diagnostic analyzer <NUM>, the monitor 206A may display data generated by one or more of the sensors and or the error detection module <NUM>. If an error code is detected, the monitor 206A may display the error code. The monitor 206A may also display instructions prompting the user of the diagnostic analyzer <NUM> to initiate a calibration procedure. For example, initiating a calibration procedure may include providing instructions to the user to perform a calibration procedure. The instructions may also include procedures to be performed by the user to complete the calibration procedure. Calibration procedures may include alignment procedures.

Additional reference is now made to <FIG>, which is a flowchart describing an embodiment of a quality control method <NUM> for the diagnostic analyzer <NUM>. The method <NUM> may be performed at least in part by the controller <NUM>. For example, instructions to perform at least portions of the method <NUM> may be stored in the memory <NUM> and executed on the processor <NUM>.

In block <NUM>, a quality control (QC) test or a plurality of specimen tests are performed. For example, the controller <NUM> may store a moving average of specimen test results. In some embodiments, the controller may calculate a variance of QC tests. In some embodiments, performing the QC test may include testing one or more QC samples. In some embodiments, performing the QC test may include testing replicate QC samples. In block <NUM>, a quality control test result or a plurality of specimen test results is determined to be outside of a threshold. In some embodiments, the variance in QC tests is determined to be outside a threshold. In some embodiments, a test result is outside of a threshold if the test result is outside of a range, which may have an upper threshold and a lower threshold. The test result is considered outside of the threshold if the test result is above the upper threshold or below the lower threshold. In the case of a single threshold, the test result being outside of the threshold depends on whether the threshold is an upper limit or a lower limit. Being above an upper limit is considered outside of the threshold and being below a lower limit is considered outside of the threshold.

A QC sample may include a known concentration of an analyte. Accordingly, when the QC sample is tested, the result of the test will be the known concentration if the diagnostic analyzer <NUM> is operating properly. Likewise, if the diagnostic analyzer <NUM> is operating properly, the variance of the QC tests will be within a threshold.

In some embodiments, the diagnostic analyzer <NUM> may analyze a plurality of specimen tests to determine if the results of the specimen tests are drifting to a threshold in block <NUM>. For example, normal specimen test results may be between a first threshold and a second threshold, below a threshold, or greater than a threshold. A plurality of the specimen test results may be analyzed to determine whether the test results are approaching a threshold. For example, a moving average of test results may be analyzed to determine if the moving average is approaching a threshold, which may be indicative of an error in the diagnostic analyzer <NUM>. In some embodiments, outlier and/or anomaly test results are not included in the moving average analysis. In some embodiments, a sharp change in the moving average of the test results may be indicative of an error in the diagnostic analyzer <NUM>.

In block <NUM>, one or more mechanical devices of the diagnostic analyzer <NUM> are monitored. The mechanical devices may include the above-described mechanical devices in addition to other mechanical devices. For example, the motors, hall-effect sensor <NUM>, pipette <NUM>, encoders 344A-344B, pump <NUM>, and/or other devices may be monitored. In block <NUM> an error code indicating an error in a mechanical device of the one or more mechanical devices or a process may be received by and/or generated by the controller <NUM>.

In block <NUM>, a calibration procedure is initiated in response to the quality control test result or the plurality of specimen test results being outside of the threshold and the generation or receipt of the error code. In some embodiments, the calibration procedure is initiated in response the variance in the QC tests being outside a threshold and generation of the error code. In some embodiments, initiating a calibration procedure may include prompting a user of the diagnostic analyzer <NUM> to initiate or perform a calibration procedure. For example, the processor <NUM> may output a prompt via the monitor 206A that instructs a user to perform a calibration procedure. In some embodiments, initiating a calibration procedure may include instructing a user as to procedures for performing a calibration procedure. For example, calibration instructions may be provided on the monitor 206A. In some embodiments, initiating a calibration procedure includes causing the diagnostic analyzer <NUM> to perform an automated calibration procedure. For example, the processor <NUM> may execute instructions stored in memory <NUM> that cause mechanical devices and/or electronic devices within the diagnostic analyzer <NUM> to perform an automatic calibration procedure as described herein.

Several calibration procedures may be performed in the diagnostic analyzer <NUM>. In some embodiments, a calibration procedure may include aligning an encoder or calibrating the output of an encoder in response to an error code indicating an error with an encoder. Referring to the first encoder 344A, calibration may be required after an error code is generating indicating a crash of the pipette <NUM> or crash of another movable device. In some embodiments, calibration of the pipette <NUM> includes moving the pipette <NUM> to a predetermined position. For example, instructions may be transmitted from the processor <NUM> to the position control module <NUM> that instruct the position control module <NUM> to move the pipette <NUM> to the predetermined position. Data regarding the position of the pipette <NUM> may be transmitted from at least one of the first encoder 344A or the second encoder 344B to the position control module <NUM>. The position data provided by at least one of the first encoder 344A or the second encoder 344B should match the predetermined position of the pipette <NUM>.

In situations where the predetermined position of the pipette <NUM> does not match data provided by at least one of the first encoder 344A or the second encoder 344B, a calibration procedure may be performed. In some embodiments, the calibration procedure may be performed automatically by the diagnostic analyzer <NUM> (e.g., by the controller <NUM>). In some embodiments, the calibration procedure may be performed by a user in response to instructions provided by the controller <NUM>. In an automatic calibration procedure, the controller <NUM> and/or the position control module <NUM> may internally offset the data provided by at least one of the first encoder 344A or the second encoder 344B to match data of the predetermined position of the pipette <NUM>. In another embodiment, the user may adjust at least one of the first encoder 344A or the second encoder 344B until data provided therefrom matches data corresponding to the predetermined position of the pipette <NUM>.

The hall-effect sensor <NUM> is another position sensor in the embodiment of the diagnostic analyzer <NUM> depicted in <FIG>. The error sensor <NUM> and/or the position control module <NUM> may generate an error code indicating an error with the hall-effect sensor <NUM>. In some embodiments, the position control module <NUM> may move the pipette <NUM> past the hall-effect sensor <NUM>, which should cause the hall-effect sensor <NUM> to generate a signal. If no signal is generated by the hall-effect sensor <NUM>, an error code indicating an error with the hall-effect sensor <NUM> may be generated. A calibration procedure may be performed by moving the pipette <NUM> in locations within the testing apparatus <NUM> to determine if the hall-effect sensor <NUM> has moved and should be realigned. Realignment may involve physically moving the hall-effect sensor <NUM> to a correct position.

In some embodiments, a calibration procedure may include testing the hall-effect sensor <NUM>. For example, the error sensor <NUM> may measure an impedance (e.g., a resistance) of the coil in the hall-effect sensor <NUM>. This calibration procedure may be performed automatically by the controller <NUM> or manually by a user. The error sensor <NUM> may measure a high impedance indicating an open circuit in the hall-effect sensor <NUM>. The error sensor <NUM> may measure a very low impedance indicating a short circuit in the hall-effect sensor <NUM>.

The calibration procedures of at least one of the first encoder 344A or the second encoder 344B and the hall-effect sensor <NUM> may align the pipette <NUM>. For example, the calibration procedures assure that data generated by the first encoder 344A, the second encoder 344B, and the hall-effect sensor <NUM> provide accurate data of the position of the pipette <NUM>. These calibration procedures may be performed in response to an error code indicating a crash of a movable device (e.g., the pipette <NUM>) within the testing apparatus <NUM>.

In some embodiments, a crash of one or more movable devices within the diagnostic analyzer <NUM> may be detected by current to and/or voltage at a motor coupled to a movable device. When a moveable device crashes, the motor coupled to the movable device may suddenly draw significant current and/or have a sudden change in voltage. A sudden rise in current and/or a change in voltage to the motor <NUM> or the z-motor 330Z may indicate that a movable device coupled to the motor <NUM> or the z-motor 330Z has encountered an object that prevents or obstructs movement of the movable device. For example, if the motor sensor 346A senses a current increase and/or a voltage change at the z-motor 330Z, the error detection module <NUM> may determine that the pipette <NUM> has encountered an obstacle. In a similar manner, if the motor sensor 346B senses a current increase and/or a voltage change at the motor <NUM>, the error detection module <NUM> may determine that the pipette <NUM> or the movable member <NUM> has encountered an obstacle. If the error detection module <NUM> detects a crash, the error detection module <NUM> may instruct the processor <NUM> to initiate calibration procedures. After encountering an obstacle, the alignment of the movable device may become offset, which may be rectified by calibration and/or alignment. The calibration procedure may include aligning at least one of the first encoder 344A, the second encoder 344B, or the hall-effect sensor <NUM> as described herein.

In some embodiments, the error detection module <NUM> may determine that the z-motor 330Z and/or the motor <NUM> has an overcurrent condition (e.g., short circuit) or an overvoltage condition. In such situations, the error detection module <NUM> may instruct the processor <NUM> to notify an operator that an item is preventing one of the pipette <NUM> or the movable member <NUM> from moving. The processor <NUM> may instruct the operator to remove the obstruction and perform a calibration procedure as described above. The calibration procedure may include aligning at least one of the first encoder 344A, the second encoder 344B, or the hall-effect sensor <NUM> as described herein.

In some embodiments, errors associated with aspiration and/or dispensing may be sensed by the pressure sensor <NUM>. For example, during aspiration and dispensing processes, the pressure sensor <NUM> may measure the pressure in the conduit <NUM>, which may be the same pressure in the pump <NUM> and/or the pipette <NUM>. In some embodiments, the error detection module <NUM> may identify an error if the pressure sensed by the pressure sensor <NUM> is outside a threshold. For example, if during aspiration, the pressure sensed by the pressure sensor <NUM> is greater than a first threshold, the error detection module <NUM> may indicate that the aspiration system has a clog. The error detection module <NUM> may also indicate that the pump <NUM> is pumping too hard and may instruct the processor <NUM> to calibrate the pressure of the pump <NUM>. If the pressure sensed by the pressure sensor <NUM> is less than a second threshold during aspiration, the error detection module may indicate that the aspiration system has a leak. The error detection module <NUM> may also indicate that the pump <NUM> is pumping too weak and may instruct the processor <NUM> to calibrate the pressure of the pump <NUM>.

Subsequent to the calibration procedure, a subsequent QC test may be performed to determine of the diagnostic analyzer <NUM> is operating properly. In some embodiments, the error detection module <NUM> may determine if the QC test result is within a threshold. In some embodiments, the error detection module <NUM> may determine if the variance in the QC tests is within a threshold, which indicates that the diagnostic analyzer <NUM> is operating correctly. If the result of the subsequent QC test indicates that the diagnostic analyzer <NUM> is not operating properly, the user of the diagnostic analyzer may contact a service agent to perform other procedures on the diagnostic analyzer <NUM>.

Reference is now made to <FIG>, which is a flowchart illustrating a method <NUM> of operating a diagnostic analyzer (e.g., diagnostic analyzer <NUM>). The method <NUM> includes, in block <NUM>, performing quality control tests. The method includes, in block <NUM>, determining, with a controller (e.g., controller <NUM>), that a variance in the quality control tests is outside of a threshold. The method <NUM> includes, in block <NUM>, monitoring one or more mechanical devices of the diagnostic analyzer with the controller. The method <NUM> includes, in block <NUM>, receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices. The method <NUM> includes, in block <NUM>, initiating a calibration procedure by the controller in response to the variance in the quality control tests being outside of the threshold and receiving the error code.

Claim 1:
A quality control method (<NUM>) for a diagnostic analyzer (<NUM>), comprising:
performing a quality control test or a plurality of specimen tests;
determining, with a controller (<NUM>), that a quality control test result or a plurality of specimen test results is outside of a threshold;
monitoring one or more mechanical devices of the diagnostic analyzer (<NUM>) with the controller (<NUM>); and
initiating a calibration procedure in response to the quality control test result or the plurality of specimen test results being outside of the threshold and receiving the error code
characterized in that
receiving, by the controller (<NUM>), an error code indicating an error in a mechanical device of the one or more mechanical devices,
wherein one or more mechanical devices includes one or more motors (<NUM>, 330Z) and wherein the error code indicates an error in one or more motors (<NUM>, 330Z),