WO2017160857A1

WO2017160857A1 - System and method for ensuring quality control of a plurality of laboratory instruments

Info

Publication number: WO2017160857A1
Application number: PCT/US2017/022327
Authority: WO
Inventors: Thomas BASKETTE; Justin PITTS
Original assignee: True Health Ip Llc
Priority date: 2016-03-16
Filing date: 2017-03-14
Publication date: 2017-09-21

Abstract

The present disclosure provides systems and methods for real-time monitoring of laboratory analysis instruments for quality control.

Description

SYSTEM AND METHOD FOR ENSURING QUALITY CONTROL OF A PLURALITY OF LABORATORY INSTRUMENTS

PRIORITY CLAIM

[0001] The present application claims priority to U.S. Provisional Patent No. 62/309,031 , filed March 16, 2016, the entirety of which is incorporated herein by reference.

BACKGROUND

[0002] Clinical laboratories are laboratories where tests are done on specimens to determine the health of patients. They typically perform a wide variety of assays related to the diagnosis and providing information for the clinical management or prevention of disease. A single laboratory may perform dozens of kinds of assays on thousands of specimens in a day. Patient specimens must be handled delicately and assays must perform accurately to avoid repetition of patient sampling or incorrect assay results, which may result in anything from increased expenses and annoyance to avoidable mortality.

[0003] The management of the laboratory process, tracking samples and quality control of the assays is a complex problem that requires constant attention. A laboratory generally has a multiplicity of instruments with individual operating conditions and required calibration protocols. To monitor the conditions of the instruments and other information, Laboratory Information Management Systems have been developed that collect information from inventory management, to sample tracking to instrument calibration.

[0004] In a large commercial laboratory, there are a wide variety of instruments including automatic chemistry instruments such as a Roche analyzer or Beckman AU, NMRs, spectrometers; ELISA platforms, Hematology platforms, PCR platforms and automatic liquid handling units for the automated transfer and separation of samples into portions ready for analysis by each instrument. [0005] Existing systems for data collection and management of laboratory instruments describe connectivity of systems, central processing and data storage, but the address distinct problems, for example, US 8,812,241 describes a system for normalizing data based on characteristics of a sample source. That system connects with a health management system to associate patient data with instrument data and adjusts the output instrument data for reporting purposes. In U.S. 8, 1 12,232, an automated system autovalidates individual results produced by the instrument. That detailed analysis alerts an administrative user if specific patient results are out of range so the user can determine if the sample needs to be re-evaluated.

[0006] These current laboratory information systems connect various instruments and connect to a common database, but fail to properly monitor instrument calibration in real time as samples are tested. Existing systems at most capture historical data from instruments for evaluation by personnel subsequent to running the instrument on samples. In a high-throughput system, this fails to address the real-time control of measurements which may result in wasted samples or reporting of faulty information on a set of samples.

[0007] The current invention seeks to address the insufficiency of existing technologies by providing a means for real-time control of instrumental calibration to laboratory instruments.

SUMMARY

[0008] Described herein is a system for real-time monitoring of laboratory analysis instruments for quality control. Individual instruments are connected to a network for transmitting packets of data on analysis and identification of samples. A listening server is connected to the same network for capture of the analysis and identifying data. The listening server is also connected to a database for storage of the data and its own output. The server calculates a moving average for packets of data and compares the moving average to an expected range. If the average exceeds a range boundary, a rapid communication protocol is initiated to alert a user to possible error in the instrument. The analysis and identification data and the average results are stored for presentation to the user for analysis.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 illustrates an example system for ensuring quality control of a plurality of laboratory instruments consistent with the present technology.

[0010] FIG. 2 illustrates an example user interface for enabling a user to monitor moving averages for a plurality of laboratory instruments in real time consistent with one embodiments of the present technology.

[0011] FIG. 3 is a flowchart illustrating a method of real-time monitoring of laboratory analysis instruments for quality control consistent with the present technology.

DETAILED DESCRIPTION

[0012] Embodiments described herein provide an interactive environment for enabling a user to monitor and, if warranted, interrupt automated sample analysis by a plurality of laboratory instruments. In some embodiments, the system includes a computing device that displays data associated with calibration of the plurality of laboratory instruments, and optionally further enables a user to cause sample analysis by the plurality of instruments to be interrupted, for example if the calibration-related data indicates that one or more laboratory instruments may require recalibration. Functionally, the system receives sample analysis data and/or calibration data from the plurality of laboratory instruments and aggregates and provides the analysis and/or calibration data to the user in an efficient and user-friendly manner.

[0013] The purpose of this system is to provide a real-time monitoring tool for assay results across multiple instruments in the clinical laboratory. The information provided by this system will be used to ensure the integrity of the results reported by a laboratory. The system comprises of three main processing centers: the moving averages engine which communicates with the laboratory instruments and database, the monitor which queries the database for a series of results and calculates a constantly updating average of queried results to identify problematic averages, and the user interface for visual representation to a human user in real time. These main parts and data flow through the processing system as illustrated in FIGS. 1 -2 below.

[0014] Referring specifically to FIG. 1 , the system 10 may include a parsing workstation 200, a database 300, a moving averages engine 250, and a moving averages monitor 400. In some embodiments, the parsing workstation 200, the database 300, the moving averages engine 250, and the moving averages monitor are collectively featured in a single device 500.

[0015] In one embodiment, data 150 from instrument(s) 100 (such as AU and E- Mod line analyzer instruments) are captured in real-time as the instrument(s) 100 generate analysis results. The data 150 are parsed by the Moving Averages Engine 250 of the parsing workstation 200 and entered into the database 300. The Moving Averages Monitor 400 polls (e.g., periodically polls or continually polls) the database 300 for results from each measuring cell of each instrument 100. Results are averaged by the moving averages monitor 400 and the averages are evaluated based on criteria selected by an administrative user. Alert emails are sent if results fall outside of these criteria.

[0016] In some embodiments, the Moving Averages Engine 250 is housed a standalone processing unit 200 in communication with the instrument(s) 100 directly. In some embodiments, the Moving Averages Engine 250 can be programmed with an event listening protocol that receives signals from the instrument(s) 100. Alternatively, the Moving Averages Engine 250 comprises a task queue protocol that times queries to each of the instrument(s) 100. After a defined period of time, such as a period of time defined by a user, the Moving Averages Engine 250 queries an instrument 100 for information about the samples run, including at a minimum their measured values. In some cases, the Moving Averages Engine 250 may be in communication with a Laboratory Information Management System (not shown) that transmits information to and from the instrument(s) 100. In either setup, a user may set the task queue to repeatedly query the instrument(s) 100 for results with appropriately spaced time gaps. In some embodiments, the time between queries corresponds to the rate of throughput (e.g., a typical rate of throughput or a specific desired rate of throughput) for any particular instrument 100. [0017] In some embodiments, the system 10 automatically causes sample analysis to stop in an instrument 100 if the moving average 360 for that instrument 100 exceeds the acceptable range (e.g., falls outside an acceptable range). In such embodiments, the acceptable range may be input by a user, for example through a user interface 20 similar to that shown in FIG. 2. In other embodiments, the acceptable range may automatically be determined based on historical sample analysis data stored by the system 10.

[0018] In one embodiment, system 10 captures data from at least one Beckman AU line instrument 100 and at least one Roche E-Mod line instrument 100. In some embodiments, system 10 captures data from at least one Beckman AU line instrument 100, at least one Roche E-Mod line instrument 100, and at least one additional instrument 100 (such as an instrumental analyzer).

[0019] Referring now to FIG. 2, the moving averages monitor 400 may include a user interface 20 such as a graphical user interface that enables users to view moving averages data graphically. In some embodiments, the user interface 20 displays averages across all instruments for each selected assay in a display panel 360. Alternatively or in addition, the user interface 20 displays averages for each measuring cell individually which helps users identify performance issues with specific measuring cells within an instrument. The user interface 20 may include a legend 21 that associates data types with a specific line type (e.g., color and/or pattern) displayed in the display panel 360. In some embodiments the display panel 360 displays one or more of: the analyte name and optionally other identifying information 361 , the moving average 366 associated with the analyte, a mean 368 associated with the analyte, a standard deviation 364 associated with the analyte (e.g., one standard deviation above and below the mean 368), and/or alert level(s) 362 associated with the analyte. In some embodiments the display panel 360 displays the analyte name and optionally other identifying information 361 , the moving average 366 associated with the analyte, a mean 368 associated with the analyte, a standard deviation 364 associated with the analyte, and alert level(s) 362 associated with the analyte.

[0020] In some embodiments, the user interface 20 includes a view options menu 22 that enables a user to select the size of each moving average point as well as the number of hours in the current view. In such embodiments, the display panel 360 displays data 362/364/366/368 associated with the analyte for the time period selected in the view options menu 22.

[0021] In some embodiments, the user interface 20 includes an assay selection menu 23 that enables a user to select an analyte of interest. In such embodiments, the display panel 360 displays data 362/364/366/368 associated with the analyte selected in the assay selection menu 23. In some embodiments, more than one analyte may be selected in the assay selection menu 23.

[0022] In some embodiments, the user interface 20 includes an assay evaluation settings menu 25 that enables a user to set one or more monitoring parameters including, for example, fixed mean, standard deviation, number of samples to be used in calculating (e.g., auto-calculating) the mean, alert levels, number of hours, etc. In some embodiments, such as the embodiment shown in FIG. 2, the assay evaluation settings menu 25 enables the user to define alert levels as a multiple of the standard deviation associated with the mean 368 associated with the analyte. For example, in the embodiment shown in FIG. 2, the alert level for serum apolipoprotein B has been set as the mean +/- 3 SD. Here, the mean serum apolipoprotein B level is auto-calculated to be about 87.5, and the standard deviation is auto-calculated to be about 25.7. The alert levels 362 are therefore shown graphically in the display panel 360 at about 10.4 (Mean - 3xSD) and at about 164.7 (Mean + 3xSD). In some embodiments, the alert level 362 set by a user, for example after a desired number of samples are analyzed by the system 10, does not automatically adjust as the system 10 continues to analyze samples. For example, as shown in FIG. 2, the alert levels 362 set at +/- 3SD based on the auto- calculated mean of about 87.5 for 1 ,000 samples analyzed on the selected date of June 24, 2014, remains constant at about 10.4 and about 164.7 as additional samples are analyzed after the selected date. In such embodiments, the alert levels are not "moving alert levels" in the same sense that the average and mean analyte levels are each shown in FIG. 2 to be "moving."

[0023] In some embodiments, the user interface 20 includes a measuring cell menu 24 that enables the user to select one or more measuring cells for evaluation. In some embodiments, the measuring cell menu 24 includes an "all cells" option that enables the user to automatically select all measuring cells that determined a value associated with the analyte(s) selected in the assay menu 23 in the time period specified in the view options menu 22. In some embodiments, the measuring cell menu automatically displays a list of measuring cells that determined a value associated with the analyte(s) selected in the assay menu 23 in the time period specified in the view options menu 22, and automatically excludes (e.g., does not list) any measuring cells that did not determine a value associated with the analyte(s) selected in the assay menu 23 in the time period specified in the view options menu 22. In other embodiments, the measuring cell menu 24 displays all measuring cells that have determined a value associated with the analyte(s) selected in the assay menu 23— regardless of the time period specified in the view options menu 22— but does not enable a user to select an individual measuring cell that did not determine a value associated with the analyte(s) selected in the assay menu 23 in the time period specified in the view options menu 22 (e.g., measuring cells that have only determined a value associated with the analyte outside of the time period specified in the view options menu 22 may be shown as unselectable, such as in a "grayed out" typesetting).

[0024] In some embodiments, the assay evaluation settings menu 25 includes a mean auto-calculation option 25a that enables the user to cause the moving averages monitor 400 to automatically calculate the mean of the analyte data over the time period selected in the view options menu 22. In some embodiments, the assay evaluation settings menu 25 includes a standard deviation auto-calculation option 25b that enables the user to cause the moving averages monitor 400 to automatically calculate the mean of the analyte data over the time period selected in the view options menu 22. Results of the auto-calculations of the mean and/or the standard deviation (e.g., when those options are selected in the mean auto-calculation option 25a and the standard deviation auto- calculation option 25b may be displayed in a text output panel 26 in some embodiments. The text output panel 26 may also include other data associated with auto-calculations of the mean and/or the standard deviation such as the number of samples specified to be used in auto-calculating the mean, the time period specified for the data analysis, and/or the number of data points found in the specified time period. The text output panel 26 provides the user a convenient place from which relevant data used for evaluating the moving average 366 for an analyte may be copied, for example for use in reporting. Alternatively or in addition, data in the text output panel 26 may be used by an associated email program for inclusion in an alert email.

[0025] In some embodiments, the assay evaluation settings menu 25 includes an automatic send alert option 25c that enables the user to cause the system 10 to automatically send an alert (e.g., an email alert) to one or more users if the moving average 366 associated with an analyte falls outside an acceptable range (e.g., alert range 362) for that analyte in at least one measuring cell of an instrument 100. In other embodiments, the user interface 20 does not include an automatic send alert option 25c, in which case the system 10 may prompt a user to review moving average data 366 associated with one or more analytes that has fallen outside an acceptable range (e.g., alert range 362) for that analyte in at least one measuring cell of an instrument 100 before an alert is sent. The alert may be sent to recipient(s) selected by the user at the time of sending the alert. Alternatively, the system 10 may store recipient(s) to receive alerts when the moving average 366 associated with an analyte falls outside an acceptable range (e.g., alert range 362) for that analyte in at least one measuring cell of an instrument 100.

[0026] The alert may include any relevant data associated with the analyte and its moving average 366. In some embodiments, the email alert may include an image of the display panel 360, an image of the legend 21 , data from the view options menu 22, information from the measuring cell menu 24, information from the assay evaluation settings menu 25, and/or data from the text output panel 26. In some embodiments, the email alert may include an image of the display panel 360, an image of the legend 21 , data from the view options menu 22, information from the measuring cell menu 24, information from the assay evaluation settings menu 25, and data from the text output panel 26. In some embodiments, the alert includes an image of the user interface 20 including the display panel 360, the legend 21 , the view options menu 22, the assay menu 23, the measuring cell menu 24, the assay evaluation settings menu 25, and the text output panel 26. [0027] In some embodiments, the user interface 20 includes a refresh button 27 that enables a user to cause the moving averages monitor 400 to recalculate relevant parameters and display a recalculated moving average 366, the mean 368, the standard deviation 367, and the alert levels 362 associated with the selected analyte. In such embodiments, the moving averages monitor 400 does not automatically refresh the user interface 20 upon each changed input by the user, but rather enables the user to change more than one parameter before causing the display panel 360 and the text output panel 26 to display recalculated data. In other embodiments (not shown), the user interface 20 does not include a refresh button 27, in which case the moving averages monitor 400 automatically recalculates and displays refreshed data upon each changed input provided by the user.

[0028] In some embodiments, the present disclosure provides a laboratory instrument calibration monitoring computing device 500 comprising a processor and a memory coupled to the processor which is configured to be capable of executing programmed instructions comprising and stored in the memory to receive one or more items of real-time data 150 from one or more laboratory instruments 100; calculate a moving average value for each of the one or more items of real-time data received from each of the one or more laboratory instruments 100; determine whether the calculated moving average value for the one or more items of real-time data 150 is within a predetermined range; and notify a user when the calculated moving average value for one or more items of real-time data 150 is determined to be outside of the pre-determined range. In some embodiments, the notification comprises a rapid communication protocol. In some embodiments, the processor coupled to the memory is further configured to be capable of executing at least one additional programmed instruction comprising and stored in the memory to display in real-time the calculated moving average value for the one or more items of real-time data 150 received from the laboratory instrument(s) 100 on a user interface 20. In some embodiments, the one or more laboratory instruments 100 are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof. In some embodiments, the processor coupled to the memory is further configured to be capable of executing at least one additional programmed instruction comprising and stored in the memory to provide a signal to one of the one or more laboratory instruments 100 to stop a sample analysis procedure performed by the laboratory instrument 100 when the calculated moving average value for the one or more items of real-time data 150 is outside of the pre-determined range. In some embodiments, the pre-determined range is input by a user through a user interface 20.

[0029] In some embodiments, the present disclosure provides a non-transitory computer readable medium having stored thereon instructions for monitoring laboratory instrument calibration comprising executable code which when executed by a processor, causes the processor to perform steps comprising receiving one or more items of realtime data 150 from one or more laboratory instruments 100; calculating a moving average value for each of the one or more items of real-time data 150 received from each of the one or more laboratory instruments 100; determining whether the calculated moving average value for the one or more items of real-time data 150 is within a predetermined range; and notifying a user when the calculated moving average value for one or more items of real-time data 150 is determined to be outside of the predetermined range. In some embodiments, the notification comprises a rapid communication protocol. In some embodiments, the non-transitory computer readable medium further has stored thereon at least one additional instruction that when executed by the processor causes the processor to perform at least one additional step comprising displaying in real-time the calculated moving average value for the one or more items of real-time data received from the laboratory instrument 100 on a user interface 20. In some embodiments, the one or more laboratory instruments 100 are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood, preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof. In some embodiments, the non-transitory computer readable medium further has stored thereon at least one additional instruction that when executed by the processor causes the processor to perform at least one additional step comprising providing a signal to one of the one or more laboratory instruments 100 to stop a sample analysis procedure performed by the laboratory instrument 100 when the calculated moving average value for the one or more items of real-time data 150 is outside of the pre-determined range. In some embodiments, the pre-determined range is input by a user through a user interface 20.

[0030] In some embodiments, the present disclosure provides a method of applying samples to a plurality of laboratory instruments 100, querying those instruments 100 in real-time for the resultant measurements of the samples, calculating an average of the measurements over a defined time period and enabling a user to interrupt operation of any one (or more) of the plurality of laboratory instruments based on the calculated average of the measurements. In some embodiments, the method further comprises generating a visual representation of the average as it is calculated in real-time.

[0031] In some embodiments, the method further comprises automatically notifying a user if the average deviates from a pre-determined range of acceptable averages. A user may review the visual representation in real-time and assess a problem with the instrument calibration if the moving average shows a trend near or outside of the predetermined range of acceptable average. In some embodiments, the method further comprises halting sample analysis on the affected instrument 100 if the user determines an error or probable error with the calibration of that instrument 100 using the moving average information. The method may further comprise resuming sample analysis with the instrument 100 after recalibration (e.g., manual recalibration or automatic recalibration). In some embodiments, the system 10 and affected instrument 100 may be programmed to halt sample analysis automatically if the moving average exceeds the acceptable range.

[0032] Referring now specifically to FIG. 3, a process 1000 for monitoring instrument calibration in real time is graphically provided. The process 1000 begins when real-time data 150 from at least one laboratory instrument 100 is received 1002, for example by a workstation. Upon receipt, the process 1000 further includes calculating 1004 a moving average value for each real-time data point 150 for each laboratory instrument 100. Thereafter, the system 10 determines 1006 whether the moving average value is within a pre-determined range for that instrument 100 for that analyte. If yes 1008, the process 1000 repeats. If no 1010, the process 1000 further includes sending 1012 an alert to one or more users. Optionally, the process 1000 further includes halting 1014 analysis of samples in the affected instrument(s) 100 after the alert is sent in step 1012. The process 1000 optionally also includes recalibrating 1016 the instrument(s) 100 before additional real-time data 150 can be received 1002 from the affected instrument(s) 100. The optional step of halting analysis 1014 in the affected instrument(s) 100 may occur manually, such as by a user after receipt of the alert sent in step 1012. Alternatively, the optional step of halting analysis 1014 in the affected instrument(s) 100 may occur automatically. The optional step of recalibrating 1016 the affected instrument(s) 100 may occur automatically, for example if the affected instrument(s) 100 includes an autocalibration feature. Alternatively, the optional step of recalibrating 1016 the affected instrument(s) 100 may be performed manually, for example by a user after the alert is sent in step 1012. If the process 1000 includes the step of recalibrating 1016 the affected instrument(s) 100, the process 1000 must also include halting 1014 analysis of samples in the affected instrument(s) 100 before the step of recalibrating 1016 occurs.

[0033] In some embodiments, the present disclosure provides a method for monitoring laboratory instrument calibration, the method comprising receiving, by a laboratory instrument calibration monitoring computing device 500, one or more items of real-time data 150 from one or more laboratory instruments 100; calculating, by the laboratory instrument calibration monitoring computing device 500, a moving average value for each of the one or more items of real-time data 150 received from each of the one or more laboratory instruments 100; determining, by the laboratory instrument calibration monitoring computing device 500, whether the calculated moving average value for the one or more items of real-time data 150 is within a pre-determined range; and notifying, by the laboratory instrument calibration monitoring computing device 500, a user when the calculated moving average value for one or more items of real-time data 150 is determined to be outside of the pre-determined range. In some embodiments, the notifying is performed automatically when the calculated moving average value for one or more items or real-time data 150 is determined to be outside of the pre-determined range. In some embodiments, the one or more laboratory instruments 100 are located remotely from the laboratory instrument calibration monitoring computing device 500. In some embodiments, the notification comprises a rapid communication protocol. In some embodiments, the method further comprises displaying, by the laboratory instrument calibration monitoring computing device 500, the calculated moving average value for the one or more items of real-time data 150 received from the laboratory instrument 100 on a user interface 20. In some embodiments, the calculated moving average is displayed in real-time. In some embodiments, the one or more laboratory instruments 100 are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof. In some embodiments, the method further comprises providing, by the laboratory instrument calibration monitoring computing device 500, a signal to one of the one or more laboratory instruments 100 to stop a sample analysis procedure performed by the laboratory instrument 100 when the calculated moving average value for the one or more items of real-time data 150 is outside of the pre-determined range. In some embodiments, the pre-determined range is input by a user through a user interface 20.

[0034] In some embodiments, the present disclosure provides a method of reducing misdiagnosis of a disease or disorder in a subject, the method comprising receiving one or more items of real-time data 150 associated with an analyte in one or more biological samples from at least one laboratory instrument 100; calculating a moving average value associated with the real-time data 150; determining whether the calculated moving average value falls within a pre-determined range associated with the analyte; and, if the calculated moving average value falls outside the pre-determined range, discarding the real-time data associated with the analyte in the one or more biological samples and notifying a user that the calculated moving average value fell outside the pre-determined range. In some embodiments, the method further comprises prompting the user to recalibrate the at least one laboratory instrument 100. In some embodiments, the method further comprises prompting the user to re-subject the one or more biological samples to analysis by the at least one laboratory instrument 100 after the at least one laboratory instrument 100 has been recalibrated.

[0035] In some embodiments, the present disclosure provides a method of treating a disease or disorder in a subject in need thereof, the method comprising determining a level of at least one analyte in a biological sample associated with the subject using at least one laboratory instrument 100; calculating a moving average value for the level of one or more analytes associated with the disease or disorder in the biological sample in combination with levels of the one or more analyte associated with the disease or disorder in biological samples from a plurality of additional subjects determined by the at least one laboratory instrument 100; determining whether the calculated moving average value falls within a pre-determined range associated with the analyte; and initiating a therapeutic regimen in the subject if the calculated moving average value falls within the pre-determined range and the level of the at least one analyte indicates that the subject is affected by the disease or disorder. In some embodiments, the method further comprises prompting a user to recalibrate the at least one laboratory instrument 100 if the calculated moving average value falls outside the pre-determined range. In some embodiments, the method further comprises prompting a user to re-subject the biological sample associated with the subject to analysis by the at least one laboratory instrument 100 after the at least one laboratory instrument 100 has been recalibrated.

EXAMPLES

[0036] Example 1 . A method for monitoring laboratory instrument calibration, the method comprising: receiving, by a laboratory instrument calibration monitoring computing device, one or more items of real-time data from one or more laboratory instruments; calculating, by the laboratory instrument calibration monitoring computing device, a moving average value for each of the one or more items of real-time data received from each of the one or more laboratory instruments; determining, by the laboratory instrument calibration monitoring computing device, whether the calculated moving average value for the one or more items of real-time data are within a pre-determined range; and notifying, by the laboratory instrument, calibration monitoring computing device, a user when the calculated moving average value for one or more items of real-time data are determined to be outside of the pre-determined range. [0037] Example 2. The method as set forth in Example 1 , wherein the notifying is performed automatically when the calculated moving average value for one or more items or real-time data are determined to be outside of the pre-determined range.

[0038] Example 3. The method as set forth in Example 1 or Example 2, wherein the one or more laboratory instruments are located remotely from the laboratory instrument calibration monitoring computing device.

[0039] Example 4. The method as set forth in any one of Examples 1 -3, wherein the notification comprises a rapid communication protocol.

[0040] Example 5. The method as set forth in any one of Examples 1 -4 further comprising displaying, by the laboratory instrument calibration monitoring computing device, the calculated moving average value for the one or more items of real-time data received from the laboratory instrument on a user interface.

[0041] Example 6. The method as set forth in Example 5, wherein the calculated moving average is displayed in real-time.

[0042] Example 7. The method as set forth in any one of Examples 1 -6, wherein the one or more laboratory instruments are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof.

[0043] Example 8. The method as set forth in any one of Examples 1 -7 further comprising providing, by the laboratory instrument calibration monitoring computing device, a signal to one of the one or more laboratory instruments to stop a sample analysis procedure performed by the laboratory instrument when the calculated moving average value for the one or more items of real-time data are outside of the predetermined range.

[0044] Example 9. The method as set forth in any one of Examples 1 -8, wherein the pre-determined range is input by a user through a user interface. [0045] Example 10. A laboratory instrument calibration monitoring computing device comprising a processor and a memory coupled to the processor which is configured to be capable of executing programmed instructions comprising and stored in the memory to: receive one or more items of real-time data from one or more laboratory instruments; calculate a moving average value for each of the one or more items of real-time data received from each of the one or more laboratory instruments; determine whether the calculated moving average value for the one or more items of real-time data are within a pre-determined range; and notify a user when the calculated moving average value for one or more items of real-time data are determined to be outside of the pre-determined range.

[0046] Example 1 1 . The device as set forth in Example 10, wherein the notification comprises a rapid communication protocol.

[0047] Example 12. The device as set forth any one of Examples 10-1 1 , wherein the processor coupled to the memory is further configured to be capable of executing at least one additional programmed instruction comprising and stored in the memory to display in real-time the calculated moving average value for the one or more items of real-time data received from the laboratory instrument on a user interface.

[0048] Example 13. The device as set forth in any one of Examples 10-12, wherein the one or more laboratory instruments are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof.

[0049] Example 14. The device as set forth in any one of Examples 10-13, wherein the processor coupled to the memory is further configured to be capable of executing at least one additional programmed instruction comprising and stored in the memory to provide a signal to one of the one or more laboratory instruments to stop a sample analysis procedure performed by the laboratory instrument when the calculated moving average value for the one or more items of real-time data are outside of the predetermined range.

[0050] Example 15. The device as set forth in any one of Examples 10-14, wherein the pre-determined range is input by a user through a user interface.

[0051] Example 16. A non-transitory computer readable medium having stored thereon instructions for monitoring laboratory instrument calibration comprising executable code which when executed by a processor, causes the processor to perform steps comprising: receiving one or more items of real-time data from one or more laboratory instruments; calculating a moving average value for each of the one or more items of real-time data received from each of the one or more laboratory instruments; determining whether the calculated moving average value for the one or more items of real-time data are within a pre-determined range; and notifying a user when the calculated moving average value for one or more items of real-tinge data are determined to be outside of the pre-determined range.

[0052] Example 17. The medium as set forth in Example 16, wherein the notification comprises a rapid communication protocol.

[0053] Example 18. The medium as set forth in any one of Examples Example 16- 17 further having stored thereon at least one additional instruction that when executed by the processor causes the processor to perform at least one additional step comprising displaying in real-time the calculated moving average value for the one or more items of real-time data received from the laboratory instrument on a user interface.

[0054] Example 19. The medium as set forth in any one of Examples 16-18, wherein the one or more laboratory instruments are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood, preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof.

[0055] Example 20. The medium as set forth in any one of Examples 16-19 further having stored thereon at least one additional instruction that when executed by the processor causes the processor to perform at least one additional step comprising providing a signal to one of the one or more laboratory instruments to stop a sample analysis procedure performed by the laboratory instrument when the calculated moving average value for the one or more items of real-time data are outside of the predetermined range.

[0056] Example 21 . The medium as set forth in any one of Examples 16-20, wherein the pre-determined range is input by a user through a user interface.

[0057] Example 22. A method of reducing misdiagnosis of a disease or disorder in a subject, the method comprising: receiving one or more items of real-time data associated with an analyte in one or more biological samples from at least one laboratory instrument; calculating a moving average value associated with the real-time data; determining whether the calculated moving average value falls within a predetermined range associated with the analyte; and if the calculated moving average value falls outside the pre-determined range, discarding the real-time data associated with the analyte in the one or more biological samples and notifying a user that the calculated moving average value fell outside the pre-determined range.

[0058] Example 23. The method of Example 22 further comprising prompting the user to recalibrate the at least one laboratory instrument.

[0059] Example 24. The method of Example 23 further comprising prompting the user to re-subject the one or more biological samples to analysis by the at least one laboratory instrument after the at least one laboratory instrument has been recalibrated. [0060] Example 25. A method of treating a disease or disorder in a subject in need thereof, the method comprising: determining a level of at least one analyte in a biological sample associated with the subject using at least one laboratory instrument; calculating a moving average value for the level of one or more analytes associated with the disease or disorder in the biological sample in combination with levels of the one or more analyte associated with the disease or disorder in biological samples from a plurality of additional subjects determined by the at least one laboratory instrument; determining whether the calculated moving average value falls within a predetermined range associated with the analyte; and initiating a therapeutic regimen in the subject if the calculated moving average value falls within the pre-determined range and the level of the at least one analyte indicates that the subject is affected by the disease or disorder.

[0061] Example 26. The method of Example 25 further comprising prompting a user to recalibrate the at least one laboratory instrument if the calculated moving average value falls outside the pre-determined range.

[0062] Example 27. The method of Example 26 further comprising prompting a user to re-subject the biological sample associated with the subject to analysis by the at least one laboratory instrument after the at least one laboratory instrument has been recalibrated.

Claims

CLAIMS I/We claim:

1 . A method for monitoring laboratory instrument calibration, the method comprising:

receiving, by a laboratory instrument calibration monitoring computing device, one or more items of real-time data from one or more laboratory instruments; calculating, by the laboratory instrument calibration monitoring computing device, a moving average value for each of the one or more items of real-time data received from each of the one or more laboratory instruments; determining, by the laboratory instrument calibration monitoring computing device, whether the calculated moving average value for the one or more items of real-time data are within a pre-determined range; and

notifying, by the laboratory instrument, calibration monitoring computing device, a user when the calculated moving average value for one or more items of real-time data are determined to be outside of the pre-determined range.

2. The method as set forth in claim 1 , wherein the notifying is performed automatically when the calculated moving average value for one or more items or realtime data are determined to be outside of the pre-determined range.

3. The method as set forth in claim 1 , wherein the one or more laboratory instruments are located remotely from the laboratory instrument calibration monitoring computing device.

4. The method as set forth in claim 1 , wherein the notification comprises a rapid communication protocol.

5. The method as set forth in claim 1 further comprising displaying, by the laboratory instrument calibration monitoring computing device, the calculated moving average value for the one or more items of real-time data received from the laboratory instrument on a user interface.

6. The method as set forth in claim 5, wherein the calculated moving average is displayed in real-time.

7. The method as set forth in claim 1 , wherein the one or more laboratory instruments are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof.

8. The method as set forth in claim 1 further comprising providing, by the laboratory instrument calibration monitoring computing device, a signal to one of the one or more laboratory instruments to stop a sample analysis procedure performed by the laboratory instrument when the calculated moving average value for the one or more items of real-time data are outside of the pre-determined range.

9. The method as set forth in claim 1 , wherein the pre-determined range is input by a user through a user interface.

10. A laboratory instrument calibration monitoring computing device comprising a processor and a memory coupled to the processor which is configured to be capable of executing programmed instructions comprising and stored in the memory to:

receive one or more items of real-time data from one or more laboratory instruments;

calculate a moving average value for each of the one or more items of real-time data received from each of the one or more laboratory instruments; determine whether the calculated moving average value for the one or more items of real-time data are within a pre-determined range; and

notify a user when the calculated moving average value for one or more items of real-time data are determined to be outside of the pre-determined range.

1 1 . The device as set forth in claim 10, wherein the notification comprises a rapid communication protocol.

12. The device as set forth claim 10, wherein the processor coupled to the memory is further configured to be capable of executing at least one additional programmed instruction comprising and stored in the memory to display in real-time the calculated moving average value for the one or more items of real-time data received from the laboratory instrument on a user interface.

13. The device as set forth in claim 10, wherein the one or more laboratory instruments are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof.

14. The device as set forth in claim 10, wherein the processor coupled to the memory is further configured to be capable of executing at least one additional programmed instruction comprising and stored in the memory to provide a signal to one of the one or more laboratory instruments to stop a sample analysis procedure performed by the laboratory instrument when the calculated moving average value for the one or more items of real-time data are outside of the pre-determined range.

15. The device as set forth in claim 10, wherein the pre-determined range is input by a user through a user interface.

16. A non-transitory computer readable medium having stored thereon instructions for monitoring laboratory instrument calibration comprising executable code which when executed by a processor, causes the processor to perform steps comprising: receiving one or more items of real-time data from one or more laboratory instruments;

calculating a moving average value for each of the one or more items of real-time data received from each of the one or more laboratory instruments;

determining whether the calculated moving average value for the one or more items of real-time data are within a pre-determined range; and notifying a user when the calculated moving average value for one or more items of real-tinge data are determined to be outside of the pre-determined range.

17. The medium as set forth in claim 16, wherein the notification comprises a rapid communication protocol.

18. The medium as set forth claim 16 further having stored thereon at least one additional instruction that when executed by the processor causes the processor to perform at least one additional step comprising displaying in real-time the calculated moving average value for the one or more items of real-time data received from the laboratory instrument on a user interface.

19. The medium as set forth in claim 16, wherein the one or more laboratory instruments are selected from the group consisting of a mass spectrometry instrument, an immunoassay instrument, a genotyping instrument, an electrophoresis instrument, a blood, preparation instrument, a clinical chemistry analyzer, an NMR instrument, or combinations thereof.

20. The medium as set forth in claim 16 further having stored thereon at least one additional instruction that when executed by the processor causes the processor to perform at least one additional step comprising providing a signal to one of the one or more laboratory instruments to stop a sample analysis procedure performed by the laboratory instrument when the calculated moving average value for the one or more items of real-time data are outside of the pre-determined range.

21 . The medium as set forth in claim 16, wherein the pre-determined range is input by a user through a user interface.

22. A method of reducing misdiagnosis of a disease or disorder in a subject, the method comprising:

receiving one or more items of real-time data associated with an analyte in one or more biological samples from at least one laboratory instrument; calculating a moving average value associated with the real-time data;

determining whether the calculated moving average value falls within a predetermined range associated with the analyte; and

if the calculated moving average value falls outside the pre-determined range, discarding the real-time data associated with the analyte in the one or more biological samples and notifying a user that the calculated moving average value fell outside the pre-determined range.

23. The method of claim 22 further comprising prompting the user to recalibrate the at least one laboratory instrument.

24. The method of claim 23 further comprising prompting the user to re-subject the one or more biological samples to analysis by the at least one laboratory instrument after the at least one laboratory instrument has been recalibrated.

25. A method of treating a disease or disorder in a subject in need thereof, the method comprising:

determining a level of at least one analyte in a biological sample associated with the subject using at least one laboratory instrument;

calculating a moving average value for the level of one or more analytes associated with the disease or disorder in the biological sample in combination with levels of the one or more analyte associated with the disease or disorder in biological samples from a plurality of additional subjects determined by the at least one laboratory instrument; determining whether the calculated moving average value falls within a predetermined range associated with the analyte; and

initiating a therapeutic regimen in the subject if the calculated moving average value falls within the pre-determined range and the level of the at least one analyte indicates that the subject is affected by the disease or disorder.

26. The method of claim 25 further comprising prompting a user to recalibrate the at least one laboratory instrument if the calculated moving average value falls outside the pre-determined range.

27. The method of claim 26 further comprising prompting a user to re-subject the biological sample associated with the subject to analysis by the at least one laboratory instrument after the at least one laboratory instrument has been recalibrated.