# US 11,441,997 B2 · Quality control for point-of-care diagnostic systems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,441,997 B2 - Document ID: US11441997B2 - Status: Granted - Kind: B2 - Application number: 16/368,929 - Filed: 2019-03-29 - Published: 2019-10-03 - Granted: 2022-09-13 - Earliest claimed: 2018-03-30 - Assignees: IDEXX Laboratories, Inc. - Applicants: IDEXX Laboratories, Inc. - Inventors: Jeremy Hammond; Timothy Butcher; Jui Ming Lin; James Russell - Web page: https://patentgrep.com/patent/US11441997B2 ## CPC - G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades - G01N 15/1425: {using an analyser being characterised by its control arrangement} - G01N 15/1429: Signal processing - G01N 35/00623: {of instruments} - G01N 35/00693: {Calibration} - G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G01N 15/01: specially adapted for biological cells, e.g. blood cells (investigating sedimentation of particle suspensions in blood G01N15/05) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract The present disclosure relates to quality control for point-of-care medical diagnostic systems. In various embodiments, the system includes an on-board storage containing a synthetic quality control material, a plurality of sub-systems having a plurality of operating parameters and including a material analyzer, a database storing quality control results that include results of the material analyzer analyzing the synthetic quality control material over time, one or more processors, and at least one memory storing instructions which, when executed by the one or more processors, cause the system to, automatically without user intervention: generate a control chart based on the quality control results, determine that a parameter of the plurality of operating parameters is out-of-tolerance based on the control chart, and adjust at least one of the plurality of sub-systems without user intervention to bring the out-of-tolerance parameter to within tolerance. ## Claims ### Claim 1 A system for point-of-care medical diagnostics, comprising: an on-board storage container storing a consumable synthetic quality control material at room temperature for automatic use by quality control operations over time, the consumable synthetic quality control material configured to provide flow cytometry sensor responses resembling flow cytometry sensor responses for cellular features of blood; a plurality of sub-systems having a plurality of operating parameters, the sub-systems including a flow cytometry hematology analyzer configured to analyze patient samples and to analyze the consumable synthetic quality control material; a database storing quality control results over time, the quality control results including results of the flow cytometry hematology analyzer analyzing the consumable synthetic quality control material over time; one or more processors; and at least one memory storing instructions which, when executed by the one or more processors, cause the system to, automatically without user intervention: perform the automatic quality control operations over time by accessing the consumable synthetic quality control material from the on-board storage container over time and analyzing the consumable synthetic quality control material over time using the flow cytometry hematology analyzer to generate the quality control results over time; store the quality control results in the database over time; generate a control chart based on the quality control results stored in the database; determine that a parameter of the plurality of operating parameters is out-of-tolerance based on the control chart; and adjust at least one of the plurality of sub-systems without user intervention to bring the out-of-tolerance parameter to within tolerance. ### Claim 2 (depends on 1) The system of claim 1, wherein the database further stores previous patient test results, the previous patient test results including results of the flow cytometry hematology analyzer analyzing samples obtained from a plurality of patients over time, wherein the instructions, when executed by the one or more processors, further cause the system to, automatically without user intervention: generate another control chart based on the previous patient test results; determine that another parameter of the plurality of operating parameters is out-of-tolerance based on the another control chart; and adjust at least one sub-system of the plurality of sub-systems without user intervention to bring the another out-of-tolerance parameter to within tolerance. ### Claim 3 (depends on 1) The system of claim 1, wherein the instructions, when executed by the one or more processors, further cause the system to provide a visual indication to an operator regarding an automatic adjustment. ### Claim 4 (depends on 1) The system of claim 1, wherein the instructions, when executed by the one or more processors, further cause the system to, automatically without user intervention: determine that another parameter of the plurality of operating parameters is out-of-tolerance; determine that the another out-of-tolerance parameter requires user intervention to bring the another out-of-tolerance parameter to within tolerance; and provide a visual indication informing an operator that the another parameter is out-of-tolerance. ### Claim 5 (depends on 1) The system of claim 1, wherein the instructions, when executed by the one or more processors, further cause the system to, automatically without user intervention: analyze a blank sample using the flow cytometry hematology analyzer, wherein the flow cytometry hematology analyzer operates on the blank sample in a same manner that the flow cytometry hematology analyzer operates on a patient sample; determine that the flow cytometry hematology analyzer should be cleaned based on the analysis of the blank sample; and provide a visual indication informing an operator that the flow cytometry hematology analyzer should be cleaned. ### Claim 6 (depends on 1) The system of claim 1, wherein the hematology analyzer includes at least one of: a chemistry analyzer, or a coagulation analyzer. ### Claim 7 (depends on 1) The system of claim 1, wherein the plurality of sub-systems includes a fluidics sub-system, an optics sub-system, and an electronics sub-system. ### Claim 8 (depends on 7) The system of claim 7, wherein the plurality of operating parameters include optical density, flow rate, extinction channel (EXT), low angle forward light scatter channel (FSL), right angle scatter channel (RAS), high angle forward light scatter channel (FSH), and time-of-flight channel (TOF). ### Claim 9 A system for point-of-care medical diagnostics, comprising: an on-board storage container storing a consumable synthetic quality control material at room temperature for automatic use by quality control operations over time, the consumable synthetic quality control material configured to provide flow cytometry sensor responses resembling flow cytometry sensor responses for cellular features of blood; a plurality of sub-systems having a plurality of operating parameters, the sub-systems including a flow cytometry hematology analyzer configured to analyze patient samples and to analyze the consumable synthetic quality control material; a database storing data including: quality control results over time, the quality control results including results of the flow cytometry hematology analyzer analyzing the consumable synthetic quality control material over time, previous patient test results, the previous patient test results including results of the flow cytometry hematology analyzer analyzing samples obtained from a plurality of patients over time, and blank sample results over time, the blank sample results including results of the flow cytometry hematology analyzer analyzing blank samples over time; one or more processors; and at least one memory storing instructions which, when executed by the one or more processors, cause the system to, automatically without user intervention: perform the automatic quality control operations over time by accessing the consumable synthetic quality control material from the on-board storage container over time and analyzing the consumable synthetic quality control material over time using the flow cytometry hematology analyzer to generate the quality control results over time; store the quality control results in the database over time; generate at least one control chart based on the quality control results, the previous patient test results, and the blank sample results stored in the database; determine that a parameter of the plurality of operating parameters is out-of-tolerance based on the at least one control chart; and adjust at least one sub-system of the plurality of sub-systems without user intervention to bring the out-of-tolerance parameter to within tolerance. ### Claim 10 (depends on 9) The system of claim 9, wherein the database further stores previous patient test results, the previous patient test results including results of the flow cytometry hematology analyzer analyzing samples obtained from a plurality of patients over time, wherein the instructions, when executed by the one or more processors, further cause the system to, automatically without user intervention: generate another control chart based on the previous patient test results; determine that another parameter of the plurality of operating parameters is out-of-tolerance based on the another control chart; and adjust at least one sub-system of the plurality of sub-systems without user intervention to bring the another out-of-tolerance parameter to within tolerance. ### Claim 11 (depends on 9) The system of claim 9, wherein the instructions, when executed by the one or more processors, further cause the system to provide a visual indication to an operator regarding an automatic adjustment. ### Claim 12 (depends on 9) The system of claim 9, wherein the instructions, when executed by the one or more processors, further cause the system to, automatically without user intervention: determine that another parameter of the plurality of operating parameters is out-of-tolerance; determine that the another out-of-tolerance parameter requires user intervention to bring the another out-of-tolerance parameter to within tolerance; and provide a visual indication informing an operator that the another parameter is out-of-tolerance. ### Claim 13 (depends on 9) The system of claim 9, wherein the instructions, when executed by the one or more processors, further cause the system to, automatically without user intervention: analyze a blank sample using the flow cytometry hematology analyzer, wherein the flow cytometry hematology analyzer operates on the blank sample in a same manner that the flow cytometry hematology analyzer operates on a patient sample; determine that the flow cytometry hematology analyzer should be cleaned based on the analysis of the blank sample; and provide a visual indication informing an operator that the flow cytometry hematology analyzer should be cleaned. ### Claim 14 (depends on 9) The system of claim 9, wherein the hematology analyzer includes at least one of: a chemistry analyzer, or a coagulation analyzer. ### Claim 15 (depends on 9) The system of claim 9, wherein the plurality of sub-systems includes a fluidics sub-system, an optics sub-system, and an electronics sub-system. ### Claim 16 (depends on 15) The system of claim 15, wherein the plurality of operating parameters include optical density, flow rate, extinction channel (EXT), low angle forward light scatter channel (FSL), right angle scatter channel (RAS), high angle forward light scatter channel (FSH), and time-of-flight channel (TOF).