US 12,374,448 B2
Quality control for point-of-care diagnostic systems
Jeremy Hammond, Standish, ME (US); Timothy Butcher, Windham, ME (US); Jui Ming Lin, Falmouth, ME (US); and James Russell, North Yarmouth, ME (US)
Assigned to IDEXX LABORATORIES, INC., Westbrook, ME (US)
Filed by IDEXX Laboratories, Inc., Westbrook, ME (US)
Filed on Jan. 29, 2024, as Appl. No. 18/425,540.
Application 18/425,540 is a continuation of application No. 17/941,562, filed on Sep. 9, 2022, granted, now 11,887,727.
Application 17/941,562 is a continuation of application No. 16/368,929, filed on Mar. 29, 2019, granted, now 11,441,997, issued on Sep. 13, 2022.
Claims priority of provisional application 62/650,609, filed on Mar. 30, 2018.
Prior Publication US 2024/0170141 A1, May 23, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 40/40 (2018.01); G01N 15/01 (2024.01); G01N 15/14 (2024.01); G01N 15/1429 (2024.01); G01N 35/00 (2006.01); G16H 10/40 (2018.01); G16H 50/20 (2018.01)
CPC G16H 40/40 (2018.01) [G01N 15/1425 (2013.01); G01N 15/1429 (2013.01); G01N 35/00623 (2013.01); G01N 35/00693 (2013.01); G16H 10/40 (2018.01); G16H 50/20 (2018.01); G01N 15/01 (2024.01)] 16 Claims
OG exemplary drawing
 
1. A method for operating a system for point-of-care medical diagnostics, the system 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 or chemical 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; and
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;
the method comprising, automatically without user intervention:
performing 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;
storing the quality control results in the database over time;
generating a control chart based on the quality control results stored in the database;
determining that a parameter of the plurality of operating parameters is out of tolerance based on the control chart; and
adjusting at least one of the plurality of sub-systems without user intervention to bring the out-of-tolerance parameter to within tolerance.