US 12,332,257 B2
Predictive quality control apparatus and methods in diagnostic testing systems
Michael Heydlauf, Cary, NC (US)
Assigned to Siemens Healthcare Diagnostics Inc., Tarrytown, NY (US)
Appl. No. 16/961,982
Filed by Siemens Healthcare Diagnostics Inc., Tarrytown, NY (US)
PCT Filed Feb. 11, 2019, PCT No. PCT/US2019/017458
§ 371(c)(1), (2) Date Jul. 14, 2020,
PCT Pub. No. WO2019/177724, PCT Pub. Date Sep. 19, 2019.
Claims priority of provisional application 62/642,763, filed on Mar. 14, 2018.
Prior Publication US 2021/0081839 A1, Mar. 18, 2021
Int. Cl. G01N 35/00 (2006.01); G06N 5/04 (2023.01); G06N 20/00 (2019.01); G16H 40/40 (2018.01)
CPC G01N 35/00623 (2013.01) [G06N 5/04 (2013.01); G06N 20/00 (2019.01); G16H 40/40 (2018.01); G01N 2035/00653 (2013.01)] 22 Claims
OG exemplary drawing
 
1. A quality control method, comprising:
receiving, at a controller, a quality control test result from a diagnostic analyzer in response to executing a quality control test;
receiving continually, at the controller, before a next quality control test, a plurality of data values related to the diagnostic analyzer, each data value associated with a first set or range of one or more values indicating acceptable analyzer operation and a second set or range of one or more values indicating unacceptable analyzer operation;
analyzing, with a decision module executing in the controller, the quality control test result and the data values related to the diagnostic analyzer to determine whether the quality control test result corresponds with an expected quality control test result and whether each of the data values corresponds with its associated first set or range of one or more values or its associated second set or range of one or more values; and
sending, from the controller to a user interface, a message indicating that the diagnostic analyzer is operating acceptably now and analyzer results received from the diagnostic analyzer are valid but the diagnostic analyzer subsequently may not continue to operate acceptably and subsequent analyzer results may not be valid in response to the decision module determining that the quality control test result corresponds with the expected quality control test result and at least one of the data values is between the first and second sets or ranges of one or more values associated with that at least one of the data values.