US 12,461,115 B2
Computerized method and laboratory equipment for fast detection of failure in laboratory equipment
Friedemann Krause, Penzberg (DE); and Ruediger Laubender, Pullach im Isartal (DE)
Assigned to Roche Diagnostics Operations, Inc., Indianapolis, IN (US)
Filed by Roche Diagnostics Operations, Inc., Indianapolis, IN (US)
Filed on Dec. 8, 2021, as Appl. No. 17/643,260.
Application 17/643,260 is a continuation of application No. PCT/EP2020/065479, filed on Jun. 4, 2020.
Claims priority of application No. 19180020 (EP), filed on Jun. 13, 2019.
Prior Publication US 2022/0099690 A1, Mar. 31, 2022
Int. Cl. G01N 35/00 (2006.01); G05B 23/02 (2006.01); G16H 10/40 (2018.01); G16H 40/40 (2018.01)
CPC G01N 35/00623 (2013.01) [G05B 23/0235 (2013.01); G16H 10/40 (2018.01); G16H 40/40 (2018.01); G01N 2035/00653 (2013.01)] 16 Claims
OG exemplary drawing
 
1. A computer-implemented method for determining out-of-control failures in laboratory equipment to efficiently improve safety for one or more patients, the method comprising:
a) receiving a desired probability of false rejection (P̌fr) and a desired error detection rate ED relating to one or more QC levels (J) of quality control (QC) samples to be processed by the laboratory equipment, wherein the laboratory equipment is structured to perform multiple different types of diagnostic tests and to test a particular substance of a patient's sample;
b) setting a number of runs (R) to one;
c) calculating an error detection rate (ÊD) based at least partially on R;
d) determining if ÊD is below ĚD, and
if so:
increase R by one, and repeat steps c) to d), and
if not:
define a rule for determining out-of-control failures in the laboratory equipment based, at least partially, on R;
e) receiving or collecting standardized QC results by operating the laboratory equipment structured to perform multiple different types of diagnostic tests, on R runs of QC samples, wherein the R runs of the QC samples is less than a quantity of runs required under Westgard rules to obtain standardized QC results;
f) applying the rule defined in step d) to the standardized QC results;
g) determining if out-of-control failures exist in the laboratory equipment that is structured to perform multiple different types of diagnostic tests based on determining whether the standardized QC results generated from the R runs of QC samples comply with the rule; and
interrupting a measurement process of samples to be processed by the laboratory equipment in response to determining, in step g), that an out-of-control failure exists in the laboratory equipment to efficiently improve safety for one or more patients associated with the samples in a bracket of a bracketed quality control system based on less than the quantity of runs required under Westgard rules.