G01N35/00623

Using patient risk in analysis of quality control strategy for lab results

Methods, apparatuses, and systems are disclosed for analyzing quality control (QC) strategies that are applied to testing processes an analyte in order to meet an acceptable level of probability of patient harm that could result from incorrect test results. The measure of patient harm takes into account severity of patient harm, as well as its occurrence. Methods include calculating, based on the parameters of the QC strategies and the test apparatus, an expected number of incorrect final results E(N.sub.uf) due to a test system failure. The value of E(N.sub.uf) can be used as part of a calculation of a predicted level of probability patient harm. The ratio of the acceptable level of probability of patient harm to the predicted level of probability patient harm can determine the adequacy of the QC strategies.

Systems and methods of efficiently performing biological assays

An automated laboratory system for processing biological samples in a batch type manner is disclosed. In one embodiment, the system may receive assay instructions for biological samples processing among a plurality of devices. The devices may include a pre-analytical instrument and one or more analysis systems. The system may include an orchestration core application for determining an order of performance for the assays ordered for the samples.

Lab instrument status monitoring

A dashboard interface may be displayed on a lab instrument to provide aggregate status information from a plurality of other interfaces organized into a single interface. The aggregate status information may be viewed by a nearby user of the lab instrument, and selecting portions of the information via a touchscreen display will navigate directly to a subsequent interface that may be used to view additional information or make configuration changes relating to the selected information. The dashboard may be used as a screensaver on a lab instrument when the instrument is not in use, or may be navigated to by an active user of a lab instrument, or both.

SAMPLE TESTING METHODS WITH AUTOMATED CLEANING
20180003617 · 2018-01-04 ·

A sample testing system includes a test receptacle support structure, an optical element positioned for transmitting electromagnetic radiation emitted or reflected by a sample disposed in a test receptacle supported by the test receptacle support structure, a cleaning member, and an automated transport arm configured to (i) detachably couple the cleaning member, (ii) move the detachably-coupled cleaning member into a position proximate to and/or contacting the optical element, and (iii) decouple the cleaning member.

METHODS, SYSTEMS, AND COMPUTER PROGRAM PRODUCTS FOR VERIFYING DISPENSING OF A FLUID FROM A PIPETTE

This invention relates to methods, systems, and computer program products for verifying dispensing of a fluid from a pipette.

QUALITY CONTROL FOR POINT-OF-CARE DIAGNOSTIC SYSTEMS
20230003633 · 2023-01-05 ·

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.

METHOD FOR DETECTING AND REPORTING AN OPERATION ERROR IN AN IN-VITRO DIAGNOSTIC SYSTEM AND AN IN-VITRO DIAGNOSTIC SYSTEM
20230229541 · 2023-07-20 ·

The present disclosure refers to a method for detecting and reporting an operation error in an in-vitro diagnostic system (1) for determining a sample of a bodily fluid, comprising: providing a plurality of sample vessels (2) each containing a sample of a bodily fluid; and providing a plurality of functional modules (3), comprising an analysis device (4) configured to determine the sample, a handling system (5) configured to handle the plurality of sample vessels (2), and an automation track (6) provided by the handling system (5) and configured to transport the plurality of sample vessels (2) to the analysis device (4). The method further comprises: providing an operation control device (7) connected to at least one of the functional modules (3) and configured to control operation of the at least one functional module (3), and comprising one or more data processors (8), wherein an application software is running on the one or more data processors (8) for controlling operation of the at least one functional module (3); controlling operation of the at least one functional module (3) by the operation control device (7); and detecting and reporting an operation error by an error detecting and reporting device (9), comprising: detecting the operating error for the operation of at least one of the plurality of functional modules (3) and the operation control device (7), providing error data indicative of the operation error, receiving a user input through a user interface (10) after detecting the operation error, providing labelling data in response to receiving the user input, the labelling data being indicative of information related to the operating error in addition to the error data, providing error report data comprising the error data and the labelling data, and transmitting the error report data to an error repository (11) remotely located with respect to both the plurality of functional modules (3) and the operation control device (7); receiving the error report data in a machine learning process running in a data processing device connected to the error repository (11); processing the error report data by the machine learning process in the data processing device; providing a application software update for the application software in response to the processing of the error report data by the machine learning process in the data processing device; providing the application software update to the operation control device (7); and controlling operation of the at least

DEVICE AND METHOD FOR MONITORING RINSING PROCESSES
20230228775 · 2023-07-20 ·

A device and a method for monitoring rinsing or flushing processes of parts in automated analyser systems like diagnostic instruments that participate in the handling of liquids.

DIAGNOSTIC ANALYZERS AND QUALITY CONTROL METHODS
20230009309 · 2023-01-12 · ·

A quality control method for a diagnostic analyzer includes performing a quality control test or a plurality of specimen tests; determining, with a controller, that a result of the quality control test or a plurality of specimen test results is outside of a threshold; monitoring one or more mechanical devices of the diagnostic analyzer with the controller; receiving, by the controller, an error code indicating an error in a mechanical device of the one or more mechanical devices; and initiating a calibration procedure in response to the result of the quality control test or the plurality of specimen test results being outside of the threshold and receiving the error code. Other apparatus and methods are disclosed.

Specimen processing system

A specimen processing system 100 which performs preprocessing and analysis of a specimen includes sensors 5a, 5b, . . . each detecting a driving state of a driving device installed in the system, an abnormality detecting part 3a determining from signal waveforms detected by the sensors 5a, 5b, . . . whether an abnormality occurs in the driving device, and a recording device sequentially recording the signal waveforms detected by the sensors 5a, 5b, . . . and storing a sensor signal waveform before or after the occurrence of an operation abnormality into an unerasable area when the abnormality is determined to have occurred in the abnormality detection part 3a. Consequently, there is provided a specimen processing system capable of realizing restoration from the time of the occurrence of an abnormality faster than in the past.