公开(公告)号：US20190120865A1

公开(公告)日：2019-04-25

申请号：US16228597

申请日：2018-12-20

Applicant: Bio-Rad Laboratories, Inc.

Inventor： John Christopher Yundt-Pacheco ,  Lakshmi Kuchipudi ,  Curtis Alan Parvin

IPC: G01N35/00 ,  G16H50/30

Abstract: 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(Nuf) due to a test system failure. The value of E(Nuf) 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.

公开(公告)号：US11579155B2

公开(公告)日：2023-02-14

申请号：US16228597

申请日：2018-12-20

Applicant: Bio-Rad Laboratories, Inc.

Inventor： John Christopher Yundt-Pacheco ,  Lakshmi Kuchipudi ,  Curtis Alan Parvin

IPC: G16H50/30 ,  G16H10/40 ,  G16H20/10 ,  G01N35/00 ,  G16Z99/00

Abstract: 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(Nuf) due to a test system failure. The value of E(Nuf) 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.

公开(公告)号：US10161947B2

公开(公告)日：2018-12-25

申请号：US14702019

申请日：2015-05-01

Applicant: Bio-Rad Laboratories, Inc.

Inventor： John Christopher Yundt-Pacheco ,  Lakshmi Kuchipudi ,  Curtis Alan Parvin

IPC: G01N35/00 ,  G16H50/30 ,  G06F19/00

Abstract: 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(Nuf) due to a test system failure. The value of E(Nuf) 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.

公开(公告)号：US20160320420A1

公开(公告)日：2016-11-03

申请号：US14702019

申请日：2015-05-01

Applicant: Bio-Rad Laboratories, Inc.

Inventor： John Christopher Yundt-Pacheco ,  Lakshmi Kuchipudi ,  Curtis Alan Parvin

IPC: G01N35/00

CPC classification number: G01N35/00623 ,  G06F19/00 ,  G06F19/36 ,  G16H50/30

Abstract: 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(Nuf) due to a test system failure. The value of E(Nuf) 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.

Abstract translation: 公开了用于分析用于测试分析物的质量控制（QC）策略的方法，装置和系统，以便满足可能由不正确的测试结果导致的可接受的患者伤害概率。 患者伤害的测量考虑到患者伤害的严重程度及其发生。 方法包括根据QC策略和测试设备的参数计算由于测试系统故障导致的不正确的最终结果E（Nuf）的预期数量。 E（Nuf）的值可以用作预测患者危害概率水平的计算的一部分。 患者伤害概率的可接受水平与预测的患者危害概率水平的比例可以确定QC策略的适当性。