Data processing: generic control systems or specific application – Specific application – apparatus or process – Product assembly or manufacturing
Reexamination Certificate
1998-03-31
2001-07-31
Gordon, Paul P. (Department: 2121)
Data processing: generic control systems or specific application
Specific application, apparatus or process
Product assembly or manufacturing
C700S096000, C700S017000, C702S081000
Reexamination Certificate
active
06269276
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to laboratory information management systems of the type wherein one or more automated or partly automated laboratory instruments, for example, instruments for determining the concentrations of medically significant components of samples of body fluids and/or tissues from patients who have submitted such samples for testing, provide information such as identifying indicia and control solution test results to a programmable machine which is programmed to test such results against statistical quality control criteria defined by way of rules.
DESCRIPTION OF THE BACKGROUND ART
Laboratory information management systems are known generally. Some such systems permit the operator to select a rule against which one or a group of such results may be tested. Typically, the way in which this is done is that control solutions having known concentrations of a medically significant component of interest, for example, a hormone, are processed by the laboratory instrument right along with patient samples. The programmable machine then tests the laboratory instrument's concentration determination results against the known concentrations of the hormone in the various controls as determined by the laboratory instrument.
The statistical quality control test, or rule, might be, for example, “Is the reported result for the control solution within one standard deviation of the known concentration?” If the answer to such a test is “Yes,” the laboratory instrument's concentration determination process is considered to be in control, and testing to determine the concentration of the hormone in patient samples proceeds. If the answer to this question is “No,” the laboratory instrument's concentration determination process is considered to be out of control, and appropriate steps are taken to bring the process back into control and/or to retest the affected patient sample concentration determinations to provide more reliable results.
There are various sources of statistical quality control rules. Examples of collections of such rules are the so-called Rilibak rules and the Westgard rules, attributed to Dr. James O. Westgard. Westgard statistical quality control has been implemented manually in the control of processes using Shewhart charts. These statistical quality control strategies, while effective, permitted only off-line, non-real time testing of process results against the statistical quality control rules. What this ordinarily meant in the manufacturing context, for example, is that by the time statisticians became aware that a manufacturing process was out of control, several potentially non-conforming units of manufacture had already been produced. This, of course, typically dictated that further quality checking be performed on suspected non-conforming units of manufacture, and/or corrective action be taken as necessary.
DISCLOSURE OF THE INVENTION
According to an aspect of the invention, a system for analyzing the results of determinations of the concentrations of medically significant components of control solutions comprises a programmable machine, and a program executable on the machine for testing the results against a set of multiple rules and for producing indications to an operator of the results of the tests.
Illustratively according to this aspect of the invention, the system further comprises an instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids and control solutions, and an interface for relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested by the program.
Further illustratively according to this aspect of the invention, the program for testing the results against multiple rules comprises a program for testing a result of a first determination of the concentration of a first medically significant component of a first sample of a first control solution against a first subset of the set of multiple rules, and subsequently testing a result of at least one of: a second determination; the concentration of a second medically significant component; a second sample; and, a second control solution against at least one of the first subset and a second subset of the set of multiple rules.
Additionally illustratively according to this aspect of the invention, the instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids and control solutions comprises an instrument for sequentially determining the concentrations of different medically significant components of samples of different body fluids and different control solutions in response to instructions to determine the concentrations of different medically significant components of samples of different body fluids and different control solutions, and the program comprises a program for instructing the instrument to determine the concentrations of different medically significant components of samples of different body fluids and different control solutions, and the system further comprises an interface for relaying instructions from the programmable machine to the instrument.
Additionally according to this aspect of the invention, the system further comprises a second instrument for sequentially determining the concentrations of medically significant components of multiple samples of body fluids and control solutions, and an interface for relaying the results of determinations by the second instrument to the programmable machine to be tested by the program.
Further illustratively according to this aspect of the invention, the instrument and the second instrument respectively comprise: an instrument for sequentially determining the concentrations of different medically significant components of samples of different body fluids and control solutions in response to instructions to determine the concentrations of different medically significant components of samples of different body fluids and control solutions; and, a second instrument for sequentially determining the concentrations of different medically significant components of samples of different body fluids and control solutions in response to instructions to determine the concentrations of different medically significant components of samples of different body fluids and control solutions, and the program comprises a program for selectively instructing one of the instrument and the second instrument to determine the concentrations of different medically significant components of samples of different body fluids and control solutions, the system further comprising an interface for relaying instructions from the programmable machine to the one of the instrument and the second instrument.
According to another aspect of the invention, a method for analyzing the results of determinations of the concentrations of medically significant components of control solutions comprises the steps of providing a programmable machine, testing the results on the machine against a set of multiple rules, and producing indications to an operator of the results of the tests.
Illustratively according to this aspect of the invention, the method further comprises the step of sequentially determining the concentrations of medically significant components of multiple samples of control solutions and body fluids, and relaying the results of the determinations of the concentrations of the medically significant components of the control solutions to the programmable machine to be tested by the program.
Additionally according to this aspect of the invention, testing the results against multiple rules comprises testing a result of a first determination of the concentration of a first medically significant component of a first sample of a first control solution against a first subset of the set of multiple rules and subsequently testing a result of at least one of: a second determination; the conc
Akhavan Kamran
Rusu Laurian I.
Scarr Gary K.
Simmons Mark J.
Wedel Dale L.
Bahta Kidest
Barnes & Thornburg
Gordon Paul P.
Roche Diagnostics Corporation
LandOfFree
Multi-rule quality control method and apparatus does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Multi-rule quality control method and apparatus, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Multi-rule quality control method and apparatus will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2560484