METHOD AND APPARATUS FOR CALIBRATION AND TESTING OF SCIENTIFIC MEASUREMENT EQUIPMENT

• US 20110022343A1
• Filed: 07/21/2010
• Published: 01/27/2011
• Est. Priority Date: 07/21/2009
• Status: Active Grant

• Current Assignee: George S. Cembrowski
• Original Assignee: George S. Cembrowski
• Inventors: Cembrowski, George S.
• Granted Patent: US 8,538,727 B2
• Time in Patent Office: Days
• US Class Current: 702/85
• CPC Class Codes: G01N 2035/00653 statistical methods comparing labs or apparatuses
• CPC Class Codes: G01N 2035/0094 optimisation; experiment design
• CPC Class Codes: G01N 35/00613 Quality control
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records

Abstract

There is described herein method and apparatus to produce precision profiles for scientific measurement equipment in general, and in particular clinical laboratory analyzers, and to use those profiles for various purposes in using, designing, calibrating and managing such equipment, for example to carry out critical laboratory testing. In this approach, either the analyzers'"'"' quality control data or serial patient data are numerically reduced to generate graphical precision profiles. Precision profiles for serial patient data show increased (im)precision vs time implying increased patient variation over increased time. Precision profiles for quality control data, according to one implementation, can demonstrate three different zones: 1) increased imprecision for quality control determinations that are close spaced (implies the discovery of an error condition and rapid reanalysis, 2) the usual imprecision and 3) a zone of increased imprecision which indicates either a need for a quality control analysis or re-calibration.

Claims

1. A method for use and calibration of a laboratory analyzer comprising:

using the analyzer to analyze a series of samples for one or more patients to produce corresponding test results;

wherein the analyzer includes at least one central processing unit and a memory including a computer program stored in the memory and executed in the central processing unit to process digital information representing physical characteristics of the samples being analyzed;

use the test results to generate a precision profile for serial patient data from the analyzer, wherein the precision profile includes a graph displayed to a user on a display device; and

calibrating the laboratory analyzer by adjusting calibration inputs of the laboratory analyzer in response to information obtained from viewing the precision profile.

2. A method according to claim 1 further wherein the precision profile comprises a graph that includes at least one of the three different visually depicted zones indicating:

1) increased imprecision for quality control determinations that are close spaced (implies the discovery of an error condition and rapid reanalysis),

     2) the usual imprecision and

     3) a zone of increased imprecision which indicates either a need for a quality control analysis or re-calibration.

3. Apparatus comprising:

an analyzer for analyzing biological samples wherein the analyzer includes one or more software programs operable on a computing device including a central processing unit to perform a computer process capable of determining a precision profile for the analyzer based on a series of samples for one or more patients, the precision profile represented by a set of profile data and stored in a memory in the analyzer;

wherein the analyzer includes at least one central processing unit and a memory including a computer program stored in the memory and executed in the central processing unit to process digital information representing physical characteristics of the samples being analyzed; and

wherein the one or more software programs are executed by the computing device'"'"'s central processing unit to further adjust the calibration of the analyzer in response to data obtained or derived from the precision profile data.

4. Apparatus according to claim 3 further wherein the precision profile comprises a graph that includes at least one of the three different visually depicted zones indicating:

1) increased imprecision for quality control determinations that are close spaced (implies the discovery of an error condition and rapid reanalysis),

     2) the usual imprecision and

     3) a zone of increased imprecision which indicates either a need for a quality control analysis or re-calibration.