Inter-laboratory performance monitoring system

• US 5,835,384 A
• Filed: 06/10/1996
• Issued: 11/10/1998
• Est. Priority Date: 07/08/1994
• Status: Expired due to Fees

• Current Assignee: Medical Analysis Systems, Inc. (Thermo Fisher Scientific Incorporated)
• Original Assignee: Dade International, Inc. (Siemens AG)
• Inventors: Lin, Lawrence I-kuei
• Primary Examiner(s): Cosimano, Edward R.
• Assistant Examiner(s): Shah, Kamini S.
• Application Number:
  US08/661,208
• Time in Patent Office: 883 Days
• Field of Search: 364/552, 364/554, 364/550, 364/571.01-571.08, 364/582, 364/138, 264/468
• US Class Current: 702/84
• CPC Class Codes: G01N 2035/00653 statistical methods comparing labs or apparatuses
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G01N 35/00603 Reinspection of samples
• CPC Class Codes: G01N 35/00712 Automatic status testing, e.g. at start-up or periodic
• CPC Class Codes: G01N 35/00871 Communications between instruments or with remote terminals
• CPC Class Codes: G05B 19/41875 characterised by quality surveillance of production
• CPC Class Codes: G05B 2219/31392 Lims laboratory information and management system
• CPC Class Codes: G05B 2219/32187 Correlation between controlling parameters for influence on quality parameters
• CPC Class Codes: G08C 25/00 Arrangements for preventing or correcting errors; Monitoring arrangements
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: Y02P 90/02 Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]

Abstract

A system and method for producing quality control evaluation information for each instrument in a large group of instruments making up a peer group which periodically (such as daily) run a set of control samples from a common lot of control materials. The control data from all instruments is reported electronically to a central station which collects all of the data and stores it along with identification information. The central station selects a golden peer group of the instruments which meet certain minimum operating criteria, and determines control targets from the golden peer group using techniques which assure horizontal and vertical robustness, so as to eliminate the need for any manual editing of the control data. A concordance correlation coefficient is determined for each instrument against the control targets, with the CCC covering an interval (such as a month). The distribution of CCC'"'"'s for all instruments in the peer group is determined, and each instrument is rated with respect to the distribution. The CCC evaluation is also used to select the golden peer group for the next interval.

Claims

1. A method of reporting quality control ratings for instruments in a peer group of instruments performing the same analysis, in which the peer group of instruments periodically performs the analysis on known calibration samples to produce control readings which are reported to a central station for processing, the method comprising the steps of

(a) determining and reporting for a given one of said instruments a concordance correlation coefficient CCC comprising a single number representative of accuracy and repeatability of the control readings for the given instrument compared against targets determined from a golden peer group selected as a subset of the best performing instruments in the peer group, and

(b) weighting the concordance correlation co-efficient for the given station against the entire peer group by determining and reporting the value and distribution of CCC'"'"'s for all instruments in peer group.

2. The method of claim 1 in which the step (a) is based on comparison of control readings for the given instrument and targets from the golden peer group performed on a periodic basis, and the step (a) determines and reports a single CCC for the given station based on comparisons for n periods where n is an integer greater than 1.

3. The method of claim 2 wherein the period is approximately daily, and n is selected to produce and store monthly reports.

4. The method of claim 3 wherein the step (a) of determining and reporting is performed daily and a "current" period is reported based on comparisons for the most recent m days.

5. The method of claim 3 wherein the steps of reporting reports both monthly comparisons and on comparisons for the last m days.

6. The method of claim 1 in which the step (a) of reporting also reports information on the correlation comparisons of the periodic control readings against the targets.

7. The method of claim 5 in which the step (a) of reporting also reports information on the correlation comparisons of the periodic control readings against the targets for the last m days.

8. In a system for storing and reporting quality control ratings for an instrument in a peer group of instruments performing the same test, and in which the instruments perform periodic tests on a control sample to produce control readings and report the control readings to a central station, the system including memory locations and a processor for determining and storing information comprising

(a) periodic concordance comparisons of the control data for the given instrument against targets determined from a golden peer group selected from the best performing instruments in the peer group,

(b) cumulative concordance ratings for n periods in which a concordance correlation coefficient CCC uses a single number to indicate accuracy and repeatability of the given instrument against the golden peer group targets over an interval of n periods, and

(c) the value and statistical distribution of CCC'"'"'s of all instruments in the peer group for the same interval of n periods.

9. The system of claim 8 in which the cumulative rates are based on comparison of control readings-for the given instrument and targets from the golden peer group performed on a periodic basis to report a single CCC for the given station based on comparisons for n periods, where n is an integer greater than 1.

10. The system of claim 9 wherein the period is approximately daily, and n is selected to produce and store monthly reports.

11. The system of claim 10 wherein the periodic concordance comparisons are performed daily and a "current" period is reported based on comparisons for the most recent m days.

12. The system of claim 11 wherein the memory stores information for both monthly comparisons and for comparisons for the last m days.

13. The system of claim 12 in which the memory stores information on the correlation comparisons of the periodic control readings against the targets for the last m days.