System and method to determine sigma of a clinical diagnostic process

• US 8,589,081 B2
• Filed: 07/24/2009
• Issued: 11/19/2013
• Est. Priority Date: 07/24/2009
• Status: Active Grant

• Current Assignee: Bio-Rad Laboratories Incorporated
• Original Assignee: Bio-Rad Laboratories Incorporated
• Inventors: Yundt-Pacheco, John, Parvin, Curtis
• Primary Examiner(s): Lau, Tung S
• Assistant Examiner(s): SUN, XIUQIN
• Application Number:
  US12/508,718
• Publication Number:
  US 20110022323A1
• Time in Patent Office: 1,579 Days
• Field of Search: 702/19, 436/89, 600/300, 600/310
• US Class Current: 702/19
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A system and method for determining a sigma of a clinical diagnostic process are disclosed. Specimen data are collected from a plurality of laboratory instruments. The specimen data are evaluated to determine a concentration and an analytical standard deviation for each data point. A clinical diagnostic process is run and patient analyte values are acquired, and a standard deviation is assigned to each patient analyte value based on the standard deviation of specimen data having a corresponding concentration. A single sigma-metric is computed based on the patient analyte assigned standard deviations, the sigma-metric representing the sigma of the clinical diagnostic process. The computed sigma-metric is reported to a user or laboratory manager.

Claims

1. A computer-implemented method of determining sigma of a clinical diagnostic process, comprising:

acquiring specimen data from a plurality of laboratory instruments;

evaluating said specimen data and determining an analytical standard deviation for a plurality of said specimen data, wherein said analytical deviation corresponds to analytical imprecision in said evaluation;

acquiring patient analyte values;

assigning a standard deviation to said patient analyte values based on said specimen data analytical standard deviations;

computing a single sigma-metric from said assigned standard deviations, wherein said single sigma-metric defines a number of process standard deviations said clinical diagnostic process can experience while remaining within allowable tolerance limits, said sigma-metric representing a sigma for said clinical diagnostic process; and

reporting said sigma-metric to a user of at least one of said plurality of laboratory instruments.

2. The computer-implemented method of claim 1, wherein said evaluating said specimen data comprises:

identifying a concentration of each of said specimen data;

selecting a representative specimen data for specimen data having similar concentrations;

compiling a series of data comprising a plurality of specimen data having dissimilar concentrations; and

determining a standard deviation for each specimen data within said series of data.

3. The computer-implemented method of claim 1, wherein said assigning a standard deviation to said patient analyte values comprises:

determining a concentration of each of said patient analyte values;

comparing said concentrations of said patient analyte values to concentrations of said specimen data; and

assigning a standard deviation to said patient analyte values from specimen data having a corresponding concentration.

4. The computer-implemented method of claim 3, wherein assigning a standard deviation comprises:

matching a concentration of said specimen data to a concentration of said patient analyte value and assigning said specimen data standard deviation to said patient analyte value;

interpolating a standard deviation for a patient analyte concentration falling between two specimen data concentrations;

extrapolating a standard deviation for a patient analyte concentration falling below or above the lowest or highest, respectively, specimen data concentrations; and

combinations thereof.

5. The computer-implemented method of claim 1, wherein said computing a single sigma-metric comprises:

applying an averaging function to said patient value assigned standard deviations to determine an estimated standard deviation for said clinical process; and

dividing a total allowable error for said clinical process by said estimated standard deviation to determine a sigma-metric.

6. The computer-implemented method of claim 5, wherein said averaging function comprises calculating an arithmetic mean of said patient value assigned standard deviations.

7. The computer-implemented method of claim 5, wherein said averaging function comprises calculating an arithmetic median of said patient value assigned standard deviations.

8. The computer-implemented method of claim 5, wherein said total allowable error includes a correction for bias.

9. The computer-implemented method of claim 1, wherein said specimen data comprises data collected over an extended period of time.

10. The computer-implemented method of claim 9, wherein said extended period of time is greater than one year.

11. The computer-implemented method of claim 1, wherein said reporting comprises generating an alert, providing a written report, providing an electronic report, transmitting data, and combinations thereof.

12. A computer-implemented method of determining sigma of a clinical diagnostic process, comprising:

acquiring specimen data from a plurality of laboratory instruments;

evaluating said specimen data and identifying a series of data corresponding to specimens having dissimilar concentrations;

determining an analytical standard deviation for each of said dissimilar concentrations in said series of data, wherein said analytical deviation corresponds to analytical imprecision in said evaluating;

computing a single sigma-metric from said analytical standard deviations, wherein said single sigma-metric defines a number of process standard deviations said clinical diagnostic process can experience while remaining within allowable tolerance limits; and

reporting said sigma-metric to a user of at least one of said plurality of laboratory instruments.

13. The computer-implemented method of claim 12, wherein said assigning a standard deviation to said patient analyte values comprises:

determining a concentration of each of said patient analyte values;

comparing said concentrations of said patient analyte values to concentrations of said specimen data; and

assigning a standard deviation to said patient analyte values from specimen data having a corresponding concentration.

14. The computer-implemented method of claim 12, wherein said computing a single sigma-metric comprises:

applying an averaging function to said patient value assigned standard deviations to determine an estimated standard deviation for said clinical process; and

dividing a total allowable error for said clinical process by said estimated standard deviation to determine a sigma-metric.

15. The computer-implemented method of claim 14, wherein said total allowable error includes a correction for bias.

16. A system for determining sigma of a clinical diagnostic process, comprising:

a plurality of laboratory instruments implementing a clinical diagnostic process and operable to acquire data related to that process; and

a computer system operable to communicate with and receive data from said plurality of laboratory instruments, said computer system having a processor operable to;

acquire specimen data from said laboratory instruments;

evaluate said specimen data and determine an analytical standard deviation for a plurality of said specimen data, wherein said analytical deviation corresponds to analytical imprecision in said evaluation;

acquire patient analyte values from said laboratory instruments;

assign a standard deviation to said patient analyte values based on said specimen data analytical standard deviations; and

compute a single sigma-metric from said assigned standard deviations, wherein said single sigma-metric defines a number of process standard deviations said clinical diagnostic process can experience while remaining within allowable tolerance limits, said sigma-metric representing a sigma for said clinical diagnostic process.

17. The system of claim 16, wherein evaluating said specimen data comprises:

identifying a concentration of each of said specimen data;

selecting a representative specimen data for specimen data having similar concentrations;

compiling a series of data comprising a plurality of specimen data having dissimilar concentrations; and

determining a standard deviation for each specimen data within said series of data.

18. The system of claim 16, wherein assigning a standard deviation to said patient analyte values comprises:

determining a concentration of each of said patient analyte values;

comparing said concentrations of said patient analyte values to concentrations of said specimen data; and

assigning a standard deviation to said patient analyte values from specimen data having a corresponding concentration.

19. The system of claim 18, wherein assigning a standard deviation comprises:

matching a concentration of said specimen data to a concentration of said patient analyte value and assigning said specimen data standard deviation to said patient analyte value;

interpolating a standard deviation for a patient analyte concentration falling between two specimen data concentrations;

extrapolating a standard deviation for a patient analyte concentration falling below or above the lowest or highest, respectively, specimen data concentrations; and

combinations thereof.

20. The system of claim 16, wherein computing a single sigma-metric comprises:

applying an averaging function to said patient value assigned standard deviations to determine an estimated standard deviation for said clinical process; and

dividing a total allowable error for said clinical process by said estimated standard deviation to determine a sigma-metric.

21. The system of claim 20, wherein said averaging function comprises calculating an arithmetic mean of said patient value assigned standard deviations.

22. The system of claim 21, wherein said averaging function comprises calculating an arithmetic median of said patient value assigned standard deviations.

23. The system of claim 20, wherein said total allowable error includes a correction for bias.

24. A computer-readable medium having computer-executable instructions for performing a method of determining sigma of a clinical diagnostic process, the method comprising:

acquiring specimen data from a plurality of laboratory instruments;

evaluating said specimen data and determining an analytical standard deviation for a plurality of said specimen data, wherein said analytical deviation corresponds to analytical imprecision in said evaluation;

acquiring patient analyte values;

assigning a standard deviation to said patient analyte values based on said specimen data analytical standard deviations;

computing a single sigma-metric from said assigned standard deviations, wherein said single sigma-metric defines a number of process standard deviations said clinical diagnostic process can experience while remaining within allowable tolerance limits, said sigma-metric representing a sigma for said clinical diagnostic process; and

reporting said sigma-metric to a user of at least one of said plurality of laboratory instruments.

25. The computer-readable medium of claim 24, wherein said evaluating said specimen data comprises:

identifying a concentration of each of said specimen data;

selecting a representative specimen data for specimen data having similar concentrations;

compiling a series of data comprising a plurality of specimen data having dissimilar concentrations; and

determining a standard deviation for each specimen data within said series of data.

26. The computer-readable medium of claim 24, wherein said assigning a standard deviation to said patient analyte values comprises:

determining a concentration of each of said patient analyte values;

comparing said concentrations of said patient analyte values to concentrations of said specimen data; and

assigning a standard deviation to said patient analyte values from specimen data having a corresponding concentration.

27. The computer-readable medium of claim 26, wherein assigning a standard deviation comprises:

matching a concentration of said specimen data to a concentration of said patient analyte value and assigning said specimen data standard deviation to said patient analyte value;

interpolating a standard deviation for a patient analyte concentration falling between two specimen data concentrations;

extrapolating a standard deviation for a patient analyte concentration falling below or above the lowest or highest, respectively, specimen data concentrations; and

combinations thereof.

28. The computer-readable medium of claim 24, wherein said computing a single sigma-metric comprises:

applying an averaging function to said patient value assigned standard deviations to determine an estimated standard deviation for said clinical process; and

dividing a total allowable error for said clinical process by said estimated standard deviation to determine a sigma-metric.

29. The computer-readable medium of claim 28, wherein said averaging function comprises calculating an arithmetic mean of said patient value assigned standard deviations.

30. The computer-readable medium of claim 28, wherein said averaging function comprises calculating an arithmetic median of said patient value assigned standard deviations.

31. The computer-readable medium of claim 28, wherein said total allowable error includes a correction for bias.

32. The computer-readable medium of claim 24, wherein said specimen data comprises data collected over an extended period of time.

33. The computer-readable medium of claim 32, wherein said extended period of time is greater than one year.

34. The computer-readable medium of claim 24, wherein said reporting comprises generating an alert, providing a written report, providing an electronic report, transmitting data, and combinations thereof.