System for statistical analysis of quality control data

• US 7,027,931 B1
• Filed: 02/26/2001
• Issued: 04/11/2006
• Est. Priority Date: 02/24/2000
• Status: Expired due to Fees

• Current Assignee: Ferraris Group, Inc.
• Original Assignee: Bionostics, Inc.
• Inventors: Jones, Jeffrey A., Balasuryan, Sundar, Hatch, David W., Hallock, Nancy D.
• Primary Examiner(s): Zeman, Mary K.
• Assistant Examiner(s): Skibinsky, Anna
• Application Number:
  US09/793,371
• Time in Patent Office: 1,870 Days
• Field of Search: 422/50, 422/68.1, 422/129, 435/6, 435/7.1, 702/19, 703/11
• US Class Current: 702/19
• CPC Class Codes: G16B 50/00 ICT programming tools or database systems specially adapted for bioinformatics
• CPC Class Codes: G16B 50/30 Data warehousing; Computing architectures
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• 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

Abstract

A statistical database system can improve error checking of quality control data used to measure the performance of quantitative analysis equipment. The quality control data can be delivered to a centralized database, wherein the database is linked to error checking functions. Data delivery can be flexible, allowing input via scanning, operator keyed summary data, operator keyed raw data, analyzer direct download, Internet-delivered summary data and Internet-delivered raw data. The received quality control data can be verified against specific lot and analyzer parameters, and data falling outside of these specified ranges can be excluded from a peer group. Excluded data can be verified against original submitted data, and excluded data can then appear on final reports. The quality control data can also be entered directly into the database and a peer group report can then be generated. The quality control data is processed in real time with the data entry and the reports are viewable in real time.

Claims

1. A computer system for evaluating the performance of a quantitative analyzer relative to a group of quantitative analyzers, the quantitative analyzer capable of measuring the composition of a test analyte having an expected composition, comprising:

a database having stored therein, for a plurality of quantitative analyzers, statistical data for the test analyte, including expected statistical data representing the expected composition of the test analyte;

a computer coupled to the database and to a communication network;

a data collection module in the computer for electronically receiving data from the communication network representing a measured composition of the test analyte from a quantitative analyzer for storage into the database; and

an error checking module in the computer for comparing the received data with the expected composition in real time with the receipt of the received data bv the data collection modules wherein the error checking module includes an error reporting function for reporting, in real time to a remote user over the communication network, received data outside a range of expected data for the expected composition and the error reporting function is capable of receiving a corrected data value from the user for entry storage into the database.

2. The computer system of claim 1, wherein the expected statistical data is specific to a control lot of the test analyte.

3. The computer system of claim 1, wherein the expected statistical data is specific to a particular quantitative analyzer model.

4. The computer system of claim 1, wherein the statistical data includes a mean data value and a standard deviation data value.

5. The computer system of claim 1, wherein the data collection module receives data from a communication network coupled between the computer and the quantitative analyzer.

6. The computer system of claim 5, wherein the received data is electronically transmitted over the communication network by the quantitative analyzer.

7. The computer system of claim 5, wherein the received data is electronically transmitted over the communication network by a remote computer coupled to the quantitative analyzer.

8. The computer system of claim 1, wherein the database has stored therein cumulative statistical data for the quantitative analyzer

9. The computer system of claim 1, further comprising a reporting module for generating query reports.

10. The computer system of claim 9, wherein the reporting module is capable of generating reports based on a peer group selected by a user.

11. The computer system of claim 9, wherein the query report is available in real time.

12. The computer system of claim 11, wherein the query report is accessible over the communication network.

13. A computer system for evaluating the performance of a quantitative analyzer relative to a group of quantitative analyzers, the quantitative analyzer capable of measuring the composition of a test analyte having an expected composition, comprising:

a database having stored therein, for a plurality of quantitative analyzer models, statistical data for a test analyte, including expected statistical data representing the expected chemical composition of the test analyte, the expected statistical data being specific to the quantitative analyzer model and to a control lot of The test analyte;

a computer coupled to the database and to a communication network;

a data collection module in the computer for electronically receiving from the communication network data representing a measured composition of the test analyte from a quantitative analyzer under test for storage into the database;

an error checking module in the computer for comparing the received data with the expected composition in real time with the receipt of the received data by the data collection module, wherein the error checking module includes an error reporting function for reporting, in real time to a remote user over the communication network, received data outside a range of expected data for the expected composition and the error reporting function is capable of receiving a corrected data value for storage into the database; and

a report generation module in the computer for generating reports from the statistical data stored in the database.

14. The computer system of claim 13, wherein the data collection module receives data from a manual user input.

15. The computer system of claim 13, wherein the statistical data includes a mean data value and a standard deviation data value.

16. The computer system of claim 13, wherein the communication network is coupled between the computer and the quantitative analyzer under test.

17. The computer system of claim 16, wherein the received data is electronically transmitted over the communication network by the quantitative analyzer under lest.

18. The computer system of claim 16, wherein the received data is electronically transmitted over the communication network by a remote computer coupled to the quantitative analyzer under test.

19. The computer system of claim 13, wherein the database has stored therein cumulative statistical data for a plurality of quantitative analyzers, including the quantitative analyzer under test.

20. The computer system of claim 13, wherein the reporting module is capable of generating reports based on a peer group selected by a user.

21. The computer system of claim 13, wherein the report is available in real time.

22. The computer system of claim 21, wherein the report is accessible over the communication network.

23. The computer system of claim 13, wherein the error checking module detects a human-induced error in the received data.

24. The computer system of claim 13, wherein the expected composition has a first unit of measure and the measured composition has a second unit of measure.

25. The computer system of claim 24 wherein the error checking module converts the first unit of measure to the second unit of measure and the generated report uses the second unit of measure.

26. A computer-implemented method for evaluating the performance of a quantitative analyzer relative to a group of quantitative analyzers using a test analyte having an expected composition, the quantitative analyzer capable of measuring the composition of the test analyte, comprising:

for a plurality of quantitative analyzers, storing statistical data for a test analyte, including expected statistical data representing the expected composition of the test analyte, in a database;

in a computer coupled to the database and to a communication network;

from the communication network, electronically receiving data representing a measured composition of the test analyte from quantitative analyzer;

comparing the received data with the expected composition and reporting, to a remote user over the communication network, received data outside a range of expected data for the expected composition in real time with the receiving, of the received data; and

receiving a corrected data value for storage into the database.

27. The method of claim 26, wherein the expected statistical data is specific to a control lot of the test analyze.

28. The method of claim 26, wherein the expected statistical data is specific to a particular quantitative analyzer model.

29. The method of claim 26, wherein the statistical data includes a mean data value and a standard deviation data value.

30. The method of claim 26, wherein receiving comprises receiving data from a communication that is coupled between the computer and the quantitative analyzer.

31. The method of claim 30, wherein the received data is electronically transmitted over the communication network by the quantitative analyzer.

32. The method of claim 30, wherein the received data is electronically transmitted over the communication network by a remote computer coupled to the quantitative analyzer.

33. The method of claim 26, wherein storing comprises storing cumulative statistical data for the quantitative analyzer in the database.

34. The method of claim 26, further comprising generating query reports.

35. The method of claim 34, wherein generating query reports comprises generating reports based on a peer group selected by a user.

36. The method of claim 34, wherein the query report is available in real time.

37. The method of claim 36, wherein the query report is accessible over the communication network.

38. A computer-implemented method of evaluating the performance of a quantitative analyzer relative to a group of quantitative analyzers for a test analyte having an expected composition, a quantitative analyzer under test capable of measuring the composition of the test analyte, comprising:

for a plurality of quantitative analyzer models, storing statistical data for a rest analyte in a database, including storing expected statistical data representing the expected composition of the test analyte, the expected statistical data being specific to the quantitative analyzer model and to a control lot of the test analyte;

in a computer coupled to the database and to a communication network;

from the communication network, electronically receiving data representing a measured composition of the test analyte from a quantitative analyzer under test;

comparing the received data with the expected composition in real time with receiving of the received data;

generating reports from the statistical data stored in the database;

reporting to a remote user over the communication network received data outside a range of expected data for the expected composition in real time with the comparing of the received data with the expected composition and

receiving a corrected data value for entry into the database.

39. The method of claim 38, wherein receiving comprises receiving data from a manual user input.

40. The method of claim 38, wherein the statistical data includes a mean data value and a standard deviation data value.

41. The method of claim 38, wherein receiving comprises receiving data from a communication network that is coupled between the computer and the quantitative analyzer under test.

42. The method of claim 41, wherein the received data is electronically transmitted over the communication network by the quantitative analyzer under test.

43. The method of claim 41, wherein the received data is electronically transmitted over the communication network by a remote computer coupled to the quantitative analyzer under test.

44. The method of claim 38, wherein storing comprises storing cumulative statistical data for a plurality of quantitative analyzers, including the quantitative analyzer under test.

45. The method of claim 38, further comprising, in the computer, generating reports based on a peer group selected by a user.

46. The method of claim 38, wherein the report is available in real time.

47. The method of claim 46, wherein the report is accessible over the communication network.

48. The method of claim 38, wherein comparing comprises detecting a human-induced error in the received data.

49. The method of claim 38, wherein the expected composition has a first unit of measure and the measured composition has a second unit of measure.

50. The method of claim 49, wherein comparing comprises converting the first unit of measure to the second unit of measure, and wherein generating comprises using the second unit of measure in the report.

51. An article of manufacture, comprising:

a computer-usable medium;

a set of computer instructions carried on the medium including instructions for a computer-implemented method for evaluating the performance of a quantitative analyzer relative to a group of quantitative analyzers using a test analyte having an expected composition, the quantitative analyzer capable of measuring the composition of the test analyte, the method including instructions to;

for a plurality of quantitative analyzers, store statistical data for a test analyte, including expected statistical data representing the expected composition of the test analyte, in a database,

in a computer coupled to the database and to a communication network;

from the communication network, electronically receive data representing a measured composition of the test analyte from a quantitative analyzer;

in real time with receipt of the received data, compare the received data with the expected composition and reporting to a remote user over the communication network received data outside a range of expected data for the expected composition; and

receive a corrected data value for storage into the database.

52. An article of manufacture, comprising:

a computer-usable medium;

a set of computer instructions carried on the medium, including instructions for a computer-implemented method of evaluating the performance of quantitative analyzer relative to a group of quantitative analyzers for a test analyte having an expected composition, a quantitative analyzer under test capable of measuring the composition of the test analyte the method including instructions to;

for a plurality of quantitative analyzer models, store statistical data for a test analyte in a database, including storing expected statistical data representing the expected composition of the test analyte, the expected statistical data being specific to the quantitative analyzer model and to a control lot of the test analyte;

in a computer coupled to the database and to a communication network;

from the communication network, electronically receive data representing a measured composition of the test analyte from a quantitative analyzer under test;

compare the received data with the expected composition in real time with he receipt of the received data;

generate reports from the statistical data stored in the database;

report to a remote user over the communication network received data outside a range of expected data for the expected composition in real time; and

receive a corrected data value for storage into the database.

53. A computer system for evaluating the performance of a quantitative analyzer relative to a group of quantitative analyzers, the quantitative analyzer capable of measuring the composition of a test analyte having an expected composition, comprising:

a database having stored therein, for a plurality of quantitative analyzers statistical data for a test analyte, including expected statistical data representing the expected composition of the test analyte, the expected statistical data for the test analyte is cumulative over time and capable of being associated with a peer group of the quantitative analyzers;

a computer coupled to the database and to a communication network;

a data collection module in the computer for electronically receiving from the communication network data representing a measured composition of the test analyte from a quantitative analyzer for storage into the database; and

an error checking module in the computer and responsive to the data collection module for comparing the received data with the expected statistical data of the expected composition in real time and excluding the received data from association with the peer group of the quantitative analyzers if the received data is outside a range of expected data for the expected composition, wherein the error checking module includes an error reporting function for reporting to a remote user, over the communication network in real time, received data outside the range of expected data for the expected composition.