System and method for integrating the internal and external quality control programs of a laboratory

• US 20040220761A1
• Filed: 05/02/2003
• Published: 11/04/2004
• Est. Priority Date: 05/02/2003
• Status: Active Grant

• Current Assignee: Bio-Rad Laboratories Incorporated
• Original Assignee: Bio-Rad Laboratories Incorporated
• Inventors: Yundt-Pacheco, John
• Granted Patent: US 7,467,054 B2
• Time in Patent Office: Days
• US Class Current: 702/84
• CPC Class Codes: G01D 18/00 Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A system and method that enables a laboratory to integrate its internal and external quality control programs to thereby control the quality of its laboratory testing services. The system comprises a storage device and a processor operable to maintain in the storage device a database identifying a plurality of laboratory tests and the corresponding internal laboratory statistical data, group statistical summary data and control rules. The processor is also operable to calculate a control range for a specified laboratory test by applying the group statistical summary data (and, in some cases, the internal laboratory statistical data) to the control rule corresponding to the specified laboratory test. Preferably, the processor is also operable to receive a test result from a laboratory instrument, and determine whether the test result falls within the calculated control range for the specified laboratory test. Various exemplary embodiments of the system and associated method are provided.

Claims

1. A system for integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, comprising:

at least one storage device;

at least one processor operable to;

maintain in the storage device at least one database identifying a plurality of laboratory tests and corresponding group statistical summary data, the database also identifying the plurality of laboratory tests data and corresponding control rules; and

calculate a control range for a specified one of the laboratory tests by applying the group statistical summary data for the specified laboratory test to the control rule for the specified laboratory test.

2. The system of claim 1, wherein the storage device and the processor are located at a laboratory.

3. The system of claim 1, wherein the storage device and the processor comprise a central storage device and a central processor, respectively, located at a central agency.

4. The system of claim 1, wherein the group statistical summary data is selected from the following group:

a mean, a median, a standard deviation, a coefficient of variation, a standard deviation index, a coefficient of variation index, and combinations thereof.

5. The system of claim 1, wherein the database also identifies the plurality of laboratory tests and corresponding internal laboratory statistical data, and wherein the processor is operable to calculate the control range for the specified one of the laboratory tests by applying both the group statistical summary data for the specified laboratory test and the internal laboratory statistical data for the specified laboratory test to the control rule for the specified laboratory test.

6. The system of claim 1, wherein the processor is further operable to receive updated group statistical summary data from a central agency and transfer the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data.

7. The system of claim 6, wherein the updated group statistical summary data received from the central agency is derived from testing carried out by a specified group of laboratory instruments.

8. The system of claim 6, wherein the processor receives the updated group statistical summary data from the central agency over the Internet.

9. The system of claim 6, wherein the processor is operable to transfer the updated group statistical summary data received from the central agency to the database prior to calculating the control range for the specified one of the laboratory tests.

10. The system of claim 6, wherein the processor receives the updated group statistical summary data from the central agency in response to a synchronization command.

11. The system of claim 6, wherein the processor receives the updated group statistical summary data from the central agency at a specified date and time.

12. The system of claim 1, wherein the processor is further operable to:

receive a test result from a laboratory instrument for the specified one of the laboratory tests; and

determine whether the test result falls within the calculated control range for the specified laboratory test.

13. The system of claim 12, wherein the processor is further operable to transmit the test result to a central agency.

14. The system of claim 1, further comprising:

at least one central storage device;

at least one central processor operable to;

maintain in the central storage device at least one central database identifying the plurality of laboratory tests and corresponding updated group statistical summary data; and

transmit the updated group statistical summary data to the processor.

15. The system of claim 14, wherein the central storage device and the central processor are located at a central agency.

16. The system of claim 14, wherein the central processor is further operable to receive a plurality of test results from a plurality of laboratory instruments for incorporation into the updated group statistical summary data.

17. A computerized method for integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, comprising:

maintaining at least one database identifying a plurality of laboratory tests and corresponding group statistical summary data, the database also identifying the plurality of laboratory tests and corresponding control rules; and

calculating a control range for a specified one of the laboratory tests by applying the group statistical summary data for the specified laboratory test to the control rule for the specified laboratory test.

18. The computerized method of claim 17, wherein the group statistical summary data is selected from the following group:

a mean, a median, a standard deviation, a coefficient of variation, a standard deviation index, a coefficient of variation index, and combinations thereof.

19. The computerized method of claim 17, wherein the database also identifies the plurality of laboratory tests and corresponding internal laboratory statistical data, and wherein the control range for the specified one of the laboratory tests is calculated by applying both the group statistical summary data for the specified laboratory test and the internal laboratory statistical data for the specified laboratory test to the control rule for the specified laboratory test.

20. The computerized method of claim 17, further comprising receiving updated group statistical summary data from a central agency and transferring the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data.

21. The computerized method of claim 20, wherein the updated group statistical summary data received from the central agency is derived from testing carried out by a specified group of laboratory instruments.

22. The computerized method of claim 20, wherein the updated group statistical summary data received from the central agency is transferred to the database prior to calculating the control range for the specified one of the laboratory tests.

23. The computerized method of claim 20, wherein the updated group statistical summary data is received from the central agency in response to a synchronization command.

24. The computerized method of claim 20, wherein the updated group statistical summary data is received from the central agency at a specified data and time.

25. The computerized method of claim 17, further comprising:

receiving a test result from a laboratory instrument for the specified one of the laboratory tests; and

determining whether the test result falls within the calculated control range for the specified laboratory test.

26. The computerized method of claim 25, further comprising transmitting the test result to a central agency.

27. A computer-readable medium having computer-executable instructions for performing a method of integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, the method comprising:

maintaining at least one database identifying a plurality of laboratory tests and corresponding group statistical summary data and further identifying the corresponding control rules for the laboratory tests; and

calculating a control range for a specified one of the laboratory tests by applying the group statistical summary data for the specified laboratory test to the corresponding control rule.

28. The computer-readable medium of claim 27, wherein the group statistical summary data is selected from the following group:

a mean, a median, a standard deviation, a coefficient of variation, a standard deviation index, a coefficient of deviation index, and combinations thereof.

29. The computer-readable medium of claim 27, wherein the database also identifies the plurality of laboratory tests and the corresponding internal laboratory statistical data, and wherein the control range for the specified one of the laboratory tests is calculated by applying both the corresponding group statistical summary data and the corresponding internal laboratory statistical data to the corresponding control rule.

30. The computer-readable medium of claim 27, wherein the method further comprises receiving updated group statistical summary data from a central agency and transferring the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data.

31. The computer-readable medium of claim 30, wherein the updated group statistical summary data received from the central agency is derived from testing carried out by a specified group of laboratory instruments.

32. The computer-readable medium of claim 30, wherein the updated group statistical summary data received from the central agency is transferred to the database prior to calculating the control range for the specified one of the laboratory tests.

33. The computer-readable medium of claim 30, wherein the updated group statistical summary data is received from the central agency in response to a synchronization command.

34. The computer-readable medium of claim 30, wherein the updated group statistical summary data is received from the central agency at a specified data and time.

35. The computer-readable medium of claim 27, wherein the method further comprises:

receiving a test result from a laboratory instrument for the specified one of the laboratory tests; and

determining whether the test result falls within the calculated control range for the specified laboratory test.

36. The computer-readable medium of claim 35, wherein the method further comprises transmitting the test result to a central agency.

37. A system for integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, comprising:

means for maintaining at least one database identifying a plurality of laboratory tests and the corresponding group statistical summary data and for identifying the plurality of laboratory tests and the corresponding control rules; and

means for calculating a control range for a specified one of the laboratory tests by applying the group statistical summary data corresponding to the specified laboratory test to the corresponding control rule.

38. The system of claim 37, wherein the database means also identifies the plurality of laboratory tests and the corresponding internal laboratory statistical data, and wherein the calculating means calculates the control range for the specified one of the laboratory tests by applying both the corresponding group statistical summary data and the corresponding internal laboratory statistical data to the corresponding control rule.

39. The system of claim 37, further comprising:

means for receiving updated group statistical summary data from a central agency; and

means for transferring the updated group statistical summary data to the database means whereby the updated group statistical summary data becomes the group statistical summary data.

40. The system of claim 37, further comprising:

means for receiving a test result from a laboratory instrument for the specified one of the laboratory tests; and

means for determining whether the test result falls within the calculated control range for the specified laboratory test.

41. The system of claim 40, further comprising means for transmitting the test result to a central agency.

42. A computer-readable medium having computer-executable instructions for performing a method of integrating the internal and external quality control programs of a laboratory utilizing control rules for specified laboratory tests, the method comprising:

maintaining at least one database identifying a plurality of laboratory tests and the corresponding group statistical summary data and the database also identifying the corresponding control rules;

receiving updated group statistical summary data from a central agency;

transferring the updated group statistical summary data to the database whereby the updated group statistical summary data becomes the group statistical summary data;

receiving a test result from a laboratory instrument for a specified one of the laboratory tests;

calculating a control range for the specified laboratory test by applying the corresponding group statistical summary data to the corresponding control rule; and

determining whether the test result falls within the calculated control range.

43. The computer-readable medium of claim 42, wherein the database also identifies the plurality of laboratory tests and the corresponding internal laboratory statistical data, and wherein the control range for the specified one of the laboratory tests is calculated by applying both the group statistical summary data for the test and the internal laboratory statistical data for the test to the corresponding control rule.

44. The computer-readable medium of claim 42, wherein the updated group statistical summary data received from the central agency is transferred to the database prior to calculating the control range for the specified one of the laboratory tests.

45. The computer-readable medium of claim 42, wherein the updated group statistical summary data is received from the central agency in response to a synchronization command.

46. The computer-readable medium of claim 42, wherein the updated group statistical summary data is received from the central agency at a specified data and time.

47. The computer-readable medium of claim 42, wherein the method further comprises transmitting the test result to the central agency.