Method and apparatus for integrating an automated system to a laboratory

• US 5,619,428 A
• Filed: 05/31/1995
• Issued: 04/08/1997
• Est. Priority Date: 05/31/1995
• Status: Expired due to Term

• Current Assignee: Tripath Imaging Incorporated (Becton, Dickinson & Co)
• Original Assignee: NeoPath, Inc. (Becton, Dickinson & Co)
• Inventors: Oh, Seho, Lee, Shih-Jong J., Kuan, Chih-Chau L., Ellison, Dayle G., Wilhelm, Paul S.
• Primary Examiner(s): Voeltz, Emanuel T.
• Assistant Examiner(s): Wachsman, Hal D.
• Application Number:
  US08/455,388
• Time in Patent Office: 678 Days
• Field of Search: 364/551.01, 364/555, 364/497, 364/413.01, 364/413.08, 364/413.1, 250/461.2, 356/39, 356/372, 356/375, 356/380, 356/400, 356/401, 377/10, 377/11, 382/133, 382/128, 382/134, 436/43-48, 436/50, 436/55, 436/63, 436/8, 348/79, 395/924
• US Class Current: 702/19
• CPC Class Codes: G01N 1/312 for samples mounted on planar substrates

Abstract

An automated biological screening system obtains biological and procedural data from a slide set of a selected clinical laboratory. The integration system tests the data on standardized criteria and passes and fails the data in selected categories. The results of the assessment are used to make process adjustment recommendations based on the results of a laboratory process adjustment procedure. Assessment and adjustment may continue until data from a slide set from the selected clinical laboratory passes in each category. The integration system then sets up, calibrates and installs the automated biological screening system. During operation, the integration system continuously monitors biological data generated by the automated biological screening system. The biological data may also be stored in a central product/service database for additional monitoring. The integration system also serves as an objective standard for reviewing and improving laboratory practices.

Claims

1. A method of integrating an automated biological screening system to a laboratory comprising the steps of:

(a) obtaining a slide set from the laboratory;

(b) gathering parameter data from the slide set wherein the parameter data is representative of the slide set;

(c) measuring characteristics of the parameter data to provide a plurality of processing quality data outputs; and

(d) integrating the plurality of processing quality data outputs with each other to provide a suitability assessment of the slide set, the suitability assessment indicating suitability for processing by the automated biological screening system.

2. The method of claim 1 wherein the step of integrating the plurality of processing quality data outputs further comprises the steps of:

(i) measuring a laboratory process parameter derived from the parameter data from the slide set to provide laboratory process assessment data;

(ii) providing a suitability assessment of laboratory processes based on the laboratory process assessment data; and

(iii) independently adjusting the laboratory processes based upon the laboratory process assessment data.

3. The method of claim 2 wherein the step of independently adjusting the laboratory processes further comprises the step of providing at least one lab process parameter adjustment recommendation.

4. The method of claim 2 wherein the step of providing a suitability assessment of laboratory processes based upon the laboratory process assessment data further comprises the steps of:

(a) evaluating preselected characteristics of the slide set; and

(b) determining laboratory process quality by checking whether the preselected characteristics are within predetermined limits.

5. The method of claim 4 wherein the step of evaluating preselected characteristics of the slide set further comprises the step of evaluating physical characteristics of a slide from the slide set.

6. The method of claim 4 wherein the step of evaluating preselected characteristics of the slide set further comprises the step of evaluating system accuracy.

7. The method of claim 4 wherein the step of evaluating preselected characteristics of the slide set further comprises the step of evaluating specimen material of a slide from the slide set.

8. The method of claim 4 wherein the step of evaluating preselected characteristics of the slide set further comprises the step of evaluating handling quality of a slide from the slide set.

9. The method of claim 4 wherein the step of evaluating preselected characteristics of the slide set further comprises the step of evaluating preparation quality of a slide from the slide set.

10. The method of claim 2 wherein the step of independently adjusting the laboratory processes further comprises the steps of:

a) comparing the laboratory process assessment data to a set of predetermined standards to provide a discrepancy output; and

b) determining at least one process adjustment recommendation based on the discrepancy output.

11. The method of claim 2 further including the step of adjusting the laboratory processes until the laboratory process assessment data are within a predetermined range.

12. The method of claim 2 wherein the step of independently adjusting the laboratory processes further comprises the step of making a standard slide and coverslip recommendation when the laboratory process assessment data indicate a slide physical characteristics test failure.

13. The method of claim 2 wherein the step of independently adjusting the laboratory processes further comprises the step of making a sample collection tool recommendation when the laboratory process assessment data indicate a specimen collection quality test failure.

14. The method of claim 2 wherein the step of independently adjusting the laboratory processes further comprises the step of making a method recommendation when the laboratory process assessment data indicate a specimen collection quality test failure.

15. The method of claim 2 wherein the step of independently adjusting the laboratory processes further comprises the step of making a slide handling protocols recommendation when the laboratory process assessment data indicate a slide handling quality failure.

16. The method of claim 2 wherein the step of independently adjusting the laboratory processes based upon the laboratory process assessment data further comprises the step of making a slide fixation recommendation when the laboratory process assessment data indicate a preparation quality test failure.

17. The method of claim 2 wherein the step of independently adjusting the laboratory processes based upon the laboratory process assessment data further comprises the step of making a specimen staining recommendation when the laboratory process assessment data indicate a preparation quality test failure.

18. The method of claim 2 wherein the step of independently adjusting the laboratory processes based upon the laboratory process assessment data further comprises the step of making a coverslip affixing recommendation when the laboratory process assessment data indicate a preparation quality test failure.

19. The method of claim 2 wherein the step of independently adjusting the laboratory processes based upon the laboratory process assessment data further comprises the step of making a sample collection tool recommendation when the laboratory process assessment data indicate a classification accuracy test failure.

20. The method of claim 2 wherein the step of independently adjusting the laboratory processes based upon the laboratory process assessment data further comprises the step of making a sample collection method recommendation when the laboratory process assessment data indicate a classification accuracy test failure.

21. The method of claim 1 further comprising the step of calibrating the automated biological screening system in response to the plurality of processing quality data outputs.

22. The method of claim 21 wherein the step of calibrating the automated biological screening system further comprises the step of providing an interface for adjusting system parameters.

23. The method of claim 21 wherein the automated biological screening system includes an imaging system, an image processing system, and a central processing system that are characterized by machine operating parameters, and wherein the method further comprises the step of adjusting the machine operating parameters according to the laboratory process assessment data.

24. The method of claim 23 wherein the step of calibrating the automated biological screening system further comprises the step of calibrating machine operating parameters to obtain a desired slide microscopy review rate.

25. The method of claim 1 wherein the automated biological screening system includes an imaging system, an image processing system, and a central processing system that are characterized by machine operating parameters, further comprising the step of measuring at least one machine operating parameter using the image data from the slide set, at intervals, to provide at least one operating parameter of the automated biological screening system.

26. The method of claim 25 further comprising the step of displaying the at least one operating parameter.

27. The method of claim 25 wherein the intervals comprise periodic time intervals.

28. The method of claim 25 wherein the intervals comprise random time periods.

29. The method of claim 25 wherein the intervals are based on the number of slides examined.

30. The method of claim 25 further comprising the step of storing the at least one operating parameter in a database.

31. The method of claim 1 further comprising the steps of measuring at least one laboratory process parameter, at intervals, based on at least one recent slide set processed by the automatic biological screening system to provide at least one laboratory process monitoring parameter.

32. The method of claim 31 further comprising the step of displaying the at least one laboratory process monitoring parameter.

33. The method of claim 31 further comprising the step of providing at least one parameter adjustment recommendation.

34. The method of claim 31 wherein the intervals are time periods that are periodic.

35. The method of claim 31 wherein the intervals are time periods that are random.

36. The method of claim 31 wherein the intervals are based on the number of slides examined.

37. The method of claim 31 further comprising the step of adjusting laboratory processes based upon the at least one laboratory process monitoring parameter.

38. The method of claim 31 further comprising the step of calibrating the automated biological screening system.

39. The method of claim 31 further comprising the step of storing the at least one laboratory process monitoring parameter in a database.

40. The method of claim 31 wherein the automated biological screening system includes an imaging system, an image processing system, and a central processing system that are characterized by machine operating parameters, further comprising the step of measuring at least one machine operating parameter, at intervals, based on the at least one recent slide set to provide at least one operating parameter of the automated biological screening system.

41. The method of claim 1 wherein the step of obtaining a slide set from the laboratory further comprises the steps of obtaining slides representative of a predetermined laboratory slide population.

42. An apparatus for integrating an automated biological screening system to a laboratory comprising:

(a) a means for automated biological screening providing a biological data output;

(b) a means for assessing laboratory processes connected to receive the biological data output and providing a laboratory process assessment output wherein the means for assessing laboratory process further comprises;

(i) a means for gathering image data representative of a population of slides from the laboratory and providing an image data output;

(ii) a means for determining processing quality data connected to receive the image data output and providing a plurality of processing quality data outputs; and

(iii) a data processing system connected to receive and integrate the plurality of processing quality data outputs with each other, wherein the data processing system provides a population suitability data output based on the plurality of processing quality data outputs, where the population suitability data output provides an indication of the suitability of the laboratory'"'"'s slide population for processing by an automated biological screening system;

(c) a means for adjusting laboratory processes connected to receive the laboratory process assessment output wherein the means for adjusting laboratory process further includes means for providing a process adjustment recommendation;

(d) a means for setup, calibration and installation of the automated biological screening system connected to receive the laboratory process assessment output and providing a calibration parameter output; and

(e) a means for monitoring operation of the automated biological screening system connected to receive the biological data output and the calibration parameter output and providing a laboratory process monitoring output.

43. The apparatus of claim 42 wherein the means for determining processing quality data further comprises a means for testing slide physical characteristics connected to receive the image data output and providing slide physical characteristics data output.

44. The apparatus of claim 42 wherein the means for determining processing quality data further comprises a means for testing specimen material quality connected to receive the image data output and providing specimen material quality data output.

45. The apparatus of claim 42 wherein the means for determining processing quality data further comprises a means for testing slide handling quality connected to receive the image data output and providing slide handling quality data output.

46. The apparatus of claim 42 wherein the means for determining processing quality data further comprises a means for testing slide preparation quality connected to receive the image data output and providing slide preparation quality data output.

47. The apparatus of claim 42 wherein the means for determining processing quality data further comprises a means for testing system accuracy connected to receive the image data output and providing system accuracy data output.

48. The apparatus of claim 42 wherein the means for gathering image data further comprises an automated microscope.

49. The apparatus of claim 42 wherein the means for assessing laboratory processes and the means for adjusting laboratory processes further comprise a central processor.

50. The apparatus of claim 42 wherein the means for monitoring operation of the automated biological screening system further comprises resident machine monitoring software and system integrity checks.

51. An apparatus for integrating an automated biological screening system to a laboratory comprising:

(a) a means for automated biological screening providing a biological data output;

(b) a means for assessing laboratory processes connected to receive the biological data output and providing a laboratory process assessment output;

(c) a means for adjusting laboratory procedures connected to receive the laboratory process assessment output and providing a process adjustment recommendation, wherein the means for adjusting laboratory procedures further comprises a databank of standard laboratory procedures and the process adjustment recommendation is selected from the databank of standard laboratory procedures;

(d) a means for setup, calibration and installation of the automated biological screening system connected to receive the laboratory process assessment output and providing a calibration parameter output; and

(e) a means for monitoring operation of the automated biological screening system connected to receive the biological data output and the calibration parameter output and providing a system status output.

52. The apparatus of claim 51 wherein the means for monitoring further comprises a product/service database for storing a plurality of system status outputs from the monitoring means.