Laboratory instrumentation information management and control network

• US 7,860,727 B2
• Filed: 01/10/2005
• Issued: 12/28/2010
• Est. Priority Date: 07/17/2003
• Status: Active Grant

• Current Assignee: Ventana Medical Systems Incorporated (Roche Holding AG)
• Original Assignee: Ventana Medical Systems Incorporated (Roche Holding AG)
• Inventors: Larson, Alain L., Showalter, Wayne
• Primary Examiner(s): Morgan; Robert W
• Assistant Examiner(s): Reyes; Reginald
• Application Number:
  US11/032,324
• Publication Number:
  US 20050159982A1
• Time in Patent Office: 2,178 Days
• Field of Search: 705 2- 3
• US Class Current: 705/2
• CPC Class Codes: G01N 2035/00881 network configurations
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

An interface point network (IPN) and a method for communication with a laboratory information system using an IPN, wherein the IPN includes at least one host computer in communication with at least one laboratory instrument, the laboratory information system and an interface point server in communication with the host computer and the laboratory information system, the interface point server being configured to function as a communication interface between the host computer and the laboratory information system in a manner responsive to a predetermined communication protocol. Use of bar code and RFID labels for tracking samples and in maintaining sample data is described.

Claims

1. A method for performing processing in a laboratory comprising:

configuring, using a computer, a host to have at least one local data element associated with a first staining protocol used only by said host, said at least one local data element having a data definition and data value used only by said host;

configuring, using a computer, said host to have global data elements each having a common data definition and data value used by said host and by one or more other hosts connected to said host;

providing a template including a first set of one or more erroneous test patterns and, for each of said erroneous test patterns in the first set, an associated action that is performed upon detection of an occurrence of said each erroneous test pattern, each of said erroneous test patterns specifying results and processing parameters for a plurality of slides;

staining a set of slides and producing first results, said staining performed in accordance with the first staining protocol using a first reagent and a stainer controlled by the host;

performing first processing by the host using the template, said first processing including determining a match between a first of the erroneous test patterns and the first results, and in response to determining the match, determining a testing failure and performing an associated action specified in the template for the first erroneous test pattern, wherein said associated action includes performing lockout processing, said lockout processing comprising;

identifying reagents used on said set of slides, said reagents including said first reagent and a second reagent; and

disallowing further processing of slides using said reagents including;

disallowing processing using any of said reagents used by said host; and

updating a plurality of said global data elements associated with said reagents to indicate that processing using the reagents is on hold; and

wherein, after said updating, said plurality of global data elements are communicated to said one or more other hosts and each of said one or more other hosts disallows further processing using the second reagent.

2. The method of claim 1, wherein said host and said one or more other hosts communicate with an interface server to maintain an up-to-date local copy of said at least one global data element.

3. The method of claim 2, further comprising:

configuring one local data element of said host as a new global data element;

communicating said new global data element to said interface server; and

configuring said one or more other hosts in accordance with said new global data element using said interface server.

4. The method of claim 2, wherein said host, said one or more other hosts and said interface server are included in a laboratory network.

5. The method of claim 4, wherein said interface server is connected to a laboratory information system.

6. The method of claim 4, wherein said host performs offline processing with respect to said one or more other hosts and said interface server, and said host uses said at least one local data element in said offline processing with at least one instrument.

7. The method of claim 6, wherein said host synchronizes said global data element with said interface server when said host completes said offline processing, said host and a first of said one or more other hosts being configured to use different global data elements.

8. The method of claim 1, wherein said data elements include at least one of:

a user password, a user privilege, reagent information, patient information, sample information, batch information, laboratory test information and a protocol.

9. The method of claim 8, wherein said global data elements include a first global data element for a reagent, a first instrument using said reagent being controlled by said host, said host being an owner of said reagent, and the method further comprising:

sending a request from a second host connected to said host requesting that said host transfer ownership of said reagent to said second host;

sending a response by said host to said second host, said response denying said request by said host if said reagent is in use by said first instrument, and otherwise said response granting said request and transferring ownership of said reagent to said second host; and

sending, by said second host, new ownership information to an interface server which maintains a database of global data elements, the database of global data elements including at least one data element for the new ownership information and including said first global data element.

10. The method of claim 9, wherein said reagent is physically relocated from said first instrument controlled by said host to a second instrument controlled by said second host when said second host is identified as having ownership of said reagent.

11. The method of claim 5, wherein information is communicated between said laboratory information system and said interface server, said information comprising a first portion and a second portion, said first portion including at least one of test order information and case information sent from said laboratory information system to said interface server, said second portion including status information about a test order.

12. The method of claim 11, wherein said first portion includes case information that is manually entered at said laboratory information system and is communicated from said laboratory information system without further manual data entry.

13. The method of claim 11, wherein said first portion includes test order information and the method further comprising:

communicating test result information from said host to said interface server for a test performed by a first instrument controlled by said host; and

sending said second portion from said interface server to said laboratory information system, said second portion including status information corresponding to said test result information.

14. The method of claim 13, wherein said interface server manages a database including information about test orders that have not been completed, and, when a test order is complete, information about said test order is removed from said database.

15. The method of claim 14, wherein said host includes a local database of information about tests performed by said first instrument, and the method further comprising:

receiving a request for test information about a completed test performed by said first instrument;

requesting said test information from said local database of said host about said completed test; and

sending a response to said request, said response including data in accordance with said test information.

16. The method of claim 1, wherein an update to any of said global data elements is automatically replicated to said host and said one or more other hosts in accordance with ongoing processing performed by each host to obtain data updates from a server managing a database of global data elements.

17. The method of claim 1, wherein at least one of said global data elements is a configuration data element having a corresponding configuration option.

18. The method of claim 17, wherein said configuration option is for a configurable symbology identifier corresponding to a symbology used with optical encodings in the laboratory.

19. The method of claim 18, wherein at least one instrument controlled by said host operates in accordance with said symbology.

20. The method of claim 19, wherein an optical scanner is an instrument controlled by said host, said scanner supporting scanning operations in accordance with said symbology.

21. The method of claim 19, wherein a label printer is an instrument controlled by said host, said label printer supporting printing operations in accordance with said symbology.

22. The method of claim 19, wherein said symbology is used with bar code labels associated with elements used in connection with processing within the laboratory.

23. The method of claim 22, wherein said elements include at least one of:

a sample, a specimen, and a reagent.

24. The method of claim 22, wherein said symbology is of a multiple dimension.

25. The method of claim 22, wherein a bar code label encodes an identifier used to obtain data from a database about an element associated with said bar code label, said data including at least one of said data elements.

26. The method of claim 1, wherein said host is configured to identify an element in a laboratory, and the method further comprising:

receiving, by a label associated with said element, an interrogator signal; and

transmitting, by said label in response to said interrogator signal, an electromagnetic response signal including at least a first portion of information used for uniquely identifying said element in said laboratory.

27. The method of claim 26, wherein said electromagnetic response signal is produced using information encoded in said label associated with said element.

28. The method of claim 26, wherein said label is one of a radio frequency identification label or an infrared identification label.

29. The method of claim 28, wherein said label is a radio frequency identification label and said element is one of a sample, a specimen, or a reagent.

30. The method of claim 29, wherein information is encoded in said radio frequency identification label and includes at least one of patient information, test information, and batch information used to identify at least one other element and said element from a same batch.

31. The method of claim 29, wherein information is read from said radio frequency identification label.

32. The method of claim 29, wherein information is written to said radio frequency identification label.

33. The method of claim 30, wherein the information includes test information about at least one test performed in an anatomical pathology laboratory.

34. The method of claim 33, wherein said element is a sample, and the method further comprising:

reading said test information from said radio frequency identification label in connection with a test to be performed as a step in laboratory processing prior to performing said test for verification that said step is to be performed.

35. The method of claim 34, further comprising:

encoding said radio frequency identification label with additional information about said test, said additional information including at least one of;

time, date, test parameters, filename, and test results.

36. The method of claim 35, wherein said filename identifies an image file.

37. The method of claim 35, further comprising:

reading at least a portion of said additional information;

determining a diagnosis in accordance with said portion; and

encoding said radio frequency identification label with data about said diagnosis.

38. The method of claim 30, wherein said information includes batch information, and the method further comprising:

determining a plurality of elements belonging to a same group in accordance with said batch information encoded on radio frequency identification labels of said plurality of elements.

39. The method of claim 26, further comprising:

determining a location of said element in said laboratory in accordance with said electromagnetic response signal.

40. The method of claim 26, wherein said label is affixed to a surface of said element.

41. The method of claim 26, wherein said label is embedded in said element.

42. The method of claim 26, wherein said label includes other information imprinted on a surface of said label.

43. The method of claim 42, wherein said other information includes optically recognizable data which is readable by a machine.

44. The method of claim 42, wherein said other information includes human readable data.

45. The method of claim 26, further comprising:

encoding said label with other information as said element is processed in accordance with at least one laboratory workflow processing step.

46. The method of claim 43, wherein said other information includes a bar code with an identifier uniquely identifying said element.

47. The method of claim 29, wherein said element is a reagent and the method further comprising:

encoding said label with other information regarding amounts of said reagent used in connection with laboratory processing.

48. The method of claim 47, further comprising:

determining when to reorder said reagent in accordance with said other information.

49. The method of claim 47, wherein ownership of said reagent by an instrument in said laboratory is determined in accordance with information encoded in said label.

50. The method of claim 26, further comprising:

using said first portion to obtain additional information about said element from a database.

51. The method of claim 1, wherein said hosts, an interface server, and a laboratory information system are included in a laboratory network, said laboratory information system in communication with said interface server, and said interface server in communication with said host, and wherein an instrument controlled by said host is a printer, and the host is configured to automatically print slide labels in response to said interface server receiving an order from said laboratory information system.

52. The method of claim 18, wherein said configuration option identifies a user-selected symbology from a plurality of symbologies and causes each bar code reader on each instrument of every host and each bar code label printing device under control of a host to operate in accordance with the selected symbology.

53. The method of claim 1, wherein said lockout processing includes sending a notification regarding the testing failure and the method further includes allowing further processing using said reagents upon receiving a user acknowledgement in response to the notification.

54. The method of claim 1, wherein said template includes a second set of one or more test result patterns identifying acceptable test results.

55. The method of claim 54, further comprising:

determining whether the first results match any of the test result patterns in the second set, and if so, determining that there has been no testing failure.

56. The method of claim 55, wherein said template specifies a default action and if the first results do not match any test result pattern included in the first set or the second set, said default action is performed.

57. The method of claim 1, the method further including automatically retesting one or more slides identified as rejected by said testing failure.

58. The method of claim 1, wherein said template is used in connection with qualification processing for qualifying any of an instrument and a reagent.

59. A system for laboratory information management and control comprising:

a laboratory information system managing patient and laboratory information;

a host configured with at least one local data element associated with a first staining protocol used only by said host, said at least one local data element having a data definition and data value used only by said host, said host configured with global data elements each having a common data definition and data value used by said host and by one or more other hosts connected to said host;

a non-transitory computer readable medium comprising executable instructions stored thereon for;

providing a template including a first set of one or more erroneous test patterns and, for each of said erroneous test patterns in the first set, an associated action that is performed upon detection of an occurrence of said each erroneous test pattern, each of said erroneous test patterns specifying results and processing parameters for a plurality of slides;

staining a set of slides and producing first results, said staining performed in accordance with the first staining protocol using a first reagent and a stainer controlled by the host;

performing first processing by the host using the template, said first processing including determining a match between a first of the erroneous test patterns and the first results, and in response to determining the match, determining a testing failure and performing an associated action specified in the template for the first erroneous test pattern, wherein said associated action includes performing lockout processing, said lockout processing comprising;

identifying reagents used on said set of slides, said reagents including said first reagent and a second reagent; and

disallowing further processing of slides using said reagents including;

disallowing processing using any of said reagents used by said host; and

updating a plurality of said global data elements associated with said reagents to indicate that processing using the reagents is on hold; and

wherein, after said updating, said plurality of global data elements are communicated to said one or more other hosts and each of said one or more other hosts disallows further processing using the second reagent; and

a server in communication with said laboratory information system, said host and said one or more other hosts, said server managing a database including said global data elements, said server communicating with said host and said one or more other hosts to maintain a current copy of said global data elements in said database, and in local copies of said global data element at each of said hosts.

60. A non-transitory computer readable medium comprising executable instructions stored thereon for performing processing in a laboratory, the non-transitory computer readable medium comprising executable instructions for:

configuring, using a computer, a host to have at least one local data element associated with a first staining protocol used only by said host, said at least one local data element having a data definition and data value used only by said host;

configuring, using a computer, said host to have global data elements each having a common data definition and data value used by said host and by one or more other hosts connected to said host;

providing a template including a first set of one or more erroneous test patterns and, for each of said erroneous test patterns in the first set, an associated action that is performed upon detection of an occurrence of said each erroneous test pattern, each of said erroneous test patterns specifying results and processing parameters for a plurality of slides;

staining a set of slides and producing first results, said staining performed in accordance with the first staining protocol using a first reagent and a stainer controlled by the host;

performing first processing by the host using the template, said first processing including determining a match between a first of the erroneous test patterns and the first results, and in response to determining the match, determining a testing failure and performing an associated action specified in the template for the first erroneous test pattern, wherein said associated action includes performing lockout processing, said lockout processing comprising;

identifying reagents used on said set of slides, said reagents including said first reagent and a second reagent; and

disallowing further processing of slides using said reagents including;

disallowing processing using any of said reagents used by said host; and

updating a plurality of said global data elements associated with said reagents to indicate that processing using the reagents is on hold, and

wherein, after said updating, said plurality of global data elements are communicated to said one or more other hosts and each of said one or more other hosts disallows further processing using the second reagent.