System and method for monitoring , reporting, managing and administering the treatment of a blood component

• US 20040088189A1
• Filed: 11/06/2002
• Published: 05/06/2004
• Est. Priority Date: 11/06/2002
• Status: Abandoned Application

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Berthiaume, Karen, Fredericks, Chris Noel, Vermeiren, Christophe, Veome, Edmond A., Johnson, Samira E., Rabe, Lori, Merkouriou, Savvas
• Application Number:
  US10/290,035
• Publication Number:
  US 20040088189A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• CPC Class Codes: A61M 2205/053 ultraviolet
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system and method for treating a biological fluid unit wherein the system ensures proper execution of the treatment by coordinating cooperation among a plurality of components operably connected to the system. The system components include a processor communicating with a memory, a unit identifier, at least one blood component treatment process, and an illumination instrument. The system includes a database stored in and accessible from the memory. The database retains information associated with a blood component, an illumination instrument, and treatment of the blood component utilizing the illumination instrument. A user interface operably connected to the processor includes a graphical screen and a data entry device for communicating information related to the blood component treatment to and from the operator.

Claims

1. A system for blood product treatment, the system comprising:

a processor;

a memory being operably connected to the processor, the memory storing a blood product treatment module;

at least one blood product treatment instrument for communicating information related to blood product treatment to the processor and memory over a communications network for treating a blood product; and

,

an interface having means for entering information, means for displaying information, and means for communicating with the processor and memory, the information being related to the blood product treatment, wherein the processor, the memory, and the interface are for at least one of monitoring, managing, reporting, and administering the blood product treatment.

2. The system of claim 1, wherein the interface comprises at least one of a personal digital assistant, a desktop computer, a laptop computer, and a wireless handheld computer.

3. The system of claim 1, wherein the means for displaying the information comprises a graphical screen.

4. The system of claim 1, wherein the means for entering the information comprises at least one of a keyboard, a bar-code reader, and a mouse.

5. The system of claim 1, wherein the blood product treatment comprises at least one of a platelet treatment, a plasma treatment, a red blood cell treatment, and a double red blood cell treatment.

6. The system of claim 1, wherein the blood product treatment comprises pathogen inactivation.

7. The system of claim 6, wherein the pathogen inactivation utilizes a photoactive agent.

8. The system of claim 7, wherein the treatment instrument is an illuminator.

9. The system of claim 8, wherein the blood product treatment module operates with the illuminator using a pathogen inactivation kit and the photoactive agent to inactivate pathogens in the blood product.

10. The system of claim 1, wherein the blood product treatment module receives pathogen inactivation kit data and receives blood product type data, and determines whether the pathogen inactivation kit data is compatible with the blood product type data.

11. The system of claim 10, wherein a compatibility message is sent to the interface indicating whether the pathogen inactivation kit data is compatible with blood product type data.

12. The system of claim 1, wherein the blood product treatment module registers blood product registration data for at least one unit of the blood product.

13. The system of claim 12, wherein the blood product registration data is received by at least one of an interface and a host, and is sent to a database in the memory.

14. The system of claim 13, wherein the blood product treatment module records blood product treatment data for storage in a database in the memory.

15. The system of claim 14, wherein the blood product treatment data is generated by an illuminator.

16. The system of claim 13, wherein the blood product treatment module evaluates blood product treatment data to ensure proper execution of a blood product treatment.

17. The system of claim 16, wherein the blood product treatment module generates a status report of an evaluation of a blood product treatment.

18. The system of claim 13, wherein the blood product treatment module determines that a predetermined time limit for processing of a blood product has met at least one of is approaching, has been reached, and has been exceeded.

19. The system of claim 18, wherein the predetermined time limit is one of at least a time for collection, a time for pre-illumination procedures, a time for illumination, a time for agitation, and a time for post-illumination procedures.

20. The system of claim 18, wherein the blood product treatment module generates a stop message for the blood product treatment indicating that the predetermined time limit has been reached or exceeded.

21. The system of claim 18, wherein the blood product treatment module generates a time limit message indicating that the predetermined time limit is one of is approaching, has been reached, and has been exceeded.

22. The system of claim 18, wherein the blood product treatment module stops the blood product treatment after the blood product treatment module has determined that the predetermined time limit has been reached or exceeded.

23. The system of claim 22, wherein the blood product treatment module receives a command to override a stopped blood product treatment.

24. The system of claim 1, wherein the blood product treatment module receives a blood product identifier.

25. The system of claim 1, wherein the blood product treatment module identifies the blood product.

26. The system of claim 1, wherein the blood product treatment module stops a blood product treatment process.

27. The system of claim 26, wherein the blood product treatment module overrides stopped blood product treatment.

28. The system of claim 1, wherein the blood product treatment module locates the treatment instrument using at least one data field.

29. The system of claim 28, wherein the data field comprises at least one of a site code, a donation number, a suffix, and a product code.

95. The system of claim 1 wherein data received from the treatment instrument regarding aspects of the blood product treatment is maintained in a database.

96. The system of claim 1 wherein current status data of each step in the blood product treatment is maintained in a database.

30. A method for at least one of monitoring, reporting, managing, and administering a blood product non-apheresis treatment, the method comprising the steps of:

providing for registering a blood product; and

,

providing for storing blood product treatment information from a treatment instrument.

31. The method of claim 30, further comprising the step of:

providing for verifying the compatibility of the blood product with a blood product treatment kit.

32. The method of claim 30, further comprising the step of:

providing for stopping a blood product treatment process.

33. The method of claim 32, further comprising the step of:

providing for overriding the stopped blood product treatment process.

34. The method of claim 30, further comprising the step of:

providing for evaluating the blood product treatment to ensure proper administration of treatment steps.

35. The method of claim 30, further comprising the step of:

providing for storing sterile connect device information.

36. For a blood product treatment system, the system comprising a memory having a database and a blood product treatment module, a processor operably connected to at least one treatment instrument and to the memory, and an interface operably connected to the processor for facilitating a blood product treatment, a method for at least one of monitoring, reporting, managing, and administering a blood product treatment comprising the steps of:

providing for receiving a blood product identifier identifying a blood product; and

,

providing for receiving a treatment kit identifier identifying a treatment kit.

37. The method of claim 36 further comprising the step of:

providing for determining whether the blood product and the treatment kit are compatible for use.

38. The method of claim 37, wherein the blood product treatment module compares the blood product identifier with the treatment kit identifier.

39. The method of claim 36, further comprising the step of:

providing for stopping the administration of the blood product treatment.

40. The method of claim 39 wherein stopping the administration of the blood product treatment is in response to the blood product treatment module determining that the treatment kit and the blood product are incompatible.

41. The method of claim 36, further comprising the step of:

providing for overriding a stopped blood product treatment.

42. The method of claim 36, further comprising the step of:

providing for storing information about a stopped blood product treatment process.

43. The method of claim 36, further comprising the step of:

providing for storing information about a stopped blood product process override.

44. The method of claim 36, further comprising the step of:

providing for storing collection information about the blood product, the collection information comprising a blood product type and a time of collection.

45. The method of claim 36, further comprising the steps of:

providing for calculating a time limit, the time limit comprising a date and a time of a blood product collection plus a fixed amount of time.

46. The method of claim 45, further comprising the step of:

providing for stopping administration of the blood product treatment in response to the blood product treatment module determining that the time limit has been reached or exceeded.

47. The method of claim 36, further comprising the step of:

providing for stopping administration of the blood product treatment in response to the blood product treatment module determining that a cell count for the blood product is less than a predetermined cell count level.

48. The method of claim 36, further comprising the step of:

providing for selecting an illuminator device to treat the blood product.

49. The method of claim 36, further comprising the step of:

providing for determining whether all necessary steps prior to illumination have been completed.

50. The method of claim 36, further comprising the step of:

providing for sending an illumination message to the interface indicating that an illumination step is ready to be completed, for inactivating pathogens within the blood product.

51. The method of claim 36, further comprising the steps of:

providing for receiving information from the treatment instrument, the information comprising an illumination exposure count transmitted by the treatment instrument.

52. The method of claim 51, further comprising the step of:

providing for determining if the illumination exposure count has reached or exceeded an illumination exposure limit.

53. The method of claim 52, further comprising the step of:

providing for stopping execution of the blood product treatment in response to the illumination exposure exceeding the illumination exposure limit.

54. The method of claim 36, further comprising the step of:

providing for generating an illumination limit message indicating that predetermined illumination exposure limit is one of is approaching, has been reached, and has been exceeded.

55. The method of claim 36, further comprising the step of:

providing for agitation of the blood product.

56. The method of claim 36, further comprising the steps of:

providing for determining whether a sorption time is one of at least approaching, reaching, or exceeding a predetermined sorption time.

57. The method of claim 56, wherein sorption is at least one of adsorption and absorption.

58. The method of claim 56, wherein the predetermined sorption time limit is a minimal duration for agitating the blood component.

59. The method of claim 36, further comprising the step of:

providing for generating a sorption limit message indicating that a predetermined sorption limit is one of is approaching, has been reached, and has been exceeded.

60. The method of claim 56, further comprising the step of:

providing for stopping execution of the blood product treatment in response to the determination that the sorption time has reached or exceeded the predetermined sorption time.

61. The method of claim 36, further comprising the step of:

providing for evaluating the blood product treatment.

62. The method of claim 61, further comprising the step of:

providing for reporting the evaluation of a completed blood product treatment.

63. The method of claim 36, further comprising the step of:

providing for monitoring the administration of blood product treatment.

64. The method of claim 36, wherein the step of providing for registering the blood product further comprises the steps of:

providing for prompting an entry of a blood product identifier;

providing for prompting an entry for a treatment kit identifier;

providing for receiving an input to the prompt for the blood product identifier, and,

providing for receiving an input to the prompt for the treatment kit identifier.

65. The method of claim 36, further comprising the step of:

providing for locating the treatment instrument using at least one data field.

66. The method of claim 65, wherein the data field comprises at least one of a site code, a donation number, a suffix, and a product code.

67. The method of claim 36, wherein the blood product treatment further comprises the step of:

registering the blood product using at least one identifier.

68. The method of claim 67, wherein the at least one identifier comprises at least one of a collection date and a collection time.

69. The method of claim 68, wherein the at least one identifier further comprises at least one of a volume amount, a platelet count, a rest period, an agitation period, and a red cell contamination status.

70. The system of claim 36, further comprising the step of:

providing for receiving blood product information from a host source.

71. The method of claim 70 wherein the blood product information is at least one of a platelet count and a volume collection amount.

72. The method of claim 36, further comprising the steps of:

providing for initiating a stop mechanism for stopping the blood product treatment in response to a platelet count being at least one of higher and lower in relation to a predetermined platelet count; and

,

providing for initiating an override mechanism for overriding the stopped blood product treatment.

73. The method of claim 36, further comprising the steps of:

providing for initiating a stop mechanism for stopping the blood product treatment in response to a volume collection amount being at least one of higher and lower in relation to a predetermined volume collection amount; and

,

providing for initiating an override mechanism for overriding the stopped blood product treatment.

74. The method of claim 36, further comprising the step of:

providing for determining whether the blood product identifier is invalid.

75. The method of claim 36, further comprising the step of:

providing for determining whether the treatment kit identifier is invalid.

76. The method of claim 36, further comprising the step of:

providing for converting the blood product identifier to a new blood product identifier using a conversion code.

77. The method of claim 76, further comprising the step of:

providing for sending a message indicating that an incorrect conversion code was used; and

,

providing for initiating a correction mechanism to allow for correcting the conversion code.

78. The method of claim 36, further comprising the step of:

providing for sending data regarding the blood product treatment of a blood product to a host system.

79. A computer readable medium having an application therein for at least one of monitoring, reporting, managing, and administering a blood product treatment of a blood product, the medium comprising:

a first segment for receiving blood product identification information; and

,

a second segment for tracking the status of the blood product treatment of the blood product throughout the blood product treatment by reference to blood product treatment identification information.

80. The medium of claim 79, further comprising:

a third segment for verifying compatibility of the blood product with a pathogen inactivation kit.

81. The medium of claim 79, further comprising:

a third segment for receiving information from a pathogen inactivation instrument utilized during treatment, the information relating to an amount of exposure of illumination transmitted from the pathogen inactivation instrument to the blood product; and

,

a fourth segment for storing the information.

82. The medium of claim 81, further comprising:

a fifth segment for determining whether the amount of illumination exposure satisfies a predetermined amount of illumination.

83. The medium of claim 82, further comprising:

a sixth segment for stopping the treatment of the blood product if the measured amount of illumination is less than the predetermined level of illumination.

84. The medium of claim 79, further comprising:

a third segment for overriding a stopped blood product treatment.

85. The medium of claim 84, further comprising:

a fourth segment for determining a time duration between a collection of the blood product and illumination of the blood product.

86. The medium of claim 85, further comprising:

an fifth segment for stopping the treatment of the blood product in response to the time duration reaching or exceeding a predetermined collection time amount.

87. The medium of claim 79, further comprising:

a third segment for evaluating a completed blood product treatment wherein a status of the completed blood product treatment is determined.

88. The medium of claim 79, further comprising:

a third segment for receiving information in a product form; and

,

a fourth segment for storing information received from the product form into a database stored in a memory.

89. The medium of claim 79, further comprising:

a third segment for generating a report, the report comprising information related to the blood product.

90. The medium of claim 79, further comprising:

a third segment for determining whether a platelet count of the blood product is acceptable.

91. The medium of claim 79, further comprising:

a third segment for determining whether a blood product volume is acceptable.

92. The medium of claim 79, further comprising:

a third segment for registering the blood product.

93. The medium of claim 79, further comprising:

a third segment for sending a message notifying that a failure to satisfy a predetermined treatment requirement has taken place.

94. The medium of claim 79, further comprising:

a third segment for maintaining integrity of a blood product wherein a conversion code is utilized in cooperation with a blood product identifier for the blood product.