Apparatus and methods for monitoring transfusion of blood

• US 20050184153A1
• Filed: 02/18/2005
• Published: 08/25/2005
• Est. Priority Date: 02/19/2004
• Status: Active Grant

• Current Assignee: Haemonetics Corporation
• Original Assignee: Neoteric Technology Ltd. (Haemonetics Corporation)
• Inventors: Auchinleck, Geoffrey Fletcher
• Granted Patent: US 7,490,766 B2
• Time in Patent Office: Days
• US Class Current: 235/385
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

Apparatus and methods are described for ensuring that blood transfused into a patient is the correct blood for that patient, is transfused in the correct manner and that a complete audit trail is created that will allow later tracing of blood from donation through to ultimate transfusion.

Claims

1. An apparatus for implementing blood sample collection, blood unit requesting, and blood unit transfusion into a patient, said apparatus comprising:

(a) a caregiver identity means comprising an electronically readable caregiver code;

(b) a patient identification wristband comprising an electronically readable patient code;

(c) a portable computer comprising a reader wherein said reader is capable of reading said caregiver code and said patient code; and

(d) a portable printer wherein said portable printer is capable of communicating with said portable computer.

2. The apparatus of claim 1 wherein said caregiver identity means is an employee identification card and wherein said employee identification card comprises said caregiver code.

3. The apparatus of claim 1 wherein said electronically readable caregiver code is selected from the group consisting of a linear barcode, a two-dimensional barcode, and a Radio Frequency Identification (RFID) tag.

4. The apparatus of claim 17 wherein said electronically readable patient code is selected from the group consisting of a linear barcode, a two-dimensional barcode, and a Radio Frequency Identification (RFID) tag.

5. The apparatus of claim 3 or claim 4 wherein said linear barcode or said two-dimensional barcode is selected from the group consisting of code39, code128, Interleave 2 of 5, PDF 417, Aztec code, and Matrix code.

6. The apparatus of claim 3 wherein said portable computer is a Personal Digital Assistant (PDA) and wherein said reader is selected from the group consisting of a barcode scanner, a barcode imager, and an RFID reader.

7. The apparatus of claim 6 wherein said PDA comprises a wireless network means, a touch screen, and a communication means for communicating with said portable printer.

8. The apparatus of claim 1 wherein said portable computer comprises software to implement the process of sample collection wherein said process of sample collection comprises the step of causing said portable computer to display messages to a caregiver that indicate to said caregiver the next step in a series of steps to be performed by said caregiver.

9. The apparatus of claim 8 wherein said messages to the caregiver comprise the following:

(a) a request to said caregiver to read a caregiver code;

(b) a request to said caregiver to read a patient code;

(c) a request to said caregiver to verify the accuracy of displayed patient identification information;

(d) a selection of tests for said caregiver to request for a blood sample;

(e) a request to said caregiver to print a blood sample label.

10. The apparatus of claim 9 wherein said selection of tests are automatically assigned by said portable computer.

11. The apparatus of claim 10 wherein said portable computer further comprises a timer wherein said timer prevents said caregiver from printing said blood sample label if more than a pre-set time has passed since said patient code was read.

12. The apparatus of claim 10 further comprising a request to said caregiver to verify that said blood sample collection is complete.

13. The apparatus of claim 10 wherein said portable computer transmits a record to a transfusion database.

14. The apparatus of claim 13 wherein said information is transmitted to said transfusion database via a wireless network connection.

15. The apparatus of claim 13 wherein a barcode reader connected to a computer connected to said transfusion database is capable of scanning said sample collection label thereby inserting said blood sample request information onto said transfusion database.

16. The apparatus of claim 1 wherein said portable computer comprises software to implement the process of blood unit requesting, said process of blood unit requesting comprising the step of causing said portable computer to display messages to a caregiver that indicate to said caregiver the next step in a series of steps to be performed by said caregiver.

17. The apparatus of claim 16 wherein said messages to said caregiver comprise the following:

(a) a request to said caregiver to read a caregiver code;

(b) a request to said caregiver to read a patient code;

(c) a request to said caregiver to verify that displayed patient identification information is correct;

(d) a selection of blood products for said caregiver to request for a blood sample;

(e) a request to said caregiver to specify a quantity of said blood products; and

(f) a request to said caregiver to print a blood unit request slip.

18. The apparatus of claim 17 wherein said request slip comprises patient information read from said patient code and the type of blood product requested.

19. The apparatus of claim 18 wherein said request slip further comprises a barcode wherein said barcode comprises said patient identification information, said patient code, a code representing the blood product required, a caregiver code, the time and date, and a unique portable computer identifier.

20. The apparatus of claim 19 wherein said barcode is a PDF-417 two-dimensional barcode.

21. The apparatus of claim 1 wherein said portable computer comprises software to implement the process of blood unit transfusion, said process of blood unit transfusion comprising the step of causing said portable computer to display messages to a caregiver that indicate to said caregiver the next step in a series of steps that said caregiver is to perform in achieving said blood unit transfusion.

22. The apparatus of claim 21 wherein said messages to the caregiver comprise the following:

(a) a request to said caregiver to read a caregiver code;

(b) a request to said caregiver to read a patient code;

(c) a request to said caregiver to verify the accuracy of displayed patient identification information; and

(d) a request to said caregiver to read a compatibility label on a blood unit to be transfused.

23. The apparatus of claim 22 wherein said software requests said caregiver to compare patient information from said compatibility label with patient identification information corresponding read from said patient code on a patient wristband.

24. The apparatus of claim 23 wherein if said patient information from said compatibility label does not match said patient information read from said patient code on a patient wristband, said software on said portable computer provides a warning to said caregiver.

25. The apparatus of claim 23 wherein if said patient information from said compatibility label matches said patient information read from said patient code on a patient wristband, said software on said portable computer requests said caregiver to read the blood unit label.

26. The apparatus of claim 25 wherein if the information on said blood unit matches information on said compatibility label, the software on said portable computer displays a message asking the caregiver to enter said patient'"'"'s vital signs.

27. The apparatus of claim 26 wherein said software requests that caregiver confirm completion of one or more pre-transfusion checks.

28. The apparatus of claim 27 wherein said software requests that caregiver confirm that the blood transfusion has started.

29. The apparatus of claim 21 wherein said software is capable of transmitting a transfusion record to said transfusion database.

30. An apparatus for securing the storage of a blood product in a lockable refrigerated storage compartment, said apparatus comprising:

(a) a computer;

(b) software installed on said computer, wherein said software in combination with said computer is capable of instructing said lockable refrigerator to become locked or to become unlocked;

(c) a reader connected to said computer;

(d) a speaker connected to said computer; and

(e) a touch screen, wherein said touch screen provides a visual display and a touch operated user interface for operating said software installed on said computer.

31. The apparatus of claim 30 wherein said reader is selected from the group consisting of a barcode scanner and an RFID reader.

32. The apparatus of claim 31 wherein said reader is a barcode scanner capable of reading both linear and two-dimensional barcodes.

33. The apparatus of claim 30 wherein said computer is connected to a transfusion database.

34. The apparatus of claim 33 wherein said transfusion database is shared between more than one apparatus of claim 30.

35. The apparatus of claim 30 wherein said software determines if the caregiver identified by said caregiver code is authorized to collect blood units.

36. The apparatus of claim 35 wherein when said caregiver is authorized to collect blood units, two buttons are displayed on said touch screen wherein a first of said two buttons indicates that caregiver is adding a blood product to said refrigerator and wherein a second of said two buttons indicates that a caregiver is removing a blood product from said refrigerator.

37. The apparatus of claim 36 wherein if caregiver touches said second of said two buttons, said touch screen in combination with said speaker asks caregiver to identify a specific blood unit the caregiver wishes to remove.

38. The apparatus of claim 36 wherein said lock becomes unlocked in connection with the selection of said identified blood unit.

39. The apparatus of claim 38 wherein said software is capable of using said touch screen and said speaker to request said caregiver to read a printed blood product request slip.

40. The apparatus of claim 38 wherein said software is capable of retrieving records from said transfusion database to determine if said blood product is useable and retrieving records from said transfusion database to determine the patient to which said blood unit was assigned, and wherein said software compares this information to that encoded on said request slip.

41. The apparatus of claim 31 wherein said reader is an RFID reader and wherein said compatibility label on said blood unit and said blood product request slip each comprise an RFID tag.

42. The apparatus of claim 41 wherein said reader reads said caregiver code located on said caregiver'"'"'s identification when said caregiver'"'"'s identification is within range of said reader.

43. The apparatus of claim 31 wherein said software on said computer is capable of instructing said reader to read said RFID tag on every blood unit inside said refrigerator in order to establish an inventory of said blood units, and engaging or disengaging said lock.

44. The apparatus of claim 43 wherein said software on said computer is capable of instructing said reader to read the RFID tagged request slip and comparing a patient identification retrieved from said transfusion database and data read from a request slip to determine if the two match and if the blood unit has been outside of a refrigerated storage compartment for more than a specified period of time.

45. A method for recording an audit trail for a blood transfusion, said method comprising the steps of:

(a) allocating from a supply of blood, a blood transfusion unit for a patient wherein the blood transfusion unit is marked with an identifying code;

(b) labeling the blood transfusion unit with a compatibility level having patient identification information and said blood transfusion unit identifying code;

(c) generating a blood request form for the patient, the blood request including patient identification information;

(d) placing the blood unit in a secured location for collection by a person authorized to collect said blood transfusion unit;

(e) recording on the blood request form for said patient (i) identification information for said authorized person collecting said blood transfusion unit, (ii) the time of collection, and (iii) the patient identification information;

(f) providing the patient with a wristband having patient identification information;

(g) recording identification information for the person performing a blood transfusion for said patient;

(h) recording the patient identification information on the patient wristband;

(i) recording the patient identification information on the compatibility label;

(j) recording the blood unit identification code on the compatibility label;

(k) recording the blood unit identification code on the blood unit;

(l) comparing the patient identification information on the patient wristband with the patient identification information on the compatibility label, and recording the results of the comparison; and

(m) comparing the blood unit identification code on the compatibility label and the blood unit identification code on the blood unit and recording the result of the comparison.

46. The method of claim 45, further comprising the step of producing a warning if the patient identification information on the wristband does not match the patient identification on the compatibility label.

47. The method of claim 45, further comprising the step of producing a warning if the blood unit identification code on the compatibility label does not match the blood unit identification code on the blood unit.

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

(a) recording the time at which the blood unit is transfused;

(b) comparing to the time of transfusion to the time the blood unit was collected and calculating the time elapsed between the time of transfusion and the time of collection; and

(c) providing a warning if the elapsed time is greater than a pre-set limit.

49. The method of claim 48, further comprising the step of recording the vital signs of the patient as the transfusion begins.

50. A method for ensuring that a medical procedure, such as blood transfusion, is correctly performed, said method comprising the steps of:

(a) providing a patient with a wristband having patient identification information;

(b) instructing the caregiver to record caregiver identification information;

(c) instructing the caregiver to record said patient'"'"'s identification information;

(d) instructing the caregiver to record said patient'"'"'s vital signs; and

(e) instructing the caregiver to record responses to a pre-defined series of operations.

51. A method for ensuring the viability of blood to be transfused, said method comprising the steps of:

(a) providing a blood unit identifying code for a blood unit;

(b) recording said blood unit identifying code when said blood unit is removed from a first refrigerated storage compartment;

(c) recording the time at which said blood unit is removed from said first refrigerated storage compartment;

(d) recording said blood unit identifying code when said blood unit is returned to a second refrigerated storage compartment;

(e) recording the time at which said blood unit is returned to said second refrigerated storage compartment;

(f) comparing the time said blood unit was removed from said first refrigerated storage compartment to the time said blood unit was returned to said second refrigerated storage compartment and calculating the time that the blood unit was outside of a refrigerated storage compartment; and

(g) providing a warning if said blood unit was outside of a refrigerator for more than a pre-set time limit.

52. A method for transfusing blood or a blood product into a patient, said method comprising the steps of:

(a) obtaining patient identification information from said patient;

(b) recording in a database said patient identification information;

(c) collecting a blood sample from said patient;

(d) testing said blood sample to determine the patient'"'"'s blood type;

(e) recording in said database said patient'"'"'s blood type;

(f) allocating for said patient a blood unit comprising said patient'"'"'s blood type, said patient allocated blood unit having a unique identifying code;

(g) recording in said database said patient allocated blood unit'"'"'s identifying code;

(h) making a request for said patient allocated blood unit;

(i) recording in said database said request for said patient allocated blood unit;

(j) transporting said patient allocated blood unit to the location of said patient;

(k) transfusing said patient with said patient allocated blood unit; and

(l) recording in said database information concerning the transfusion of said patient allocated blood unit.

53. A method for recording the movement of a blood product unit into and out of a refrigerated storage compartment, said method comprising the steps of:

(a) labelling said blood product unit with a Radio Frequency Identification (RFID) tag wherein said RFID tag comprises a blood unit identification code;

(b) providing a person authorized to move said blood product into or out of a refrigerated storage compartment with an RFID tag comprising a user identification code;

(c) providing a first RFID tag reader in the vicinity of said refrigerated storage compartment;

(d) providing a second RFID tag reader to be carried by said user;

(e) providing a computer connected to said first and said second RFID tag reader.

54. The method of claim 53 wherein said computer comprises software capable of performing the steps of:

(a) recording at pre-determined intervals a blood product unit identification code for a blood product unit located within said refrigerated compartment;

(b) recording said user identification code of a user in the vicinity of the refrigerated storage compartment;

(c) determining if a blood unit has been added to or removed from the inside of said refrigerated storage compartment; and

(d) storing a record of the removal or addition of any blood units.

55. The method of claim 54 wherein said computer software is capable of performing the following steps:

(a) recording the time and date at which a blood unit is removed from said first refrigerated storage compartment;

(b) recording the time and date at which said blood unit is returned to a second refrigerated storage compartment; and

(c) activating a warning means if said blood unit is out of said first refrigerated storage compartment for longer than a pre-determined time.

56. The method of claim 55 wherein said first refrigerated storage compartment and said second refrigerated storage compartment further comprise a locking device, wherein said locking device locks either of said refrigerated storage compartments when said RFID tag reader carried by said user is unable to read a user identification code in the vicinity of either of said refrigerated storage device.

57. The method of claim 56 wherein each of said refrigerated storage compartments comprises an RFID tag reader and a computer and wherein each of said computers is capable of sharing records over a computer network.

58. An apparatus for recording the movement of blood products into and out of a refrigerator, said apparatus comprising:

(a) a first Radio Frequency Identification (RFID) tag attached to a blood unit, wherein said RFID tag encodes a blood unit identification code for said blood unit;

(b) a second RFID tag for a user of said apparatus, wherein said second RFID tag encodes a user identification code;

(c) an antenna disposed to read all RFID tags inside and in the vicinity of a refrigerated storage compartment;

(d) a device for receiving data via said antenna from said first RFID tag and said second RFID tag and sending said received data to a computer; and

(e) a computer for receiving data from said data receiving device.

59. The apparatus of claim 58 wherein said computer comprises software capable of performing the following steps:

(a) recording, at a pre-determined interval, said blood unit identification code on a blood unit within the refrigerated storage compartment;

(b) recording said user identification code of a user in the vicinity of said refrigerated storage compartment;

(c) determining if a blood unit has been placed into or removed from said refrigerated storage compartment by detecting said blood unit identification code; and

(d) storing a record of the presence or absence of said blood unit having said blood unit identification code.

60. The apparatus of claim 59, further comprising a lock for locking said refrigerated storage compartment, wherein said lock is connected to said computer and wherein said lock is in a locked position when said second RFID tag is undetected.

61. The apparatus of claim 59 wherein said refrigerated storage compartment is divided into one or more sub-compartment, wherein each said sub-compartment comprises a second lock and wherein said computer unlocks a sub-compartment containing a blood product comprising said first RFID tag.

62. An apparatus for recording the movement of blood products into and out of a refrigerated storage compartment, said apparatus comprising:

(a) a barcode label attached to a blood product unit, wherein said barcode label comprises a blood unit identification code for said blood product unit;

(b) a barcode label for a user of said apparatus, wherein said user barcode label comprises a user identification code for said user;

(c) a barcode reader for reading the barcode label on said blood product unit and the barcode label of said user;

(d) a refrigerated storage compartment comprising one or more compartment(s), each of said compartment(s) being equipped with an electronically controlled lock;

(e) a computer for receiving data from each of said barcode readers.

63. The apparatus of claim 62 wherein said computer comprises software that is capable of performing the following functions:

(a) reading the barcode for said user;

(b) receiving patient identification information from said user;

(c) receiving compatibility information about a blood unit requested for said patient;

(d) unlocking a compartment to permit user access to said requested blood unit; and

(e) storing a record of said user barcode and said blood unit barcode.

64. A method for collecting and storing information about blood transfusions in a computer database, said method comprising the steps of:

(a) providing a reader for patient identification information on a patient wristband;

(b) printing a sample identification label for a blood sample collected from said patient, wherein said sample identification label comprises said patient identification information;

(c) transmitting said patient identification information to a computer database when a sample identification label is printed and/or when a blood sample is collected;

(d) testing said blood sample;

(e) selecting a blood unit suitable for transfusion into said patient, wherein said blood unit is marked with a unique blood unit identification code;

(f) printing and applying a compatibility label to said selected blood unit wherein said compatibility label comprises said patient identification information and said blood unit identification code;

(g) reading said patient identification information and said blood unit identification code from said compatibility label;

(h) reading said patient identification information from said wristband, and comparing said wristband patient identification information to patient identification information on said compatibility label;

(i) comparing the blood unit identification code on said compatibility label with the blood unit identification code on said blood unit;

(j) providing a warning if the wristband patient identification information does not match the patient identification information on said compatibility label or if the blood unit identification code on said compatibility label does not match the blood unit identification code on said blood unit; and

(k) transmitting the patient identification read from the patient wristband, the blood unit identification read from the blood unit, and the patient identification and blood unit identification read from the compatibility label to a computer database.

65. The apparatus of claim 64, further comprising a means for retrieving data from the computer database so that information collected with respect to a particular patient or particular blood unit can be reviewed.

66. A method for ensuring that a person performing a procedure follows a pre-defined sequence of actions, said method comprising the steps of:

(a) providing a portable display for displaying instructions to a user;

(b) providing a reader for reading an electronically readable indicia;

(c) providing an electronically readable indicia to identify said user;

(d) providing an electronically readable indicia on an item to be used in said procedure;

(e) displaying instructions on said portable display.

67. The method of claim 66 wherein said instructions tell the user to perform the following steps:

(a) read the electronically readable indicia identifying the user;

(b) read the electronically readable indicia on an item to be used in the procedure; and

(c) perform the steps of the procedure.

68. A method for managing the remote electronic issue of a blood unit for a patient, said method comprising the steps of:

(a) reading patient identification information;

(b) querying a blood bank computer with said patient identification to determine if said patient is suitable for electronic issue of said blood unit and to determine the appropriate type of blood unit to select;

(c) selecting and scanning said blood unit for said patient;

(d) printing a compatibility label;

(e) scanning said blood unit and said label to confirm a match between said unit and said label; and

(f) controlling a refrigerated storage compartment with an electronic lock to ensure that only the appropriate type of blood is accessible for pickup.

69. The method of claim 68 wherein said refrigerated storage compartment comprises two or more sub-compartments wherein each of said sub-compartments comprises an electronic lock.

70. A system for facilitating a complex process such as blood transfusion, said system comprising:

(a) a portable computer comprising audible and visible prompts; and

(b) a series of instructions to achieve the following;

(i) scanning of an electronically readable indicia;

(ii) confirming data; and

(iii) entering data.