Electronic custody and control system for human assay test samples

• US 20040033501A1
• Filed: 08/19/2002
• Published: 02/19/2004
• Est. Priority Date: 08/19/2002
• Status: Active Grant

• Current Assignee: eScreen (Abbott Laboratories Incorporated)
• Original Assignee: E-Screen, Inc.
• Inventors: Rein, Brad, Lappe, Murray
• Granted Patent: US 8,200,438 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: G01N 33/483 Physical analysis of biological material
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06V 30/36 Matching; Classification
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system, method, and computer program that may used to more quickly, accurately, and efficiently identify, catalog, and track human assay samples and create documentation with respect to the human assay samples. The computer program and method include the steps of: storing donor information in a donor information database accessible by a computer; storing client information in a client information database accessible by the computer; retrieving client information necessary to determine a type of test to be performed on a specimen; storing collection facility information in a collection facility database accessible by the computer; administering a human analyte test using the computer program to guide a collector of the specimen and identify problematic exceptions; receiving the test result electronically and storing the result in a test result database accessible by the computer; and permitting the client, Medical Review Officer, and other authorized persons to electronically access the test result via a communications network.

Claims

1. A method for identifying, cataloging, and tracking human analyte samples, the method comprising the steps of:

obtaining donor information about a donor from whom a specimen is collected;

storing the donor information in a computer-accessible memory;

collecting the human analyte specimen from the donor;

obtaining a test result for the specimen;

storing the test result in the computer-accessible memory; and

permitting authorized persons to retrieve the donor information and the test result electronically via a communications network.

2. The method as set forth in claim 1, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

3. The method as set forth in claim 1, wherein the human analyte specimen is selected from the group consisting of urine, blood, breath, saliva, hair, and sweat.

4. The method as set forth in claim 1, wherein the test result is obtained from an instant testing device.

5. The method as set forth in claim 1, wherein the test result is obtained from a lab.

6. The method as set forth in claim 4, wherein the test result is electronically received from an instant testing device.

7. The method as set forth in claim 5, wherein the test result is electronically received from a lab via the communications network.

8. The method as set forth in claim 1, wherein the authorized persons include clients, Medical Review Officers, and other collection facilities.

9. A computer program stored on a computer-readable medium for directing operation of a computer to assist an entity in identifying, cataloging, and tracking human analyte samples, the computer program comprising:

a code segment operable to receive donor information about a donor from whom a specimen is collected;

a code segment operable to store the donor information in a computer-accessible memory;

a code segment operable to assist a user in collecting the human analyte specimen from the donor;

a code segment operable to receive a test result for the specimen;

a code segment operable to store the test result in the computer-accessible memory; and

a code segment operable to permit authorized persons to retrieve the donor information and the test result electronically via a communications network.

10. The computer program as set forth claim 9, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

11. The computer program as set forth in claim 9, wherein the human analyte specimen is selected from the group consisting of urine, blood, breath, saliva, hair, and sweat.

12. The computer program as set forth in claim 9, wherein the test result is obtained from an instant testing device.

13. The computer program as set forth in claim 9, wherein the test result is obtained from a lab.

14. The computer program as set forth in claim 12, wherein the test result is electronically received from an instant testing device.

15. The computer program as set forth in claim 13, wherein the test result is electronically received from a lab via the communications network.

16. The computer program as set forth in claim 9, wherein the authorized persons include clients, Medical Review Officers, and other collection facilities.

17. A method of tracking the custody and control of a specimen, the method comprising the steps of:

collecting a human analyte specimen from a donor;

identifying the specimen using a unique identifier;

entering the unique identifier into a computer;

storing the unique identifier in a computer-accessible memory; and

creating an electronic Custody and Control form (CCF) for the specimen, the Custody and Control form including the unique identifier which identifies the specimen.

18. The method as set forth in claim 17, further including the steps of:

obtaining donor information about the donor from whom the specimen is collected;

storing the donor information in the computer-accessible memory;

obtaining client information with respect to the donor from whom the specimen is collected;

storing the client information in the computer-accessible memory;

obtaining collection facility information about a collection facility collecting the specimen from the donor;

storing the collection facility information in the computer-accessible memory;

creating an electronic Custody and Control form (CCF) for the specimen, the Custody and Control form further including the donor information, the client information, and the collection facility information; and

permitting authorized persons to electronically access the Custody and Control form to reference information contained in the Custody and Control form.

19. The method as set forth in claim 18, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

20. The method as set forth in claim 18, the client information including the client'"'"'s name, address, billing number, and contact person.

21. The method as set forth in claim 20, wherein the client is an employer or a potential employer of the donor to be tested.

22. The method as set forth in claim 18, the collection facility information including the collection facility'"'"'s name, address, identification number, and a name of a collector collecting the specimen.

23. The method as set forth in claim 17, wherein the human analyte specimen is selected from the group consisting of urine, blood, breath, saliva, hair, and sweat.

24. The method as set forth in claim 17, wherein the unique identifier is a bar code.

25. The method as set forth in claim 17, wherein the unique identifier is stored in a unique identifier database.

26. The method as set forth in claim 17, wherein the unique identifier is attached to a specimen container containing the specimen.

27. The method as set forth in claim 17, wherein the unique identifier is read from an instant testing device.

28. The method as set forth in claim 17, wherein the unique identifier is manually entered into the computer.

29. The method as set forth in claim 17, wherein the unique identifier is electronically transmitted to the computer.

30. The method as set forth in claim 18, the CCF further including:

a lab identification number and account number;

a Medical Review Officer'"'"'s name;

an indication of whether the specimen was within an acceptable temperature range;

an indication that the donor'"'"'s identification was verified;

information regarding the type of specimen;

a reason for taking the test;

the donor'"'"'s signature;

the name of the collector collecting the specimen;

the signature of the collector;

a lab personnel'"'"'s signature;

an indication whether the test result is negative; and

the MRO'"'"'s signature.

31. The method as set forth in claim 30, wherein the CCF is created using the unique identifier attached to a specimen container containing the specimen.

32. The method as set forth in claim 30, wherein the CCF is created using the unique identifier read from an instant testing device.

33. The method as set forth in claim 30, wherein the CCF is electronically retrieved from a computer-accessible memory.

34. The method as set forth in claim 33, wherein the CCF is electronically accessed via a communications network.

35. The method as set forth in claim 33, wherein the CCF is electronically retrievable by cross-referencing the donor'"'"'s first or last name or the donor'"'"'s social security number with the donor information database.

36. The method as set forth in claim 33, wherein the CCF is electronically retrievable by cross-referencing the unique identifier with the unique identifier database.

37. A computer program stored on a computer-readable medium for directing operation of a computer to assist an entity in identifying, cataloging, and tracking human analyte samples, the computer program comprising:

a code segment operable to assist a collector in collecting a human analyte specimen from a donor;

a code segment operable to identify the specimen using a unique identifier;

a code segment operable to receive the unique identifier;

a code segment operable to store the unique identifier in a computer-accessible memory; and

a code segment operable to create an electronic Custody and Control form (CCF) for the specimen, the Custody and Control form including the unique identifier which identifies the specimen.

38. A computer program as set forth in claim 37, further comprising:

a code segment operable to receive donor information about a donor to be tested;

a code segment operable to store the donor information in the computer-accessible memory;

a code segment operable to receive client information with respect to the donor from whom a specimen is collected;

a code segment operable to store the client information in the computer-accessible memory;

a code segment operable to receive collection facility information about a collection facility collecting the specimen from the donor;

a code segment operable to store the collection facility information in the computer-accessible memory;

a code segment operable to create an electronic Custody and Control form (CCF) for the specimen, the Custody and Control form further including the donor information, the client information, and the collection facility information; and

a code segment operable to permit authorized persons to electronically access the Custody and Control form to reference information contained in the Custody and Control form.

39. The computer program as set forth in claim 38, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

40. The computer program as set forth in claim 39, wherein the donor information is stored in a donor information database.

41. The computer program as set forth in claim 38, the client information includes client'"'"'s name, address, billing number, and contact person.

42. The computer program as set forth in claim 41, wherein the client is an employer or a potential employer of the donor to be tested.

43. The computer program as set forth in claim 38, the collection facility information including the collection facility'"'"'s name, address, identification number, and a name of a collector collecting the specimen.

44. The computer program as set forth in claim 37, wherein the human analyte specimen is selected from the group consisting of urine, blood, breath, saliva, hair, and sweat.

45. The computer program as set forth in claim 37, wherein the unique identifier is a bar code.

46. The computer program as set forth in claim 45, wherein the unique identifier is stored in a unique identifier database.

47. The computer program as set forth in claim 45, wherein the unique identifier is attached to a specimen container containing the specimen.

48. The computer program as set forth in claim 38, wherein the unique identifier is manually entered into the computer.

49. The computer program as set forth in claim 38, wherein the unique identifier is electronically transmitted to the computer.

50. The computer program as set forth in claim 38, the CCF further including:

a lab identification number and account number;

a Medical Review Officer'"'"'s name;

an indication of whether the specimen was within an acceptable temperature range;

an indication that the donor'"'"'s identification was verified;

information regarding the type of specimen;

a reason for taking the test;

the donor'"'"'s signature;

the name of the collector collecting the specimen;

a signature of the collector;

a lab personnel'"'"'s signature;

an indication whether the test result is negative; and

the MRO'"'"'s signature.

51. The computer program as set forth in claim 50, wherein the CCF is electronically retrieved from a computer-accessible memory.

52. The computer program as set forth in claim 51, wherein the CCF is electronically accessed via a communications network.

53. The computer program as set forth in claim 51, wherein the CCF is electronically retrievable by cross-referencing the donor'"'"'s first or last name or the donor'"'"'s social security number with the donor information database.

54. The computer program as set forth in claim 51, wherein the CCF is electronically retrievable by cross-referencing the unique identifier with the unique identifier database.

55. A method for identifying, cataloging, and tracking human analyte samples, the method comprising the steps of:

obtaining donor information about a donor from whom a specimen is collected;

storing the donor information in a computer-accessible memory;

collecting the human analyte specimen from the donor;

obtaining a test result for the specimen;

storing the test result in the computer-accessible memory;

creating an electronic report containing the test result; and

permitting authorized persons to retrieve the electronic report via a communications network.

56. The method as set forth in claim 55, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

57. The method as set forth in claim 56, wherein the donor information is stored in a donor information database.

58. The method as set forth in claim 55, wherein the human analyte specimen is selected from the group consisting of urine, blood, breath, saliva, hair, and sweat.

59. The method as set forth in claim 55, wherein a unique identifier identifying the specimen is attached to a container holding the specimen.

60. The method as set forth in claim 59, wherein the unique identifier is a bar code.

61. The method as set forth in claim 55, wherein the collection of the human analyte specimen is documented with a unique identifier.

62. The method as set forth in claim 61, wherein the unique identifier documenting the collection of the human analyte specimen is a bar code.

63. The method as set forth in claim 59, wherein the unique identifier attached to the container holding the specimen is stored in a unique identifier database.

64. The method as set forth in claim 61, wherein the unique identifier documenting the collection of the human analyte specimen is stored in a unique identifier database.

65. The method as set forth in claim 55, wherein the test result is obtained from an instant testing device.

66. The method as set forth in claim 55, wherein the test result is obtained from a lab.

67. The method as set forth in claim 55, wherein the test result is stored in the test result database.

68. The method as set forth in claim 65, wherein the test result stored in the test result database is electronically received from an instant testing device.

69. The method as set forth in claim 55, wherein the test result stored in the test result database is electronically received from a lab via the communications network.

70. The method as set forth in claim 57, wherein the electronic report is electronically retrievable via the communications network by cross-referencing the donor'"'"'s first or last name or the donor'"'"'s social security number with the donor information database.

71. The method as set forth in claim 63, wherein the electronic report is electronically retrievable via the communications network by cross-referencing the unique identifier attached to the container holding the specimen with the unique identifier database.

72. The method as set forth in claim 64, wherein the electronic report is electronically retrievable via the communications network by cross-referencing the unique identifier documenting the collection of the human analyte specimen with the unique identifier database.

73. A computer program stored on a computer-readable medium for directing operation of a computer to assist an entity in identifying, cataloging, and tracking human analyte samples, the computer program comprising:

a code segment operable to receive donor information about a donor from whom a specimen is collected;

a code segment operable to store the donor information in a computer-accessible memory;

a code segment operable to assist a user in collecting the human analyte specimen from the donor;

a code segment operable to receive a test result for the specimen;

a code segment operable to store the test result in the computer-accessible memory;

a code segment operable to create an electronic report containing the test result; and

a code segment operable to permit authorized persons to retrieve the electronic report via a communications network.

74. The computer program as set forth in claim 73, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

75. The computer program as set forth in claim 73, wherein the donor information is stored in a donor information database.

76. The computer program as set forth in claim 73, wherein the human analyte specimen is selected from the group consisting of urine, blood, breath, saliva, hair, and sweat.

77. The computer program as set forth in claim 73, wherein a bar code is written on a container holding the specimen.

78. The computer program as set forth in claim 73, wherein the collection of the human analyte specimen is documented with a bar code.

79. The computer program as set forth in claim 77, wherein the bar code written on the container holding the specimen is stored in a bar code database.

80. The computer program as set forth in claim 78, wherein the bar code documenting the collection of the human analyte specimen is stored in a bar code database.

81. The computer program as set forth in claim 73, wherein the test result is obtained from an instant testing device.

82. The computer program as set forth in claim 73, wherein the test result is obtained from a lab.

83. The computer program as set forth in claim 73, wherein the test result is stored in the test result database.

84. The computer program as set forth in claim 83, wherein the test result stored in the test result database is electronically received from an instant testing device.

85. The computer program as set forth in claim 83, wherein the test result stored in the test result database is electronically received from a lab via the communications network.

86. The computer program as set forth in claim 75, wherein the electronic report is electronically retrievable via the communications network by cross-referencing the donor'"'"'s first or last name or the donor'"'"'s social security number with the donor information database.

87. The computer program as set forth in claim 79, wherein the electronic report is electronically retrievable via the communications network by cross-referencing the bar code written on the container holding the specimen with the bar code database.

88. The computer program as set forth in claim 80, wherein the electronic report is electronically retrievable via the communications network by cross-referencing the bar code documenting the collection of the human analyte specimen with the bar code database.

89. A method for identifying, cataloging, and tracking human analyte samples, the method comprising the steps of:

maintaining in a computer a donor information database containing donor information for at least one donor;

maintaining in the computer a client information database containing client information for at least one client;

retrieving client information necessary to determine a type of test to be performed on a specimen;

collecting the human analyte specimen from the donor;

administering a human analyte test on the specimen;

reading a unique identifier identifying the specimen;

transmitting the unique identifier to a unique identifier database containing unique identifiers for at least one specimen;

obtaining a test result for the specimen;

storing the test result in a test result database containing test results for at least one test;

creating a Custody and Control form for the specimen, the Custody and Control form including the unique identifier which identifies the specimen; and

permitting authorized persons to retrieve the test result electronically via a communications network.

90. The method as set forth in claim 89, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

91. The method as set forth in claim 89, the client information including the client'"'"'s name, address, phone number, account number, and the test(s) to be performed on the specimen.

92. The method as set forth in claim 89, wherein the test meets the procedural requirements for the Department of Transportation.

93. The method as set forth in claim 89, wherein the test is any human analyte test.

94. The method as set forth in claim 89, wherein a collector of the specimen examines the specimen for signs of adulteration

95. The method as set forth in claim 89, wherein a collector of the specimen determines the temperature of the specimen.

96. The method as set forth in claim 89, wherein the unique identifier is a bar code.

97. The method as set forth in claim 96, wherein the bar code is written on the specimen container or on a label attached to the specimen container.

98. The method as set forth in claim 89, wherein the collection of the human analyte specimen is documented with a unique identifier.

99. The method as set forth in claim 98, wherein the unique identifier documenting the collection of the human analyte specimen is a bar code.

100. The method as set forth in claim 97, wherein the bar code is read from the specimen container with a bar code scanner/reader.

101. The method as set forth in claim 100, wherein the bar code is transmitted to the computer by a scanner/reader.

102. The method as set forth in claim 99, wherein the bar code documenting the specimen collection is manually entered into the computer.

103. The method as set forth in claim 89, wherein the test result stored in the test result database is electronically received from an instant testing device.

104. The method as set forth in claim 89, wherein the test result stored in the test result database is electronically received from a lab via the communications network.

105. The method as set forth in claim 103, wherein the test result that is electronically received from the instant testing device includes information regarding whether the test result is negative or non-negative.

106. The method as set forth in claim 104, wherein the test result that is electronically received from the lab via the communications network includes information regarding whether the test result is negative or non-negative.

107. The method as set forth in claim 89, the CCF further including:

a lab identification number and account number;

information regarding the client;

a name of a Medical Review Officer;

an indication of whether the specimen was within an acceptable temperature range;

an indication that the donor'"'"'s identification was verified;

information regarding the type of specimen;

a reason for taking the test;

information regarding the donor;

the donor'"'"'s signature;

information regarding a collection facility;

a name of the collector collecting the specimen;

a signature of the collector;

a lab personnel'"'"'s signature;

an indication whether the test result is negative; and

the MRO'"'"'s signature.

108. The method as set forth in claim 89, wherein the test result is electronically accessed by clients, Medical Review Officers, and other collection facilities.

109. A computer program stored on a computer-readable medium for directing operation of a computer to assist an entity in identifying, cataloging, and tracking human analyte samples, the computer program comprising:

a code segment operable to maintain in a computer a donor information database containing donor information for at least one donor;

a code segment operable to maintain in the computer a client information database containing client information for at least one client;

a code segment operable to store client information necessary to determine a type of test to be performed on a specimen;

a code segment operable to assist a collector in collecting the human analyte specimen from the donor;

a code segment operable to assist the collector in administering a human analyte test on the specimen;

a code segment operable to read a unique identifier identifying the specimen;

a code segment operable to transmit the unique identifier to a unique identifier database containing unique identifiers for at least one specimen;

a code segment operable to receive a test result for the specimen;

a code segment operable to store the test result in a test result database containing test results for at least one test;

a code segment operable to create a Custody and Control form for the specimen, the Custody and Control form including the unique identifier which identifies the specimen; and

a code segment operable to permit authorized persons to retrieve the test result electronically via a communications network.

110. The computer program as set forth in claim 109, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

111. The computer program as set forth in claim 109, the client information including the client'"'"'s name, address, phone number, account number, and the test(s) to be performed on the specimen.

112. The computer program as set forth in claim 109, wherein the test meets the procedural requirements for the Department of Transportation.

113. The computer program as set forth in claim 109, wherein the test is any human analyte test.

114. The computer program as set forth in claim 109, wherein the collector of the specimen examines the specimen for signs of adulteration

115. The computer program as set forth in claim 109, wherein the collector of the specimen determines the temperature of the specimen.

116. The computer program as set forth in claim 109, wherein the unique identifier is a bar code.

117. The computer program as set forth in claim 116, wherein the bar code is written on the specimen container or on a label attached to the specimen container.

118. The computer program as set forth in claim 109, wherein the collection of the human analyte specimen is documented with a unique identifier.

119. The computer program as set forth in claim 118, wherein the unique identifier documenting the collection of the human analyte specimen is a bar code.

120. The computer program as set forth in claim 117, wherein the bar code is read from the specimen container with a bar code scanner/reader.

121. The computer program as set forth in claim 120, wherein the bar code is transmitted to the computer by the scanner/reader.

122. The computer program as set forth in claim 119, wherein the bar code documenting the specimen collection is manually entered into the computer.

123. The computer program as set forth in claim 109, wherein the test result stored in the test result database is electronically received from an instant testing device.

124. The computer program as set forth in claim 109, wherein the test result stored in the test result database is electronically received from a lab via the communications network.

125. The computer program as set forth in claim 123, wherein the test result that is electronically received from the instant testing device includes information regarding whether the test result is negative or non-negative.

126. The computer program as set forth in claim 124, wherein the test result that is electronically received from the lab via the communications network includes information regarding whether the test result is negative or non-negative.

127. The computer program as set forth in claim 109, the CCF further including:

a lab identification number and account number;

information regarding the client;

a Medical Review Officer'"'"'s name;

an indication of whether the specimen was within an acceptable temperature range;

an indication that the donor'"'"'s identification was verified;

information regarding the type of specimen;

a reason for taking the test;

information regarding the donor;

the donor'"'"'s signature;

information regarding the collection facility;

the name of the collector collecting the specimen;

a signature of the collector;

a lab personnel'"'"'s signature;

an indication whether the test result is negative; and

the MRO'"'"'s signature.

128. The computer program as set forth in claim 109, wherein the test result is electronically accessed by clients, Medical Review Officers, and other collection facilities.

129. A method for identifying, cataloging, and tracking human analyte samples, the method comprising the steps of:

obtaining donor information about a donor from whom a specimen is collected;

storing the donor information in a computer-accessible memory;

collecting the human analyte specimen from the donor;

storing a test result in the computer-accessible memory; and

permitting authorized persons to retrieve the donor information and the test result electronically via a communications network.

130. The method as set forth in claim 129, the donor information including the donor'"'"'s first and last name, social security number, date of birth, and daytime and evening phone number(s).

131. The method as set forth in claim 129, wherein the human analyte specimen is selected from the group consisting of urine, blood, breath, saliva, hair, and sweat.

132. The method as set forth in claim 129, wherein the test result is obtained from an instant testing device.

133. The method as set forth in claim 129, wherein the test result is obtained from a lab.

134. The method as set forth in claim 132, wherein the test result is electronically received from an instant testing device.

135. The method as set forth in claim 133, wherein the test result is electronically received from a lab via the communications network.

136. The method as set forth in claim 129, wherein the authorized persons include clients, Medical Review Officers, and other collection facilities.