Method and computer program for creating electronic custody and control forms for human assay test samples

• US 8,200,438 B2
• Filed: 08/19/2002
• Issued: 06/12/2012
• Est. Priority Date: 08/19/2002
• Status: Expired due to Term

• Current Assignee: eScreen (Abbott Laboratories Incorporated)
• Original Assignee: eScreen (Abbott Laboratories Incorporated)
• Inventors: Lappe, Murray, Rein, Brad
• Primary Examiner(s): LY, CHEYNE D
• Application Number:
  US10/224,233
• Publication Number:
  US 20040033501A1
• Time in Patent Office: 3,585 Days
• Field of Search: 702/19, 281/900, 705/2, 705/3, 700/225, 726/26, 283/67
• US Class Current: 702/19
• 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 quickly, accurately, and efficiently identifies, catalogs, and tracks human assay samples and creates documentation for 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 of assisting an entity in tracking the custody and control of a human analyte specimen provided by a donor, wherein a client is requesting that the donor provide the specimen so that a test of the specimen can be performed, the method comprising the steps of:

collecting the human analyte specimen from the donor;

storing the specimen in a container associated with a unique identifier, wherein the unique identifier is a bar code;

entering the unique identifier into a computer by scanning the bar code with a bar code reader;

creating a computer-generated Custody and Control Form (CCF) that associates the specimen with the donor,

wherein the CCF is electronically available to the client via a web application;

receiving an electronic signature, wherein the electronic signature is provided by the donor by applying the donor'"'"'s handwritten signature to an electronic signature reader;

storing said electronic signature as part of the CCF; and

enabling said client access to the CCF via said web application.

2. The method as set forth in claim 1, further including the steps of:

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

storing the client information in a 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;

populating the CCF with the donor information, the client information, and the collection facility information; and

permitting authorized persons to electronically access the CCF to reference information contained in the CCF.

3. The method as set forth in claim 2, the collection facility information including the collection facility'"'"'s name, address, identification number, and a name of a collector collecting the specimen.

4. 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.

5. The method as set forth in claim 1, wherein the unique identifier is stored in a unique identifier database.

6. The method as set forth in claim 2, the CCF further including:

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 a collector collecting the specimen; and

the signature of the collector.

7. The method as set forth in claim 6, wherein the CCF is electronically retrieved from the computer-accessible memory.

8. The method as set forth in claim 7, wherein the CCF is electronically accessed via a communications network.

9. The method as set forth in claim 7, wherein the CCF is electronically retrievable by cross-referencing a first or last name or a social security number of the donor with the donor information database.

10. The method as set forth in claim 5, wherein the CCF is electronically retrievable by cross-referencing the unique identifier with the unique identifier database.

19. The method as claimed in claim 1, wherein the step of creating the computer-generated CCF is performed subsequent to entering the unique identifier into the computer.

20. The method as claimed in claim 1, wherein the step of creating the electronic CCF is performed subsequent to entering the unique identifier into the computer, such that the donor is not associated with the specimen container until the unique identifier is entered into the computer.

11. A non-transitory computer-readable medium encoded with code segments for directing operation of at least one computer to assist an entity in tracking the custody and control of a human analyte specimen provided by a donor, wherein a client is requesting that the donor provide the specimen so that a test of the specimen can be performed, the computer-readable medium comprising:

a code segment executed by the at least one computer for assisting a collector in collecting the human analyte specimen from the donor, wherein the specimen is stored in a container associated with a unique identifier,

wherein the unique identifier is a bar code;

a code segment executed by the at least one computer for receiving a scan of the bar code;

a code segment executed by the computer for entering information indicative of the bar code into the computer;

a code segment executed by the at least one computer for creating a computer-generated Custody and Control Form (CCF) that associates the specimen with the donor,

wherein the CCF is electronically available to the client via a web application;

a code segment executed by the at least one computer for receiving an electronic signature from an electronic signature reader, wherein the electronic signature is provided by a donor by signing the electronic signature reader;

a code segment executed by the at least one computer for storing said electronic signature as part of the CCF; and

a code segment executed by the at least one computer for enabling said client access to the CCF via said web application.

12. The computer readable-medium as set forth in claim 11, further comprising:

a code segment executed by the at least one computer for receiving client information with respect to the donor from whom the specimen is collected;

a code segment executed by the at least one computer for storing client information in a client information database stored on a computer-accessible memory;

a code segment executed by the at least one computer for receiving collection facility information about a collection facility collecting the specimen from the donor;

a code segment executed by the at least one computer for storing the collection facility information in a collection facility database stored on the computer-accessible memory; and

a code segment executed by the computer for permitting authorized persons to electronically access the CCF to reference information contained in the CCF.

13. The computer readable-medium as set forth in claim 12, the collection facility information including the collection facility'"'"'s name, address, identification number, and a name of a collector collecting the specimen.

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

15. The computer readable-medium as set forth in claim 12, the CCF further including:

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 a collector collecting the specimen; and

a signature of the collector.

16. The computer readable-medium as set forth in claim 15, wherein the CCF is electronically retrieved from the computer-accessible memory.

17. The computer readable-medium as set forth in claim 16, wherein the CCF is electronically accessed via a communications network.

18. The computer readable-medium as set forth in claim 16, wherein the CCF is electronically retrievable by cross-referencing a first or last name or a social security number of the donor with the donor information database.

21. The computer-readable medium as set forth in claim 11, wherein the electronic signature of the donor is reproduced on the computer-generated CCF.