METHOD AND SYSTEM FOR TESTING AND CONTROLLING A CUSTODY OF A FLUID SPECIMEN

• US 20070048875A1
• Filed: 10/27/2006
• Published: 03/01/2007
• Est. Priority Date: 02/05/1999
• Status: Abandoned Application

• Current Assignee: Escreen Inc (Abbott Laboratories)
• Original Assignee: Escreen Inc (Abbott Laboratories)
• Inventors: Whitford, Bill, Goodin, John, Patten, Keith, Lappe, Murray, Birkner, David
• Application Number:
  US11/553,819
• Publication Number:
  US 20070048875A1
• Time in Patent Office: Days
• US Class Current: 436/164
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/025 Displaying results or values with integrated means
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 35/00871 : Communications between instruments or with remote terminals
• CPC Class Codes: G06K 19/10 : at least one kind of marking being used for authentication, e.g. of credit or identity cards verification of coded identity or credit cards in mechanisms actuated by them G07F7/12
• CPC Class Codes: G06K 2019/06253 : for a specific application
• CPC Class Codes: G06Q 30/018 : Certifying business or products
• CPC Class Codes: G06V 40/30 : Writer recognition; Reading and verifying signatures
• 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
• CPC Class Codes: Y10T 436/12 : Condition responsive control
• CPC Class Codes: Y10T 436/13 : Tracers or tags
• CPC Class Codes: Y10T 436/25 : including sample preparation

Abstract

A system for automatically testing a fluid specimen, e.g., urine, to indicate the presence of specified chemical components in the specimen. The system preferably utilizes an assaying device comprised of a specimen container having a unique identifier thereon and a cap which carries at least one test strip. A method for testing and controlling a custody of the specimen comprises obtaining a specimen from a donor, wherein the specimen is obtained at a service site; storing the specimen in the specimen container; performing a test on the specimen using a reader device in communication with a computer, wherein the test is performed at the service site; providing an electronic chain of custody form that controls a chain of custody procedure for the specimen; and allowing the donor to sign the electronic chain of custody form at the service site by signinig an electronic signature pad.

Claims

1. A method of testing a specimen comprising:

obtaining a specimen from a donor;

storing the specimen in a specimen container;

performing a test on the specimen;

providing an electronic chain of custody form that controls a chain of custody procedure for the specimen; and

allowing the donor to sign the electronic chain of custody form by signing an electronic signature pad.

2. The method as claimed in claim 1, wherein the specimen is obtained at a service site.

3. The method as claimed in claim 2, wherein the test is performed on the specimen at the service site.

4. The method as claimed in claim 3, wherein the test is performed using a reader device.

5. A method of testing a specimen comprising:

obtaining a specimen from a donor, wherein the specimen is obtained at a service site;

storing the specimen in a specimen container;

performing a test on the specimen using a reader device in communication with a computer, wherein the test is performed at the service site;

providing an electronic chain of custody form that controls a chain of custody procedure for the specimen; and

allowing the donor to sign the electronic chain of custody form at the service site by signing an electronic signature pad.

6. The method as claimed in claim 5, wherein the reader device is in communication with an input/output device that enables entering of information.

7. The method as claimed in claim 6, wherein the input/output device is in communication with the computer.

8. The method as claimed in claim 6, further comprising the step of entering donor information into the input/output device.

9. The method as claimed in claim 5, wherein the specimen is identified by a unique identifier.

10. The method as claimed in claim 9, further comprising the step of validating the unique identifier.

11. A method comprising:

obtaining a specimen from a donor;

storing the specimen in a specimen container on which is located a unique identifier for positively associating the specimen with the donor;

performing a test on the specimen using a reader device in communication with a computer;

uploading a test result obtained with the reader device to the computer;

providing an electronic chain of custody form that controls a chain of custody procedure for the specimen; and

having the donor sign the electronic chain of custody form by signing an electronic signature pad, such that by signing the chain of custody form, a closely controlled chain of custody procedure is administered.

12. The method as claimed in claim 11, wherein the computer is a host computer, and the reader device is in communication with the host computer via a communications network.

13. The method as claimed in claim 12, wherein the test result is uploaded to the host computer via the communications network.

14. The method as claimed in claim 12, wherein the reader device is in communication with an input/output device that enables entering of information and subsequent uploading of the information to the host computer.

15. The method as claimed in claim 11, further comprising the step of entering donor information into the input/output device.

16. The method as claimed in claim 11, further comprising the step of printing a copy of the electronic chain of custody form.

17. The method as claimed in claim 12, further comprising the step of uploading the donor information to the host computer.

18. The method as claimed in claim 11, wherein the reader device is an on-site device operable to perform the test at a service site.

19. The method as claimed in claim 11, further comprising the step of validating the unique identifier.

20. A method of testing a specimen comprising:

obtaining a specimen from a donor;

storing the specimen in a specimen container having a unique identifier associated with it;

inputting the unique identifier into a computer;

performing a test on the specimen;

providing an electronic chain of custody form that controls a chain of custody procedure for the specimen; and

allowing the donor to sign the electronic chain of custody form by signing an electronic signature pad.

21. The method as claimed in claim 20, wherein the specimen is obtained at a service site.

22. The method as claimed in claim 21, wherein the test is performed on the specimen at the service site.

23. The method as claimed in claim 22, wherein the test is performed using a reader device.

24. The method as claimed in claim 23, wherein the reader device reads the unique identifier associated with the specimen container.