IP Library Granted Patent US 9,018,015
Granted Patent B2
US 9,018,015 · App. 13/908,833 · Granted Apr 28, 2015

Method of securing a chain of custody of a specimen of a donor

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Quick Facts
Patent No.
US 9,018,015
App. No.
13/908,833
Granted
Apr 28, 2015
Kind
B2
Abstract

A method of securing a chain of custody of a specimen of a donor prevents tampering with or accidental mismanagement of the specimen. The method includes providing a tamper evident seal operable to indicate that an assaying device has been tampered with once the seal is sealed, the seal including a label having at least one portion including a machine-readable indicia area. The assaying device comprises a collection cup and a cap that carries at least one test strip.

Claims (28)

1. A non-transitory computer-readable storage medium have a computer program stored thereon for securing a chain of custody of a specimen of a donor, said computer program when executed by a processor operable to perform the following steps:

receive, via the processor, information identifying the donor;

receive, via the processor, information identifying a specimen container associated with the donor,

wherein the information identifying the specimen container comprises machine-readable indicia located on the specimen container,

wherein the specimen container includes an assaying device for generating a test result of the specimen,

wherein the specimen container includes a tamper evident seal operable to indicate that the assaying device has been tampered with once the seal is sealed;

associate, via the processor, an electronic chain of custody document with the donor;

receive, via the processor and from an electronic signature pad, a digital representation of the donor's signature as executed on the electronic signature pad; and

associate, via the processor, the donor's signature, as received on the electronic signature pad, with the donor's electronic chain of custody document.

2. The computer-readable storage medium of claim 1 , wherein the processor is further operable to perform the step of reading the machine-readable indicia.

3. The computer-readable storage medium of claim 2 , wherein the machine-readable indicia is a bar code.

4. The computer-readable storage medium of claim 1 , wherein the processor is further operable to perform the step of transmitting, to a host computer, the electronic representation of the donor's signature, as received on the electronic signature pad, and associated electronic chain of custody document.

5. The computer-readable storage medium of claim 4 , wherein the processor is further operable to perform the step of receiving a test result of the specimen from a portable, electronic testing device.

6. The computer-readable storage medium of claim 5 , wherein the processor is further operable to perform the step of electronically associating the test result with the donor's electronic chain of custody document.

7. A method for securing a chain of custody of a specimen of a donor, said method comprising the following steps:

receiving, via a processor, information identifying the donor;

receiving, via a processor, information identifying a specimen container associated with the donor,

wherein the information identifying the specimen container comprises machine-readable indicia located on the specimen container,

wherein the specimen container includes an assaying device for generating a test result of the specimen,

wherein the specimen container includes a tamper evident seal operable to indicate that the assaying device has been tampered with once the seal is sealed;

associating, via a processor, an electronic chain of custody document with the donor;

receiving, via a processor and from an electronic signature pad, a digital representation of the donor's signature as executed on the electronic signature pad; and

associating, via a processor, the donor's signature, as received on the electronic signature pad, with the donor's electronic chain of custody document.

8. The method of claim 7 , further including the step of reading the machine-readable indicia.

9. The method of claim 8 , wherein the machine-readable indicia is a bar code.

10. The method of claim 7 , further including the step of transmitting, via a processor and to a host computer, the electronic representation of the donor's signature, as received on the electronic signature pad, and associated electronic chain of custody document.

11. The method of claim 10 , further including the step of receiving, via a processor, a test result of the specimen from a portable, electronic testing device.

12. The method of claim 11 , further including the step of associating the test result with the donor's electronic chain of custody document.

Assignments (5)
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY RECORDED AT REEL 036994, FRAME 0192 AND REEL 037115, FRAME 0498 Recorded Oct 5, 2017
From: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS COLLATERAL AGENT
To: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
Reel/Frame 044213/0258 →
ASSIGNMENT OF IP SECURITY AGREEMENT, PREVIOUSLY RECORDED AT REEL 036994, FRAME 0192 Recorded Nov 16, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING ADMINISTRATIVE AGENT
To: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR ADMINISTRATIVE AGENT
Reel/Frame 037115/0498 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Oct 29, 2015
From: ALERE CONNECT, LLC; ALERE SAN DIEGO, INC. (FKA BIOSITE INC. OR FKA CHOLESTECH CORP. OR FKA HEMOSENSE INC. OR FKA INVERNESS MEDICAL-BIOSTAR INC. OR FKA ISCHEMIA TECHNOLOGIES, INC. OR FKA TWISTDX, INC.); ALERE SCARBOROUGH, INC. (FKA MATRITECH, INC. FKA ADVANTAGE DIAGNOSTICS CORP. OR FKA BINAX, INC. OR FKA MILANO ACQUISITION CORP.); INNOVACON, INC. (FKA APPLIED BIOTECH, INC. OR FKA AMEDITECH INC.); IONIAN TECHNOLOGIES, LLC (FKA IONIAN TECHNOLOGIES, INC.); QUALITY ASSURED SERVICES INC. (FKA ZYCARE INC.); STANDING STONE, LLC; ESCREEN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 036994/0192 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2014
From: LAPPE, MURRAY I.; BIRKNER, DAVID A.; GOODIN, JOHN W.; PATTEN, KEITH W.; WHITFORD, BILL
To: NATIONAL MEDICAL REVIEW OFFICES INC.
Reel/Frame 032725/0565 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2014
From: NATIONAL MEDICAL REVIEW OFFICES INC.
To: ESCREEN INC,
Reel/Frame 032725/0656 →