IP Library Granted Patent US 9,189,602
Granted Patent B2
US 9,189,602 · App. 13/478,956 · Granted Nov 17, 2015

Electronic custody and control system for human assay test samples

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Quick Facts
Patent No.
US 9,189,602
App. No.
13/478,956
Granted
Nov 17, 2015
Kind
B2
Abstract

A system, method, and computer program for more quickly, accurately, and efficiently identifying, cataloging, and tracking human assay samples and creating 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 authorized persons to electronically access the test result via a communications network.

Claims (51)

1. A non-transitory computer-readable storage medium with an executable program stored thereon for assisting an entity in tracking the custody and control of a human analyte specimen provided by a donor, wherein the specimen is stored in a container assigned with a unique identifier, wherein the program instructs one or more processors respectively associated with one or more computers to perform the steps of:

receiving, from an employer, information identifying the donor, wherein the employer is requesting that a test be performed on the human analyte specimen provided by the donor, and the donor is either an employee or a candidate for employment with the employer;

storing the information identifying the donor in a donor database;

receiving, from an employer, information identifying the employer and at least one test requested by the employer to be performed on the specimen;

storing the information identifying the employer and the at least one test in an employer database;

enabling a collector associated with a collection facility to access the information identifying the donor from the donor database and the information identifying the employer and the at least one test requested by the employer from the employer database;

receiving information identifying the unique identifier assigned with the specimen container,

wherein the information identifying the unique identifier is initially received by the program via scanning the unique identifier assigned with the specimen container or inputting the unique identifier assigned with the specimen container into the program;

subsequent to receiving the information identifying the unique identifier assigned with the specimen container, associating a computer-generated, forensically-defensible Custody and Control Form (CCF) that identifies the donor with the unique identifier assigned with the specimen container, such that the CCF is identified, for a first time, with the unique identifier assigned with the specimen container;

wherein said associating the CCF using the unique identifier assigned with the specimen container occurs subsequent to said receiving the information identifying the unique identifier assigned with the specimen container,

wherein the CCF is electronically available to the entity via an application accessible via a communications network;

populating the CCF with the at least some of the information identifying the donor, wherein said step of populating the CCF includes importing the at least some of the information identifying the donor from the donor database;

receiving an electronic signature from an electronic signature reader, wherein the electronic signature is provided by the donor by signing the electronic signature reader and wherein the received electronic signature from the donor verifies an accuracy of information on the CCF;

storing said electronic signature as part of the CCF;

in response to performing the at least one test, obtaining at least one test result for the at least one test requested by the employer on the specimen;

populating the CCF with the at least one test result; and

enabling the employer to access the CCF for the specimen associated with the donor, including the at least one test result for the specimen, via the application.

2. The computer-readable storage medium of claim 1 , wherein the program further instructs the one or more processors to associate the employer information with the CCF for the specimen upon performing a look up of the donor based on at least some of the information identifying the donor.

3. The computer-readable storage medium of claim 2 , wherein the program further instructs the one or more processors to retrieve the CCF upon receipt from the employer of a first or last name or a social security number of the donor.

4. The computer-readable storage medium of claim 1 , wherein the information identifying the unique identifier is received via manual input by the collector.

5. The computer-readable storage medium of claim 1 , wherein the unique identifier is a bar code, and the information identifying the unique identifier is received via scanning of the bar code with a bar code reader.

6. The computer-readable storage medium of claim 1 , wherein the application is a web application, and the communications network is the Internet.

7. The computer-readable storage medium of claim 1 , wherein the program further instructs the one or more processors to reproduce the electronic signature of the donor on the computer-generated CCF.

8. A system for assisting an entity in tracking the custody and control of a human analyte specimen provided by a donor, wherein the specimen is stored in a container assigned with a unique identifier, the system comprising:

one or more processors associated with one or more computers, the one or more processors configured for executing a computer program operable to perform the steps of:

receive, from an employer, information identifying the donor, wherein the employer is requesting that a test be performed on the human analyte specimen provided by the donor, and the donor is either an employee or a candidate for employment with the employer;

store the information identifying the donor in a donor database;

receive, from an employer, information identifying the employer and at least one test requested by the employer to be performed on the specimen;

store the information identifying the employer and the at least one test in an employer database;

enable a collector associated with a collection facility to access the information identifying the donor from the donor database and the information identifying the employer and the at least one test requested by the employer from the employer database;

receive information identifying the unique identifier assigned with the specimen container,

wherein the information identifying the unique identifier is initially received by the program via scanning the unique identifier assigned with the specimen container or inputting the unique identifier assigned with the specimen container into the program;

subsequent to receiving the information identifying the unique identifier assigned with the specimen container, associating a computer-generated, forensically-defensible Custody and Control Form (CCF) that identifies the donor with the unique identifier assigned with the specimen container, such that the CCF is identified, for a first time, with the unique identifier assigned with the specimen container;

wherein said associating the CCF using the unique identifier assigned with the specimen container occurs subsequent to said receiving the information identifying the unique identifier assigned with the specimen container,

wherein the CCF is electronically available to the entity via an application accessible via a communications network;

populate the CCF with the at least some of the information identifying the donor, wherein said step of populating the CCF includes importing the at least some of the information identifying the donor from the donor database;

receive an electronic signature from an electronic signature reader, wherein the electronic signature is provided by the donor by signing the electronic signature reader and wherein the received electronic signature from the donor verifies an accuracy of information on the CCF;

store said electronic signature as part of the CCF;

in response to performing the at least one test, obtain at least one test result for the at least one test requested by the employer on the specimen;

populate the CCF with the at least one test result; and

enable the employer to access the CCF for the specimen associated with the donor, including the at least one test result for the specimen, via the application.

9. The system of claim 8 ,

wherein the program instructs the processor to perform the step of:

enable the collector to perform a look up of the donor based on information identifying the donor.

10. The system of claim 9 ,

wherein the program instructs the processor to perform the following steps:

associate the employer information with the CCF for the specimen upon performing said look up of the donor based on information identifying the donor,

retrieve the CCF upon receipt from the employer of a first or last name or a social security number of the donor.

11. The system of claim 8 , wherein the information identifying the unique identifier is received via manual input by a collector.

12. The system of claim 8 , wherein the unique identifier is a bar code, and the information identifying the unique identifier is received via scanning of the bar code with a bar code reader.

13. The system of claim 8 , wherein the program further instructs the processor to reproduce the electronic signature of the donor on the computer-generated CCF.

Assignments (6)
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 →
NOTICE OF RELEASE OF SECURITY INTEREST IN PATENTS RECORDED AT REEL 030462 FRAME 0532 Recorded Jun 23, 2015
From: GENERAL ELECTRIC CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: ESCREEN, INC.
Reel/Frame 036009/0105 →
SUPPLEMENTAL INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded May 21, 2013
From: ESCREEN, INC.
To: GENERAL ELECTRIC CAPITAL CORPORATION
Reel/Frame 030462/0532 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2012
From: LAPPE, MURRAY; REIN, BRAD
To: ESCREEN, INC.
Reel/Frame 028259/0066 →