System for securing a chain of custody of a specimen of a donor

Abstract

A system and method for 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.

1 . A system for securing a chain of custody of a specimen of a donor, said system comprising:
 a non-transitory computer-readable storage medium; and   a processor associated with the storage medium and operable to perform the following steps:
 receive information identifying the donor, 
 receive information identifying a specimen container associated with the donor, 
 wherein the information identifying the specimen container comprises machine-readable indicia associated with the specimen container, 
 receive information indicative of a test result for the specimen, 
 associate an electronic chain of custody document with the donor, 
 receive, from an electronic signature pad, a digital representation of the donor's signature as executed on the electronic signature pad, and 
 associate the donor's signature, as received on the electronic signature pad, with the donor's electronic chain of custody document. 
   
     
     
         2 . The system of  claim 1 , wherein the processor is further operable to perform the step of reading the machine-readable indicia. 
     
     
         3 . The system of  claim 2 , wherein the machine-readable indicia is a bar code. 
     
     
         4 . The system 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 system 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 system 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 system for securing a chain of custody of a specimen of a donor provided in a specimen container, said system comprising:
 a non-transitory computer-readable storage medium; and   a processor associated with the storage medium and operable to perform the following steps:
 receive an instruction to generate a label for associating with the specimen container, 
 wherein the instruction includes information indicative of machine-readable indicia for printing on the label, 
 wherein said machine-readable indicia uniquely identifies the specimen container as associated with the donor; 
 receive, from a specimen testing device, information indicative of a test result for the specimen; 
 receive, from an electronic signature pad, information indicative of a handwritten signature provided by the donor on the electronic signature pad; 
 receive, from a reader for reading the machine-readable indicia, information indicative of the machine-readable indicia; 
 create an electronic chain of custody document that electronically associates the information indicative of the test result with the information indicative of the machine-readable indicia and the information indicative of the handwritten signature provided by the donor; and 
 transmit the electronic chain of custody document to a host computer. 
   
     
     
         8 . The system of  claim 7 , wherein the processor comprises the reader for reading the machine-readable indicia. 
     
     
         9 . The system of  claim 7 , wherein the machine-readable indicia is a bar code. 
     
     
         10 . The system of  claim 7 , wherein the electronic representation of the donor's signature is shown on the electronic chain of custody document. 
     
     
         11 . A system for securing a chain of custody of a specimen of a donor, said specimen provided in a specimen container, said system comprising:
 means for performing a test on the specimen;   means for obtaining information indicative of a unique identifier associated with the specimen container;   means for obtaining a digital representation of the donor's handwritten signature; and   means for generating an electronic chain of custody document associated with the donor,   wherein said electronic chain of custody document identifies a test result for the specimen, the information indicative of the unique identifier associated with the specimen container, and the digital representation of the donor's handwritten signature.   
     
     
         12 . The system of  claim 11 , wherein the means for performing the test on the specimen is a portable assaying device. 
     
     
         13 . The system of  claim 11 ,
 wherein the unique identifier is a bar code,   wherein the means for obtaining information indicative of the unique identifier associated with the specimen container is a bar code reader.   
     
     
         14 . The system of  claim 11 , wherein the means for obtaining the digital representation of the donor's handwritten signature is an electronic signature pad. 
     
     
         15 . The system of  claim 11 , wherein the means for generating an electronic chain of custody document associated with the donor is a processor operable to perform the following steps:
 receive information identifying the donor;   receive the information indicative of the test result for the specimen;   receive the information indicative of the unique identifier associated with the specimen container;   receive the information indicative of the handwritten signature provided by the donor on the electronic signature pad; and   transmit the electronic chain of custody document to a host computer.   
     
     
         16 . The system of  claim 15 , wherein the processor is further operable to perform the step of reading the unique identifier. 
     
     
         17 . The system of  claim 16 , wherein the unique identifier is a bar code.