Method and apparatus to minimize diagnostic and other errors due to transposition of biological specimens among subjects

Abstract

A method and apparatus for minimizing diagnostic errors due to transposition of biological specimens among subjects provides for independent biometric confirmation that a given specimen is from a given donor. In certain embodiments, a biological specimen confirmation kit comprises a portable and openable case housing components of the kit, at least one biological specimen container adapted to receive a biological testing specimen from a donor, and at least one reference sample device adapted to receive a biological reference specimen from the same donor, such that the testing and reference specimens can later be compared for donor match verification by a reference verification entity.

What is claimed is: 
     
         1 . A donor match verification kit configured to be provided to a physician at a collections site, comprising:
 (1) a portable and openable case adapted to house components of the kit;   (2) at least one biological specimen container housed within the portable case during transport and storage of the case and removable from the case during use of the container, wherein the biological specimen container is adapted to receive a biological testing specimen collected from a donor at the collections site during a physician office visit; and   (3) at least one reference sample device housed within the portable case during transport and storage of the case and removable from the case during use of the device, wherein the reference sample device is adapted to receive a biological reference specimen collected from the donor at the collections site during the same physician office visit, wherein the reference sample device is discrete and detached from the biological specimen container;   wherein each of the case, the container and the device are pre-marked with the same donor-unique identifier, the identifier on each of the case, the container and the device being the same.   
     
     
         2 . The kit of  claim 1 , wherein the biological specimen container is a vial containing an amount of buffered formalin. 
     
     
         3 . The kit of  claim 1 , wherein the reference sample device is a buccal swab. 
     
     
         4 . The kit of  claim 1 , wherein the reference sample device is a vial adapted for collecting an amount of blood or urine from the donor. 
     
     
         5 . The kit of  claim 1 , wherein the donor-unique identifier is a bar code. 
     
     
         6 . The kit of  claim 1 , wherein the donor-unique identifier is a radio frequency identification tag. 
     
     
         7 . The kit of  claim 1 , further comprising written instructions for properly using the components housed within the case. 
     
     
         8 . The kit of  claim 1 , further comprising at least one discrete donor-unique identifier adapted for affixation to a medical document corresponding to the donor. 
     
     
         9 . The kit of  claim 1 , further comprising an envelope adapted for housing the reference sample device through to transport to an independent reference verification entity. 
     
     
         10 . The kit of  claim 1 , further comprising at least one container adapted for receiving and housing a tissue sample taken from the biological testing specimen for transport to an independent reference verification entity. 
     
     
         11 . The kit of  claim 1 , wherein each of the case, the biological specimen container and the reference sample device include a tamper-evidence security seal placed thereon to detect tampering. 
     
     
         12 . The kit of  claim 1 , wherein the biological specimen container is adapted to receive a surgical biopsy tissue specimen collected from the donor as the biological testing specimen, wherein the surgical biopsy tissue specimen is to be tested for cancer at a testing site different from the collections site. 
     
     
         13 . The kit of  claim 1 , wherein the reference sample device is configured to be transported to an independent reference verification entity different from the collections site, and wherein the biological testing specimen is configured to be transported to a testing site different from the collections site and the verification entity. 
     
     
         14 . The kit of  claim 1 , further comprising written instructions directing the transport of the reference sample device to an independent reference verification entity different from the collections site and directing the transport of the biological testing specimen to a testing site different from the collections site and the verification entity. 
     
     
         15 . A donor match verification kit configured to be provided to a physician at a collections site, comprising:
 a portable and openable case adapted to house components of the kit, the case having at least two separate and non-overlapping compartments, including a procedures compartment and a testing compartment;   wherein the procedures compartment includes:
 at least one biological specimen container housed within the portable case during transport and storage of the case and removable from the case during use of the biological specimen container, wherein the biological specimen container is adapted to receive a biological testing specimen collected from a donor at a collections site during a physician office visit; and 
 at least one reference sample device housed within the portable case during transport and storage of the case and removable from the case during use of the swab, wherein the reference sample device is adapted to receive a biological reference specimen collected from the donor at the collections site during the same physician office visit, wherein the reference sample device is discrete and detached from the biological specimen container; 
   wherein the testing compartment includes:
 at least one post-testing specimen container housed within the portable case during transport and storage of the case and removable from the case during use of the post-testing specimen container, wherein the post-testing specimen container is adapted to receive a tissue sample taken from the biological testing specimen at a testing site different from the collections site to allow for transport of the tissue sample to an independent reference verification entity from the testing site following biopsy testing at the testing site, wherein the independent reference verification entity is different from and independent of the collections and testing sites; 
   wherein each of the case, the biological specimen container, the reference sample device and the testing specimen container are pre-marked with a donor-unique bar code label, the bar code label on each of the case, the biological specimen container, the reference sample device and the testing specimen container being identical.   
     
     
         16 . The kit of  claim 15 , wherein each of the case, the biological specimen container and the reference sample device include a tamper-evidence security seal placed thereon to detect tampering. 
     
     
         17 . The kit of  claim 15 , wherein the biological specimen container is a vial containing an amount of buffered formalin. 
     
     
         18 . The kit of  claim 15 , wherein the reference sample device is a buccal swab. 
     
     
         19 . The kit of  claim 15 , wherein the donor-unique identifier is a bar code. 
     
     
         20 . The kit of  claim 15 , further comprising an envelope adapted for housing the reference sample device through to transport to the independent reference verification entity. 
     
     
         21 . The kit of  claim 15 , wherein the biological specimen container is adapted to receive a surgical biopsy tissue specimen collected from the donor as the biological testing specimen, wherein the surgical biopsy tissue specimen is to be tested for cancer at the testing site. 
     
     
         22 . The kit of  claim 15 , wherein the reference sample device is configured to be transported to the independent reference verification entity from the collections site, and wherein the biological testing specimen is configured to be transported to the testing site from the collections site. 
     
     
         23 . The kit of  claim 15 , further comprising written instructions directing the transport of the reference sample device to the independent reference verification entity and directing the transport of the biological testing specimen to the testing site.