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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 61 / 055,628, filed May 23, 2008, which is hereby incorporated by reference.FIELD OF THE DISCLOSURE [0002] The present disclosure relates generally to the processing of tissue or other biological specimens from subjects, and more particularly to methods and apparatuses to minimize diagnostic and other errors due to transposition of biological specimens among subjects. BACKGROUND OF THE DISCLOSURE [0003] Several methods are known for administering the collection of biological specimens and processing of same by a laboratory in order to assess the pathology, histology, toxicology, or other important attributes of the specimen of interest, while attempting to maintain the correct association of a given specimen to the donor of that specimen. These methods can include any number of process controls such as unique specimen numbering, clean laboratory technique, standardiza...

AI Technical Summary

Problems solved by technology

These methods, however, necessarily place a heavy reliance on human handling and compliance, and are therefore susceptible to human error.

It is known, for example, that cases of accidentally switched specimens among cancer biopsy patients may result in misdiagnosis at rates approaching 1% of all cases.

The ramifications of such errors are significant in that they can lead to dramatic treatments such as mastectomy or prostatectomy, for example, on patients who do not require these procedures, and conversely the neglected treatment of patients who are unaware of their malignant condition having been incorrectly diagnosed as benign.

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