In an effort to reduce the number of labeling errors that may lead to the switching of biopsy tissue samples, a number of error reduction systems have been suggested and/or utilized in addition to quality assurance processes already in place. Detecting these errors is exceedingly important since the switching of a biopsy result may lead to serious consequences for the patients involved, such as the unnecessary treatment of a cancer-free patient or no treatment for a patient who has cancer and needs immediate treatment.
One such error reduction method is the "inking" of specimens whereby at the time of grossing, each specimen is directly inked through the bag in one of 6 colors. The colors are always applied in the same sequence. The dissector writes the color used on the original requisition slip and dictates the color for the gross description. Each block is then routinely processed and entirely sectioned to produce at least 5 slides and 2 levels per slide. When the slides from the cases are reviewed, the pathologist compares the color of the ink in the tissue with that written in the gross description.[1]
Another error reduction method is suggested by the Mayo Clinic. Mindful of the importance of reducing identity errors and the potential for adverse consequences, the Mayo Clinic recently adopted radio frequency technology in their GI lab in Rochester, MN in an effort to determine and reduce the incidents of identification errors. An article published on the web site www.endonurse.com in October of 2007 discusses a study on this topic conducted by the Mayo Clinic.
Per the Mayo Clinic study, in Q1 of 2008 AFTER implementing an error reduction program (i.e. state of the art RFID), 47 errors were still made! Since errors can still occur even after implementation of an "error reduction system," patients remain exposed to the risk of a biopsy switching error resulting in over-treatment/under-treatment, and the hospital/physician reputation is also put at risk.
A "safer" system might be to implement an "error reduction program" (e.g. bar coding, RFID, inking) AND take steps to prevent adverse patient outcomes. There have been many published reports which have advocated the use of DNA "fingerprinting" to catch those errors which are undetected by existing quality systems. One such system is the know error® system available from Diagnostic ID, LLC.
The know error® system employs both bar-coding AND forensic DNA confirmation in a process which, when adopted by pathology labs and their referring physicians, can reduce switching errors and assure that no adverse patient outcomes will occur from otherwise undetected misidentifications.
To learn more about the know error® system, please visit our website www.knowerror.com.
[1] Andrew A. Renshaw, MD, Richard Kish, MHS, and Edwin W. Gould, MD The Value of Inking Breast Cores to Reduce Specimen Mix-up
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