Why it is Necessary

Numerous medical research studies have documented the incidence of error among the handling of biopsy tissue specimens and the resulting need for an additional level of patient safety.  One such study, conducted by the College of American Pathologists revealed “Misidentification errors are common in laboratory medicine…” The study extrapolated that reported misidentification errors from 120 pathology labs would lead to more than 160,000 adverse patient outcomes per year.¹

Additionally, there are real-life examples, such as the case of Darrie Eason, who had an unnecessary double mastectomy due to her biopsy test results being switched with those of another patient.  Consequently, necessary treatment was delayed for the woman who did have breast cancer.  When going beyond a research study and looking at the devastating effects these errors can have on an individual, the consequences of even one such biopsy switching error become clear.

In addition to the detrimental effects these costly errors can have on an individual, there are also a high costs to pay for all others involved in the process – physicians, labs and medical facilities.  There are medical-legal implications and the reputations of physicians, hospitals, and labs are put at risk.

Most switching errors are caught by the quality assurance systems in place at collection sites and pathology labs prior to an adverse patient outcome.  However, when considering the complexity of the process and the fact that millions of biopsies are performed and evaluated each year, some level of human error is unavoidable.  And in the case of switched biopsy results, it only takes one occurrence to start a chain reaction of negative consequences for all parties involved. 

Introduced in 2009, the know error® specimen security system provides an additional layer of safety to the biopsy evaluation process by utilizing unique patient identification bar coding along with DNA matching technology.  The know error® system was designed specifically to prevent switching errors and virtually eliminates the possibility of adverse patient outcomes.

¹Valenstein PN, Raab SS, Walsh MK. Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions. Arch Pathol Lab Med. 2006