The know error® specimen security system, introduced in 2009, utilizes DNA "fingerprinting" technology and virtually eliminates the possibility that a biopsy misidentification error will result in an adverse patient outcome. The system was designed to increase patient safety and the quality of patient care and represents an important innovation in the process of evaluating biopsies. In October 2007, TodayShow.com contributor, Mike Celizic, discussed the case of a biopsy labeling error that had devastating consequences for one New York woman. Here is an excerpt from his story:
Because of a mislabeled tissue sample that led to a misdiagnosis, Darrie Eason had both of her breasts removed to save her from a cancer that she never had. No amount of money will make Eason whole again, but the Long Island, N.Y., woman hopes that her experience and a lawsuit she is pressing may help other women. "Maybe if people hear about my case, they'll know. Maybe somebody will do something differently next time," she told TODAY co-host Meredith Vieira during an interview Thursday. "I don't want this to happen to anyone else." Eason is a 35-year-old single mother who works in the accounts receivable department of a local community newspaper chain. She has a 15-year-old son. In 2006, she was told she needed to undergo a radical double mastectomy because she had an invasive form of breast cancer. "I just broke down and cried," she recalled of the moment she got the diagnosis. Eason went to another doctor for a second opinion, and was again told she had cancer. The doctor relied on the same mislabeled tissue sample.
"I was told I had lobular breast cancer, which everybody said would come back," she told Vieira. Armed with that information, she had both breasts removed and underwent the first phase of reconstructive surgery in May 2006. While waiting to heal so she could begin chemotherapy, her surgeon, who had submitted removed tissue to a lab for routine testing, told her that something was wrong: She didn't have cancer. "You can't even explain it," Eason said of her emotions when she was told she had had both her breasts removed for no reason. An investigation by the New York State Department of Health would reveal that the lab that handled her biopsy samples had mixed up her sample with that of another woman.
The other woman, who actually did have breast cancer, was told she was cancer-free. Only when Eason's error was discovered did the other woman, who has not been identified, learn that she had cancer. "She has to live with the idea that she had breast cancer and hers was not diagnosed at the earliest possible time," said Eason's attorney, Steven Pegalis, of the other woman. The state report said "the most likely source of the error" was the technician engaging in a practice called "batching," which involves handling more than one specimen at a time. The state health department determined that the lab's error was isolated and found "no systemic problems and no deficiencies" at the lab. Eason's attorney, Steven Pegalis, told Vieira he's not so sure. "It may be one person, but personally I doubt it. One of the things we may learn is 'Was there a system failure, and if so, what can be done to improve the system?' Personally, I doubt this is a one-time event by someone who was careless for one time in his or her life," he said.
By implementing an innovative system, such as the know error® specimen security system, errors like the one in the Darrie Eason case would be detected BEFORE a patient suffers an adverse outcome. With each biopsy switch identified by the know error® system, all parties involved -- patients, physicians, and pathology labs -- are protected from potentially devastating consequences.
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