The first case involved a man who was mistakenly told he had prostate cancer after the pathologist who reviewed his slides attributed his results to those of another patient who did have cancer. This led to the unnecessary removal of his prostate, incontinence, and erectile dysfunction.
The hospital responsible for the mix-up has stated, "...it will take several simple steps, including requiring pathologists to initial biopsy reports to show they took a "time out'' to make sure the reports match the slides." While many of the cases documented in this blog discuss the mix-up of biopsy tissue samples or tissue contamination, this case is different in that the tissue samples were evaluated correctly. The complication didn't occur until the very end of the biopsy evaluation process when the pathologist applied one patient's results to another patient.
This misapplication by the pathologist is just one type of Specimen Provenance Complication (SPC) that can occur as a result of the complex biopsy evaluation process. SPCs may arise due to instances of specimen transposition, foreign cell contamination, and patient misidentification (as in this case) that occur in clinical or anatomical pathology.
In the article, Dr. Gordon Schiff, associate professor at Harvard Medical School states, "One way to prevent mix-ups with biopsy tissue, for example, is to use bar codes to match specimens and slides." While methods such as bar coding and mandatory "time outs" may be effective at reducing SPCs, they may not be enough to prevent adverse patient outcomes such as those discussed here.
Launched in the spring of 2009, the know error® system for prostate biopsies brings new levels of safety and accuracy to the biopsy evaluation process. The system incorporates bar code technology as well as DNA Specimen Provenance Assignment (DSPA). By performing DNA testing of biopsy tissue samples PRIOR to any treatment taking place, the know error® system virtually eliminates any adverse patient outcomes due to SPC.
For more information about the know error® system for prostate biopsies, please visit our website www.knowerror.com.
]]> ]]>She delayed her scheduled surgery in order to take a long-planned family vacation. Two days before the trip, she found out there was a mistake in her diagnosis and that she was cancer-free. The pathology lab had mislabeled her specimen container with the name of another woman who did have breast cancer. The mix-up was only discovered because the other woman's doctor was concerned that his patient, who had all the signs of breast cancer, was reported to be cancer-free.
While the outcome could have been far worse, both women were still negatively affected by Specimen Provenance Complications (SPC). SPCs are a by-product of the complicated biopsy evaluation process and may arise due to instances of specimen transposition, foreign cell contamination, and patient misidentification that occur in clinical or anatomical pathology. The first woman (Romona Champion) had to deal with the belief that she had breast cancer and the second experienced a delay in treatment.
Launched in the summer of 2010, the know error® system for breast biopsies brings new levels of safety and accuracy to the biopsy evaluation process. Through the use of DNA Specimen Provenance Assignment (DSPA) and bar code technology, this innovative system dramatically reduces the incidence of Specimen Provenance Complications (SPC) enhancing patient safety and diagnostic accuracy. By performing DNA testing of biopsy tissue samples PRIOR to any treatment taking place, the know error® system virtually eliminates any adverse patient outcomes due to SPC.
For more information about the know error® system for breast biopsies, please visit our website www.knowerror.com.
The know error® system for breast biopsies, introduced in the summer of 2010 by Diagnostic ID, LLC, provides an effective way to establish specimen provenance. Through the use of DNA Specimen Provenance Assignment (DSPA) and bar code technology, the know error® system brings new levels of safety and accuracy to the biopsy evaluation process.
This innovative system dramatically reduces the incidence of Specimen Provenance Complications (SPC) which may arise due to instances of specimen transposition, foreign cell contamination, and patient misidentification that occur in clinical or anatomical pathology. By performing DNA testing of biopsy tissue samples PRIOR to any treatment taking place, the know error® system virtually eliminates any adverse patient outcomes due to SPC.
For more information about the know error® system for breast biopsies, please visit our website www.knowerror.com.
]]>As with similar cases documented in this blog, the mix up was discovered by a pathologist performing routine post-surgical tests that revealed no cancer in the patient's tissue samples. The report states, "...DNA tests confirmed on July 16 that the woman's initial biopsy...was accidentally switched with a similar biopsy from another woman." This type of mix up is just one of many types of Specimen Provenance Complications (SPC) that can lead to diagnostic mistakes. Other examples of SPC are specimen transposition and foreign cell contamination.
Launched in the summer of 2010, the know error® system for breast biopsies brings new levels of safety and accuracy to the biopsy evaluation process. Through the use of DNA Specimen Provenance Assignment (DSPA) and bar code technology, this innovative system dramatically reduces the incidence of SPC so that diagnostic mistakes are minimized.
While the DNA tests in this case confirmed the mix up, this was unfortunately AFTER the unnecessary surgery and delay in treatment. The know error® system performs DSPA of biopsy tissue samples PRIOR to any treatment taking place and virtually eliminates diagnostic mistakes due to SPC. This allows both patient and physician to proceed confidently with treatment options based on the patient's biopsy results.
For more information about the know error® system for breast biopsies, please visit our website www.knowerror.com.
]]>The diagnosis stunned both Kavecic and her family physician but the biggest shock came after the surgery when routine post surgical tests revealed her stomach was cancer-free. Her biopsy tissue samples had been switched with those of another patient, who in fact did have stomach cancer, resulting in the removal of her perfectly healthy stomach.
]]> Due to language translation issues, it is difficult to fully understand the outcome of this case, but it appears that Kavecic was awarded €40,000 in compensation. From what can be discerned, it also appears there may have been insurance limitations involving coverage of a medical error. She has sought expert legal counsel to negotiate a higher compensation.
As with many cases documented in this blog, such as the case of Janelle Trenchfield who underwent an unneccesary lumpectomy, Kavecic's case involved an unnecessary surgery due to a Specimen Provenance Complication (SPC), e.g., specimen transposition, foreign cell contamination or patient misidentification. However, this is the first case we have covered involving removal of a healthy stomach which brings with it a completely different set of issues and post surgical concerns. The American Cancer Society provides further details of a total gastrectomy, which also includes the removal of lymph nodes, as well as potential side effects of the surgery.
According to the article referenced above, the hospital had no procedure in place to prevent this type of complication from resulting in an adverse patient outcome. The know error® system, introduced in 2009 by Diagnostic, ID LLC, was designed specifically to detect this type of SPC and to prevent resulting unnecessary treatments and surgeries. The know error® system utilizes DNA Specimen Provenance Assignment (DSPA) to confirm that a positive biopsy result belongs to the right patient before proceeding with treatment plans.
For more information about the know error® system, please visit our website www.knowerror.com.
]]>This delay in treatment could have numerous adverse effects on a patient. It could mean a more rigorous and potentially life threatening treatment plan since the cancer would have time to advance. It could mean the cancer would have a chance to spread to other parts of the body. Or, the worst case scenario could mean the patient wouldn't survive as a result of the delay.
If a system to establish specimen provenance, such as the know error® system for breast biopsies, had been in place to detect the misidentification, the adverse outcomes for both victims in each of these cases could have been averted. The know error® system utilizes DNA Specimen Provenance Assignment (DSPA) and bar code technology to confirm that a positive biopsy result belongs to the right patient before proceeding with treatment plans.
For more information about the know error® system for breast biopsies, please visit our website www.knowerror.com.
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The new "Lean" protocol involved bar-coding all patient-related materials - requisition form, tissue cassettes, specimen containers, and slides - all at the same time. Upon entering a patient into the system, the accessioner would print all of the bar codes for a particular patient. There were technological challenges with the bar-coding since linear bar codes couldn't be used. Tuthill partnered with General Data out of Cincinnati which had created a new cassette labeling system which could work in conjunction with the existing lab information system.
The story discloses: "If the clinician has put the wrong patient identifiers on the requisition form, there's no way to catch it." As discussed in an earlier blog post, "18 Steps Between Your Biopsy and Your Biopsy Result," evaluation of a biopsy tissue specimen is an extremely complex process. There are numerous steps and individuals involved. Even with safeguards such as these implemented at the Henry Ford Health System, there is still room for human error. While these improvements have reduced labeling problems by 85%, that itself is proof that errors still find their way through even the smallest cracks in the system.
Implementing a system to establish specimen provenance, such as the know error® system, is one way to ensure that complications, such as specimen transposition and patient misidentification, undetected by protocols already in place do not remain undetected. Like the system at Henry Ford, the know error® system also employs a bar-coding system; however, it is the addition of DNA Specimen Provenance Assignment (DSPA) that virtually eliminates the possibility that Specimen Provenance Complications (SPC) will result in an adverse patient outcome.
For more information about the know error® system, please visit our web site at www.knowerror.com.
]]>Kim was awarded 51 million won or the equivalent of about $40,000.
This type of patient misidentification can be avoided by the implementation of a system that establishes specimen provenance, such as the know error® system. Introduced in the summer of 2010, the know error® system for breast biopsies utilizes DNA Specimen Provenance Assignment (DSPA) and bar code technology to confirm biopsy results. Had this system been in place, the switched charts would have been discovered when a tissue sample from the positive biopsy was compared to a sample of the patient's DNA. The samples would not have matched thus detecting the misidentification PRIOR to any adverse patient outcome.
For more information about the know error® system for breast biopsies, please visit our website at www.knowerror.com.
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SPCs can be virtually eliminated through the implementation of a system that establishes specimen provenance, such as know error® system. Through the use of DNA Specimen Provenance Assignment (DSPA) and bar code technology, the know error® system brings new levels of safey and accuracy to the biposy evaluation process. The system dramatically reduces the incidence of SPC and virtually eliminates diagnostic mistakes due to SPC. By performing DNA matching prior to treatment, the know error® system assures that SPCs will be detected prior to any adverse patient outcomes.
For more information about the know error® system, please visit our website at www.knowerror.com.
]]>The know error® system for breast biopsies, introduced by Diagnostic ID, LLC in 2010, employs DNA Specimen Provenance Assignment (DSPA) and bar code technology to dramatically reduce Specimen Provenance Complications (SPC), such as patient misidentification, virtually eliminating diagnostic mistakes from resulting in adverse patient outcomes. This innovative system dramatically reduces the incidence of SPCs enhancing patient safety and diagnostic accuracy. In cases like Scott Aprile's, the know error®system detects when biopsies have been switched with another patient's prior to any cancer treatment or surgery taking place.
For more information about the know error® system for breast biopsies, please visit our website at www.knowerror.com.
Eric J. Suba, John D. Pfeifer and Stephen S. Raab Patient Identification Error Among Prostate Needle Core Biopsy Specimens--Are We Ready for a DNA Time-Out? Journal of Urology Vol. 178, 1245-1248, October 2007
]]>The know error® system for breast biopsies, introduced in 2010 by Diagnostic ID, LLC, provides a solution to ensure second opinions do not have to mean second biopsies. Through the use of DNA Specimen Provenance Assignment (DSPA) and bar code technology, the know error® system brings new levels of safety and accuracy to the biopsy evaluation process. By peforming DNA matching prior to treatment, the know error® system virtually eliminates diagnostic mistakes due to SPC.
For more information about the know error® system for breast biopsies, please visit our website at www.knowerror.com.
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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.