Recently in vanishing cancer Category

A Boston Globe article, "Mistakes That Matter," reported on two lawsuits filed as a result of medical mistakes that led to one unnecessary prostate surgery and another delay in prostate cancer treatment. While the cases in this article are similar, they are not related and consequently, will be discussed in separate posts.

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.

In July 2010, Fox 4 News in Dallas reported on a medical mix-up that nearly led to an unnecessary double mastectomy for one Texas woman. Romona Champion had a routine mammogram in February of 2009 that showed a suspicious mass. She had a biopsy done three weeks later and soon found out the biopsy revealed she had breast cancer. 

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 is being showcased at the National Consortium of Breast Centers' National Interdisciplinary Breast Center Conference. The meeting is being held March 12-13, 2011 at the Planet Hollywood Resort & Casino in Las Vegas. Look for us at Booth #23. For more information on this meeting, visit www.breastcare.org.

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.

On July 20, 2010, a story in The Vancouver Sun revealed a case where an accidental biopsy mix up resulted in an unnecessary lumpectomy for one woman and a 10 week delay in treatment for another.

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.

In December 2009, a report out of Obrezje, Slovenia revealed a lab mix up that resulted in the unnecessary complete stomach removal of a healthy woman, 50-year old Anica Kavecic.  Kavecic had no history of gastric problems, but when a biopsy showed a pervasive cancer in her stomach, she was urged to have an immediate and total gastrectomy. 

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.   

Recent posts discussing the cases of Darrie Eason, Scott Aprile and "Kim," a woman from Korea, revealed three similar. Each involved some form of patient misidentification that resulted in a cancer-free patient undergoing unnecessary breast removal surgery. Media coverage of these types of cases tends to focus on the patient who received some form of unnecessary treatment. While tragic for these patients, the reports seem to overlook a second and possibly more tragic victim - the patient WITH cancer who received delayed treatment or worse, no treatment at all.

The January 2009 feature story of CAP TODAY, "Using Lean to End Labeling Errors," discussed the implementation of a bar-coding initiative at the surgical pathology lab at Henry Ford Health System. The program was considered a success after reducing labeling problems by 85%, according to Dr. Mark Tuthill, Director of Pathology Informatics. 

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.

On August 12, 2009, an article published in The Korea Times revealed that two of Korea's top hospitals had been held liable in the case of a cancer-free woman, referred to as "Kim," who mistakenly had part of her right breast removed. In 2005, a tumor was found in Kim's right breast during a routine check-up. She had an ultrasound and biopsy to further examine the tumor; however, as the tests were being evaluated, the hospital mistakenly switched her chart with that of another patient. Based on the another patient's chart, she was diagnosed with cancer and it was recommended that she have part of her right breast removed. Upon seeking a second opinion, some simple tests were performed, but there was no second biopsy and the cancer diagnosis was confirmed based on the switched biopsy results.  

An October 2009 report from The Australian revealed a medical mistake involving a Japanese man who was mistakenly diagnosed with rectal cancer and was given an artificial rectum.  While the information on this case is quite limited, it appears to be similar to other cases we have covered in that post surgical tests revealed no cancer in the removed tissue.  The man is suing the hospital for 35 million yen or approximately $415,000 in compensation. 

In May 2009, media reports surfaced about a 28 year old man who mistakenly underwent a radical mastectomy only to find out a few months later that he never had cancer.  Scott Aprile, a personal trainer from New York, received the devastating news that he had breast cancer in December of 2008. Just one month later, in January 2009, surgeons removed his right breast along with three lymph nodes. About two weeks after his surgery, Aprile was told that his biopsy had been switched with a woman's biopsy that had been performed the same day.

A recent blog post discussing second opinions focused on a theoretical patient who was misdiagnosed with cancer and was not helped by a second opinion since it was based on the original biopsy which had been mistakenly switched with another patient's biopsy results.  This happened in the case of Darrie Eason, a 35-year old single mother who mistakenly had both breasts removed after a lab mix-up led to her cancer misdiagnosis.  When appearing on Good Morning America and asked what could be learned from this, Eason, who herself sought a second opinion, responded "Maybe it's that second opinions are good but second biopsies are better." 

 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.