Know Error Blog: DNA Confirmation of Positive Biopsy

Specimen Provenance Complications (SPC) Nearly Result in Unneccessary Double Mastectomy

2011-03-21T10:00:00Z

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.

Unnecessary Lumpectomy Attributed to Specimen Provenance Complication (SPC)

2010-07-23T19:11:51Z

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.

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.

When Best Practices for Reducing Specimen Labeling Errors Fail

2010-04-19T17:15:18Z

On February 23, 2010, The College of American Pathologists posted an article on its web site titled, "When a Rose Is Not a Rose." The article discusses the problem of mislabeled specimens and the procedural improvements that can be made to prevent labeling errors.

The article explains that "...reporting a wrong result can have potentially devastating effects on the patient. This can be doubly true if there is a patient identification mix-up: one patient could receive the wrong medical or surgical treatment while another doesn't get the treatment he or she needs. Either situation can result in severe, irreversible consequences." As a remedy to the various types of labeling errors it covers, the article offers several procedural improvements such as reviewing definitions, guidelines and the protocol for what to do when an error is detected.

]]> As discussed in previous posts, procedural improvements can go a long way in the effort to reduce labeling errors but the question remains, "What happens when these processes fail?". The "best practices" suggested in this article spend a great deal of time discussing what to do when an error has been detected, how to remedy the error and how to learn from the error. However, the article does not discuss the prevention of adverse patient consequences that may result when a patient identification error remains undetected, even when these improved quality assurance practices are in place.

The know error® system, introduced in the spring of 2009 by Diagnostic ID, LLC, was designed to not only detect these types of complications but to prevent the potential resulting misdiagnoses of patients. The know error® system utilizes bar code technology and DNA Specimen Provenance Assignment (DSPA) to detect identification errors and dramatically reduces the likelihood of any resulting adverse patient outcomes. This innovative system delivers the benefits of greater patient safety and improved diagnostic accuracy while reducing risk to all involved in the biopsy process.

For more information about the know error® system, please visit our website www.knowerror.com.

Lab Mix Up Resulted in Woman's Healthy Stomach Removal

2010-04-06T14:48:21Z

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.

]]> 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.

Korean Hospitals Held Liable in Case of Switched Patient Charts

2010-02-18T12:00:00Z

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.

]]> After the removal, routine post surgical tests revealed no cancer cells in the removed tissue. It was only AFTER the surgery that it was discovered that the patient charts had been switched. Initially, the court ruled that the hospital responsible for the file mix up and the resulting cancer misdiagnosis was liable but the second hospital, where she received the second opinion and where the surgery was performed, was not. The court claimed that it was common not to conduct a second biopsy when giving a second opinion. However, this was overruled by Korea's high court and the second hospital was also found liable. The ruling found that since the patient had gone there for confirmation of her original diagnosis, the second hospital had an obligation to conduct an additional biopsy to verify the diagnosis.

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.

Mix-up with Woman's Biopsy Resulted in Unneccessary Mastectomy for 28 Year Old Man

2010-02-01T15:00:00Z

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.

]]> Aprile is suing the hospital and the doctors who performed the unnecessary mastectomy. The hospital issued a statement claiming, among other things, "...[it] has put procedures in place to prevent such an occurrence in the future." This claim by the hospital raises questions since it would be nearly impossible to completely prevent such errors through procedural improvements. A study published in the Journal of Urology and conducted by Drs. John Pfeifer, Stephen Raab, and Eric Suba concluded: "Patient identification errors among prostate needle biopsies may be difficult to entirely prevent through optimization of work flow processes." The study further suggested that DNA confirmation of patient identification may be the only way to entirely prevent misidentification among all needle biopsies.

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

With DNA Specimen Provenance Assignment (DSPA), Second Opinions Don't Have to Mean Second Biopsies

2010-01-25T06:30:00Z

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."

]]> In some cases, second biopsies may be necessary when an original biopsy doesn't provide enough detail to make a conclusive diagnosis. However, why should a patient like Darrie Eason be subjected to a second biopsy when seeking a second opinion for the purpose of confirming that the original biopsy belonged to her? This raises many questions about the biopsy evaluation process. It is a complex process with numerous steps and individuals involved (click here for more information), and it is inevitable that complications will occur at some point in this process. Further, research shows that these complications cannot be eliminated by procedural improvements alone (click here for more information).

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.