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 Errors (SPE) that can lead to diagnostic mistakes.  Other examples of SPE are specimen transposition and foreign cell contamination. 

Launched in the spring of 2009, the know error® system brings new levels of safety and accuracy to the biopsy evaluation process.  Through the use of forensic DNA testing and bar code technology, this innovative system dramatically reduces the incidence of SPE -- and identifies otherwise undetected SPE -- 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 forensic DNA testing of biopsy tissue samples PRIOR to any treatment taking place and virtually eliminates diagnostic mistakes due to SPE.  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, please visit our web site www.knowerror.com.

In December 2009, a report out of Obrezje, Slovenia revealed a lab switching error 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 yet different situations.  Each involved some form of patient misidentification error 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 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 wrong 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." 

In an effort to reduce the number of labeling errors that may lead to the switching of biopsy tissue samples, a number of error reduction systems have been suggested and/or utilized in addition to quality assurance processes already in place.  Detecting these errors is exceedingly important since the switching of a biopsy result may lead to serious consequences for the patients involved, such as the unnecessary treatment of a cancer-free patient or no treatment for a patient who has cancer and needs immediate treatment.

After receiving the life changing diagnosis of cancer, some physicians may encourage a patient to seek a second opinion.  Friends and family would most certainly insist on this; perhaps even go to the lengths of seeking out an expert in the field or a world-class hospital that specializes in a particular type of cancer.

In most cases, the purpose of the second "opinion" is to verify the cancer diagnosis and more importantly, to validate the treatment plan suggested by the first physician.  For instance, if a patient seeks the second opinion of a physician taking part in a clinical study, the approach to treatment may be drastically different.  After gaining both opinions, it is then up to the patient to compare both opinions and determine which approach is right for him.

However, what if the problem to be found had nothing to do with the diagnosis but rather the fact that the diagnosis was based on the wrong patient's biopsy results?  In other words, a cancer free patient's results were switched with the results of a patient who had cancer (click here to read about such a switching error).  In this case, a second opinion (or third or fourth) would do nothing to protect the patient.  Unless a second biopsy was ordered by the physician offering the second opinion, this switching error would very likely remain undetected. At that point, a cancer free patient may have undergone an unneccessary surgery such as a double masectomy or prostatecomy.

The know error® specimen security system, introduced in 2009 by Diagnostic ID, LLC, employs a DNA matching technology that provides DNA confirmation of a positive biopsy result.  With the know error® system in place, patients and physicians alike are ensured that the first opinion and any given thereafter are based on the right biopsy results. 

For more information about the know error® specimen security system with unique patient code and DNA confirmation, please visit our web site at www.knowerror.com. 

A Newsday article published on November 11, 2009, revealed another biopsy switching error that resulted in an unnecessary lumpectomy and removal of lymph nodes.  In this case, the patient was 35 year-old Janelle Trenchfield who has filed a negligence lawsuit against the medical facility where her surgery was performed.

As with cases previously covered by this blog, Trenchfield didn't find out she was cancer-free until AFTER the surgery when routine post surgical tests showed the tissue samples from the surgery were negative for cancer.  Her biopsy lab results had been switched after a label with her name was attached to another patient's tissue samples.  Additionally, in this case, the error was also attributed to "human error and procedural issues."  A hospital spokesman claimed, "All procedures for the handling and labeling of tissue samples were immediately revised." 

In each of the cases we have covered, revising or improving procedures appears to be the common solution proposed to solve these patient misidentification errors.  While procedural improvements can serve to reduce the number of errors that occur, a study* published in the Journal of Urology suggested that these types of errors likely cannot be eliminated through procedural improvements alone.  Additionally, the study proposed these types of errors may be entirely eliminated with the use of DNA matching prior to any treatment taking place.

The know error® specimen security system, introduced in 2009 by Diagnostic ID, LLC,  provides a solution to finding biopsy identity switches by incorporating both an error reduction system and DNA fingerprinting technology. The know error® system employs patient-specific bar-coding for the purpose of reducing errors and forensic DNA fingerprinting for the purpose of preventing errors that may result in an adverse patient outcome. 

The know error® system uncovers patient identification errors by matching tissue from a positive biopsy result to a reference sample taken from the patient via a simple cheek swab to confirm that the tissue belongs to the patient.  By performing DNA matching PRIOR to treatment, the know error® specimen security system assures that biopsy switching errors will be detected prior to any unnecessary surgery or treatment.

For more information about the know error® specimen security system with unique patient code and DNA confirmation, please visit our web site 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