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.

The know error® system for breast biopsies to be Featured at the American Society of Breast Surgeons' Annual Meeting

2011-02-13T01:31:03Z

The know error® system for breast biopsies is being showcased at the Annual Meeting of the American Society of Breast Surgeons. The meeting will be held April 27- May 1, 2011 at the Marriott Wardman Park in Washington, DC. Look for us at Booth #429. For more information on this meeting, click here.

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.

The know error® system for breast biopsies to be featured at National Consortium of Breast Centers' Conference

2011-02-13T00:34:43Z

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.

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.

Delayed Cancer Treatment Likely Worse than Unneccessary Treatment

2010-03-22T14:30:00Z

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.

]]> While the cancer-free patient was unnecessarily receiving treatment and/or undergoing surgery, the patient who needed treatment likely resumed life as normal believing she was cancer-free. Neither patient would know there had been a misidentification until after the surgery when routine tests would reveal no cancer.

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.

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.

Second Opinions Don't Protect Patients From Switched Biopsy Results

2009-11-23T16:06:21Z

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® 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® system, please visit our website www.knowerror.com.

Lab Mix-Up Results in Another Unneccessary Surgery

2009-11-16T18:32:12Z

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® 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® system assures that biopsy switching errors will be detected prior to any unnecessary surgery or treatment.

For more information about the know error® system, please visit our website 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

Specimen Provenance Complications (SPC) Resulted in New York Woman's Death

2009-10-06T16:35:38Z

Recent posts have discussed several cases where medical mix-ups have resulted in unnecessary cancer removal surgeries. One case was that of Scott Aprile, a 28 year old personal trainer, who had his breast tissue and several lymph nodes removed after his lab results were switched with another patient's. Another case discussed a 32 year old woman from Melbourne, Australia, who underwent a radical hysterectomy after her biopsy sample had been contaminated with tissue from a patient who did have cancer. In each of these cases, both patients underwent unnecessary surgeries as well as the immeasurable pain and suffering that go along with a cancer diagnosis. But, they also had another thing in common - they both survived.

In early 2008, a similar lab mix up resulted in the death of a young New York woman. She had been mistakenly diagnosed with breast cancer and decided to move ahead with treatment quickly since breast cancer ran in her family. She opted for a double mastectomy in conjunction with reconstructive surgery. The day after the surgery she died due to complications from the surgery. As with the two cases above, post surgical tests revealed there was no cancer in the first place. The hospital also made similar claims as those made in the other two cases, i.e., they had taken steps "to ensure that such an event [would] not occur in the future."

While it is unknown what specific steps have been taken or will be taken by these hospitals, it is known that these types of Specimen Provenance Complications (SPC) cannot be prevented through procedural improvements alone. (Read more on this here.) One way to truly prevent SPCs is to utilize DNA matching technology to confirm the positive biopsy tissue belongs to the patient prior to beginning any treatment plans or surgery.

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 SPCs enhancing patient safety and diagnostic accuracy. By performing DNA testing prior to treatment, the know error® system virtually eliminates diagnostic mistakes due to SPC.

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