Recently in Lab Mixup Category

The know error® system for breast biopsies will be participating at the Society of Breast Imaging's (SBI) next course -- Practical Breast MRI: Case Based Review." The course takes place January 28 - 29, 2012 at the Hilton Bonnet Creek Hotel in Orlando, FL. Look for our tabletop display in the registration area.

Know Error develops and markets the know error® system for breast biopsies which utilizes bar coding, forensic principles and DNA matching to confirm that the biopsy samples being evaluated belong to the patient being diagnosed. Available for a diverse range of tissue types, including breast, the know error® system brings new levels of patient safety and diagnostic accuracy to the biopsy evaluation process.

Since the company's launch in 2009, hundreds of physicians in a variety of specialties have incorporated the know error® system as a standard for their patient care. To learn more about the know error® system for breast biopsies, visit our website www.knowerror.com.

According to an article in the New York Post, a New York woman who was undergoing surgery for injuries caused in a car accident was misdiagnosed with Stage 4 metastatic breast cancer based on a lab's mishandling of her biopsy tissue. During routine post surgical tests, the woman's biopsy was contaminated with tissue from the sample of a patient who did have cancer. Since the diagnosis was Stage 4 cancer, her doctors recommended radiation treatment as soon as possible. However, after doctors were unable to pinpoint her type of cancer, they asked for a second opinion from a different lab. The new test revealed the misdiagnosis but not before she had already undergone 6 radiation treatments.

This is different than the chain of events leading to a misdiagnosis that have occurred in most cases covered in this blog. Typically, a lab mix up occurs which results in a false diagnosis, ultimately leading to unnecessary surgery and/or treatment for cancer. It is not until after the surgery that the routine post surgical tests of the biopsied tissue reveal there was no cancer in the first place. In this case, the testing of the post surgical biopsy tissue (from an unrelated surgery) was where the mistake and resulting misdiagnosis occurred.

Regardless of where the error occurred in the complex biopsy evaluation process, it is possible to avoid adverse outcomes such as these. Know Error develops and markets the know error® system which utilizes bar coding, forensic principles and DNA matching to confirm that the biopsy samples being evaluated belong to the patient being diagnosed. In this case, DNA testing conducted prior to treatment would have revealed two tissue types and that the one with cancer did not match this patient's DNA.

Available for a diverse range of tissue types, the know error® system brings new levels of patient safety and diagnostic accuracy to the biopsy evaluation process. Since the company's launch in 2009, hundreds of physicians in a variety of specialties have incorporated the know error® system as a standard for their patient care.

To learn more about the know error® system, visit our website www.knowerror.com.

Know Error is hosting a User's Group Luncheon Meeting prior to the Large Urology Group Practice Association's 2011 Annual Meeting. The luncheon is being held on November 3rd, from 11:00 am - 2:00 pm, at the Drake Hotel in Chicago. Invitations have been extended to urologists attending LUGPA 2011.

A keynote presentation will be provided on the significance of DNA testing in the biopsy evaluation process, as well as an update and discussion on the know error® system's performance within large urology group practice settings.

"We Are Ready for a DNA Timeout"
John Pfeifer, MD, PhD, Vice Chairman for Clinical Affairs, Pathology and Immunology,
Washington University School of Medicine

"Know Error Best Practices"
Ann Anderson, MD, Director of Pathology, Integrated Medical Professionals

Know Error develops and markets the know error® system which utilizes bar coding, forensic principles and DNA matching to confirm that the biopsy samples being evaluated belong to the patient being diagnosed. Since the company's launch in 2009, hundreds of physicians in a variety of specialties, including urology, have incorporated the know error® system as a standard for their patient care.

To learn more about the know error® system for prostate biopsies, visit our website www.knowerror.com.

Know Error is proud to be a part of the 8th Annual Lee-Ann Riley Memorial Breast Symposium -- "Emerging Trends in Breast Cancer Management: From Diagnosis to Survivorship." The symposium is being hosted by the Norma F. Pfriem Breast Care Center at Bridgeport Hospital and takes place on October 26, 2011 in Shelton, CT. Click here for more information on this meeting.

The Norma F. Pfriem Breast Care Center is dedicated to providing a comprehensive network of services for complete breast health. Its multidisciplinary team of breast cancer specialists provides one-on-one care, with dignity, privacy, and warmth, in a serene, comfortable, thoroughly professional setting.

Know Error develops and markets the know error® system for breast biopsies which utilizes bar coding, forensic principles and DNA matching to confirm that the biopsy samples being evaluated belong to the patient being diagnosed. Available for a diverse range of tissue types, including breast, the know error® system brings new levels of patient safety and diagnostic accuracy to the biopsy evaluation process.

To learn more about the know error® system for breast biopsies, visit our website www.knowerror.com.

The know error® system for prostate biopsies is set to exhibit at the upcoming joint meeting of the New England and Mid-Atlantic Sections of the AUA. The meeting runs from November 3-6, 2011 at the Walt Disney World Swan Hotel in Orlando, FL. Click here for more information on this meeting.

Know Error develops and markets the know error® system which utilizes bar coding, forensic principles and DNA matching to confirm that the biopsy samples being evaluated belong to the patient being diagnosed. Available for a diverse range of tissue types, including prostate, the know error® system brings new levels of patient safety and diagnostic accuracy to the biopsy evaluation process.

Since the company's launch in 2009, hundreds of physicians in a variety of specialties, including urology, have incorporated the know error® system as a standard for their patient care. To learn more about the know error® system for prostate biopsies, visit our website www.knowerror.com.

On October 1, 2011, the Victoria Herald Sun reported on a biopsy labeling mix-up that resulted in the unnecessary removal of an Australian woman's spleen as well as part of her pancreas. Fifty-six year old, Christine Korolew, was given the diagnosis of cancer in January 2010 after a pancreatic lesion was biopsied and revealed cancer.

As with most cases covered in this blog, the mix-up was revealed when routine post surgical tests showed no evidence of cancer. Korolew is pursuing legal action and her claim alleges that "a slide containing a biopsy specimen from another patient had been mislabeled with [her] name." The unnecessary removal of part of her pancreas additionally caused her to develop diabetes which requires two injections of insulin every day. The suit also claims that her ability to continue working has been affected and her former employer confirmed that "she is unlikely to be gainfully employed again."

The article makes no mention of the patient with whom Ms. Korolew's slides were switched.

Launched in 2009, the know error® system was developed to prevent this type of mix-up from occurring. The system utilizes bar coding, forensic principles and DNA matching to confirm that the biopsy samples being evaluated belong to the patient being diagnosed. In this case, the mislabeling would have been detected prior to any treatment taking place. Ms. Korolew would not have undergone unnecessary surgery or developed diabetes and the other patient involved in the mix-up would not have experienced any delay in treatment.

Available for a diverse range of tissue types, the know error® system brings new levels of patient safety and diagnostic accuracy to the biopsy evaluation process. To learn more about the know error® system, visit our website www.knowerror.com.

A Boston Globe article, "Mistakes That Matter," discussed the case of two men who were adversely affected by mix ups in the biopsy evaluation process. This post covers the case of the second man in the article (read previous post) who experienced an 8 month delay in his cancer treatment due to a lab mix up. The delay resulted in his cancer spreading to a lymph node and could mean radiation treatment (that would not have been necessary) in addition to the removal of his prostate.

In the article, the patient commented, "Labs are a pretty important part of the whole medical thing, and to have them screw up a fairly simple thing like that makes me wary." From a patient's perspective, it may seem like this would be a simple process, but medical experts have shown that evaluating biopsies is far from simple (read more).

In the first case from the article, the mix-up occurred when the slides were being reviewed by the pathologist (after leaving the pathology lab). In the second case, the mix up occurred at the lab when the lab technician placed the patient's tissue samples on blank slides labeled for another patient. By the time the pathologist reviewed the slides, the mix up had already occurred. Further, the mix up happened even though there were numbering and color coding quality control processes in place. This reemphasizes the complexity of the biopsy evaluation process and the need for a system that goes beyond procedural improvements.

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 Specimen Provenance Complications (see previous post for more on SPCs). Through these combined features, the system allows both patient and physician to proceed confidently with treatment options based on the patient's lab results.

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

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.

The know error® system for prostate biopsies is being showcased at the Annual Meeting of the American Urological Association (AUA). The meeting takes place May 14-19, 2011 Walter E. Washington Convention Center in Washington, DC. Look for us at booth #3150. For more information on this meeting, click here.

The know error® system, introduced in the spring of 2009 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 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 prostate biopsies is being showcased at the 75th Annual Meeting of the Southeastern Section of the American Urological Association (AUA). The meeting is being held March 17-20, 2011 at the Marriott New Orleans. For more information on this meeting, click here.

The know error® system, introduced in the spring of 2009 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 prostate 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.

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. 

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." 

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® 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. 

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