Know Error Blog: DNA Confirmation of Positive Biopsy

Know Error is Participating in the Society of Breast Imaging's Breast MRI Course

2012-01-29T16:51:55Z

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.

Woman Undergoes Unneccessary Radiation Treatment Due to Lab Error

2011-12-28T19:07:40Z

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 Sponsoring the Connecticut Challenge Survivorship Summit

2011-11-11T16:04:00Z

Know Error is sponsoring the 2nd Annual Connecticut Challenge Survivorship Summit: "Bringing Together Leaders in Cancer Survivorship." This annual symposium will be held November 15, 2011 at the New Haven Lawn Club in New Haven, CT. The event is featuring speakers from world renowned cancer centers, including Memorial Sloan Kettering Cancer Center and the Abramson Cancer Center of the University of Pennsylvania. Kenneth Miller, MD, Director of the Lance Armstrong Foundation Adult Survivorship Program at Dana-Farber Cancer Institute and Instructor in Medicine at Harvard Medical School, will wrap up the program with a presentation titled: "Buy-in and Pushback: How survivorship fits into the system." Click here to learn more about this meeting.

The mission of the Connecticut Challenge is "to empower cancer survivors to live healthier, happier and longer lives." According to its website, the Connecticut Challenge raised more than $1.4 million in 2010 with 86 cents of every dollar going towards program services and grants.

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 and breast, the know error® system brings new levels of patient safety and diagnostic accuracy to the biopsy evaluation process.

Know Error Sponsored Key to the Cure Event at Saks Fifth Avenue

2011-11-08T16:26:44Z

Know Error was a proud sponsor of the 5th Annual "Key to the Cure" event hosted by the St. Vincent Foundation and Saks Fifth Avenue. The event was held October 15th, 2011 at Saks Fifth Avenue at Keystone at the Crossing and was part of a nationwide Saks fundraising initiative to raise funds for cancer treatment and research. The proceeds from the Indianapolis event will benefit St. Vincent Cancer Care.

The black-tie event included a cocktail reception, seated dinner, fashion show, live auction and dancing. According to the Indianapolis Star, the 2011 fundraiser raised close to $500,000 which will support important initiatives at St. Vincent Cancer Care. To date, the Saks Fifth Avenue and St. Vincent Foundation partnership has raised more than $2 million.

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 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 to Participate in Breast Cancer Symposium

2011-10-31T05:00:00Z

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.

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

The know error® system Will Participate at Society of Breast Imaging's Breast MRI Course

2011-08-22T18:30:37Z

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 September 17-18, 2011 at the Loews Santa Monica Beach Hotel in Santa Monica, CA. Look for our tabletop display in the registration area.

The know error® system for breast biopsies brings a new standard of patient safety and diagnostic accuracy to the biopsy evaluation process. By establishing specimen provenance as part of the biopsy evaluation process, the know error® system arms physicians with critical information to recommend the appropriate path for patient treatment. Since its launch in the spring of 2010, the system has identified DNA non-matches in more than 1% of the patient cases for whom testing has been performed.

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

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.

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