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.

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 to be Highlighted at New England and Mid-Atlantic AUA Meeting

2011-10-30T19:51:17Z

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.

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.

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.

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.