Know Error Blog: DNA Confirmation of Positive Biopsy

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.

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.

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.

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.