September 2009 Archives

The know error® specimen security system will be showcased at the Annual Meeting of the Mid-Atlantic Section of the American Urological Association (AUA), October 1-4, 2009, at the Williamsburg Lodge, in Williamsburg, Virginia. Look for us at Table 27 (T27) in the exhibit hall. 

The know error® specimen security 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. 

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® specimen security system assures that biopsy switching errors will be detected prior to any adverse patient outcomes.

For more information about the know error® specimen security system with unique patient code and DNA confirmation, please visit our web site at www.knowerror.com.

The know error® system for prostate biopsies will be showcased at several upcoming Section Meetings of the American Urological Association (AUA). The first stop is the Annual Meeting of the New England Section of the AUA, September 24-27, 2009, at the Rennaissance Hotel in Washington, DC. Look for us at Booth #23 in the exhibit hall. 

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 virtually eliminates the possibililty of adverse patient outcomes due to Specimen Provenance Complications (SPC). By performing DSPA prior to treatment, the know error® system assures that SPCs will be detected prior to any unnecessary surgeries or treatment plans.

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

A study published in the Journal of Urology (October 2007) suggested that the medical community may be ready for a "DNA Timeout" utilizing forensic DNA to prevent biopsy switching errors that may result in adverse patient outcomes. The study, 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. A DNA time-out, whereby DNA polymorphic microsatellite analysis is used to confirm patient identification before radiation therapy or radical surgery, may eliminate patient identification errors among needle biopsies."

As identified in this study, a process often referred to as DNA "fingerprinting" has been advocated to catch those errors which are undetected by existing quality systems, even those systems which adopt sophisticated error reduction systems. While many facilities have implemented improved processes and protocols, these improvements serve to reduce the number of errors; however, according to the study, DNA matching may provide a way to prevent patient misidentification in the biopsy evaluation process.

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 virtually eliminates the possibililty of adverse patient outcomes due to Specimen Provenance Complications (SPC). By performing DSPA prior to treatment, the know error® system assures that SPCs will be detected prior to any unnecessary surgeries or treatment plans.

When adopted by pathology labs and their referring physicians, the know error® system dramatically reduces the incidence of SPCs enhancing patient safety and diagnostic accuracy. For more information about the know error® system, 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

On September 5, 2009, a story out of Australia discussed the case of a Melbourne woman who went in for laparoscopic procedure in December of 2008 to investigate a uterine cyst.  Pathology reports showed the diagnosis of stage three uterine cancer, and she was advised to have a radical hysterectomy. 

To further exacerbate the diagnosis, the woman's experience with the "overstretched" medical system was extremely challenging.  It took more than a month for her to get her lab results, even though it only took two days for the pathology lab to process her sample.  Furthermore, she was notified over the phone by a nurse who offered no additional information other than the fact that she had cancer.  The nurse advised her that she would need to wait a couple of weeks for a call back from the doctor.  In February 2009, a month after her diagnosis and after additional tests revealed the cancer had not spread, she was advised to have a radical hysterectomy.  She had planned to have more children and asked if her ovaries could be saved but was informed that everything would need to be removed.

She had her surgery in March 2009 and about two weeks later she received a call from a nurse informing her "...there was good news..." and that she didn't have cancer.  Again, with no additional information, she was told that someone would call to explain. 

A hospital investigation revealed her sample had been contaminated with tissue from a patient who had cancer.  The hospital apologized but did not offer further explanation about what happened in the lab, why the woman was notified over the phone, or if another patient was affected by this misdiagnosis.  The hospital insists it has reviewed its procedures to prevent this from happening again, but without establishing specimen provenance, there is no way to fully ensure this.

With the complexity of the biopsy evaluation process, physicians and patients need an effective way to establish specimen provenance of biopsy tissue samples. 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 virtually eliminates the possibililty of adverse patient outcomes due to Specimen Provenance Complications (SPC). By performing DSPA prior to treatment, the know error® system assures that SPCs will be detected prior to any unnecessary surgeries or treatment plans.

The know error® system dramatically reduces the incidence of SPCs enhancing patient safety and diagnostic accuracy. For more information about the know error® system, visit our website at www.knowerror.com.

 The know error® specimen security system, introduced in 2009, utilizes DNA "fingerprinting" technology and virtually eliminates the possibility that a biopsy misidentification error will result in an adverse patient outcome.  The system was designed to increase patient safety and the quality of patient care and represents an important innovation in the process of evaluating biopsies.  In October 2007, TodayShow.com contributor, Mike Celizic, discussed the case of a biopsy labeling error that had devastating consequences for one New York woman.  Here is an excerpt from his story:

Because of a mislabeled tissue sample that led to a misdiagnosis, Darrie Eason had both of her breasts removed to save her from a cancer that she never had.  No amount of money will make Eason whole again, but the Long Island, N.Y., woman hopes that her experience and a lawsuit she is pressing may help other women. "Maybe if people hear about my case, they'll know. Maybe somebody will do something differently next time," she told TODAY co-host Meredith Vieira during an interview Thursday. "I don't want this to happen to anyone else." Eason is a 35-year-old single mother who works in the accounts receivable department of a local community newspaper chain. She has a 15-year-old son. In 2006, she was told she needed to undergo a radical double mastectomy because she had an invasive form of breast cancer. "I just broke down and cried," she recalled of the moment she got the diagnosis. Eason went to another doctor for a second opinion, and was again told she had cancer. The doctor relied on the same mislabeled tissue sample.
 
"I was told I had lobular breast cancer, which everybody said would come back," she told Vieira. Armed with that information, she had both breasts removed and underwent the first phase of reconstructive surgery in May 2006. While waiting to heal so she could begin chemotherapy, her surgeon, who had submitted removed tissue to a lab for routine testing, told her that something was wrong: She didn't have cancer. "You can't even explain it," Eason said of her emotions when she was told she had had both her breasts removed for no reason. An investigation by the New York State Department of Health would reveal that the lab that handled her biopsy samples had mixed up her sample with that of another woman.
 
The other woman, who actually did have breast cancer, was told she was cancer-free. Only when Eason's error was discovered did the other woman, who has not been identified, learn that she had cancer. "She has to live with the idea that she had breast cancer and hers was not diagnosed at the earliest possible time," said Eason's attorney, Steven Pegalis, of the other woman. The state report said "the most likely source of the error" was the technician engaging in a practice called "batching," which involves handling more than one specimen at a time. The state health department determined that the lab's error was isolated and found "no systemic problems and no deficiencies" at the lab. Eason's attorney, Steven Pegalis, told Vieira he's not so sure. "It may be one person, but personally I doubt it. One of the things we may learn is 'Was there a system failure, and if so, what can be done to improve the system?' Personally, I doubt this is a one-time event by someone who was careless for one time in his or her life," he said.

By implementing an innovative system, such as the know error® specimen security system, errors like the one in the Darrie Eason case would be detected BEFORE a patient suffers an adverse outcome. With each biopsy switch identified by the know error® system, all parties involved -- patients, physicians, and pathology labs -- are protected from potentially devastating consequences.