Recently in foreign cell contamination Category

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 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 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.

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. 

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." 

The know error® system for prostate biopsies is being showcased this week at the Annual Meeting of the South Central Section of the American Urological Association (AUA). The meeting is being held October 14-17, 2009, at the Camelback Inn, JW Marriott Resort, in Scottsdale, Arizona. Look for us at Booth #151 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 dramatically reduces the incidence of Specimen Provenance Complications (SPC) enhancing patient safety and diagnostic accuracy.

The know error® system uncovers SPCs 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 virtually eliminates diagnostic mistakes due SPC.

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

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. 

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.