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
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 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.
]]> Due to language translation issues, it is difficult to fully understand the outcome of this case, but it appears that Kavecic was awarded €40,000 in compensation. From what can be discerned, it also appears there may have been insurance limitations involving coverage of a medical error. She has sought expert legal counsel to negotiate a higher compensation.
As with many cases documented in this blog, such as the case of Janelle Trenchfield who underwent an unneccesary lumpectomy, Kavecic's case involved an unnecessary surgery due to a Specimen Provenance Complication (SPC), e.g., specimen transposition, foreign cell contamination or patient misidentification. However, this is the first case we have covered involving removal of a healthy stomach which brings with it a completely different set of issues and post surgical concerns. The American Cancer Society provides further details of a total gastrectomy, which also includes the removal of lymph nodes, as well as potential side effects of the surgery.
According to the article referenced above, the hospital had no procedure in place to prevent this type of complication from resulting in an adverse patient outcome. The know error® system, introduced in 2009 by Diagnostic, ID LLC, was designed specifically to detect this type of SPC and to prevent resulting unnecessary treatments and surgeries. The know error® system utilizes DNA Specimen Provenance Assignment (DSPA) 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, please visit our website www.knowerror.com.
]]>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
]]>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.