Know Error Blog: DNA Confirmation of Positive Biopsy

High Tech Error Reduction Methods Employed to Reduce Labeling Errors

2010-01-10T17:46:47Z

In an effort to reduce the number of labeling errors that may lead to the switching of biopsy tissue samples, a number of error reduction systems have been suggested and/or utilized in addition to quality assurance processes already in place. Detecting these errors is exceedingly important since the switching of a biopsy result may lead to serious consequences for the patients involved, such as the unnecessary treatment of a cancer-free patient or no treatment for a patient who has cancer and needs immediate treatment.

]]> One such error reduction method is the "inking" of specimens whereby at the time of grossing, each specimen is directly inked through the bag in one of 6 colors. The colors are always applied in the same sequence. The dissector writes the color used on the original requisition slip and dictates the color for the gross description. Each block is then routinely processed and entirely sectioned to produce at least 5 slides and 2 levels per slide. When the slides from the cases are reviewed, the pathologist compares the color of the ink in the tissue with that written in the gross description.[1]

Another error reduction method is suggested by the Mayo Clinic. Mindful of the importance of reducing identity errors and the potential for adverse consequences, the Mayo Clinic recently adopted radio frequency technology in their GI lab in Rochester, MN in an effort to determine and reduce the incidents of identification errors. An article published on the web site www.endonurse.com in October of 2007 discusses a study on this topic conducted by the Mayo Clinic.

Per the Mayo Clinic study, in Q1 of 2008 AFTER implementing an error reduction program (i.e. state of the art RFID), 47 errors were still made! Since errors can still occur even after implementation of an "error reduction system," patients remain exposed to the risk of a biopsy switching error resulting in over-treatment/under-treatment, and the hospital/physician reputation is also put at risk.

A "safer" system might be to implement an "error reduction program" (e.g. bar coding, RFID, inking) AND take steps to prevent adverse patient outcomes. There have been many published reports which have advocated the use of DNA "fingerprinting" to catch those errors which are undetected by existing quality systems. One such system is the know error® system available from Diagnostic ID, LLC.

The know error® system employs both bar-coding AND forensic DNA confirmation in a process which, when adopted by pathology labs and their referring physicians, can reduce switching errors and assure that no adverse patient outcomes will occur from otherwise undetected misidentifications.

To learn more about the know error® system, please visit our website www.knowerror.com.

[1] Andrew A. Renshaw, MD, Richard Kish, MHS, and Edwin W. Gould, MD The Value of Inking Breast Cores to Reduce Specimen Mix-up

Second Opinions Don't Protect Patients From Switched Biopsy Results

2009-11-23T16:06:21Z

After receiving the life changing diagnosis of cancer, some physicians may encourage a patient to seek a second opinion. Friends and family would most certainly insist on this; perhaps even go to the lengths of seeking out an expert in the field or a world-class hospital that specializes in a particular type of cancer.

In most cases, the purpose of the second "opinion" is to verify the cancer diagnosis and more importantly, to validate the treatment plan suggested by the first physician. For instance, if a patient seeks the second opinion of a physician taking part in a clinical study, the approach to treatment may be drastically different. After gaining both opinions, it is then up to the patient to compare both opinions and determine which approach is right for him.

However, what if the problem to be found had nothing to do with the diagnosis but rather the fact that the diagnosis was based on the wrong patient's biopsy results? In other words, a cancer free patient's results were switched with the results of a patient who had cancer (click here to read about such a switching error). In this case, a second opinion (or third or fourth) would do nothing to protect the patient. Unless a second biopsy was ordered by the physician offering the second opinion, this switching error would very likely remain undetected. At that point, a cancer free patient may have undergone an unneccessary surgery such as a double masectomy or prostatecomy.

The know error® system, introduced in 2009 by Diagnostic ID, LLC, employs a DNA matching technology that provides DNA confirmation of a positive biopsy result. With the know error® system in place, patients and physicians alike are ensured that the first opinion and any given thereafter are based on the right biopsy results.

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

Video overview of the know error® system

2009-11-05T17:25:41Z

A new video overview of the know error® system has been created and can be viewed online at www.knowerror.com/video. The video illustrates the three key elements that make up the know error® system process: swab. sample. dna match.

swab. Before a biopsy procedure, a reference sample of a patient's DNA is taken by gently swabbing the inside of his cheek. The swab is sent to an independent forensic DNA lab with the patient's unique patient ID.

sample. The unique bar code is attached to the patient's file along with all other materials in the biopsy kit.

dna match. When a patient's pathology result is positive for cancer, all positive specimens are sent to the DNA lab for DNA matching with the reference sample.

By confirming a DNA match, patients and physicians can confidently proceed with treatment options based on the patient's lab results. When adopted by pathology labs and their referring physicians, the know error® system can reduce Specimen Provenance Complications (SPC) and assure that no adverse patient outcomes will occur from undetected complications.

The know error® system, introduced in 2009 by Diagnostic ID, LLC, brings new levels of safety and accuracy to the biopsy evaluation process. Through DNA Specimen Provenance Assignment (DSPA) and bar code technology, this innovative system virtually eliminates the possibility of diagnostic mistakes due to SPC.

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