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 identification errors in the biopsy evaluation process.

The know error® specimen security system, introduced in 2009 by Diagnostic ID, LLC,  provides a solution to finding biopsy identity switches, such as those discussed in the study, 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.

When adopted by pathology labs and their referring physicians, the know error® system can reduce switching errors and assure that no adverse patient outcomes will occur from otherwise undetected misidentifications. 

To learn more about the know error® specimen security system, visit 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

Highly revered medical facilities, such as the Mayo Clinic and the Cleveland Clinic, have acknowledged in independent studies that too many errors occur in medical testing.  Even with quality assurance systems in place, something as simple as mislabeling, sample contamination or a misplaced slide can lead to switched results among a group of patients.  There are relatively new, high-tech error reduction systems available today such as Inking and RFID (read more about these below) that have proven to reduce the incidence of switching errors.  But even with these enhanced systems in place, errors do still occur, some of which may have devastating consequences.

It should be noted that not all switching errors result in adverse effects.  Take, for example, a case in which a negative biopsy result is switched with another negative biopsy.  While a switching error technically has occurred, the mistake would likely never be discovered and neither patient would experience an adverse effect as a result of the switch.  The same would be true if a positive biopsy result is switched with another positive biopsy result, although it is possible the treatment plans would differ based on applying the wrong positive results to each patient.  In this case, there could be an adverse effect on one or both patients.  But the errors are most costly when a switch occurs between a positive biopsy result and a negative one or vice versa.  These types of switching errors can be catastrophic, resulting in unnecessary and grueling treatment for a cancer-free patient and delayed or no treatment for a patient with cancer.  These adverse medical outcomes have both medical and legal consequences for every person and / or entity involved in the biopsy process.

With the introduction of the know error® specimen security system, the medical community can now benefit from a system that incorporates forensic DNA science to reduce switching errors and resulting adverse patient outcomes.  Utilizing DNA "fingerprinting," the know error® system is able to catch errors that would be otherwise undetected by existing quality assurance systems, including those which employ sophisticated technology (e.g., Inking, RFID).  The know error® system method identifies biopsy identity switches before a patient suffers an adverse outcome (i.e., under treatment/overtreatment) and ensures the biopsy tissue specimen belongs to the patient by developing a DNA profile from a sample taken from the patient via a simple cheek swab.  This sample is then matched to the DNA profile from the patient's biopsy sample to confirm a match.

The know error® specimen security system assures the patient and treating physician that the biopsy is that of the patient before treatment begins.  It also allows the doctor to proceed with confidence regarding the treatment recommendation.  By implementing the know error® system, doctors and patients benefit from improved accuracy and reduced risk.

For more information about the know error® specimen security system with unique patient code and DNA identity confirmation (patent pending), please visit www.knowerror.com.

Numerous studies, including one published by the College of American Pathologists in 2006, have revealed that "misidentification errors are common in laboratory medicine"[1].  While most medical mix-ups are caught by quality assurance processes already in place, those that are not can have devastating consequences.  "Everyone makes mistakes" is something often heard in everyday conversation, but when it comes to an error as significant as the switching of a biopsy result, a simple mistake can lead to adverse patient outcomes.  These adverse medical outcomes have both medical and legal consequences for every person and / or entity involved in the biopsy process.

The know error® specimen security system virtually eliminates the possibility that an identification switching error will result in an adverse patient outcome.  Utilizing existing forensic DNA science, it was designed to increase patient safety and the quality of patient care. It represents an important innovation in the process of evaluating biopsies.  There are 3 basic steps to the know error® system - 1) Swab, 2) Sample and 3) DNA Match.  These steps are outlined below in greater detail. 

To make the process more relatable, we'll be using a hypothetical patient - let's say "Mr. Smith"--  who will be going in for a prostate biopsy.

First, it should be explained that Mr. Smith's doctor incorporates the know error® system -- a comprehensive biopsy kit that includes all of the necessary materials to be used in obtaining a sample of Mr. Smith's DNA as well as all of the materials that will be used by the doctor performing the biopsy to collect Mr. Smith's tissue samples.

Now let's take a look at the know error® system in action:

1) Swab:  Before Mr. Smith goes in for his biopsy, a DNA sample is taken by swabbing the inside of his cheek.  Mr. Smith will sign the envelope containing his DNA sample and a uniquely bar-coded patient ID label.  The swab is then sent to an independent forensics lab along with Mr. Smith's unique bar-coded patient ID.

2) Sample: Mr. Smith's same unique patient ID is attached to his file along with all of the other materials in the biopsy kit that will be used by the physician collecting his prostate tissue samples.  Once Mr. Smith's biopsy has taken place, the tissue samples collected will be placed in containers with his bar-coded patient ID and sent to the pathology lab.  Once Mr. Smith's samples arrive at the lab, the bar-coded label will be checked before any testing begins.

3) DNA Match:  If Mr. Smith's biopsy results reveal that he does have cancer, this will trigger the third step of the know error® system process, and small "scrolls" of his tissue samples will be sent to the same forensics lab where his reference DNA sample (the swab) was already sent.  The lab will analyze the biopsy tissue and compare it to Mr. Smith's DNA sample confirming a DNA match.  The DNA match of Mr. Smith's cheek swab and his biopsy tissue samples will give him complete confidence in knowing that he does have cancer and that his doctor's treatment recommendation is based on his biopsy results. 

In cases where a DNA match is not confirmed, the forensics lab will know the biopsy tissue samples have been switched with those of another patient. At that point, the lab will notify the appropriate parties to rectify the situation. 

Only by implementing an innovative specimen security system such as the know error® system can the medical community be assured that specimen misidentifications are detected before a patient suffers an adverse outcome. For each switch identified by the know error® system, all parties involved -- patients, physicians, and pathology labs -- are protected from potentially devastating consequences.   

To learn more about the know error® specimen security system, visit www.knowerror.com

[1] Valenstein PN, Raab SS, Walsh MK. Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions. Arch Pathol Lab Med. 2006