How it Works

The process of evaluating a prostate biopsy requires numerous steps and several medical professionals. 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. If left undetected, these switching errors can have both medical and legal consequences for every person and/or entity involved in the biopsy process.

The know error® specimen security system was designed to increase patient safety and quality of patient care and represents an important innovation in the process of evaluating biopsies. The know error® system 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 from resulting in adverse patient outcomes.

The know error® system incorporates three important steps: swab, sample and DNA match.  These elements are described below:

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 forensics 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 the patient's pathology results come back, the forensics lab analyzes the tissue yielding those results and compares it to the reference sample confirming a DNA match.

With these steps, the know error® specimen security system vastly reduces the number of switching errors and virtually eliminates the possibility that one will result in an adverse patient outcome.  By confirming a DNA match, both patient and physician can confidently proceed with treatment options based on the patient’s lab results.