How the know error® system works

The core features of the know error® system include:

- Advanced Biopsy Kit with Unique Patient Identification Bar Code
All know error® system biopsy kits feature a unique patient identification bar code that is applied to the kit components. This helps reduce Specimen Provenance Errors (SPE)About Specimen Provenance Errors (SPE)
SPE encompasses a wide spectrum of error conditions including specimen transposition, foreign cell contamination, and patient misidentification that occur in clinical or anatomical pathology. Occult SPE can lead to serious diagnostic mistakes and adverse patient outcomes. that can occur in the collection, handling and processing of biopsy tissues.

- Forensic Chain of Custody
The know error® system employs forensic chain of custody protocols, providing a means of control and documentation for the handling of samples.

- DNA Specimen Provenance Assay (DSPA)
The know error® system features a DNA verification test that virtually eliminates diagnostic errors due to SPE. This testing incorporates three important steps:

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

sample. The patient’s biopsy tissue samples are placed in bar coded specimen containers from the biopsy kit and sent to the pathology lab for evaluation.

DNA match. If the biopsy results come back positive, the forensics lab performs a DNA Specimen Provenance Assay (DSPA) using genetic microsatellite analysis.  This test compares the Short Tandem Repeat (STR) profile of the patient's biopsy tissue to the patient's reference sample.  Concurrence of these STR profiles allows the practitioner to rule out SPE.  

- Conclusive Report
Once a DNA test is complete, the forensics lab issues an electronic report (compatible with most EMR systems).  If potential SPE is indicated, the appropriate parties are notified to address the error via a defined protocol.

Through these combined features, the know error® system virtually eliminates diagnostic mistakes due to SPE, allowing both patient and physician to proceed confidently with treatment options based on the patient’s biopsy results.

Click here to learn more about why the know error® system is necessary.

Click here to read about Dr. Peter M. Knapp Jr.'s use of the know error® system for prostate biopsies in his practice.