Evidence of Error

Errors are not Uncommon in the Biopsy Evaluation Process

Medical research, reports from respected news organizations, and real-life cases document the existence of 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. such as specimen transposition, foreign cell contamination, and patient misidentification, among the handling of biopsy tissue samples and the resulting need for an additional level of patient safety and improved diagnostic accuracy.

One such study, conducted by the College of American Pathologists (2006), extrapolated that reported misidentification errors from 120 pathology labs would result in more than 160,000 adverse patient outcomes per year.¹ The study further cautioned that the true incidence of both errors and resulting adverse events would be much higher than can be presently measured since the research results were based soley on errors that were detected.

A Wall Street Journal article from June 2006 reported, “3 percent to 5 percent of the billions of specimens taken each year are defective, be it a biopsy that doesn't extract the tumor cells, blood that isn't drawn correctly or a mix-up with another patient's sample.”²

Specimen Provenance Errors encompass a wide spectrum of error conditions including sample contamination such as seen in the case of an Australian woman who had an unnecessary radical hysterectomy after her biopsy sample was contaminated with tissue from a woman who did have cancer. Another example of SPE is patient misidentification which occurred in the case of Darrie Eason, who had an unnecessary double mastectomy due to her biopsy test results being switched with those of another patient. Consequently, necessary treatment was delayed for the woman who did have breast cancer. When looking beyond research studies at the effects SPE can have on an individual, the importance of preventing these errors from leading to diagnostic mistakes becomes increasingly clear.

In a study published in the Journal Of Urology (October 2007), Drs. John Pfeifer, Stephen Raab, and Eric Suba suggested that the medical community may be ready for a “DNA Timeout” utilizing forensic DNA, and concluded: “Patient identification errors among prostate needle biopsies may be difficult to entirely prevent through the 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."³

The know error® system provides a solution to identify Specimen Provenance Errors (SPE), such as those identified above, by incorporating forensic DNA testing and bar code technology in the biopsy evaluation process. This innovative system dramatically reduces the incidence of SPE — and identifies otherwise undetected SPE — so that diagnostic mistakes are minimized.

For more detailed information about supporting research, click here to read "Bx Switching and Misidentification Errors - Frequency of Occurrence, Detection Methods, and Prevention."

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 

² “Hospitals Move To Cut Dangerous Lab Errors” June 14, 2006 By Laura Landro The Wall Street Journal

³ 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