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On February 23, 2010, The College of American Pathologists posted an article on its web site titled, "When a Rose Is Not a Rose."  The article discusses the problem of mislabeled specimens and the procedural improvements that can be made to prevent labeling errors.

The article explains that "...reporting a wrong result can have potentially devastating effects on the patient. This can be doubly true if there is a patient identification mix-up: one patient could receive the wrong medical or surgical treatment while another doesn't get the treatment he or she needs. Either situation can result in severe, irreversible consequences."  As a remedy to the various types of labeling errors it covers, the article offers several procedural improvements such as reviewing definitions, guidelines and the protocol for what to do when an error is detected. 

 

The January 2009 feature story of CAP TODAY, "Using Lean to End Labeling Errors," discussed the implementation of a bar-coding initiative at the surgical pathology lab at Henry Ford Health System. The program was considered a success after reducing labeling problems by 85%, according to Dr. Mark Tuthill, Director of Pathology Informatics. 

The new "Lean" protocol involved bar-coding all patient-related materials - requisition form, tissue cassettes, specimen containers, and slides - all at the same time.  Upon entering a patient into the system, the accessioner would print all of the bar codes for a particular patient.  There were technological challenges with the bar-coding since linear bar codes couldn't be used.  Tuthill partnered with General Data out of Cincinnati which had created a new cassette labeling system which could work in conjunction with the existing lab information system.


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 misidentification in the biopsy evaluation process.

Through the use of DNA Specimen Provenance Assignment (DSPA) and bar code technology, the know error® system brings new levels of safety and accuracy to the biopsy evaluation process. This innovative system virtually eliminates the possibililty of adverse patient outcomes due to Specimen Provenance Complications (SPC). By performing DSPA prior to treatment, the know error® system assures that SPCs will be detected prior to any unnecessary surgeries or treatment plans.

When adopted by pathology labs and their referring physicians, the know error® system dramatically reduces the incidence of SPCs enhancing patient safety and diagnostic accuracy. For more information about the know error® system, visit our website at 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