Know Error Blog: DNA Confirmation of Positive Biopsy

When Best Practices for Reducing Specimen Labeling Errors Fail

2010-04-19T17:15:18Z

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.

]]> As discussed in previous posts, procedural improvements can go a long way in the effort to reduce labeling errors but the question remains, "What happens when these processes fail?". The "best practices" suggested in this article spend a great deal of time discussing what to do when an error has been detected, how to remedy the error and how to learn from the error. However, the article does not discuss the prevention of adverse patient consequences that may result when a patient identification error remains undetected, even when these improved quality assurance practices are in place.

The know error® system, introduced in the spring of 2009 by Diagnostic ID, LLC, was designed to not only detect these types of complications but to prevent the potential resulting misdiagnoses of patients. The know error® system utilizes bar code technology and DNA Specimen Provenance Assignment (DSPA) to detect identification errors and dramatically reduces the likelihood of any resulting adverse patient outcomes. This innovative system delivers the benefits of greater patient safety and improved diagnostic accuracy while reducing risk to all involved in the biopsy process.

For more information about the know error® system, please visit our website www.knowerror.com.

"Lean" Protocol Reduces Lab Errors but Leaves Room for Improvement

2010-02-25T14:00:57Z

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.

]]> Further improvements were made once the bar-coding system was up and running to provide an additional set of checks and balances. The additional steps required the accessioner to: 1) Scan the requisition form using an optical scanner, 2) Re-key patient name, medical case number, and surgical path case number, and 3) Confirm a match between the requisition label generated by the computer (with bar code label) and the one provided by the clinician (without bar code label).

The story discloses: "If the clinician has put the wrong patient identifiers on the requisition form, there's no way to catch it." As discussed in an earlier blog post, "18 Steps Between Your Biopsy and Your Biopsy Result," evaluation of a biopsy tissue specimen is an extremely complex process. There are numerous steps and individuals involved. Even with safeguards such as these implemented at the Henry Ford Health System, there is still room for human error. While these improvements have reduced labeling problems by 85%, that itself is proof that errors still find their way through even the smallest cracks in the system.

Implementing a system to establish specimen provenance, such as the know error® system, is one way to ensure that complications, such as specimen transposition and patient misidentification, undetected by protocols already in place do not remain undetected. Like the system at Henry Ford, the know error® system also employs a bar-coding system; however, it is the addition of DNA Specimen Provenance Assignment (DSPA) that virtually eliminates the possibility that Specimen Provenance Complications (SPC) will result in an adverse patient outcome.

For more information about the know error® system, please visit our web site at www.knowerror.com.

A "DNA Time-Out" is Recommended to Help Reduce Patient Misidentification

2009-09-15T16:06:35Z

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