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DNA time-out procedure may help reduce patient identification error among prostate needle core biopsy specimens

The elimination of patient identification error is a major goal of the patient safety movement. In surgical pathology, such errors are uncommon and yet potentially catastrophic events. Most malpractice claims against pathologists involve accidentally switched specimens among patients, with most of these errors involving breast needle or prostate needle core biopsy specimens. A DNA time-out procedure may help reduce patient identification error among prostate needle core biopsy specimens, suggests a new study.

The authors had access to records on three cases of prostate needle biopsy identification errors and performed a root cause analysis to discover why the errors had occurred. They developed a surgical pathology work flow table listing 19 separate steps associated with the biopsy examination process, as well as the associated risks of error for each of the steps and potential error reduction strategies.

Errors may occur at many stages in the process, and are usually due to slips or lapses of automatic actions. The authors believe that, even if laboratory work flow optimization could be implemented, it would be difficult to entirely prevent these types of errors. They recommend a new method known as a DNA time-out, which may eliminate patient identification errors among needle biopsies. The DNA time-out procedure verifies correct patient identification through a DNA polymorphic microsatellite analysis before the patient undergoes surgery. In such an analysis, molecular analyses would be performed on two specimens, one taken from the prostate needle biopsy, and the other from a blood sample or saliva swab drawn from the same patient.

Surgery would not take place until any questions or concerns were resolved. Commercial kits for the highly accurate performance of this test are currently available. The direct lab costs of the DNA time-out would be approximately $110 per specimen pair. However, a formal evaluation of the cost-effectiveness of the DNA time-out cannot be performed at this time, since the true incidence of such errors is not yet known.

The study was supported by the Agency for Healthcare Research and Quality (HS13321).

See "Patient identification error among prostate needle core biopsy specimens—Are we ready for a DNA time-out?" by Eric J. Suba, M.D., John D. Pfeifer, M.D., Ph.D., and Stephen S. Raab, M.D. in the October 2007 Journal of Urology 178, pp. 1245-1248.

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