"But Doctor, How Do You Know that is MY Biopsy?" -- Maintaining Patient Identification.

dylan    It ain't me babe
    No, no, no, it ain't me babe.
Bob Dylan, 1964

Get the right diagnosis to the right patient. That is the mantra of any good laboratory. No institution does it exactly the same way, but linking each specimen received to the patient it came from is an essential part of laboratory management and quality. A laboratory cannot receive accreditation without having the process totally embedded within standard operating procedures. But a lab like ours that handles hundreds of core biopsies of the prostate a week faces a special challenge. To the naked eye, all those biopsies look the same. How do we tell one from another?

Our system actually begins in the urologists office. Prostate biopsies usually consist of between eight and 12 very skinny cores of tissue taken from different areas of the prostate, each placed in a separate jar of formalin preservative. Before the doctor performs the biopsy, an order is placed in the electronic health record. Our system is designed to automatically print labels to be placed on each formalin jar. These labels are required to have the patient's name, plus at least one other "identifier," such as birth date or a medical record number, unique to each patient. The label goes on the jar (NEVER on the lid!) the tissue goes in the jar, and then our medical group adds one special documentation. The patient is required to look at each jar and sign a statement indicating that the label on the jar has his name on it. We even want the patient involved in our quality process!

Once the specimen is received by the lab, our team takes control. In every step of the processing protocol which transforms the tissue cores into thin, stained slices on glass slides, we take care to maintain proper identification. We require that only one patient's specimens are in any working area at a given time so that jars or specimens can't be mixed. We have rules that require a second technologist review labeling at certain key steps. We also utilize bar coding, though we plan on taking a great leap forward in that area with installation of a new information system this fall. And then we take an added step. All cores from each  patient are inked with one of five different colors, and the color noted in the working documents. If at any time we see an outlier such as one blue core mixed with 11 yellow ones, we know we have a potential problem.

bx cropped

A prostate biopsy after formalin fixation

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The biopsy following inking with black ink.






How would we resolve that problem? I'll tell you in a minute, but first I want to mention a new step we have taken to ensure that our process has worked as planned. We now have available a system from a company in Indianapolis that compares the DNA from a patient's cheek, obtained with a cotton tipped swab at time of the procedure, with the DNA in the patient's biopsy. A match here is a virtual guarantee that the biopsy is from the right patient. The system is not free, and some of our patient's elect not to utilize it, but we appreciate the certainty it provides. We would also use that system to straighten out the blue/yellow mix up I hypothesized above.

No matter what system we use, we must always be diligent. Good patient identification means never having to say you're sorry.

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