College of American Pathologists
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  FNA and the Universal Protocol





November 2007
PAP/NGC Programs Review

Rosemary H. Tambouret, MD

The Universal Protocol has been required by the Joint Commission since July 2004. The UP was developed to prevent errors of surgery on the wrong patient and the wrong side of the patient, as well as performance of the wrong surgical procedure, in the wake of reports of such errors to the Joint Commission. As of 2001, 150 events had been reported to the Joint Commission, most involving orthopedic procedures performed on the wrong side. None of the events were fine-needle aspirations.

The standardized Universal Protocol employs multiple strategies best suited to the operating room where the surgical team will carry out the operation on an unconscious patient. In this situation, site marking and checks by multiple members of the team, including a "time-out" to go through a final verification just before the start of the surgery, are necessary steps to avoid potentially catastrophic errors.

But the UP is adaptable to all operative and other invasive procedures occurring in settings other than the operating suite that expose patients to more than minimal risk.

Three elements make up the Universal Protocol: The preoperative verification process, in which the patient should be involved as much as possible, ensures that all necessary documents are available and reviewed before the procedure.

  • Marking the operative site before the procedure with a marker that will not wash off when the skin is prepped and in such a way that the mark is visible even after the patient is draped.
  • Final time-out is carried out immediately before the procedure with active communication among all team members and conducted in a fail-safe mode-that is, the procedure does not start until all questions are resolved. Time-out must be documented by a checklist or other approach.

Excluded minor procedures include venipuncture, peripheral IV line placement, NG tube insertion, and Foley catheter placement. Most other procedures, including fine-needle aspiration, must abide by the UP.

Site marking is not necessary if there is an obvious wound or lesion-for instance, the patient being seen in the FNA clinic for a palpable nodule. Also, if the practitioner performing the procedure remains with the patient continuously from the time the decision is made to do the procedure (and consent is obtained) to the time of the procedure itself, site marking is not required. However, if the person performing the procedure leaves the patient for any amount of time during that interval, then the site should be marked before leaving the patient.

Even when there is only one person performing the procedure, a brief pause to confirm the correct patient, procedure, and site is appropriate. It is not necessary to engage others in this verification process if they would not otherwise be involved in the procedure.

The solution we have opted for in the FNA clinic at Massachusetts General Hospital is to add a consent statement (Related article: Patient Consent) that serves also as a verification of the patient's name and the site and side of the procedure. This works well in our clinic because the pathologist remains with the patient from start to finish of the FNA procedure.

In summary, the FNA clinic is mandated by the Joint Commission to implement the Universal Protocol. Additional information can be found at the following site:

Dr. Tambouret, a liaison to the CAP Cytopathology Committee from the American Society of Cytopathology, is in the Department of Pathology, Massachusetts General Hospital, Boston.


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