FMEA prevents chemo dispensing process errors

New recommendations in Sentinel Event Alert

Tragic errors caused by administration of vincristine into the subarachnoid space of chemotherapy patients continue to occur, even though these "wrong-route" errors are preventable, according to a recent Sentinel Event Alert issued by JCAHO. Although only a single case has been reported to the JCAHO’s Sentinel Event database, with the error resulting in permanent paralysis of the patient, numerous cases have been reported by the U.S. media in recent years, including several fatalities.

That suggests health care organizations are failing to voluntarily report these errors to the Joint Commission or the U.S. Pharmacopeia, possibly due to concerns over legal discoverability of the related information, according to the alert.

JCAHO’s recommendations include: Diluting IV vincristine in a volume that prevents administration via the intrathecal route; labeling each vincristine syringe: "Fatal if given intrathecally. For IV use only. Do not remove covering until moment of injection" — never dispensing IV vincristine in a manner that would permit it to be administered at a time and location where intrathecal medications are administered and conducting a timeout with at least two health care professionals to independently verify and document drug, dose, and route.

At Gwinnett Health System in Lawrenceville, GA, the chemotherapy dispensing process was chosen for a proactive risk assessment, using failure mode and effect analysis (FMEA) tools to conduct the assessment. "We identified a number of opportunities to improve our dispensing process to reduce the likelihood of error," says Suzanne Compau, BSN, MHSA, director of patient safety and quality resources.

Any medication safety alerts from JCAHO, the Institute for Safe Medication Practices, or the Food and Drug Administration are addressed through the organization’s Medication Error Reduction Team. In this case, the alert also was addressed by a multidisciplinary chemotherapy team, which was formed specifically to conduct this analysis, working with Compau and the organization’s pharmacy performance improvement coordinator.

"We are currently implementing our corrective action plan," Compau reports. "The team has decided to continue meeting through the next fiscal year and will be conducting a proactive risk assessment of the chemotherapy administration process at the bedside. I will also facilitate that review as the representative from the quality resources department."

The same team will review JCAHO’s recommendations and determine which actions or monitoring, if any, would be appropriate, she notes.

The chemotherapy team consists of a group of physicians, nurses, and pharmacists who have been performing the FMEA on the chemotherapy dispensing and administration process. "So we thought this team would have some good insights on how to proceed with the JCAHO recommendations as well," Compau adds. "We already follow the labeling precautions discussed in the alert and will see if the other recommendations can be incorporated as well."

[For more information, contact:

  • Suzanne Compau, BSN, MHSA, Director, Patient Safety/Quality Resources, Gwinnett Health System, 1000 Medical Center Blvd, Lawrenceville, GA 30045. Phone: (678) 442-4683. E-mail:
  • To see a complete list of JCAHO’s recommendations, go to Click on "Sentinel Events," "Sentinel Event Alert," and under "Preventing vincristine administration errors," click on "Complete Text."]