A patient was being treated for a liver tumor and the dosage was delivered to the wrong lobe. The physician prescribed 17 mCi of
Y-90 to the left lobe of the liver. The prescribing physician was not present during the dose administration procedure. The intervention radiologist examined a fluoroscope of the patient's liver and noted a larger tumor on the right lobe. The prescribed dosage was then delivered to the right lobe of the liver, not in accordance with the prescribed dosage plan. Patient examination detected no observable impact, and the physician is developing another dosage plan for the patient. The
Iowa Department of Public Health will perform an onsite investigation.
A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
- * * UPDATE FROM RANDAL DAHLIN TO CHARLES TEAL ON 11/2/12 AT 1408 EDT * * *
The following was received from the State of Iowa via email:
The University of Iowa nuclear medicine staff notified the Environmental Health & Safety (EHS) office on October 19, 2012 that they had discovered a reportable medical event that occurred during an October 18, 2012, therapy administration of Yttrium-90 microspheres (SIRSpheres) to a patient with liver metastases from a carcinoid tumor.
The Nuclear Medicine authorized user had prescribed for the delivery of 17 millicuries of the Y-90 microspheres to the left lobe of the patient's liver with plans to also administer 34 millicuries of the Y-90 microspheres to the right lobe of the patient's liver at a later time. Y-90 activity to be administered was calculated based on body surface area and tumor involvement. However, the interventional radiologist performing the Y-90 microsphere administration under fluoroscopic guidance noted that the angiogram of the patient's liver showed more tumor blood flow in the right lobe of the patient's liver and decided it would be medically more advantageous for the patient to treat the right lobe of the liver first. He proceeded to treat the right lobe without consulting the authorized user.
The interventional radiologist was only able to deliver 96% of the 17 millicurie Y-90 dose to the right lobe of the patient's liver before the right artery occluded. The authorized user discovered the administration discrepancy the next day when the patient was scheduled for post therapy imaging on October 19th. Both the patient and referring physician were informed of the medical event on October 19th. The physicians involved concluded that the patient's health and outcome were not affected by treating the right lobe of the liver first with only 17 millicuries of Y-90 microspheres since only 96% of activity could be injected before full embolization of the right hepatic artery occurred.
The physicians plan to treat the left lobe of the patient's liver in approximately 4 weeks. The Iowa Department of Public Health (IDPH) performed an onsite investigation of this medical event on October 23, 2012. The IDPH inspector interviewed the University Radiation Safety Officer, the Nuclear Medicine Authorized User, the Interventional Radiologist performing the Y-90 administration, the Chief Nuclear Pharmacist, the Chairman of the Medical Radiation Protection Committee, and Hospital Radiation Safety Review Group. The cause of the event was a lack of understanding of the requirements for administering radioactive material under the supervision of an authorized user. The interventional radiologist made a medical decision to alter the administration site without consulting the prescribing authorized user.
To avoid recurrence the following actions are being taken by the University of Iowa. All nuclear medicine authorized users prescribing Y-90 microsphere therapy will review the supervision requirements specified in Iowa Administrative Code 641-41.2(11) with all interventional radiologists on staff to ensure that they understand that they are required to follow the instructions of the prescribing authorized user. A roster of the individuals receiving this training will be forwarded to the IDPH upon completion. Additionally, nuclear medicine and interventional radiology will develop a written policy regarding the proper steps to be taken in the event that any deviation from the authorized user's written directive for the medical administration of radioactive materials is required. A copy of the policy will be forwarded to IDPH upon completion.
Reporting Requirement: 35.3045(a)(1(i) - Total dose delivered that differs from the prescribed dose by 20% or more; and differs from the prescribed dose by more than 0.05 Sv (50 rem) SDE.
IA Report: IA120006
Notified R3DO (Kozak) and the
FSME Event Resource via email.