| AGREEMENT STATE REPORT - UNDERDOSE OF Y-90 THERASPHERE TREATMENT|
The following information was obtained from the state of Iowa via email:
"The University of Iowa Radiation Safety Officer notified the Iowa Department of Public Health (IDPH) on May 23, 2019, of a possible medical event that had occurred at the University of Iowa Hospital on May 22, 2019. The event occurred during a therapeutic Yttrium-90 (Y-90) microsphere (TheraSphere) administration to the liver. The signed written directive from the authorized user was 1.37 GBq (37.03 milliCuries). During the administration, it appeared that the spheres were being administered without incident until the point at which the flow of spheres ceased. The interventional radiologist determined that stasis had been reached, which prevented the remainder of the prescribed dose from being administered and appeared to be the only explanation for what happened. Based on the final survey reading of the source vial and tubing in the waste container, the initial determined dose was 0.586 GBq (15.84 milliCuries) which is 42% of the written directive.
"The following morning, May 23, 2019, routine imaging of the patient indicated no Y-90 activity in the patient's liver or abdominal areas. A second whole-body scan to determine any migration of activity was also negative for Y-90. The University of Iowa Radiation Safety Staff initiated an investigation into the location of the remainder of activity that was not remaining in the dose vial by surveying the procedure room and patient's room which were background levels and verified correct imaging protocol for the patient. The dose vial was re-surveyed and was found to contain all the original activity and no Y-90 TheraSpheres.
"The licensee's preliminary probable cause is an occluded needle in the vial that could have prevented either the flow of saline into the source vial, or the flow of microspheres out of the vial to the patient. The authorized user, the interventional radiologist, and the patient have been informed of the issue with this administration. No direct harm to the patient has occurred because no radioactivity had been delivered to the patient.
"This is a preliminary report and IDPH will be conducting an investigation to provide additional updated information. Items to initially get resolved include but are not limited to the licensee's issue with how dosages are measured before and after the procedure, independently verifying that no dose had been delivered to the patient, examine the integrity of the tubing and needles used in the procedure, and communication with the manufacturer about the circumstances surrounding this event and if they or the NRC are aware of any similar events."
NMED Report No.: IA190001
* * * RETRACTION AT 1641 EDT ON 5/30/19 FROM STUART JORDAN TO JEFF HERRERA * * *
The following retraction was received from the Iowa Bureau of Radiological Health via email:
"The Iowa Department of Public Health requests to retract the NRC Event Notification No. 54084 (Item No. IA190001) that was transmitted to the NRC Operations Center on May 24, 2019. After conversations with the licensee's radiation safety officer and review of information provided by the licensee we have determined that no detectable amount of Y-90 TheraSpheres was administered to the patient, and therefore no dose was delivered. Based on a discussion with NRC Region III Office, we have determined that the circumstances surrounding this incident do not meet the reportable medical event described in 10 CFR 35.3045."
Notified the R3DO (Daley), NMSS Events (via email).
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.