ENS 56766: Difference between revisions

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| NRC officer = Thomas Herrity
| NRC officer = Thomas Herrity
| event date = 09/28/2023 00:00 CDT
| event date = 09/28/2023 00:00 CDT
| last update date = 09/29/2023
| last update date = 10/13/2023
| title = Underdose to Patient  
| title = Underdose to Patient  
| event text = The following was received from the Illinois Emergency Management Agency (the Agency) via email:  
| event text = The following was received from the Illinois Emergency Management Agency (the Agency) via email:  
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Illinois Item Number: IL230027
Illinois Item Number: IL230027
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.
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.
| URL = https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2023/20231010en.html#en56766
* * * UPDATE ON 10/13/23 AT 1638 EDT FROM GARY FORSEE TO KAREN COTTON * * *
The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:
On September 29, 2023, the Agency was contacted by Rush University Medical Center (IL-01766-01) to advise of a Y-90 Therasphere under dose that occurred the day before. The prescribed dose was 200 Gy and the prescribed activity was 45.92 mCi. The administered dose was 153.1 Gy with an administered activity of 35.15 mCi. This is a 23.5 percent deviation (under dose). The administration was determined to be clinically effective with no adverse patient impact reported. The patient and the referring physician were notified within 24 hours.
Agency inspectors performed a reactionary inspection on October 3, 2023. The infusion of the Y-90 TheraSpheres went as intended with no identifiable irregularities. Post-admin calculations were performed which calculated that the dose delivered was 35.15 mCi. At this time the [accredited medical practitioner] (AMP) determined the dose delivered was 23.5 percent less than the written directive resulting in a potential medical event. The RSO interviewed all staff involved in the procedure and performed PET/CT imaging of the waste container (with dose vial, administration tubing kit, connector, extension tubing, microcatheter, forceps, etc.). This image was processed, and 3D volume renderings were utilized to identify where hot spots were located within the waste materials. Images of the waste container showed the highest activity was located in the dose vial. No additional apparent issues were discovered by the RSO. During an interview with the AMP, they stated that they tilted the dose vial back and forth to 90 degrees and tapped the vial on a hard surface. After the inspectors reviewed the procedures and through further questioning, they realized that the AMP was not tapping the vial sharply enough against a hard surface.
Agency investigation findings identified the root cause of this event as inadequate agitation of the dose vial. Inspectors determined that the tapping process was not performed firmly enough against a hard surface to release the microspheres from the septum of the dose vial. This likely resulted in an increased number of microspheres remaining on the septum of the dose vial, and not released into the solution for administration to the patient. The RSO stated that they had begun the process of revising the checklist utilized during Y-90 TheraSphere procedures to better describe the dose vial preparation which includes the agitation process.
Pending no further developments, this matter is considered closed.
Notified R3DO (Orth) and NMSS Events Notification (email).
| URL = https://www.nrc.gov/reading-rm/doc-collections/event-status/event/2023/20231016en.html#en56766
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Latest revision as of 06:30, 16 October 2023

ENS 56766 +/-
Where
Rush University Medical Center
Chicago, Illinois (NRC Region 3)
License number: IL-01766-01
Organization: Illinois Emergency Mgmt. Agency
Reporting
Agreement State
Time - Person (Reporting Time:+33.92 h1.413 days <br />0.202 weeks <br />0.0465 months <br />)
Opened: Whitney Cox
14:55 Sep 29, 2023
NRC Officer: Thomas Herrity
Last Updated: Oct 13, 2023
56766 - NRC Website