ENS Event | |
|---|---|
07:00 Jun 9, 2016 | |
| Title | Agreement State Report - Patient Received Threapeutic Dose at Location Not Authorized by Facility License |
| Event Description | The following information was received from the State of California via email:
Cedar Sinai called LA County Radiation Management on Friday 6/17/16 at 4:25pm [PDT] to report that Cardinal Health delivered Xofigo (Ra-223) to a Los Angeles clinic which is not authorized to have the material. The therapy dose was then given to the patient. Cedar Sinai has a broad scope license and is authorized to have the material, the location that received the material is not an authorized use location, and the doctor who administered the material is not an authorized user for the material. The current assumption which is being verified is the clinic (previously Targenix RML#7145) had its own license prior to a merge and was allowed to have the material and the doctor was previously authorized to administer the material. The patient records have been reviewed by an authorized doctor and [the patient] would have received the treatment at an authorized location by an authorized user if referred. The balance of the treatments will be at an authorized location with an authorized user. Cedar Sinai will continue to investigate and report their findings. 5010 Number: 061716 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. |
| Where | |
|---|---|
| Cedars-Sinai Medical Center Los Angeles, California (NRC Region 4) | |
| License number: | 0404-19 |
| Organization: | California Radiation Control Prgm |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+205.77 h8.574 days <br />1.225 weeks <br />0.282 months <br />) | |
| Opened: | Jeff Day 20:46 Jun 17, 2016 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Jun 17, 2016 |
| 52018 - NRC Website | |
Cedars-Sinai Medical Center with Agreement State | |
WEEKMONTHYEARENS 520182016-06-09T07:00:0009 June 2016 07:00:00
[Table view]Agreement State Agreement State Report - Patient Received Threapeutic Dose at Location Not Authorized by Facility License 2016-06-09T07:00:00 | |