EN Revision Text: AGREEMENT STATE REPORT - UNINTENDED DOSE TO NON-TARGET TISSUE
The following was received from the state of California:
The licensee reported an unintended dose to non-target tissue of a patient from an HDR [High Dose Rate] treatment, apparently due to mispositioning of the uterus-ovary applicator. The unintended dose occurred on the final of four fractions. The target tissue received the intended dose in each of the four fractions, but non-target tissue of the bowel received in excess of 50 rem and 150 percent of the expected dose to the non-target bowel tissue from the four fractions combined, with the excess non-target bowel dose occurring in the final fraction due to the mispositioned applicator.
The licensee will submit a 15-day written report to the California Department of Public Health-Radiologic Health Branch (CDPH-RHB) in accordance with 10 CFR 35.3045(d), and will include the calculated dose to the non-target tissue of concern. That report will be forwarded to NRC by CDPH-RHB.
The referring physician was informed of the unintended dose to the non-target bowel tissue.
CA 5010 Number: 022719
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.
- * * RETRACTION AT 1644 EDT ON 03/27/2019 FROM ROBERT GREGER TO JOANNA BRIDGE * * *
The following was received via e-mail:
The licensee determined that a dose volume of 5 cc was appropriate for the unintended tissue exposure (instead of 2 cc). Based on the 5 cc tissue volume, the dose was less than the Medical Event reporting criteria contained in 10 CFR 35.3045(a)(3). Please note that the original event submittal by California erroneously referenced the applicable regulatory reporting requirement as 10 CFR 35.3045(a)(1)(iii).
Notified R4DO (Kozal) and
NMSS Events.