Or. Admin. Code § 333-116-1011
Current through Register Vol. 64, No. 1, January 1, 2025
Section 333-116-1011 - Report and Notification for an Eluate Exceeding Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations(1) The licensee shall notify the Authority by telephone at 1-800-452-0311 and request for Radiation Protection Services to call. In addition, the licensee must call the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in OAR 333-116-0330(1) at the time of generator elution. The telephone report to the Authority must include the manufacturer, model number, and serial number (or lot number) of the generator, the results of the measurement, the date of the measurement, whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.(2) The licensee shall submit a written report to Radiation Protection Services, 800 NE Oregon Street, Suite 640, Portland Oregon, 97232 within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by section (1) of this rule.Or. Admin. Code § 333-116-1011
PH 81-2021, adopt filed 11/19/2021, effective 11/23/2021Statutory/Other Authority: ORS 453.635
Statutes/Other Implemented: ORS 453.605 - 453.807