Section 180-7-120 - REPORT AND NOTIFICATION FOR AN ELUATE EXCEEDING PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATIONSThe licensee must:
(A) The Notify the Department and the distributor of the generator by telephone within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in 180 NAC 7-045.01 at the time of generator elution. The telephone report to the Department 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; and(B) The Submit a written report to the Department within thirty 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 180 NAC 7-120(A).180 Neb. Admin. Code, ch. 7, § 120
Adopted effective 11/3/2020Amended effective 6/14/2023