1. (1) The licensee shall notify by telephone the Division and the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in paragraph (1) of Rule 0400-20-07-.41 at the time of generator elution. The telephone report to the Division must include:

   1. (a) The name of the manufacturer;
   2. (b) The model number and serial number (or lot number) of the generator;
   3. (c) The results of the measurement;
   4. (d) The date of the measurement;
   5. (e) Whether dosages were administered to patients or human research subjects, when the distributor was notified; and
   6. (f) The action taken.

2. (2) By an appropriate method listed in Rule 0400-20-04-.07, the licensee shall submit a written report to the Division 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:

   1. (a) Action taken by the licensee;
   2. (b) Patient dose assessment;
   3. (c) Methodology used to make this dose assessment if the eluate was administered to patients or human research subjects;
   4. (d) 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
   5. (e) Information in the telephone report as required by paragraph (1) of this rule.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq. Administrative History: New rule filed December 4, 2023; effective March 3, 2024.