Section 0400-20-05-.165 - REPORT, NOTIFICATION, AND RECORDS OF A DOSE TO AN EMBRYO/FETUS OR A NURSING CHILD(1) A licensee or registrant shall report to the Division at the address listed in Rule 0400-20-04-.07, any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.(2) A licensee or registrant shall report any dose to a nursing child, that was not specifically approved, in advance, by the authorized user, that is a result of an administration of radioactive material to a breast-feeding individual that: (a) Is greater than 50 mSv (5 rem) total effective dose equivalent; or(b) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.(3) A licensee or registrant shall notify the Division at the number given in Rule 0400-20-04-.07 no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraph (1) or (2) of this rule.(4) A licensee or registrant shall submit a written report to the Division within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraph (1) or (2) of this rule.(a) The written report must include:1. The licensee or registrant's name;2. The name of the prescribing physician;3. A brief description of the event;4. Why the event occurred;5. The effect, if any, on the embryo/fetus or the nursing child;6. What actions, if any, have been taken or are planned to prevent recurrence; and7. Certification that the licensee or registrant notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.(b) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.(5) A licensee or registrant shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under paragraph (1) or (2) of this rule, unless the referring physician personally informs the licensee or registrant either that they will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee or registrant is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, the licensee or registrant shall make the appropriate notifications as soon as possible thereafter. The licensee or registrant may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee or registrant shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee or registrant shall provide a written description if requested.(6) A licensee or registrant shall: (a) Retain a record of a dose to an embryo/fetus or a nursing child in accordance with this rule for three years;(b) Annotate a copy of the report of the event provided to the Division with: 1. The licensee's or registrant's name;2. The names of the individuals involved;3. The identification number, or if no other identification number is available, the social security number of the individual who is subject of the event;4. A brief description of the event and why it occurred;5. The effect, if any, on the individual, embryo/fetus, or nursing child;6. The actions, if any, taken or planned, to prevent recurrence; and7. Whether the licensee or registrant notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian) and, if not, whether such failure to notify was based on guidance from the referring physician.(c) Provide a copy of the annotated report to the referring physician if other than the licensee or registrant within 15 days after discovery of the event.Tenn. Comp. R. & Regs. 0400-20-05-.165
Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.