Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4526 - DOSE TO AN EMBRYO/FETUS OR CHILD; REPORT AND NOTIFICATION

Subpart 1. Report required; embryo/fetus.

A licensee must report any dose to an embryo/fetus that is greater than five rems (50 mSv) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant woman unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

Subp. 2. Report required; nursing child.

A licensee must report a dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding woman that:

A. is greater than five rems (50 mSv) 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.

Subp. 3. 24-hour notification required.

A licensee must notify the commissioner within 24 hours after discovery of a dose to an embryo/fetus or nursing child that requires a report under subpart 1 or 2.

Subp. 4. Written report.

A licensee must submit a written report to the commissioner within 15 days after discovery of a dose to an embryo/fetus or nursing child that requires a report under subpart 1 or 2. 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. The report must include:

A. the licensee's name;

B. the name of the prescribing physician;

C. a brief description of the event;

D. why the event occurred;

E. the effect, if any, on the embryo/fetus or the nursing child;

F. what actions, if any, have been taken or are planned to prevent recurrence; and

G. certification that the licensee notified the pregnant woman or mother, or the mother's or child's responsible relative or guardian, and if not, why.

Subp. 6. Individual identification.

A licensee must:

A. annotate a copy of the report provided to the commissioner with:

(1) the name of the pregnant individual or the nursing child who is the subject of the event; and

(2) the identification number or if no other identification number is available, the Social Security number of the individual who is the subject of the event; and

B. provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.

Notes

Minn. R. agency 144, ch. 4731, MEDICAL USE OF RADIOACTIVE MATERIAL, pt. 4731.4526

29 SR 755; 36 SR 74 46 SR 790

Statutory Authority: MS s 144.1202; 144.1203