N.H. Admin. Code § He-P 4035.38

Current through Register No. 50, December 12, 2024

Section He-P 4035.38 - Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child

(a) A licensee shall report any dose to an embryo/fetus, that is greater than 50 millisieverts (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

(b) A license shall report any dose to a nursing child that is a result of an administration of byproduct material to a breast-feeding individual that:

(1) Is greater than 50 millisieverts (5 rem) total effective dose equivalent; or

(2) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

(c) The licensee shall notify by telephone DHHS/RHS no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in He-P 4035.38(a) or He-P 4035.38(b).

(d) The licensee shall submit a written report to DHHS/RHS within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in He-P 4035.38(a) or He-P 4035.38(b). The written report shall include:

(1) The licensee'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;

(7) Certification that the licensee notified the pregnant individual or mother (or the mother's child's responsible relative or guardian), and if not, why not; and

(8) The report shall not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

(e) The licensee 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 He-P 4035.38(a) or He-P 4035.38(b), unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee shall:

(1) Not be 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 shall make the appropriate notifications as soon as possible thereafter;

(2) 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;

(3) Notify the mother's or child's responsible relative or guardian instead of the mother;

(4) Inform the mother, or the mother's or child's responsible relative or guardian, if a verbal notification is made, that a written description of the event can be obtained from the licensee upon request; and

(5) Provide such a written description if requested.

(f) In the report, a licensee shall:

(1) Annotate a copy of the report provided to DHHS/RHS with the following:

a. Name of the pregnant individual or the nursing child who is the subject of the event; and

b. 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

(2) 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.

N.H. Admin. Code § He-P 4035.38

(See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07

Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10897, Effective 7/22/2015, Expires1/18/2016.

Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11011, Effective 1/15/2016, Expires 1/15/2026.

Amended by Volume XXXVI Number 49, Filed December 8, 2016, Proposed by #12054, Effective 11/19/2016, Expires 11/19/2026.

Amended by Volume XLII Number 45, Filed November 10, 2022, Proposed by #13473, Effective 10/25/2022, Expires 10/25/2032