Current through Register Vol. 30, No. 38, September 20, 2024
A. A licensee shall provide radiation safety
instruction, initially and at least annually, for all personnel caring for the
patient or human research subject receiving radiopharmaceutical therapy and
hospitalized for compliance with R9-7-717. To satisfy this requirement, the
instruction shall describe the licensee's procedures for:
1. Patient or human research subject
control,
2. Visitor
control,
3. Contamination control,
and
4. Waste control.
B. For each patient or human
research subject who cannot be released under R9-7-717, a licensee shall:
1. Quarter the patient or the human research
subject in a private room with a private sanitary facility;
2. Visibly post the patient's or the human
research subject's room with a "Radioactive Materials" sign;
3. Note on the door or in the patient's or
human research subject's chart where and how long visitors may stay in the
patient's or the human research subject's room; and
4. Monitor material and items removed from
the patient's or the human research subject's room to determine that their
radioactivity cannot be distinguished from the natural background radiation
level with a radiation detection survey instrument set on its most sensitive
scale and with no interposed shielding, or handle the material and items as
radioactive waste.
C. A
licensee shall notify the Radiation Safety Officer, or his or her designee, and
the authorized user as soon as possible if the patient or human research
subject has a medical emergency or dies.
D. A licensee may use any unsealed byproduct
material identified in R9-7-723(A)(2)(b)(vi) prepared for medical use and for
which a written directive is required that is:
1. Obtained from:
a. A manufacturer or preparer licensed under
R9-7-311 or equivalent Agreement State requirements, or
b. A PET radioactive drug producer licensed
under R9-7-311 or equivalent Agreement State requirements;
2. Excluding production of PET radionuclides,
prepared by:
a. An authorized nuclear
pharmacist;
b. A physician who is
an authorized user and who meets the requirements specified R-7-723;
or
c. An individual under the
supervision, as specified in R9-7-712, of the authorized nuclear pharmacist in
subsection (D)(2)(a) or the physician who is an authorized user in subsection
(D)(2)(b);
3. Obtained
from and prepared by an NRC or Agreement State licensee for use in research in
accordance with an Investigational New Drug (IND) protocol accepted by FDA;
or
4. Prepared by the licensee for
use in research in accordance with an Investigational New Drug (IND) protocol
accepted by FDA.
E. A licensee shall
retain records of instruction and safety procedures performed under this rule
for three years from the date of the activity.
