| (B) a physician who is an authorized user and who meets
the requirements specified in subsections (jj) or (nn) of this section;
or
(C) an individual under the supervision, as specified
in subsection (s) of this section, of the authorized nuclear pharmacist
in subparagraph (A) of this paragraph, or the physician who is an
authorized user in subparagraph (B) of this paragraph; or
(3) is obtained from and prepared by an NRC or agreement
state licensee for use in research in accordance with an IND protocol
accepted by the FDA; or
(4) is prepared by the licensee for use in research
in accordance with an IND protocol accepted by the FDA.
(ll) Safety instruction to personnel.
(1) The licensee shall provide radiation safety instruction,
initially and at least annually, to personnel caring for patients
or human or animal research subjects who cannot be released in accordance
with subsection (cc) of this section. The instruction shall be appropriate
to the personnel's assigned duties and include the following:
(A) patient or human or animal research subject control;
and
(B) visitor control to include the following:
(i) routine visitation to hospitalized individuals
or animals in accordance with §289.202(n) of this title;
(ii) contamination control;
(iii) waste control; and
(iv) notification of the RSO, or his or her designee,
and an authorized user if the patient or the human or animal research
subject has a medical emergency or dies.
(2) The licensee shall maintain a record for inspection
by the department, in accordance with subsection (xxx) of this section,
of individuals receiving instruction. The record shall include the
following:
(A) list of the topics covered;
(B) date of the instruction or training;
(C) name(s) of the attendee(s); and
(D) name(s) of the individual(s) who provided the instruction.
(mm) Safety precautions. For each human patient or
human research subject who cannot be released in accordance with subsection
(cc) of this section, the licensee shall do the following:
(1) provide a private room with a private sanitary
facility; or
(2) provide a room with a private sanitary facility
with another individual who also has received therapy with an unsealed
radioactive material and who also cannot be released in accordance
with subsection (cc) of this section;
(3) post the patient's or the research subject's room
with a "Radioactive Materials" sign and note on the door and in the
patient's or research subject's chart where and how long visitors
may stay in the patient's or the research subject's room; and
(4) either monitor material and items removed from
the patient's or the 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
such material and items as radioactive waste; and
(5) notify the RSO, or his or her designee, and the
authorized user immediately if the patient or research subject has
a medical emergency or dies.
(nn) Training for use of unsealed radioactive material
that requires a written directive. Except as provided in subsection
(l) of this section, the licensee shall require an authorized user
of unsealed radioactive material for the uses authorized in subsection
(kk) of this section to be a physician who:
(1) is certified by a medical specialty board whose
certification process has been recognized by the department, the NRC,
or an agreement state and who meets the requirements in paragraph
(2)(A)(ii)(VI) of this subsection. The names of board certifications
that have been recognized by the department, the NRC, or an agreement
state are posted on the NRC's Medical Uses Licensee Toolkit web page.
To be recognized, a specialty board shall require all candidates for
certification to:
(A) successfully complete residency training in a radiation
therapy or nuclear medicine training program or a program in a related
medical specialty. These residency training programs shall include
700 hours of training and experience as described in paragraph (2)(A)(i)
- (2)(A)(ii)(V) of this subsection. Eligible training programs shall
be approved by the Residency Review Committee of the Accreditation
Council for Graduate Medical Education, the Royal College of Physicians
and Surgeons of Canada, or the Committee on Post-Graduate Training
of the American Osteopathic Association; and
(B) pass an examination, administered by diplomates
of the specialty board, which tests knowledge and competence in radiation
safety, radionuclide handling, quality assurance, and clinical use
of unsealed radioactive material for which a written directive is
required; or
(2) has completed 700 hours of training and experience,
including a minimum of 200 hours of classroom and laboratory training,
in basic radionuclide handling techniques applicable to the medical
use of unsealed radioactive material requiring a written directive.
(A) The training and experience shall include the following.
(i) classroom and laboratory training in the following
areas:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
of radioactivity;
(IV) chemistry of radioactive material for medical
use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
user who meets the requirements of subsection (l) of this section,
this subsection or equivalent NRC or agreement state requirements.
A supervising authorized user, who meets the requirements of this
paragraph shall also have experience in administering dosages in the
same dosage category or categories (i.e. subclause (VI) of this clause)
as the individual requesting authorized user status. The work experience
shall involve the following:
(I) ordering, receiving, and unpacking radioactive
materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
used to determine the activity of dosages and performing checks for
proper operation of survey meters;
(III) calculating, measuring, and safely preparing
patient or human research subject dosages;
(IV) using administrative controls to prevent a medical
event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
material safely and using proper decontamination procedures; and
(VI) administering dosages of radioactive drugs to
patients or human research subjects from the three categories in the
following items. Radioactive drugs containing radionuclides in categories
not included in this paragraph are regulated under subsection (q)
of this section. This work experience must involve a minimum of three
cases in each of the following categories for which the individual
is requesting authorized user status:
(-a-) oral administration of less than or equal to
33 mCi (1.22 GBq) of sodium iodide I-131, for which a written directive
is required;
(-b-) oral administration of greater than 33 mCi (1.22
GBq) of sodium iodide I-131 (experience with at least three cases
in this item also satisfies the requirement of item (-a-) of this
subclause; and
(-c-) parenteral administration of any radioactive
drug that contains a radionuclide that is primarily used for its electron
emission, beta radiation characteristics, alpha radiation characteristics,
or photon energy of less than 150 kiloelectron volts (keV) for which
a written directive is required; and
(B) has obtained written attestation that the individual
has satisfactorily completed the requirements of paragraph (2)(A)
of this subsection, and is able to independently fulfill the radiation
safety-related duties as an authorized user for the medical uses authorized
under subsection (kk) of this section for which the individual is
requesting authorized user status. The attestation must be obtained
from either:
(i) a preceptor authorized user who meets the requirements
of subsection (l) of this section, this subsection or equivalent NRC
or agreement state requirements and has experience in administering
dosages in the same dosage category or categories as the individual
requesting authorized user status; or
Cont'd... |
