Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4731 - RADIATION SAFETY
MEDICAL USE OF RADIOACTIVE MATERIAL
Part 4731.4443 - UNSEALED RADIOACTIVE MATERIAL; WRITTEN DIRECTIVE REQUIRED; TRAINING
Universal Citation: MN Rules 4731.4443
Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1. Training and education requirements. Except as provided under part 4731.4414, a licensee must require an authorized user of unsealed radioactive material for the uses authorized under part 4731.4440 to be a physician who:
A. is certified by a medical specialty board
whose certification process has been recognized by the NRC or an agreement
state, and meets the requirements in item B, subitem (1), unit (b), subunit vi.
The names of board certifications that have been recognized by the NRC or an
agreement state are posted on the NRCs Medical Use Licensee Toolkit web page;
or
B. has:
(1) 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. The
training and experience must include:
(a)
classroom and laboratory training in:
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
(b) work experience, under the
supervision of an authorized user who meets the requirements in this part, part
4731.4414, or equivalent requirements of the NRC or an agreement state. A
supervising authorized user who meets the requirements in this item must also
have experience in administering dosages in the same dosage category or
categories under subunit vi as the individual requesting authorized user
status. The work experience must involve:
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 radioactive
material;
v. using procedures to
safely contain spilled radioactive material and using proper decontamination
procedures; and
vi. administering
dosages of radioactive drugs to patients or human research subjects from the
three categories in this subunit. Radioactive drugs containing radionuclides in
categories not included in this subunit are regulated under part 4731.4404.
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: oral administration of less than or equal to 33 millicuries (1.22 GBq)
of sodium iodide (I-131) for which a written directive is required; oral
administration of greater than 33 millicuries (1.22 GBq) of sodium iodide
(I-131) (experience with at least three cases also satisfies the requirement of
oral administration of less than or equal to 33 millicuries of I-131);
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 a photon energy of less
than 150 kilo electron volts for which a written directive is required; ;
and
(2)
obtained written attestation that the individual has satisfactorily completed
the requirements in this item and is able to independently fulfill the
radiation safety-related duties as an authorized user for the medical uses
authorized under part 4731.4440 for which the individual is requesting
authorized user status. The attestation must be obtained from either:
(a) a preceptor authorized user who meets the
requirements of this part, part 4731.4414, or equivalent requirements of the
NRC or an agreement state and has experience in administering dosages in the
same dosage category or categories as the individual requesting authorized user
status; or
(b) a residency program
director who affirms in writing that the attestation represents the consensus
of the residency program faculty where at least one faculty member is an
authorized user who meets the requirements of this part, part 4731.4414, or
equivalent requirements of the NRC or an agreement state; has experience in
administering dosages in the same dosage category or categories as the
individual requesting authorized user status; and concurs with the attestation
provided by the residency program director. The residency training program must
be approved by the Residency Review Committee of the Accreditation Council for
Graduate Medical Education or the Royal College of Physicians and Surgeons of
Canada or the Council on Postdoctoral Training of the American Osteopathic
Association and must include training and experience specified in subitem (1).
Subp. 2. Certification requirements.
A specialty board under subpart 1, item A, 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 must include 700 hours of training and experience
as described in subpart 1, item B, subitem (1), units (a) and (b), subunits i
to v. Eligible training programs must 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 Council on
Postdoctoral Training of the American Osteopathic Association; and
B. pass an examination, administered by
diplomates of the specialty board, that 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.
Statutory Authority: MS s 144.1202; 144.1203
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