New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 4000 - NEW HAMPSHIRE RULES FOR THE CONTROL OF RADIATION
Part He-P 4035 - USE OF RADIONUCLIDES IN THE HEALING ARTS
Section He-P 4035.64 - Training for Imaging and Localization Studies
Universal Citation: NH Admin Rules He-P 4035.64
Current through Register No. 40, October 3, 2024
(a) Except as provided in He-P 4035.71, the licensee shall require the authorized user of unsealed byproduct material listed in He-P 4035.31 to be a physician who:
(1) Is certified by a medical specialty board
whose certification process has been recognized by DHHS/RHS, or an agreement
state, or the Nuclear Regulatory Commission. The names of board certification
have been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory
Commission are posted on the NRC's Medical Uses Licensee Toolkit web page; or
(2) Is an authorized user under
He-P
4035.62 and meets the requirements in He-P
4035.64(c)(1)b.7, or the equivalent requirements of an agreement state, or the
Nuclear Regulatory Commission requirements.
(b) To have its certification process recognized, a specialty board shall require all candidates for certification to:
(1) Complete 700 hours of training and
experience in basic radionuclide handling techniques and radiation safety
applicable to the medical use of unsealed byproduct material for imaging and
localization studies as described in He-P 4035.64(c)(1)a. through (c)(1)b.7.;
and,
(2) Pass an examination,
administered by diplomats of the specialty board, which assesses knowledge and
competence in radiation safety, radionuclide handling, and quality
control.
(c) Except as provided in He-P 4035.65 and meets the requirements in He-P 4035.64(c)(1)b.7., or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, an authorized user who:
(1) Has completed 700 hours of training and
experience, including a minimum of 80 hours of classroom and laboratory
training, in basic radionuclide handling techniques applicable to the medical
use of unsealed byproduct material for imaging and localization studies. The
training and experience shall include, at a minimum:
a. Classroom and laboratory training in the
following areas:
1. Radiation physics and
instrumentation;
2. Radiation
protection;
3. Mathematics
pertaining to the use and measurement of radioactivity;
4. Chemistry of byproduct material for
medical use;
5. Radiation biology
and
b. Work experience,
under the supervision of an authorized user who meets the requirements in He-P
4035.64, He-P 4035.71, or
He-P
4035.65 and He-P 4035.64(c)(1)b.7, or the equivalent
requirements of an agreement state, or the Nuclear Regulatory Commission
requirements. An authorized nuclear pharmacist who meets the requirements in
He-P
4035.71 or
He-P
4035.74, the equivalent requirements of an agreement
state, or the Nuclear Regulatory Commission may provide the supervised work
experience for He-P 4035.64(c)(1)b.7. Work experience shall involve:
1. Ordering, receiving and unpacking
radioactive materials safely and performing the related radiation
surveys;
2. Performing quality
control procedures on instruments used to determine the activity of dosages and
performing checks for proper operation of survey meters;
3. Calculating, measuring and safely
preparing patient or human research subject dosages;
4. Using administrative controls to prevent a
medical event involving the use of unsealed byproduct material;
5. Using procedures to contain spilled
byproduct material safely and using proper decontamination
procedures;
6. Administering
dosages of radioactive drugs to patients or human research subjects; and
7. Eluting generator systems
appropriate for preparation of radioactive drugs for imaging and localization
studies, measuring and testing the eluate for radionuclide purity, and
processing the eluate with reagent kits to prepare labeled radioactive drugs;
and
(2)
Obtained a written attestation that the individual has satisfactorily completed
the requirements in He-P 4035.64(c)(1) and is able to independently fulfill the
radiation safety-related duties as an authorized user for the medical uses
authorized under He-P 4035.27 and
He-P
4035.31. The attestation shall be obtained from
either:
a. A preceptor authorized user who
meets the requirements in He-P 4035.64,
He-P
4035.71, or
He-P
4035.65 and He-P 4035.64(c)(1)b.7., or the equivalent
requirements of an agreement state, or the Nuclear Regulatory Commission;
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 in He-P 4035.64,
He-P
4035.71, or
He-P
4035.65 and He-P 4035.64(c)(1)b.7., or the equivalent
requirements of an agreement state, or the Nuclear Regulatory Commission, and
concurs with the attestation provided by the residency program director. The
residency training program shall 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 shall include training and
experience specified in He-P 4035.64(c)(1).
(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
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