Section He-P 4035.64 - Training for Imaging and Localization Studies(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;3. Mathematics pertaining to the use and measurement of radioactivity;4. Chemistry of byproduct material for medical use;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; orb. 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).N.H. Admin. Code § He-P 4035.64
(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 XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.