Section He-P 4035.65 - Training for Use of Unsealed Byproduct Material for Which a Written Directive Is Required(a) Except as provided in He-P 4035.71, the licensee shall require the authorized user of unsealed byproduct material listed in He-P 4035.35 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 certifications that 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; and(2) Meets the requirements in He-P 4035.65(c)(2)b. and He-P 4035.65(d) through (e).(b) To have its certification process recognized, a specialty board shall require all candidates for certification to:(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a related medical specialty. These residency training programs shall include 700 hours of training and experience as described in He-P 4035.65(c)(1) through He-P 4035.65(c)(2)a.5. 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,(2) Pass an examination, administered by diplomats of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality assurance and clinical use of unsealed byproduct material for which a written directive is required; or(c) Except as provided in He-P 4035.71, an authorized user of unsealed byproduct material for the uses authorized under He-P 4035.35 shall be a physician who 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 byproduct material requiring a written directive. The classroom and laboratory training shall include:a. Radiation physics and instrumentation;c. Mathematics pertaining to the use and measurement of radioactivity;d. Chemistry of byproduct material for medical use;e. Radiation biology; and(2) Work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission. A supervising authorized user, who meets the requirements in He-P 4035.65(c) through (e), shall also have experience in administering dosages in the same dosage category or categories (i.e., He-P 4035.65(c)(2)b.) as the individual requesting authorized user status. a. The 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;b. Administering dosages of radioactive drugs to patients or human research subjects from the 3 categories in this paragraph. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under He-P 4035.29. This work experience shall involve a minimum of 3 cases in each of the following categories for which the individual is requesting authorized user status:1. Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodine I-131, for which a written directive is required;2. Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodine I-131[Experience with at least 3 cases in Category (c)(2)b.2. also satisfies the requirement in Category(c)(2)b.1.]; or3. 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 a photon energy less than 150 keV, for which a written directive is required; and(d) In addition to meeting the requirements of (a) or (b) or (c) above, a licensee shall require an authorized user to obtain a written attestation that the individual has satisfactorily completed the requirements in He-P 4035.65(c) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under He-P 4035.35 for which the individual is requesting authorized user status.(e) The written attestation shall be obtained from either: (1) A preceptor authorized user who meets the requirements in He-P 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or(2) 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 4035.65 or He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, has experience in administering dosages in the same dosage category or categories as the individual authorized user status, 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 and experience specified in He-P 4035.65(c).N.H. Admin. Code § He-P 4035.65
(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.