Section He-P 4035.66 - Training for the Oral Administration of Sodium Iodide I-131 and for the Parenteral Administration Requiring a Written Directive(a) Except as provided in He-P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries), to be a physician who: (1) Is certified by a medical specialty board whose certification process includes all the requirements in He-P 4035.66(b)(1), (b) (2), and whose certification process has been recognized by DHHS/RHS, an agreement state, or the Nuclear Regulatory Commission. The names of board certifications that have been recognized by DHHS/RHS, an agreement state, or Nuclear Regulatory Commission on the NRC's Medical Uses Licensee Toolkit web page; or(2) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(c)(2)b.1. or He-P 4035.65(c)(2)b.2., or He-P 4035.66(d) and (e), or equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or(b) Except as provided in He-P 4035.71, a physician who does not meet the requirement of He-P 4035.66(a) above shall: successfully complete 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. (1) The 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; ande. Radiation biology; and(2) Has work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(a) through (e), 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 as specified in He-P 4035.65(c)(2)b.1. or (c)(2)b.2. The work experience shall include:a. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;b. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;c. Calculating, measuring, and safely preparing patients or human research subject dosages;d. Using administrative controls to prevent a medical event involving the use of byproduct material;e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; andf. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and(3) Have obtained a written attestation that the physician has satisfactorily completed the requirements in He-P 4035.66(b)(1) and (b) (2), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerel (33 millicuries) of sodium iodide I-133 for medical uses authorized under He-P 4035.35.(c) The written attestation shall be obtained from either:(1) A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(a)through (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; and(2) Has experience in administering dosages as specified in He-P 4035.65(c)(2)b.1. or 2.; or(3) 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, He-P 4035.66(a) through (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, has experience in administering dosages as specified in He-P 4035.65(c)(2)b.1., or b.2., 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 4035.66(b)(1) and (2).(d) Except as provided in He-P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who: (1) Is certified by a medical specialty board whose certification process includes all of the requirements in He-P 4035.66(e)(1) and (2), and whose certification has been recognized by the 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; or(2) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(c)(2)b.2., or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or(e) Except as provided in He-P 4035.71, the licensee shall require the authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who: (1) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The 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; ande. Radiation biology; and(2) Has work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(d) and (e), 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 as specified in He-P 4035.65(c)(2)b.2. The work experience shall involve: a. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;b. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;c. Calculating, measuring, and safely preparing patient or human research subject dosages;d. Using administrative controls to prevent a medical event involving the use of byproduct material;e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; andf. Administering dosages to patients or human research subjects, that include at least 3 cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in He-P 4035.66(e)(1) and (e) (2), and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under He-P 4035.35. The attestation shall be obtained from either: a. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(d), and (e), He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, and has experience in administering dosages as specified in He-P 4035.65(c)(2)b.2.; 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 4035.65, He-P 4035.66(d) and (e), He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, has experience in administering dosages as specified in He-P 4035.65(c)(2)b.2., 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 4035.66(e)(1) and (2).(f) Except as provided in He-P 4035.71, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who: (1) Is an authorized user under He-P 4035.65 for uses listed in He-P 4035.65(c)(2)b.3.the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission; or(2) Is an authorized user under He-P 4035.59 or He-P 4035.69, or the equivalent requirements of an agreement state, or Nuclear Regulatory Commission and meets the requirements in He-P 4035.66(f)(4) - (f) (6); or(3) Is certified by a medical specialty board whose certification process has been recognized by DHHS/RHS, under He-P 4035.59 or He-P 4035.69 or the equivalent requirements of an agreement state or the Nuclear Regulatory Commission, and who meets the requirements in He-P 4035.66(f)(4) through (f) (6); and(4) Shall have successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in He-P 4035.65(c)(2)b.3. The 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; ande. Radiation biology; and(5) Has work experience, under the supervision of an authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f) and He-P 4035.71, or the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, in the parenteral administration listed in He-P 4035.65(c)(2)b.3. A supervising authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f), or equivalent requirements of an agreement state, or the Nuclear Regulatory Commission, shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience shall involve:a. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;b. Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;c. Calculating, measuring, and safely preparing patient or human research subject dosages;d. Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;e. Using procedures to contain spilled byproduct material safely and using proper decontamination procedures;f. Administering dosages to patients or human research subjects that include a minimum of 3 cases involving the parenteral administration as specified in He-P 4035.65(c)(2)b.3.; and(6) Has obtained written attestation that the individual has satisfactorily completed the requirements in He-P 4035.66(f)(4) and (f) (5) is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation shall be obtained from either: a. A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f), He-P 4035.71, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission A preceptor authorized user who meets the requirements in He-P 4035.65, He-P 4035.66(f), the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission shall have experience in administering dosages in the same category or categories as the individual requesting authorized user status; 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 4035.65, He-P 4035.66(f), 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 requesting 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 4035.66(f)(4) and (5).N.H. Admin. Code § He-P 4035.66
(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 XXXVI Number 49, Filed December 8, 2016, Proposed by #12054, Effective 11/19/2016, Expires 11/19/2026.Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.