6 Colo. Code Regs. § 1007-1-7G

Current through Register Vol. 47, No. 11, June 10, 2024
Appendix 6 CCR 1007-1-7G - TRAINING 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)

Except as provided in Appendix 7P, the licensee shall require an authorized user for the oral administration of sodium iodide requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who:

7G1 Is certified by a medical specialty board whose certification process includes all of the requirements in 7G3.1 and 7G3.2 of this Appendix and whose certification process has been recognized by the NRC or an Agreement State. The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page;

or

7G2 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii), Appendix 7H, or equivalent NRC or Agreement State requirements;

or

7G3

7G3.1 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 must include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Chemistry of radioactive material for medical use; and

(5) Radiation biology;

and

7G3.2 Has work experience, under the supervision of an authorized user who meets the requirements in Appendix 7P, Appendix 7F, Appendix 7G, Appendix 7H or equivalent Agreement State or NRC requirements. A supervising authorized user, who meets the requirements in 7F2, must also have experience in administering dosages as specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii). The work experience must 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 radioactive material;

(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

and

(6) 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

7G3.3 Has obtained written attestation that the individual has satisfactorily completed the requirements in 7G3.1 and 7G3.2, 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 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 7.36. The attestation must be obtained from either:

(1) A preceptor authorized user who meets the requirements in Appendix 7P, Appendix 7F, Appendix 7G, Appendix 7H, or equivalent NRC or Agreement State requirements and has experience administering dosages as specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii);

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 Appendix 7P, Appendix 7F, Appendix 7G, Appendix 7H, or equivalent NRC or Agreement State requirements, has experience in administering dosages as specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii), 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 7G3.1 and 7G3.2.

6 CCR 1007-1-7G

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014
38 CR 02, January 25, 2015, effective 2/14/2015
38 CR 05, March 10, 2015, effective 3/30/2015
38 CR 12, June 25, 2015, effective 7/15/2015
38 CR 14, July 25, 2015, effective 8/14/2015
39 CR 02, January 25, 2016, effective 2/14/2016
39 CR 16, August 25, 2016, effective 9/14/2016
39 CR 22, November 25, 2016, effective 12/15/2016
40 CR 11, June 10, 2017, effective 6/30/2017
40 CR 20, October 25, 2017, effective 11/14/2017
42 CR 24, December 25, 2019, effective 1/14/2020
43 CR 14, July 25, 2020, effective 8/14/2020
43 CR 18, September 25, 2020, effective 10/15/2020
44 CR 11, June 10, 2021, effective 7/15/2021
44 CR 14, July 25, 2021, effective 8/14/2021
45 CR 22, November 25, 2022, effective 12/15/2022