6 Colo. Code Regs. § 1007-1-7E

Current through Register Vol. 47, No. 11, June 10, 2024
Appendix 6 CCR 1007-1-7E - TRAINING FOR IMAGING AND LOCALIZATION STUDIES

Except as provided in Appendix 7P, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under 7.32 to be a physician who:

7E1 Is certified by a medical specialty board 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. To have its certification process recognized, a specialty board shall require all candidates for certification to:

7E1.1 Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive materials for imaging and localization studies as described in 7E3.1(1) through 7E3.1(2)(g);

and

7E1.2 Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control;

or

7E2 Is an authorized user under Appendix 7F and meets the requirements in 7E3.1(2)(g), or equivalent Agreement State or NRC requirements;

or

7E3

7E3.1 Has satisfactorily completed 700 hours, including a minimum of 80 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include at a minimum:

(1) Classroom and laboratory training in the following areas:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

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

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

(e) Radiation biology;

and

(2) Work experience, under the supervision of an authorized user who meets the requirements in Appendix 7P, 7E, or 7F and 7E3.1(2)(g), or equivalent NRC or Agreement State requirements. An authorized nuclear pharmacist who meets the requirements in Appendix 7C or Appendix 7P may provide the supervised work experience for 7E3.1(2)(g). Work experience must 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 radioactive material;

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

(f) Administering dosages to patients or human research subjects; and

(g) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radiochemical purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs;

and

7E3.2 Has obtained written attestation that the individual has satisfactorily completed the requirements in 7E3.1 and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 7.30 and 7.32. The attestation must be obtained from either:

(1) A preceptor authorized user who meets the requirements in Appendix 7P, 7E, or 7F and 7E3.1(2)(g), or equivalent NRC or Agreement State requirements;

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, 7E, or 7F and 7E3.1(2)(g), or equivalent NRC or Agreement State requirements, 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 7E3.1.

6 CCR 1007-1-7E

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