6 Colo. Code Regs. § 1007-1-7I

Current through Register Vol. 47, No. 11, June 10, 2024
Appendix 6 CCR 1007-1-7I - TRAINING FOR THE PARENTERAL ADMINISTRATION OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE

7I1 Except as provided in Appendix 7P, the licensee shall require an authorized user for the parenteral administration requiring a written directive to be a physician who:

7I1.1 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(iii), or equivalent NRC or Agreement State requirements;

or

7I1.2 Is an authorized user under Appendix 7K, Appendix 7M, or equivalent NRC or Agreement State requirements and who meets the requirements in 7I2;

or

7I1.3 Is certified by a medical specialty board whose certification process has been recognized by the NRC or an Agreement State under Appendix 7K or Appendix 7M, and who meets the requirements in paragraph 7I2 of this section.

7I2 The physician:

7I2.1 Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations listed in 7F2.1(2)(f)(iii). 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

7I2.2 Has work experience under the supervision of an authorized user who meets the requirements of Appendix 7P, Appendix 7F, Appendix 7I, or equivalent Agreement State or NRC requirements, in the parenteral administrations listed in 7F2.1(2)(f)(iii).A supervising authorized user, who meets the requirements in Appendix 7F, 7I, or equivalent Agreement State or NRC requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. 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 unsealed 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 include at least 3 cases involving the parenteral administrations as specified in 7F2.1(2)(f)(iii)

and

7I2.3 Has obtained written attestation that the individual has satisfactorily completed the requirements in 7I2.1 or 7I2.2, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The attestation must be obtained from either:

(1) A preceptor authorized user who meets the requirements in Appendix 7P, Appendix 7F, 7I, or equivalent Agreement State or NRC requirements. A preceptor authorized user who meets the requirements in Appendix 7F, 7I, or equivalent Agreement State or NRC requirements, must have experience in administering dosages in the same category or categories as the individuals 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 Appendix 7P, Appendix 7F, Appendix 7I, or equivalent Agreement State or NRC requirements, has experience in administering dosages in the same dose 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 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 7I2.1 and 7I2.2.

6 CCR 1007-1-7I

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