6 Colo. Code Regs. § 1007-1-7-E
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-7-E - Unsealed Radioactive Material - Written Directive Required7.36Use of unsealed radioactive material for which a written directive is required.7.36.1 A licensee may use any unsealed radioactive material identified in 7F2.1(2)(f) prepared for medical use and for which a written directive is required that is: 7.36.1.1 Obtained from: (1) A manufacturer or preparer licensed under Part 3, Section 3.12.10 or equivalent regulations of NRC or an Agreement State; or(2) A PET radioactive drug producer licensed under Part 3, Section 3.8.10 or equivalent Agreement State or NRC regulations; or7.36.1.2 Excluding production of PET radioactive material, prepared by:(1) An authorized nuclear pharmacist;(2) A physician who is an authorized user and who meets the requirements specified in Appendix 7E, or Appendix 7F; or(3) An individual under the supervision, as specified in 7.10, of the authorized nuclear pharmacist in 7.36.1.2(1) or the physician who is authorized under 7.36.1.2(2); or7.36.1.3 Obtained from and prepared by a Department, Agreement State, or NRC licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or7.36.1.4 Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.7.36.2 Training For Use Of Any Unsealed Radioactive Material For Diagnostic Or Therapeutic Medical Use For Which A Written Directive Is Required. The licensee shall require an authorized user of an unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required under 7.36 to meet the requirements of Appendix 7F.
7.36.3 Training For Oral Administration of < / = 1.22 GBq 131I (33 mCi) Sodium Iodide Requiring A Written Directive. The licensee shall require an authorized user of an unsealed radioactive material for oral administration of < / = 1.22 GBq 131I (33 mCi) sodium iodide requiring a written directive under 7.36 to meet the requirements of Appendix 7G.
7.36.4 Training For Oral Administration Of > 1.22 GBq 131I (33 mCi) Sodium Iodide Requiring A Written Directive. The licensee shall require an authorized user of an unsealed radioactive material for oral administration of > 1.22 GBq 131I (33 mCi) sodium iodide requiring a written directive under 7.36 to meet the requirements of Appendix 7H.
7.36.5 Training For Parenteral Administration Requiring A Written Directive. The licensee shall require an authorized user of an unsealed radioactive material for parenteral administration requiring a written directive under 7.36 to meet the requirements of Appendix 7I.
7.37Safety instruction.In addition to the requirements of Part 10 of these regulations:
7.37.1 A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released in accordance with 7.26. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include: 7.37.1.1 Patient or human research subject control;7.37.1.2 Visitor control, including:(1) Routine visitation to hospitalized individuals in accordance with Part 4, Section 4.14.1.1 of these regulations; and(2) Visitation authorized in accordance with Part 4, Section 4.14.2;7.37.1.3 Contamination control;7.37.1.4 Waste control; and7.37.1.5 Notification of the RSO, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.7.37.2 A licensee shall retain a record of individuals receiving safety instructions required by 7.37 and maintain such records for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.7.38Safety precautions.7.38.1 For each patient or human research subject who cannot be released under 7.26, a licensee shall: 7.38.1.1 Quarter the patient or the human research subject either in:(1) A private room with a private sanitary facility; or(2) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed radioactive material and who also cannot be released in accordance with 7.26; and7.38.1.2 Visibly post the patient's or the human research subject's room with a "Radioactive Materials" sign.7.38.1.3 Note on the door or in the patient's or the human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and7.38.1.4 Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle the materials and items as radioactive waste.7.38.2 A licensee shall notify the RSO, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/201438 CR 02, January 25, 2015, effective 2/14/201538 CR 05, March 10, 2015, effective 3/30/201538 CR 12, June 25, 2015, effective 7/15/201538 CR 14, July 25, 2015, effective 8/14/201539 CR 02, January 25, 2016, effective 2/14/201639 CR 16, August 25, 2016, effective 9/14/201639 CR 22, November 25, 2016, effective 12/15/201640 CR 11, June 10, 2017, effective 6/30/201740 CR 20, October 25, 2017, effective 11/14/201742 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202043 CR 18, September 25, 2020, effective 10/15/202044 CR 11, June 10, 2021, effective 7/15/202144 CR 14, July 25, 2021, effective 8/14/202145 CR 22, November 25, 2022, effective 12/15/2022