6 Colo. Code Regs. § 1007-1-7-B

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-7-B - General Administrative Requirements

7.7Authority and responsibilities for the radiation protection program

7.7.1 In addition to the radiation protection program requirements of Part 4, Section 4.5 of these regulations, a licensee's management shall approve in writing:

7.7.1.1 Requests for license application, renewal, or amendments before submittal to the Department;

7.7.1.2 Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist; and

7.7.1.3 Radiation protection program changes that do not require a license amendment and are permitted under 7.7.

7.7.2 A licensee's management shall appoint a Radiation Safety Officer (RSO), who agrees in writing to be responsible for implementing the radiation safety program. The licensee, through the RSO, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more Associate Radiation Safety Officers (ARSO) to support the RSO. The RSO, with written agreement of the licensee's management, must assign the specific duties and tasks to each ARSO. These duties and tasks are restricted to the types of use for which the ARSO is listed on a license. The RSO may delegate duties and tasks to the ARSO but shall not delegate the authority or responsibilities for implementing the radiation protection program.

7.7.3 For up to 60 days each year, a licensee may permit an individual qualified to be a Radiation Safety Officer, under Appendix 7A and 7.65, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in 7.7.6, if the licensee takes the actions required in 7.7.2, 7.7.5, 7.7.6, and 7.7.7 and notifies the Department in accordance with 7.5.2.

7.7.4 A licensee may simultaneously appoint more than one temporary Radiation Safety Officer in accordance with 7.7.3, if needed to ensure that the licensee has a temporary Radiation Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of the different types of uses of radioactive material permitted by the license.

7.7.5 A licensee shall establish the authority, duties, and responsibilities of the Radiation Safety Officer in writing.

7.7.6 A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:

7.7.6.1 Identify radiation safety problems;

7.7.6.2 Initiate, recommend, or provide corrective actions;

7.7.6.3 Stop unsafe operations; and

7.7.6.4 Verify implementation of corrective actions.

7.7.7 A licensee shall retain a record of actions taken under 7.7.1, 7.7.2, and 7.7.5 as follows: Records of authority and responsibilities for radiation protection programs.

7.7.7.1 A licensee shall retain a record of actions taken by the licensee's management in accordance with 7.7.1 for 5 years. The record must include a summary of the actions taken and a signature of licensee management.

7.7.7.2 The licensee shall retain a copy of both authority, duties, and responsibilities of the Radiation Safety Officer as required by 7.7.5, and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by 7.7.2, for the duration of the license. The records must include the signature of the Radiation Safety Officer and licensee management.

7.7.7.3 For each Associate Radiation Safety Officer appointed under 7.7.2, the licensee shall retain, for 5 years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee's management.

7.8Radiation safety committee.

7.8.1 Licensees that are authorized for one or more different types of radioactive material use under 7.36, 7.42, 7.48, or 7.62 shall establish a Radiation Safety Committee to oversee all uses of radioactive material permitted by the license.

7.8.2 The Committee shall:

7.8.2.1 Include:

(1) An authorized user of each type of use permitted by the license;

(2) The Radiation Safety Officer

(3) A representative of the nursing service

(4) A representative of management who is neither an authorized user nor a Radiation Safety Officer; and

(5) Other members as the licensee deems appropriate.

7.8.2.2 Meet as necessary, but at a minimum shall meet at intervals not to exceed 6 months.

7.8.2.3 Maintain minutes of each meeting, including:

(1) The date of the meeting;

(2) Members present;

(3) Members absent; and

(4) Summary of deliberations and discussions.

7.9Radiation protection program changes.

7.9.1 A licensee may revise its radiation protection program without Department approval if:

7.9.1.1 The revision does not require an amendment under 7.4;

7.9.1.2 The revision is in compliance with the regulations and the license;

7.9.1.3 The revision has been reviewed and approved by the Radiation Safety Officer, licensee management and licensee's Radiation Safety Committee (if applicable); and

7.9.1.4 The affected individuals are instructed on the revised program before the changes are implemented.

7.9.2 A licensee shall retain a record of each change for 5 years, including

7.9.2.1 A copy of the old and new procedures;

7.9.2.2 The effective date of the change; and

7.9.2.2 The signature of the licensee management that reviewed and approved the change.

7.10Supervision.

7.10.1 A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by 7.3.1.2(1) shall:

7.10.1.1 In addition to the requirements of Part 10, Section 10.3 of these regulations, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of Part 7, and license conditions with respect to the use of radioactive material; and

7.10.1.2 Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures, written directive procedures, regulations of Part 7, and license conditions with respect to the medical use of radioactive material.

7.10.2 A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by 7.3.1.2(2), shall:

7.10.2.1 In addition to the requirements of Part 10, Section 10.3, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's use of radioactive material; and

7.10.2.2 Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures, the regulations of Part 7, and license conditions.

7.10.3 Unless physical presence as described in other sections of Part 7 is required, a licensee who permits supervised activities under 7.10.1 and 7.10.2 shall require an authorized user to be immediately available by telephone within ten minutes to communicate with the supervised individual, unless otherwise authorized by the Department with prior written approval.

7.10.4 A licensee who permits supervised activities under 7.10.1 and 7.10.2 is responsible for the acts and omissions of the supervising authorized user and supervised individual(s).

7.10.5 A licensee who permits supervised activities under 7.10.1 and 7.10.2 shall require that the administration of radioactive material or radiation from radioactive material under the supervision of an authorized user be performed only by:

7.10.5.1 A physician;

7.10.5.2 An individual who meets the requirements of Appendix 7B or 7N;

7.10.5.3 An individual in training in medical physics while under personal supervision of an individual meeting the requirements of Appendix 7B;

7.10.5.4 An individual in training in nuclear medicine technology while under personal supervision of an individual meeting the requirements of Appendix 7N; or

7.10.5.5 An individual otherwise authorized in writing by the Department, or through license condition(s).

7.11Written directives.

7.11.1 A written directive must be dated and signed by an authorized user, including the signatory's printed or typed name, before the administration of:

7.11.1.1 I-131 sodium iodide greater than 1.11 MBq (30 µCi), or

7.11.1.2 Any therapeutic dosage of radioactive material, or

7.11.1.3 Any therapeutic dose of radiation from radioactive material.

If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within 48 hours of the oral directive.

7.11.2 The written directive must contain the patient or human research subject's name and the following:

7.11.2.1 For an administration of a dosage of radioactive drug containing radioactive material, the name of the radioactive drug containing radioactive material, dosage, and route of administration;

7.11.2.2 For gamma stereotactic radiosurgery, the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

7.11.2.3 For teletherapy, the total dose, dose per fraction, number of fractions, and treatment site;

7.11.2.4 For high dose rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;

7.11.2.5 For permanent implant brachytherapy:

(1) Before implantation: the treatment site, the radionuclide, and the total source strength: and

(2) After implantation but before the patient leaves the post treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date; or

7.11.2.6 For all other brachytherapy, including LDR, MDR, and PDR:

(1) Before implantation: the treatment site, radionuclide, and dose; and

(2) After implantation but before completion of the procedure: the radionuclide; treatment site; number of sources; total source strength and exposure time (or the total dose); and date.

7.11.3 A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

7.11.3.1 If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within 48 hours of the oral revision.

7.11.4 The licensee shall retain a copy of each written directive and/or written revision to an existing written directive for 3 years.

7.12Procedures for administrations requiring a written directive.

7.12.1 For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

7.12.1.1 The patient's or human research subject's identity is verified before each administration; and

7.12.1.2 Each administration is in accordance with the written directive.

7.12.2 At a minimum, the procedures required by 7.12.1 must address the following items that are applicable for the licensee's use of radioactive material:

7.12.2.1 Verifying the identity of the patient or human research subject;

7.12.2.2 Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

7.12.2.3 Checking both manual and computer-generated dose calculations;

7.12.2.4 Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by 7.48 or 7.62.

7.12.2.5 Determining if a medical event, as defined in 7.21, has occurred; and

7.12.2.6 Determining, for a permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

7.12.3 A licensee shall retain a copy of the procedures required under 7.12.1 for the duration of the license.

7.13Duties of authorized user and authorized medical physicist.

7.13.1 A licensee shall assure that only authorized users for the type of radioactive material used:

7.13.1.1 Prescribe the radiopharmaceutical dosage and/or dose to be administered through the issuance of a written directive or reference to the diagnostic clinical procedures manual; and

7.13.1.2 Direct, as specified in 7.10 and 7.12, or in license conditions, the administration of radioactive material for medical use to patients or human research subjects;

7.13.1.3 Prepare and administer, or supervise the preparation and administration of radioactive material for medical use, in accordance with 7.3.1.2(1), 7.3.1.2(2) and 7.10;

7.13.2 A licensee shall assure that only authorized medical physicists perform, as applicable:

7.13.2.1 Measurements and calculations as described in 7.41;

7.13.2.2 Full calibration measurements as described in 7.54, 7.55, and 7.56;

7.13.2.3 Periodic spot checks as described in 7.58, 7.59 and 7.61; and

7.13.2.4 Radiation surveys as described in 7.57.

7.14Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use:

7.14.1 Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to Part 3 of these regulations or the equivalent regulations of an Agreement State or NRC;

7.14.2 Sealed source or devices non-commercially transferred from a Part 7 licensee or an Agreement State or NRC medical use licensee; or

7.14.3 Teletherapy sources manufactured and distributed in accordance with a license issued pursuant to Part 3 of these regulations, or the equivalent regulations of an Agreement State or NRC.

6 CCR 1007-1-7-B

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