6 Colo. Code Regs. § 1007-1-7-G
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-7-G - Manual Brachytherapy7.41Calibration measurements of brachytherapy sources.7.41.1 Before the first medical use of a brachytherapy source, a licensee shall have: 7.41.1.1 Determined the source output or activity using a dosimetry system that meets the requirements of 7.53;7.41.1.2 Determined source positioning accuracy within applicators; and7.41.1.3 Used published protocols currently accepted by nationally recognized bodies to meet the requirements of 7.41.1.1 and 7.41.1.2.7.41.2 Instead of a licensee making its own measurements as required in 7.41.1, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with 7.41.1.7.41.3 A licensee shall mathematically correct the outputs or activities determined in 7.41.1 for physical decay at intervals consistent with 1 percent physical decay.7.41.4 An authorized medical physicist shall perform or review the measurements and calculations made pursuant to 7.41.1, 7.41.2, or 7.41.3.7.41.5 A licensee shall retain a record of each calibration as follows: 7.41.5.1 A licensee shall maintain a record of the calibrations of brachytherapy sources required by 7.41.1 for 3 years after the last use of the source.7.41.5.2 The record must include: (1) The date of the calibration;(2) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;(3) The source output or activity;(4) The source positioning accuracy within the applicators; and(5) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.7.41.6 Strontium-90 sources for ophthalmic treatments.7.41.6.1 Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in 7.41.6.2 are performed by either: (1) An authorized medical physicist; or(2) An individual who: (a) Is identified as an ophthalmic physicist on a specific medical use license issued by NRC or an Agreement State; permit issued by a NRC or Agreement State broad scope medical use licensee; medical use permit issued by a NRC master material licensee; or permit issued by a NRC master material license broad scope medical use permittee; and(b) Holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and(c) Has successfully completed 1 year full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and(d) Has documented training in: (i) The creation, modification, and completion of written directives;(ii) Procedures for administrations requiring a written directive; and(iii) Performing the calibration measurements of brachytherapy sources as detailed in 7.41.1 through 7.41.5.7.41.6.2 The individuals who are identified in 7.41.6.1 must:(1) Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under 7.41.1 through 7.41.5; and(2) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in 7.41.6.1 will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.7.41.6.3 Licensees must retain a record of the activity of each strontium-90 source as follows: (1) A licensee shall maintain a record of the activity of a strontium-90 source required by 7.41.6 for the life of the source.(2) The record must include:(a) The date and initial activity of the source as determined under 7.41.1 through 7.41.5; and(b) For each decay calculation, the date and the source activity as determined under 7.41.6.7.42Use of sealed sources for manual brachytherapy.7.42.1 A licensee must use only brachytherapy sources:7.42.1.1 Approved in the Sealed Source and Device Registry for manual brachytherapy use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or7.42.1.2 In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 7.14.1 are met.7.42.2 Authorized User Training For Use Of Sealed Sources For Manual Brachytherapy. The licensee shall require an authorized user under 7.42 to meet the requirements of Appendix 7K.
7.42.3 Authorized User Training For Use Of Strontium-90 Sealed Sources For Ophthalmic Uses. The licensee shall require an authorized user of strontium-90 sealed sources for ophthalmic uses under 7.42 to meet the requirements of Appendix 7L.
7.43Safety instruction.In addition to the requirements of Part 10 of these regulations:
7.43.1 The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects that are undergoing implant therapy and cannot be released in accordance with 7.26.7.43.2 The instruction required by 7.43.1 shall be commensurate with the duties of the personnel and include:7.43.2.1 Size and appearance of the brachytherapy sources;7.43.2.2 Safe handling and shielding instructions in case of a dislodged source;7.43.2.3 Patient or human research subject control;7.43.2.4 Visitor control, including both;(1) Routine visitation to hospitalized individuals in accordance with Part 4, Section 4.14.1.1; and(2) Visitation authorized in accordance with Part 4, Section 4.14.3; and7.43.2.5 Notification of the RSO, or his or her designee, and the authorized user if the patient or the human research subject dies or has a medical emergency.7.43.3 A licensee shall retain a record of individuals receiving safety instructions required by 7.43.1 and maintain such records for 3 years. The record must include a list of the topics covered, the date of the instruction, the names(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.7.44Safety precautions.7.44.1 For each patient or the human research subject that is receiving brachytherapy and cannot be released in accordance with 7.26, a licensee shall:7.44.1.1 Not place the patient or the human research subject in the same room with a patient who is not receiving radiation therapy;7.44.1.2 Visibly post the patient's or human research subject's door with a "Caution: Radioactive Material" sign and note on the door or on the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.7.44.2 A licensee shall have emergency response equipment available near each treatment room to respond to a source that inadvertently becomes: 7.44.2.1 Dislodged from the patient; or7.44.2.2 Lodged within the patient following removal of the source applicators.7.44.3 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.7.45Brachytherapy sources inventory.7.45.1 A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.7.45.2 As soon as possible after removing brachytherapy sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area and count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned.7.45.3 A licensee shall maintain a record of brachytherapy source accountability for 3 years. 7.45.3.1 For temporary implants, the record must include:(1) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and(2) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.7.45.3.2 For permanent implants, the record must include: (1) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;(2) The number and activity of sources not implanted, the date they were returned to storage, the date they were returned to storage, and the name of the individual who returned them to storage; and(3) The number and activity of sources permanently implanted in the patient or human research subject.7.46Surveys after source implant and removal.7.46.1 Immediately after implanting sources in a patient or a human research subject, the licensee shall perform a survey to locate and account for all sources that have not been implanted.7.46.2 Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall perform a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. The licensee shall not release from confinement for medical care a patient treated by temporary implant until all sources have been removed.7.46.3 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.46.1 and 7.46.2 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.7.47Therapy-related computer systems.7.47.1 The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies.7.47.2 At a minimum, the acceptance testing required by 7.47.1 shall include, as applicable, verification of:7.47.2.1 The source-specific input parameters required by the dose calculation algorithm;7.47.2.2 The accuracy of dose, dwell time, and treatment time calculations at representative points;7.47.2.3 The accuracy of isodose plots and graphic displays; and7.47.2.4 The accuracy of the software used to determine radioactive source positions from radiographic images.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