reglab/statecodes huggingface dataset:
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-706 - Supervision

Current through Register Vol. 30, No. 28, July 12, 2024
A. For purposes of
				this rule, "supervision" means the exercise of control over or direction of the
				use of radioactive material in the practice of medicine by an authorized user
				named on a radioactive material license. Supervision does not require a
				supervising physician's constant physical presence if the supervising physician
				can be easily contacted by radio, telephone, or telecommunication.
B. A physician may use radioactive material
				if the person is licensed by the Arizona Medical Board or Board of Osteo-pathic
				Examiners in Medicine and Surgery and is listed as an authorized user on the
				Arizona radioactive material license under which the radioactive material is
				obtained.
C. A licensee that
				permits the receipt, possession, use, or transfer of radioactive material by an
				individual under the supervision of an authorized user, shall:
1. Instruct the supervised individual in the
				licensee's written radiation protection procedures, written directive
				procedures, rules, and license conditions with respect to the use of
				radioactive material; and
2.
				Require the supervised individual to follow the instructions of the supervising
				authorized user for medical uses of radioactive material, written radiation
				protection procedures established by the licensee, written directive
				procedures, rules, and license conditions with respect to the medical use of
				radioactive material.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-707 - Written Directives

Current through Register Vol. 30, No. 28, July 12, 2024
A. A
				licensee shall ensure that a written directive is dated and signed by an
				authorized user before the administration of I-131 sodium iodide greater than
				1.11 MBq (30 microcuries (µCi)), any therapeutic dosage of unsealed radioactive
				material or 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 shall
				be documented as soon as possible in writing in the patient's record. A written
				directive shall be prepared within 48 hours of the oral directive.
B. A written directive shall contain the
				patient or human research subject's name and the following information:
1. For any administration of quantities
				greater than 1.11 MBq (30 µCi) of sodium iodide I-131: the dosage;
2. For an administration of a therapeutic
				dosage of unsealed radioactive material other than sodium iodide I-131: the
				radiopharma-ceutical, dosage, and route of administration;
3. For gamma stereotactic radiosurgery: the
				total dose, treatment site, and values for the target coordinate settings per
				treatment for each anatomically distinct treatment site;
4. For teletherapy: the total dose, dose per
				fraction, number of fractions, and treatment site;
5. For high dose-rate remote afterloading
				brachytherapy: the radionuclide, treatment site, dose per fraction, number of
				fractions, and total dose;
6. For
				permanent implant brachytherapy:
a. Before
				implantation: the treatment site, radionuclide, and total strength;
				and
b. After implantation but
				before the patient leaves the post-treatment recovery area: the treatment site,
				number of sources implanted, total source strength implanted, and date;
				or
7. For all other brachytherapy, including low, medium,
				and pulsed dose rate remote afterloaders:
a.
				Before implantation: the treatment site, radionuclide, and dose; and
b. 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.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-708 - Procedures for Administrations Requiring a Written Directive

Current through Register Vol. 30, No. 28, July 12, 2024
For any administration requiring a written directive, the
				  licensee shall develop, implement, and maintain written procedures to provide
				  high confidence that:
1. The patient's
				or human research subject's identity is verified before each administration;
				and
2. Each administration is in
				accordance with the written directive.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-709 - Sealed Sources or Devices for Medical Use

Current through Register Vol. 30, No. 28, July 12, 2024
A licensee may only use:
1. Sealed sources, including teletherapy
				sources, or devices manufactured, labeled, packaged, and distributed in
				accordance with a license issued under Article 3 of this Chapter, equivalent
				regulations of the NRC or equivalent requirements of an Agreement State;
				or
2. Sealed sources or devices
				noncommercially transferred from another medical licensee; or
3. Teletherapy sources manufactured and
				distributed in accordance with a license issued by the Department, the NRC, or
				another Agreement State.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-710 - Radiation Safety Officer and Associate Radiation Safety Officer Training

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee shall
				require an individual fulfilling the responsibilities of the Radiation Safety
				Officer, described in R9-7-705, to be an individual who:
1. Is certified by a specialty board whose
				certification process includes all of the requirements in subsection (A)(2)(a)
				and (B) and whose certification has been recognized by the Department, the NRC,
				or an Agreement State. To have its certification process recognized, a
				specialty board shall require all candidates for certification to:
a. Meet the following minimum requirements:
i. Hold a bachelor's or graduate degree from
				an accredited college or university in physical science or engineering or
				bio-logical science with a minimum of 20 college credits in physical
				science;
ii. Have five or more
				years of professional experience in health physics (graduate training may be
				substituted for no more than two years of the required experience) including at
				least three years in applied health physics; and
iii. Pass an examination administered by
				diplomates of the specialty board, which evaluates knowledge and competence in
				radiation physics and instrumentation, radiation protection, mathematics
				pertaining to the use and measurement of radioactivity, radiation biology, and
				radiation dosimetry; or
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-711 - Authorized Medical Physicist Training

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee shall require an authorized
				medical physicist to be an individual who:
1.
				Is certified by a specialty board whose certification process includes all of
				the training and experience requirements in subsections (A)(2)(a) and (B) and
				whose certification has been recognized by the Department, the NRC, or an
				Agreement State. To have its certification process recognized, a specialty
				board shall require all candidates for certification to:
a. Hold a master's or doctor's degree in
				physics, medical physics, other physical science, engineering, or applied
				mathematics from an accredited college or university;
b. Have two years of full-time practical
				training and/or supervised experience in medical physics:
i. Under the supervision of a medical
				physicist who is certified in medical physics by a specialty board recognized
				by the NRC or an Agreement State; or
ii. In clinical radiation facilities
				providing high-energy, external beam therapy (photons and electrons with
				energies greater than or equal to 1 million electron volts) and brachytherapy
				services under the direction of physicians who meet the requirements for
				authorized users in
				R9-7-710,
				R9-7-719,
				R9-7-721,
				R9-7-723,
				R9-7-727,
				R9-7-728,
				or
				R9-7-744;
				and
c. Pass an
				examination, administered by diplomates of the specialty board, that assesses
				knowledge and competence in clinical radiation therapy, radiation safety,
				calibration, quality assurance, and treatment planning for external beam
				therapy, brachytherapy, and stereotactic radiosurgery; or
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-712 - Authorized Nuclear Pharmacist Training

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee shall require the authorized
				nuclear pharmacist to be a pharmacist who:
1.
				Is certified as a nuclear pharmacist by a specialty board whose certification
				process has been recognized by the Department, the NRC, or an Agreement State.
				To have its certification process recognized, a specialty board shall require
				all candidates for certification to:
a. Have
				graduated from a pharmacy program accredited by the Accreditation Council for
				Pharmacy Education (ACPE) (previously named the American Council on
				Pharmaceutical Education), or have passed the Foreign Pharmacy Graduate
				Examination Committee (FPGEC) examination;
b. Hold a current, active license to practice
				pharmacy in Arizona;
c. Provide
				evidence of having acquired at least 4000 hours of training/experience in
				nuclear pharmacy practice. Academic training may be substituted for no more
				than 2000 hours of the required training and experience; and
d. Pass an examination in nuclear pharmacy
				administered by diplomates of the specialty board, that assesses knowledge and
				competency in procurement, compounding, quality assurance, dispensing,
				distribution, health and safety, radiation safety, pro-vision of information
				and consultation, monitoring patient outcomes, research and development;
				or
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-713 - Determination of Prescribed Dosages, and Possession, Use, and Calibration of Instruments

Current through Register Vol. 30, No. 28, July 12, 2024
A. A
				licensee shall determine and record the activity of each dosage before medical
				use.
B. For a unit dosage, this
				determination shall be made by:
1. Direct
				measurement of radioactivity; or
2.
				Decay correction, based on the activity or activity concentration determined
				by:
a. A manufacturer or preparer licensed
				under R9-7-311 or equivalent NRC or
				Agreement State requirements; or
b.
				A Department, a NRC, or an Agreement State licensee for use in research in
				accordance with a Radioactive Drug Research Committee-approved protocol or an
				Investigational New Drug (IND) protocol accepted by FDA or;
c. A PET radioactive drug producer licensed
				under 1 R9-7-311 or equivalent NRC or
				Agreement State requirements.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-714 - Authorization for Calibration, Transmission, and Reference Sources

Current through Register Vol. 30, No. 28, July 12, 2024
Any person authorized by R9-7-703 for medical use of
				  radioactive material may receive, possess, and use any of the following
				  radioactive material for check, calibration, transmission, and reference
				  use.
1. Sealed sources, not exceeding
				1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under
				Article 3 of this Chapter or equivalent NRC or Agreement State
				regulations.
2. Sealed sources, not
				exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to
				redistribute the sealed sources manufactured and distributed by a person
				licensed under Article 3 of this Chapter, providing the redistributed sealed
				sources are in the original packaging and shielding and are accompanied by the
				manufacturer's approved instructions.
3. Any radioactive material with a half-life
				not longer than 120 days in individual amounts not to exceed 0.56 GBq (15
				mCi).
4. Any radioactive material
				with a half-life longer than 120 days in individual amounts not to exceed the
				smaller of 7.4 MBq (200 µCi) or 1000 times the quantities in Article 4,
				Appendix B of this Chapter.
5.
				Technetium-99m in amounts as needed.
6. A licensee is limited to five sources of
				radiation authorized under subsections (1) through (3), unless otherwise
				specified in the licensee's radioactive material license.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-715 - Requirements for Possession of Sealed Sources and Brachytherapy Sources

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee in
				possession of any sealed source or brachytherapy source shall follow the
				radiation safety and handling instructions supplied by the
				manufacturer.
B. A licensee in
				possession of a sealed source shall test the source for leakage in accordance
				with R9-7-417.
C. A licensee in possession of sealed sources
				or brachytherapy sources, except for gamma stereotactic radiosurgery sources,
				shall conduct a physical inventory every six months of all sources in its
				possession. During the period of time between the inventories, the licensee
				shall add each acquired sealed source to the inventory record and remove from
				the inventory record each source that leaves the licensee's control.
D. A licensee shall document the inventories
				conducted under subsection (C) and maintain inventory records in accordance
				with R9-7-450.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-716 - Surveys of Ambient Radiation Exposure Rate, Surveys for Contamination, and PET Radiation Exposure Concerns

Current through Register Vol. 30, No. 28, July 12, 2024
A. In addition to the surveys required in
				Article 4 of this Chapter, a licensee shall survey with a radiation detection
				survey instrument at the end of each day of use all areas where unsealed
				radioactive material, requiring a written directive, is prepared for use or
				administered. In areas of routine use, that are to be released for unrestricted
				use, a licensee shall perform a survey of the area using an instrument
				appropriate for detecting contamination before releasing the area for
				unrestricted use.
B. A licensee
				shall obtain the services of a person, experienced in the principles of
				radiation protection and installation design, to design a PET facility and
				perform a radiation survey when the facility is ready for patient imaging. The
				licensee shall provide a copy of the installation radiation survey to the
				Department within 30 days of imaging the first patient.
C. The licensee shall use engineering
				controls or shield each PET use area with protective barriers necessary to
				comply with the radiation exposure limits in
				R9-7-408 and
				R9-7-416.
1. At the time of application for a new
				license or amendment to an existing license, and before imaging of the first
				patient, the licensee shall provide to the Department a copy of the
				installation report signed by the contractor who installed the shielding
				material recommended by a person meeting the requirements in subsection (B) and
				a copy of the installation radiation survey required in subsection
				(B).
2. The licensee shall perform
				shielding calculations in accordance with
AAPM Task Group 108: PET and
				PET/ CT Shielding Requirements
, in Medical Physics, Vol. 33, No. 1,
				January 2006, which is incorporated by reference, published by the American
				Association of Physicists in Medicine, One Physics Ellipse, College Park, MD
				20740, and on file with the Department. This incorporation by reference
				contains no future editions or amendments. In lieu of these procedures, the
				licensee may use equivalent calculations approved by the Department.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-717 - Release of Individuals Containing Radioactive Material or Implants Containing Radioactive Material

Current through Register Vol. 30, No. 28, July 12, 2024
A. A
				licensee may authorize the release from its control of any individual who has
				been administered unsealed radioactive material or implants containing
				radioactive material, if the total effective dose equivalent to any other
				individual from exposure to the released individual is not likely to exceed 5
				millisieverts (0.5 rem).
B. A
				licensee shall provide the released individual, or the individual's parent or
				guardian, with instructions, including written instructions, on actions
				recommended to maintain doses to other individuals as low as is reasonably
				achievable if the total effective dose equivalent to any other individual is
				likely to exceed 1 millisievert (0.1 rem). If the total effective dose
				equivalent to a nursing infant or child could exceed 1 millisievert (0.1 rem)
				assuming there were no interruption of breast-feeding, the instructions shall
				also include:
1. Guidance on the interruption
				or discontinuation of breastfeeding; and
2. Information on the potential consequences,
				if any, of failure to follow the guidance.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-718 - Mobile Medical Service

Current through Register Vol. 30, No. 28, July 12, 2024
A.
				A licensee providing mobile medical service shall:
1. Obtain a letter signed by the management
				of each client for which services are rendered that permits the use of
				radioactive material at the client's address and clearly delineates the
				authority and responsibility of the licensee and the client;
2. Check instruments used to measure the
				activity of unsealed radioactive material for proper function before medical
				use at each client's address or on each day of use, whichever is more frequent.
				At a minimum, the check for proper function required by this subsection shall
				include a constancy check;
3. Check
				survey instruments for proper operation with a dedicated check source before
				use at each client's address; and
4. Before leaving a client's address, survey
				all areas of use to ensure compliance with the requirements in Article 4 of
				this Chapter.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-719 - Training for Uptake, Dilution, and Excretion Studies

Current through Register Vol. 30, No. 28, July 12, 2024
A. Except as provided in R9-7-710, the
				licensee shall require an authorized user of unsealed radioactive material for
				the uses authorized under Group 100 in Exhibit A of this Article to be a
				physician who:
1. Is certified by a medical
				specialty board whose certification process has been recognized by the NRC or
				an Agreement State, as specified in the NRC's Medical Uses Licensee Toolkit
				available through
https://www.nrc.gov
,
				and who meets the requirements in subsection (A)(3). To have its certification
				process recognized, a specialty board shall require all candidates for
				certification to:
a. Complete 60 hours of
				training and experience in basic radionuclide handling techniques and radiation
				safety applicable to the medical use of unsealed radioactive material for
				uptake, dilution, and excretion studies as described in subsection (A)(3);
				and
b. Pass an examination,
				administered by diplomates of the specialty board, that assesses knowledge and
				competence in radiation safety, radionuclide handling, and quality
				control;
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-720 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee may
				not administer to humans a radiopharmaceutical that contains more than 0.15
				kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15
				microcurie of molybdenum-99 per millicurie of technetium-99m) or, more than
				0.02 kilo-becquerel of strontium-82 per megabecquerel of rubidium-82 chloride
				injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82
				chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of
				rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie
				of rubidium-82).
B. A licensee that
				uses molybdenum-99/technetium-99m generators for preparing a technetium-99m
				radiopharmaceutical shall measure the molybdenum-99 concentration of the first
				eluate after receipt of a generator to demonstrate compliance with subsection
				(A).
C. A licensee that uses a
				strontium-82/rubidium-82 generator for preparing a rubidium-82
				radiopharmaceutical shall, before the first patient use of the day, measure the
				concentration of radionuclides strontium-82 and strontium-85 to demonstrate
				compliance with subsection (A).
D.
				A licensee shall maintain a record of each molybdenum-99 concentration
				measurement or strontium-82 and strontium-85 concentrations measurements for
				three years following completion of the measurement.
E. A licensee shall notify by telephone the
				NRC Operations Center and the distributor of the generator within seven
				calendar days after discovery that an eluate exceeded the permissible
				concentration listed in subsection (A) at the time of generator elution. The
				telephone report to the NRC must include the manufacturer, model number, and
				serial number (or lot number) of the generator; the results of the measurement;
				the date of the measurement; whether dosages were administered to patients or
				human research subjects; when the distributor was notified; and the action
				taken.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-721 - Training for Imaging and Localization Studies Not Requiring a Written Directive

Current through Register Vol. 30, No. 28, July 12, 2024
Except as provided in R9-7-710, the licensee shall require an
				  authorized user of unsealed radioactive material for the uses authorized under
				  Group 200 in Exhibit A of this Article to be a physician who:
1. Is certified by a medical specialty board
				whose certification process has been recognized by the NRC or an Agreement
				State, as specified in the NRC's Medical Uses Licensee Toolkit available
				through
https://www.nrc.gov
, and who
				meets the requirements in subsection (3). To have its certification process
				recognized, a specialty board shall require all candidates for certification
				to:
a. Complete 700 hours of training and
				experience in basic radionuclide handling techniques and radiation safety
				applicable to the medical use of unsealed radioactive material for imaging and
				localization studies as described in subsection (3); and
b. Pass an examination, administered by
				diplomates of the specialty board, that assesses knowledge and competence in
				radiation safety, radionuclide handling, and quality control;
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-722 - Safety Instruction and Precautions for Use of Unsealed Radioactive Material Requiring a Written Directive

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee shall provide radiation safety
				instruction, initially and at least annually, for all personnel caring for the
				patient or human research subject receiving radiopharmaceutical therapy and
				hospitalized for compliance with R9-7-717. To satisfy this requirement, the
				instruction shall describe the licensee's procedures for:
1. Patient or human research subject
				control,
2. Visitor
				control,
3. Contamination control,
				and
4. Waste control.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-723 - Training for Use of Unsealed Radioactive Material Requiring a Written Directive, Including Treatment of Hyperthyroidism, and Treatment of Thyroid Carcinoma

Current through Register Vol. 30, No. 28, July 12, 2024
A.
				Except as provided in
				R9-7-710,
				the licensee shall require an authorized user of unsealed radioactive material
				for the uses authorized under Group 300 in Exhibit A, Medical Use Groups of
				this Article to be a physician who:
1. Is
				certified by a medical specialty board whose certification process has been
				recognized by the NRC or an Agreement State, as specified in the NRC's Medical
				Uses Licensee Toolkit available through
https://www.nrc.gov
, and who meets the
				requirements in subsection (A)(2). To have its certification process
				recognized, a specialty board shall require all candidates for certification
				to:
a. Successfully complete residency
				training in a radiation therapy or nuclear medicine training program or a
				program in a related medical specialty. These residency training programs must
				include 700 hours of training and experience as described in (A)(2) subsection
				(A)(2)(a). Eligible training programs must be approved by the Residency Review
				Committee of the Accreditation Council for Graduate Medical Education, the
				Royal College of Physicians and Surgeons of Canada, or the Council on
				Postdoctoral Training of the American Osteopathic Association; and
b. Pass an examination, administered by
				diplomates of the specialty board, which tests knowledge and competence in
				radiation safety, radionuclide handling, and quality assurance, and clinical
				use of unsealed radioactive material for which a written directive is required;
				or
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-724 - Surveys after Brachytherapy Source Implant and Removal; Accountability

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee shall
				make a survey to locate and account for all sources that have not been
				implanted immediately after implanting sources in a patient or a human research
				subject.
B. A licensee shall make a
				survey of the patient or the human research subject with a radiation detection
				survey instrument immediately after removing the last temporary implant source
				to confirm that all sources have been removed.
C. A licensee shall maintain accountability
				at all times for all sources in storage or use.
D. A licensee shall return brachytherapy
				sources to a secure storage area as soon as possible after removing sources
				from a patient or a human research subject.
E. A licensee shall record the procedures
				performed in subsections (A) through (D) and retain the records for three years
				following completion of the record.
F. A licensee must use only brachytherapy
				sources:
1. Approved in the Sealed Source and
				Device Registry for manual brachytherapy medical 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; or
2.
				In research to deliver therapeutic doses for medical use in accordance with an
				active Investigational Device Exemption (IDE) application accepted by the U.S.
				Food and Drug Administration, provided the requirements of R9-7-450(A) are
				met.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-725 - Safety Instructions and Precautions for Brachytherapy Patients that Cannot be Released Under R9-7- 717

Current through Register Vol. 30, No. 28, July 12, 2024
A.
				In addition to the training requirements in Article 10, a licensee shall
				provide radiation safety instruction, initially and at least annually, to
				personnel caring for patients or human research subjects who are receiving
				brachytherapy and cannot be released under R9-7-717. To satisfy this
				requirement, the instruction shall be commensurate with the duties of the
				personnel and include the:
1. Size and
				appearance of the brachytherapy sources;
2. Safe handling and shielding
				instructions;
3. Patient or human
				research subject control;
4.
				Visitor control, including both:
a. Routine
				visitation of hospitalized individuals in accordance with Article 4 of this
				Chapter,
b. Visitation authorized
				in accordance with Article 4 of this Chapter, and
5. Notification of the radiation safety
				officer, or his or her designee, and an authorized user if the patient or the
				human research subject has a medical emergency or dies.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-726 - Calibration Measurements of Brachytherapy Sources, Decay of Sources Used for Ophthalmic Treatments, and Computerized Treatment Planning Systems

Current through Register Vol. 30, No. 28, July 12, 2024
A. Before the first
				medical use of a brachytherapy source after the effective date of this rule, a
				licensee shall have:
1. Determined the source
				output or activity using a dosimetry system that meets the requirements of
				R9-7-733(A);
2. Determined source
				positioning accuracy within applicators; and
3. Used published protocols currently
				accepted by nationally recognized bodies to meet the requirements of
				subsections (A)(1) and (A)(2).
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-727 - Training for Use of Manual Brachytherapy Sources and Training for the Use of Strontium-90 Sources for Treatment of Ophthalmic Disease

Current through Register Vol. 30, No. 28, July 12, 2024
A. Except as provided in
				R9-7-710,
				the licensee shall require an authorized user of a manual brachytherapy source
				for the uses authorized under this Article to be a physician who:
1. Is certified by a medical specialty board
				whose certification process has been recognized by the NRC or an Agreement
				State and who meets the requirements in subsection (A)(2). The names of board
				certifications that have been recognized by the NRC or an Agreement State are
				specified in the NRC's Medical Uses Licensee Toolkit available through
https://www.nrc.gov
. To have its
				certification process recognized, a specialty board shall require all
				candidates for certification to:
a.
				Successfully complete a minimum of three years of residency training in a
				radiation oncology program 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
b. Pass an examination, administered by
				diplomates of the specialty board, that tests knowledge and competence in
				radiation safety, radionuclide handling, treatment planning, quality assurance,
				and clinical use of manual brachytherapy; or
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-728 - Training for Use of Sealed Sources for Diagnosis

Current through Register Vol. 30, No. 28, July 12, 2024
A. Except as provided in R9-7-710, the
				licensee shall require the authorized user of a diagnostic sealed source for
				use in a device authorized under Group 500 in Exhibit A of this Article to be a
				physician, dentist, or podiatrist who:
1. Is
				certified by a medical specialty board whose certification process has been
				recognized by the NRC or an Agreement State and who meets the requirements in
				subsections (A)(3) and (B) and whose certification has been recognized by the
				Department, the NRC, or another Agreement State as specified in the NRC's
				Medical Uses Licensee Toolkit available through
https://www.nrc.gov
;
2. Is an authorized user for uses listed in
				Group 200 of Exhibit A of this Article or equivalent NRC or Agreement State
				requirements; or
3. Has completed eight hours of classroom and
				laboratory training in basic radionuclide handling techniques specifically
				applicable to the use of the device. The training must include:
a. Radiation physics and
				instrumentation;
b. Radiation
				protection;
c. Mathematics
				pertaining to the use and measurement of radioactivity;
d. Radiation biology.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-729 - Surveys of Patients and Human Research Subjects Treated with a Remote Afterloader Unit

Current through Register Vol. 30, No. 28, July 12, 2024
A.
				Before releasing a patient or a human research subject from licensee control, a
				licensee shall survey the patient or the human research subject and the remote
				afterloader unit with a portable radiation detection survey instrument to
				confirm that each source has been removed from the patient or human research
				subject and returned to the safe shielded position.
B. A licensee shall make records of these
				surveys conducted under subsection (A) and retain them for three years from the
				date of each survey.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-730 - Installation, Maintenance, Adjustment, and Repair of an Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit

Current through Register Vol. 30, No. 28, July 12, 2024
A. Only a person specifically licensed by the
				Department, the NRC, or an Agreement State shall install, maintain, adjust, or
				repair a remote afterloader unit, teletherapy unit, or gamma stereotactic
				radiosurgery unit that involves work on any source shielding, the source's
				driving unit, or other electronic or mechanical component that could expose a
				source, reduce the shielding around a source, or compromise the radiation
				safety of a unit or a source.
B.
				Except for low dose-rate remote afterloader units, only a person specifically
				licensed by the Department, the NRC, or an Agreement State shall install,
				replace, relocate, or remove a sealed source or source contained in other
				remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
				units.
C. For a low dose-rate
				remote afterloader unit, only a person specifically licensed by the Department,
				the NRC, or an Agreement State or an authorized medical physicist shall
				install, replace, relocate, or remove a sealed source contained in the
				unit.
D. A licensee shall retain a
				record of the installation, maintenance, adjustment, and repair of remote
				afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
				for three years from the completion date of the activity listed in this
				Section.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-731 - Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee shall:
1. Secure the unit, the console, the console
				keys, and the treatment room when not in use or unattended;
2. Permit only individuals approved by the
				authorized user, Radiation Safety Officer, or authorized medical physicist to
				be present in the treatment room during treatment with a source;
3. Prevent dual operation of more than one
				radiation producing device in a treatment room if applicable; and
4. Develop, implement, and maintain written
				procedures for responding to an abnormal situation when the operator is unable
				to place a source in the shielded position, or remove the patient or human
				research subject from the radiation field with controls from outside the
				treatment room. These procedures shall include:
a. Instructions for responding to equipment
				failures and the names of the individuals responsible for implementing
				corrective actions;
b. The process
				for restricting access to and posting of the treatment area to minimize the
				risk of inadvertent exposure; and
c. The names and telephone numbers of the
				authorized users, the authorized medical physicist, and the Radiation Safety
				Officer to be contacted if the unit or console operates abnormally.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-732 - Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee shall control access at each
				entrance to a treatment room.
B. A
				licensee shall equip each entrance to the treatment room with an electrical
				interlock system that will:
1. Prevent the
				operator from initiating the treatment cycle unless each treatment room
				entrance door is closed;
2. Cause
				each source to be shielded when an entrance door is opened; and
3. Prevent any source from being exposed
				following an interlock interruption until all treatment room entrance doors are
				closed and the source's on-off control is reset at the console.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-733 - Dosimetry Equipment

Current through Register Vol. 30, No. 28, July 12, 2024
A.
				Except for low dose-rate remote afterloader sources where the source output or
				activity is determined by the manufacturer, a licensee shall have a calibrated
				dosimetry system available for use. To satisfy this requirement, one of the
				following two conditions shall be met.
1. The
				system shall have been calibrated using a system or source traceable to the
				National Institute of Science and Technology (NIST) and published protocols
				accepted by nationally recognized bodies; or by a calibration laboratory
				accredited by the American Association of Physicists in Medicine (AAPM). The
				calibration shall have been performed within the previous two years and after
				any servicing that may have affected system calibration; or
2. The system shall have been calibrated
				within the previous four years. Eighteen to 30 months after that calibration,
				the system shall have been intercompared with another dosimetry system that was
				calibrated within the past 24 months by NIST or by a calibration laboratory
				accredited by the AAPM. The results of the intercomparison shall indicate that
				the calibration factor of the licensee's system had not changed by more than
				two percent. The licensee may not use the intercomparison result to change the
				calibration factor. When intercomparing dosimetry systems to be used for
				calibrating sealed sources for therapeutic units, the licensee shall use a
				comparable unit with beam attenuators or collimators, as applicable, and
				sources of the same radionuclide as the source used at the licensee's
				facility.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-734 - Full Calibration Measurements on Teletherapy Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee authorized to use a teletherapy
				unit for medical use shall perform full calibration measurements on each
				teletherapy unit:
1. Before the first medical
				use of the unit; and
2. Before
				medical use under the following conditions:
a.
				Whenever spot-check measurements indicate that the output differs by more than
				5 percent from the output obtained at the last full calibration corrected
				mathematically for radioactive decay;
b. Following replacement of the source or
				following reinstallation of the teletherapy unit in a new location;
c. Following any repair of the teletherapy
				unit that includes removal of the source or major repair of the components
				associated with the source exposure assembly; and
3. At intervals not exceeding one
				year.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-735 - Full Calibration Measurements on Remote After-loader Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee
				authorized to use a remote afterloader unit for medical use shall perform full
				calibration measurements on each unit:
1.
				Before the first medical use of the unit;
2. Before medical use under the following
				conditions:
a. Following replacement of the
				source or following reinstallation of the unit in a new location outside the
				facility; and
b. Following any
				repair of the unit that includes removal of the source or major repair of the
				components associated with the source exposure assembly; and
3. At intervals not exceeding one
				quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote
				after-loader units with sources whose half-life exceeds 75 days; and
4. At intervals not exceeding one year for
				low dose-rate remote afterloader units.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-736 - Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A
				licensee authorized to use a gamma stereotactic radiosurgery unit for medical
				use shall perform full calibration measurements on each unit:
1. Before the first medical use of the
				unit;
2. Before medical use under
				the following conditions:
a. Whenever
				spot-check measurements indicate that the output differs by more than 5 percent
				from the output obtained at the last full calibration corrected mathematically
				for radioactive decay;
b. Following
				replacement of the sources or following reinstallation of the gamma
				stereotactic radiosurgery unit in a new location; and
c. Following any repair of the gamma
				stereotactic radiosurgery unit that includes removal of the sources or major
				repair of the components associated with the source assembly; and
3. At intervals not exceeding one
				year, with the exception that relative helmet factors need only be determined
				before the first medical use of a helmet and following any damage to a
				helmet.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-737 - Periodic Spot-checks for Teletherapy Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee authorized to use teletherapy
				units for medical use shall perform output spot-checks on each teletherapy unit
				once in each calendar month that include determination of:
1. Timer accuracy, and timer linearity over
				the range of use;
2. On-off
				error;
3. The coincidence of the
				radiation field and the field indicated by the light beam localizing
				device;
4. The accuracy of all
				distance measuring and localization devices used for medical use;
5. The output for one typical set of
				operating conditions measured with the dosimetry system described in
				R9-7-733(B); and
6. The difference
				between the measurement made in subsection (A)(5) and the anticipated output,
				expressed as a percentage of the anticipated output.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-738 - Periodic Spot-checks for Remote Afterloader Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee authorized to use a remote
				afterloader unit for medical use shall perform spot-checks of each remote
				afterloader facility and on each unit:
1.
				Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate
				remote afterloader unit on a given day;
2. Before each patient treatment with a low
				dose-rate remote afterloader unit; and
3. After each source installation.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-739 - Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee
				authorized to use a gamma stereotactic radiosurgery unit for medical use shall
				perform spot-checks of each gamma stereotactic radiosurgery facility and on
				each unit:
1. Monthly;
2. Before the first use of the unit on a
				given day; and
3. After each source
				installation.
Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 7 - MEDICAL USES OF RADIOACTIVE MATERIAL › Section R9-7-740 - Additional Requirements for Mobile Remote Afterloader Units

Current through Register Vol. 30, No. 28, July 12, 2024
A. A licensee
				providing mobile remote afterloader service shall:
1. Check survey instruments before medical
				use at each address of use or on each day of use, whichever is more frequent;
				and
2. Account for all sources
				before departure from a client's address of use.