reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0540 - Radiation Monitoring Device

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 licensee must have in each teletherapy room a permanent radiation monitor
			 capable of continuously monitoring beam status.
(2) Each radiation monitor must be capable of
			 providing visible evidence of a teletherapy unit malfunction that results in an
			 exposed or partially exposed source. The visible indicator of high radiation
			 levels must be observable by an individual prior to entering the teletherapy
			 room.
(3) Each radiation monitor
			 must be equipped with a backup power supply separate from the power supply to
			 the teletherapy unit. This backup power supply may be a battery system or other
			 type of uninterruptible power supply (UPS).
(4) Each radiation monitor must be checked
			 with a dedicated check source for proper operation each day before the
			 teletherapy unit is used for treatment of patients.
(5) A licensee must maintain a record of the
			 check required by section (4) of this rule until inspection by the Authority.
			 The record must include the date of the check, notation that the monitor
			 indicates when the source is exposed and the initials of the individual who
			 performed the check.
(6) If a
			 radiation monitor is inoperable, the licensee must require any individual
			 entering the teletherapy room to use a survey instrument or audible alarm
			 personal dosimeter to monitor for any malfunction of the source exposure
			 mechanism that may result in an exposed or partially exposed source. The
			 instrument or dosimeter must be checked with a dedicated check source for
			 proper operation at the beginning of each day of use. The licensee must keep a
			 record as described in section (4) of this rule.
(7) If a radiation monitor is inoperable, the
			 licensee must require any individual entering the teletherapy room to use a
			 survey instrument or audible alarm personal dosimeter to monitor for any
			 malfunction of the source exposure mechanism. The instrument or dosimeter must
			 be checked with a dedicated check source for proper operation at the beginning
			 of each day of use. The licensee must keep a record as described in section (5)
			 of this rule.
(8) A licensee must
			 promptly repair or replace the radiation monitor if it is inoperable.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0550 - Viewing System

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee must construct or equip each teletherapy room to
				permit continuous observation of the patient from the teletherapy unit console
				during irradiation.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0560 - Dosimetry Equipment

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Except for
			 low dose-rate remote afterloader sources where the source output or activity is
			 determined by the manufacturer, a licensee must have a calibrated dosimetry
			 system available for use. To satisfy this requirement, one of the following two
			 conditions must be met.
(a) The system must
			 have been calibrated using a system or source traceable to the National
			 Institute of Standards 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 must
			 have been performed within the previous two years and after any servicing that
			 may have affected system calibration; or
(b) The system must have been calibrated
			 within the previous four years; 18 to 30 months after that calibration, the
			 system must have been intercompared at an intercomparison meeting with another
			 dosimetry system that was calibrated within the past 24 months by the National
			 Institute of Standards and Technology or by a calibration laboratory accredited
			 by the AAPM. The intercomparison meeting must be sanctioned by a calibration
			 laboratory or radiologic physics center accredited by the AAPM. The results of
			 the intercomparison meeting must show that the calibration factor of the
			 licensee's system had not changed by more than two percent. The licensee must
			 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 must 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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0570 - Full Calibration Measurement

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee authorized to use a
			 teletherapy unit for medical use must perform full calibration measurements on
			 each teletherapy unit:
(a) Before the first
			 medical use of the unit; and
(b)
			 Before medical use under the following conditions:
(A) Whenever spot-check measurements indicate
			 that the output differs by more than five percent from the output obtained at
			 the last full calibration corrected mathematically for radioactive
			 decay;
(B) Following replacement of
			 the radioactive 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 radioactive source
			 or major repair of the components associated with the source exposure assembly;
			 and
(c) At intervals not
			 exceeding one year.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0573 - Full Calibration Measurements on Remote Afterloader Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee
			 authorized to use a remote afterloader unit for medical use must perform full
			 calibration measurements on each unit:
(a)
			 Before the first medical use of the unit;
(b) 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
(c) At intervals not
			 exceeding three months for high dose-rate, medium dose-rate, and pulsed
			 dose-rate remote afterloader units with sources whose half-life exceeds 75
			 days; and
(d) At intervals not
			 exceeding one year for low dose-rate remote afterloader
			 units.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0577 - Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee
			 authorized to use a gamma stereotactic radiosurgery unit for medical use must
			 perform full calibration measurements on each unit:
(a) Before the first medical use of the
			 unit;
(b) Before medical use under
			 the following conditions:
(A) Whenever
			 spot-check measurements indicate that the output differs by more than five
			 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
(c) 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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0580 - Periodic Spot-Checks for Teletherapy Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee authorized to use teletherapy
			 units for medical use must perform output spot-checks on each teletherapy unit
			 at intervals not to exceed one month that include the determination of:
(a) Timer constancy, accuracy, and linearity
			 over the range of use;
(b) On-off
			 error;
(c) The coincidence of the
			 radiation field and the field indicated by the light beam localizing
			 device;
(d) The accuracy of all
			 distance measuring and localization devices used for medical use;
(e) The output for one typical set of
			 operating conditions measured with the dosimetry system described in OAR
			 333-116-0560; and
(f) The
			 difference between the measurement made in section (1) of this rule and the
			 anticipated output, expressed as a percentage of the anticipated value obtained
			 at last full calibration corrected mathematically for physical
			 decay.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0583 - Periodic Spot-checks for Remote Afterloader Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee authorized to use a remote
			 afterloader unit for medical use must perform spot-checks of each remote
			 afterloader facility and on each unit:
(a)
			 Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate
			 remote afterloader unit on a given day;
(b) Before each patient treatment with a low
			 dose-rate remote afterloader unit; and
(c) After each source installation.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0585 - Additional Technical Requirements for Mobile Remote Afterloader Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee
			 providing mobile remote afterloader service must:
(a) Check survey instruments before medical
			 use at each address of use or on each day of use, whichever is more frequent;
			 and
(b) Account for all sources
			 before departure from a client's address of use.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0587 - Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee
			 authorized to use a gamma stereotactic radiosurgery unit for medical use must
			 perform spot-checks of each gamma stereotactic radiosurgery facility and on
			 each unit:
(a) Monthly;
(b) Before the first use of the unit on a
			 given day; and
(c) After each
			 source installation.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0590 - Radiation Surveys Therapeutic Treatment Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) In addition to the survey requirement in
			 OAR 333-120-0200, a person licensed under this rule must make surveys to ensure
			 that the maximum radiation levels and average radiation levels from the surface
			 of the main source safe with the source(s) in the shielded position do not
			 exceed the levels stated in the Sealed Source and Device Registry.
(2) The licensee must make the survey
			 required by section (1) of this rule at installation of a new source and
			 following repairs to the source(s) shielding, the source(s) driving unit, or
			 other electronic or mechanical component that could expose the source, reduce
			 the shielding around the source(s), or compromise the radiation safety of the
			 unit or the source(s).
(3) A
			 licensee must retain a record of the radiation surveys required by section (1)
			 of this rule for the duration of use of the unit. The record must include:
(a) The date of the measurements;
(b) The manufacturer's name, model number and
			 serial number of the treatment unit, source, and instrument used to measure
			 radiation levels;
(c) Each dose
			 rate measured around the source while the unit is in the off position and the
			 average of all measurements; and
(d) The signature of the individual who
			 performed the test.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0600 - Safety Checks and Five-year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 licensee must have each teletherapy unit and gamma stereotactic radiosurgery
			 unit fully inspected and serviced during source replacement to assure proper
			 functioning of the source exposure mechanism and other safety components. The
			 interval between each full inspection servicing shall not exceed five years for
			 each teletherapy unit and shall not exceed seven years for each gamma
			 stereotactic radiosurgery unit.
(2)
			 This inspection and servicing may only be performed by persons specifically
			 licensed to do so by the Nuclear Regulatory Commission or an Agreement
			 State.
(3) If the results of the
			 checks required in section (1) of this rule indicate the malfunction of any
			 system, the licensee must lock the control console in the "off" position and
			 not use the unit except as may be necessary to repair, replace or check the
			 malfunctioning system.
(4) A
			 licensee must retain, in accordance with OAR 333-100-0057, a record of the
			 facility checks following installation of a source. The record must include
			 notations indicating the operability of each entrance door interlock, each
			 electrical or mechanical stop, each beam condition indicator light, the viewing
			 system and doors and the signature of the Radiation Safety Officer. In addition
			 each record must contain:
(a) The inspector's
			 radioactive materials license number;
(b) The date of inspection;
(c) The manufacturer's name and model number
			 and serial number of both the treatment unit and source;
(d) A list of components inspected and
			 serviced, and the type of service; and
(e) The signature of the inspector.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0605 - Therapy-Related Computer Systems

Current through Register Vol. 63, No. 7, July 1, 2024
The licensee must perform acceptance testing on the treatment
				planning system of therapy-related computer systems in accordance with
				published protocols accepted by nationally recognized bodies. At a minimum, the
				acceptance testing must include, as applicable, verification of:
(1) The source-specific input parameters
			 required by the dose calculation algorithm;
(2) The accuracy of dose, dwell time, and
			 treatment time calculations at representative points;
(3) The accuracy of isodose plots and graphic
			 displays;
(4) The accuracy of the
			 software used to determine sealed source positions from radiographic images;
			 and
(5) The accuracy of electronic
			 transfer of the treatment delivery parameters to the treatment delivery unit
			 from the treatment planning system.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0610 - Modification of Teletherapy Unit or Room Before Beginning a Treatment Program

Current through Register Vol. 63, No. 7, July 1, 2024
(1) If the
			 survey required by OAR 333-116-0590  indicates that any individual member of the
			 public is likely to receive a dose in excess of the limits specified in
			 333-120-0180, before beginning the treatment program the licensee must:
(a) Either equip the unit with stops or add
			 additional radiation shielding to ensure compliance with OAR
			 333-120-0180;
(b) Perform the
			 survey required by OAR 333-116-0590  again; and
(c) Include in the report required by OAR
			 333-116-0620  the results of the initial survey, a description of the
			 modification made to comply with subsection (1)(a) of this rule, and the
			 results of the second survey.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0620 - Reports of Teletherapy Surveys, Checks, Tests and Measurements

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee must furnish a copy of the records required in OAR
				333-116-0590, 333-116-0600, 333-116-0610  and the output from the teletherapy
				source expressed as rem (Sv) per hour at one meter from the source and
				determined during the full calibration required in OAR 333-116-0570  to the
				Authority within 30 days following completion of the action that initiated the
				record requirement.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0640 - Radiation Safety Officer and Associate Radiation Safety Officer Training and Experience Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee shall
				require an individual fulfilling the responsibilities of the Radiation Safety
				Officer or an individual assigned duties and tasks as an Associate Radiation
				Safety Officer as provided in OAR 333-116-0090  to be an individual who:
(1) Is certified by a specialty board whose
			 certification process has been recognized by the U.S. Nuclear Regulatory
			 Commission or an Agreement State and who meets the requirements in section (4)
			 of this rule.
(a) The names of board
			 certifications which have been recognized by the U.S. Nuclear Regulatory
			 Commission or an Agreement State are posted on the U.S. Nuclear Regulatory
			 Commission's Medical Uses Licensee Toolkit webpage. To have its certification
			 process recognized, a specialty board shall require all candidates for
			 certification to:
(A) Hold a bachelor's or
			 graduate degree from an accredited college or university in physical science or
			 engineering or biological science with a minimum of 20 college credits in
			 physical science;
(B) 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
(C) Pass an examination administered by
			 diplomats 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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0650 - Training for Experienced Radiation Safety Officer

Current through Register Vol. 63, No. 7, July 1, 2024
An individual identified as a Radiation Safety Officer on an
				Agency, Agreement State, Licensing State or U.S. Nuclear Regulatory Commission
				license on July 1, 2006 who oversees only the use of radioactive material for
				which the licensee was authorized on that date need not comply with the
				training requirements of OAR 333-116-0640.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0660 - Training for Uptake, Dilution or Excretion Studies

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee shall
				require the authorized user of a radiopharmaceutical listed in OAR 333-116-0300 to be a physician who:
(1) Is
			 certified by a medical specialty board whose certification process has been
			 recognized by the U.S. Nuclear Regulatory Commission or an Agreement State. The
			 names of board certifications that have been recognized by the U.S. Nuclear
			 Regulatory Commission or an Agreement State are posted on the NRC's Medical
			 Uses Licensee Toolkit webpage. 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 byproduct material for uptake,
			 dilution, and excretion studies as described in paragraphs (3)(a)(A) through
			 (3)(b)(F) of this rule; and
(b)
			 Pass an examination administered by diplomats of the specialty board that
			 assesses knowledge and competence in radiation safety, radionuclide handling
			 and quality control; or
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0670 - Training for Imaging and Localization Studies

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee shall
				require an authorized user of unsealed byproduct material for the uses
				authorized under OAR 333-116-0320  to be a physician who:
(1) Is certified by a medical specialty board
			 whose certification process has been recognized by the U.S. Nuclear Regulatory
			 Commission or an Agreement State. The names of board certifications that have
			 been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State
			 are posted on the NRC's Medical Uses Licensee Toolkit webpage. 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 byproduct
			 material for imaging and localization studies as described in subsection (3)(a)
			 through paragraph (2)(b)(G) of this rule; and
(b) Pass an examination administered by
			 diplomats of the specialty board, which assesses knowledge and competence in
			 radiation safety, radionuclide handling and quality control; or
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0680 - Training for Use of Unsealed Byproduct Material for Which a Written Directive is Required

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee must
				require an authorized user of unsealed byproduct material for the uses
				authorized under OAR 333-116-0360  to be a physician who:
(1) Is certified by a medical specialty board
			 whose certification process has been recognized by the U.S. Nuclear Regulatory
			 Commission or an Agreement State and who meets the requirements in paragraph
			 (2)(b)(F) of this rule. The names of board certifications that have been
			 recognized by the U.S. Nuclear Regulatory Commission or Agreement State are
			 posted on the U.S. Nuclear Regulatory Commission's Medical Uses License Toolkit
			 webpage at
https://www.nrc.gov/materials/miau/med-use-toolkit.html
.
			 To be 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 subsection
			 (2)(a) through paragraph (2)(b)(E) of this rule. 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 diplomats of the specialty board, which tests
			 knowledge and competence in radiation safety, radionuclide handling, quality
			 assurance, and clinical use of unsealed byproduct material for which a written
			 directive is required; or
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0683 - Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 Gigabecquerels (33 millicuries)

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee shall
				require an authorized user for the oral administration of sodium iodide I-131
				requiring a written directive and the total treatment quantity is less than or
				equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who:
(1) Is certified by a medical specialty board
			 whose certification process includes all of the requirements in section (3) of
			 this rule and whose certification has been recognized by the U.S. Nuclear
			 Regulatory Commission, or an Agreement State. The names of board certifications
			 that have been recognized by the U.S. Nuclear Regulatory Commission or an
			 Agreement State are posted on the NRC's Medical Uses Licensee Toolkit webpage;
			 or
(2) Is an authorized user under
			 OAR 333-116-0680  for uses listed in OAR 333-116-0680(2)(b)(F)(i) or (ii)  or
			 333-116-0687, or equivalent Agreement State requirements; or
(3) Has successfully completed 80 hours of
			 classroom and laboratory training, applicable to the medical use of sodium
			 iodide I-131 for procedures requiring a written directive.
(a) The training must include:
(A) Radiation physics and
			 instrumentation;
(B) Radiation
			 protection;
(C) Mathematics
			 pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for
			 medical use; and
(E) Radiation
			 biology; and
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0687 - Training for Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater than 1.22 Gigabecquerels (33 millicuries)

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee must
				require an authorized user for the oral administration of sodium iodide I-131
				requiring a written directive in quantities greater than 1.22 Gigabecquerels
				(33 millicuries), to be a physician who:
(1) Is certified by a medical specialty board
			 whose certification process includes all of the requirements in subsection
			 (3)(a) and (3)(b) of this rule and whose certification has been recognized by
			 the U.S. Nuclear Regulatory Commission or an Agreement State. The names of
			 board certifications that have been recognized by the U.S. Nuclear Regulatory
			 Commission or an Agreement State are posted on the NRC's Medical Uses Licensee
			 Toolkit web page; or
(2) Is an
			 authorized user under OAR 333-116-0680  for uses listed in OAR
			 333-116-0680(2)(b)(F)(ii), or equivalent NRC or Agreement State requirements;
			 or
(3) Has successfully completed
			 80 hours of classroom and laboratory training, applicable to the medical use of
			 sodium iodide I-131 for procedures requiring a written directive.
(a) The training must include:
(A) Radiation physics and
			 instrumentation;
(B) Radiation
			 protection;
(C) Mathematics
			 pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for
			 medical use; and
(E) Radiation
			 biology; and
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0690 - Training for Use of Manual Brachytherapy Source

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee must
				require the authorized user using manual brachytherapy sources specified in OAR
				333-116-0420  for therapy to be a physician who:
(1) Is certified by a medical specialty board
			 whose certification process has been recognized by the U.S. Nuclear Regulatory
			 Commission or an Agreement State. The names of board certifications that have
			 been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State
			 are posted on the U.S. Nuclear Regulatory Commission's Medical Uses Licensee
			 Toolkit web page. 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 diplomats 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
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0700 - Training for Ophthalmic Use of Strontium-90

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee must
				require the authorized user using only strontium-90 for ophthalmic radiotherapy
				to be a physician who:
(1) Is an
			 authorized user under OAR 333-116-0690  or equivalent U.S. Nuclear Regulatory
			 Commission or Agreement State requirements; or
(2) Has completed 24 hours of classroom and
			 laboratory training applicable to the medical use of strontium-90 for
			 ophthalmic radiotherapy.
(a) The training must
			 include:
(A) Radiation physics and
			 instrumentation;
(B) Radiation
			 protection;
(C) Mathematics
			 pertaining to the use and measurement of radioactivity; and
(D) Radiation biology; and
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0710 - Training for Use of Sealed Sources for Diagnosis

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740  the licensee must
				require the authorized user using a sealed source in a device specified in OAR
				333-116-0400  to be a physician, dentist or podiatrist who:
(1) Is certified by a specialty board whose
			 certification process includes all of the requirements in sections (3) and (4)
			 of this rule and whose certification has been recognized by the U.S. Nuclear
			 Regulatory Commission or an Agreement State. The names of board certifications
			 that have been recognized by the U.S. Nuclear Regulatory Commission or an
			 Agreement State are posted on the U.S. Nuclear Regulatory Commission's Medical
			 Uses Licensee Toolkit webpage or:
(2) Is an authorized user for uses listed in
			 OAR 333-116-0320  or equivalent U.S. Nuclear Regulatory Commission 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 protections;
(c) Mathematics pertaining to the use and
			 measurement of radioactivity; and
(d) Radiation biology
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0715 - Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee shall
				require an authorized user for the parenteral administration requiring a
				written directive, to be a physician who:
(1) Is an authorized user under OAR
			 333-116-0680  for uses listed in 333-116-0680(2)(b)(F) (iii) or
			 333-116-0680(2)(b)(F)(iv)  or equivalent U.S. Nuclear Regulatory Commission or
			 Agreement State requirements; or
(2) Is an authorized user under OAR
			 333-116-0690  or 333-116-0720, or equivalent U.S. Nuclear Regulatory Commission
			 or Agreement State requirements and who meets the requirements in section (4)
			 of this rule; or
(3) Is certified
			 by a medical specialty board whose certification process has been recognized by
			 the U.S. Nuclear Regulatory Commission or an Agreement State under OAR
			 333-116-0690  or 333-116-0720, and who meets the requirements in section (4) of
			 this rule.
(4) Has successfully
			 completed 80 hours of classroom and laboratory training, applicable to
			 parenteral administrations listed in OAR 333-116-0680(2)(b)(F)(ii).
(a) The training must include:
(A) Radiation physics and
			 instrumentation;
(B) Radiation
			 protection;
(C) Mathematics
			 pertaining to the use and measurement of radioactivity;
(D) Chemistry of byproduct material for
			 medical use; and
(E) Radiation
			 biology; and
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0720 - Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 63, No. 7, July 1, 2024
Except as provided in OAR 333-116-0740, the licensee must
				require the authorized user of a sealed source specified in OAR 333-116-0480  to
				be a physician who:
(1) Is certified
			 by a medical specialty board whose certification process has been recognized by
			 the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State and who
			 meets the requirements in subsection (2)(c) and section (3) of this rule. The
			 names of board certifications which have been recognized by the U.S. Nuclear
			 Regulatory Commission or an Agreement State are posted on the U.S. Nuclear
			 Regulatory Commission's Medical Uses Licensee Toolkit webpage. 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 therapy 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
			 diplomats of the specialty board, which tests knowledge and competence in
			 radiation safety, radionuclide handling, treatment planning, quality assurance,
			 and clinical use of stereotactic radiosurgery, remote afterloaders and external
			 beam therapy; or
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0730 - Training for Teletherapy or Brachytherapy Physicist

Current through Register Vol. 63, No. 7, July 1, 2024
The licensee must require the teletherapy physicist to:
(1) Be certified by the American Board of
			 Radiology in:
(a) Therapeutic radiological
			 physics; or
(b) Roentgen ray and
			 gamma ray physics; or
(c) X-ray and
			 radium physics; or
(d) Radiological
			 physics; or
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0750 - Physician Training in a Three Month Program

Current through Register Vol. 63, No. 7, July 1, 2024
A physician who, before July 1, 1984, began a three month
				nuclear medicine training program approved by the Accreditation Council for
				Graduate Medical Education and has successfully completed the program is
				exempted from the requirements of OAR 333-116-0660  or
				333-116-0670.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0760 - Recentness of Training

Current through Register Vol. 63, No. 7, July 1, 2024
The training and experience specified in OAR 333-116-0640 through 333-116-0730  and 333-116-0905  through 333-116-0910  must have been
				obtained within the seven years preceding the date of application or the
				individual must have had continuing education and experience since the required
				training and experience was completed.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605  - 453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0800 - Licensing and Registration of Positron Emission Tomography (PET) Facilities

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each
			 component of a PET facility (accelerator, radiopharmacy, and clinic) must be
			 separately licensed pursuant to OAR 333-101-0005, 333-102-0200, 333-103-0005  or
			 333-103-0010.
(2) The licensee or
			 registrant must receive applicable Authority authorization at least 30 days
			 prior to the production of any accelerator-produced radioactive material or any
			 change in accelerator configuration, shielding, location, room shielding or
			 configuration, nuclide production method, ventilation systems, rabbit or other
			 delivery systems, operating or emergency procedures, radiation safety
			 personnel, authorized users or operators, or other applicable provisions
			 authorized pursuant to these rules.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0810 - Supervision of PET Facilities

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Management must ensure that there is a qualified Radiation Safety Officer (RSO)
			 who must oversee the radiation safety aspects of the PET facility and be
			 responsible for radiation safety of the accelerator facility, pharmacy, and PET
			 clinic.
(a) In the case of separate licenses
			 for different components in a PET facility, there must be a cooperative
			 consortium of management and radiation safety personnel that acts as directors
			 for the facility.
(b) Management,
			 whether singular or in consortium, must write a statement of authority and
			 responsibility for all staff handling or controlling the production and use of
			 PET isotopes.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0820 - Other Applicable Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The licensee must ensure that any
			 radiopharmaceutical for which an Investigational New Drug (IND) status does not
			 exist, or which must be used for research purposes in humans, is reviewed by an
			 Institutional Review Board (IRB) or Human Subjects Review Board or Committee.
			 The licensee must establish procedures, reviews, quality assurance, and
			 emergency procedures for all procedures reviewed by the IRB. The IRB, the PET
			 Radiation Safety Committee or subcommittee, and the PET or facility Radiation
			 Safety Officer must review and approve any and all PET procedures, unless
			 otherwise authorized in a radioactive materials license pursuant to OAR
			 333-102-0200.
(2) Transfers of
			 radioisotopes must be in accordance with requirements in OAR
			 333-102-0330.
(3) PET facility
			 radiation protection programs, occupational dose limits, radiation dose limits
			 for the public, surveys and monitoring, restricted area control, storage of
			 radioactive materials, internal exposure control, precautionary procedures,
			 waste disposal, records, and reports must meet all applicable requirements of
			 division 333-120.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0830 - Accelerator Facility Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
((1) Accelerators must meet all requirements
			 of division 333-109. Shielded-room accelerators must be equipped with
			 interlocks and personnel control; self-shielded accelerators must be shielded
			 such that personnel access is prevented during operation.
(2) Non-ionizing radiation must meet
			 requirements of division 333-112.
(3) Target maintenance and repair,
			 contamination control, and emergency actions must be conducted pursuant to
			 division 333-120.
(4) There must be
			 an Understanding of Transfer (UOT) when isotopes are transferred from one
			 licensee or entity to another for processing, specifying at what point control
			 is transferred to personnel handling radiochemical production or radiopharmacy
			 operation.
(5) Radiation surveys
			 must be made prior to any accelerator operation or isotope production with a
			 radiation survey instrument calibrated in accordance with requirements in OAR
			 333-116-0390. Periodic surveys must be done throughout times of operation to
			 ensure that radiation levels meet all applicable requirements in division
			 333-120 (Radiation Protection Standards).
(6) Ventilation controls must be implemented
			 to ensure compliance with all applicable local, state, and federal
			 requirements. Controls must include monitoring of stacks and computer modeling
			 of air emissions to confirm compliance with standards.
(7) Real-time (integrating) monitors must be
			 used to confirm requirements in OAR 333-120-0100, 333-120-0160, 333-120-0170,
			 and 333-120-0180.
(8) Contamination
			 wipes for radioactive material must be made pursuant to requirements in OAR
			 333-116-0250;
(9) Dosimetry must
			 address both gamma and beta doses in all areas of the facility. Licensees and
			 registrants must monitor extremities to ensure compliance with OAR
			 333-120-0100. Bioassays, as defined in 333-100-0005, are not required, but
			 there must be evaluation of internal exposures, pursuant to 333-120-0130, based
			 on calculated releases and monitoring.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0840 - Safety Considerations and Quality Management for PET Facilities

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The licensee
			 must establish and implement a Quality Management program pursuant to OAR
			 333-116-0125  for PET products, as well as other production and calibration
			 products.
(2) PET instrumentation
			 and other equipment unique to the PET process must meet all applicable
			 radiation protection standards pursuant to division 120 of these
			 rules.
(3) Area monitors must be
			 visible and audible to accelerator operators. Monitors must be checked for
			 proper operation daily.
(4) Wasted
			 targets must be treated as radioactive waste and must be properly dismantled,
			 shielded, stored, and disposed.
(5)
			 Accelerator shielding design and safety must meet requirements of OAR
			 333-109-0025.
(6) Shielding around
			 guide-bends, targets, hot-cells, purification manifolds, etc. must ensure that
			 limits in OAR 333-120-0180  and 333-120-0190  have been met in all areas of beam
			 and nuclide production.
(7)
			 Security provisions for unauthorized access, janitorial services, maintenance,
			 visitors, tours, and personnel-in-training must conform to requirements in OAR
			 333-120-0180, 333-120-0250  and 333-120-0260.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0850 - Radiopharmacy and Radiochemical Production

Current through Register Vol. 63, No. 7, July 1, 2024
(1) All preparations used in humans must meet
			 the Oregon State Board of Pharmacy standards, as well as applicable federal
			 Food and Drug Administration (FDA) requirements.
(a) All research products to be used in
			 humans must be reviewed and approved by the licensee's or consortium
			 Institutional Review Board (IRB).
(b) No research radiopharmaceutical must be
			 used in a human being until its pyrogenicity and purity have been shown to meet
			 applicable standards.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0870 - Rubidium-82 Generator

Current through Register Vol. 63, No. 7, July 1, 2024
Rubidium-82 generators require quality assurance procedures for
				equipment, patient injection, waiting area, imaging, and post-imaging care.
				There also must be a procedure for spills, and a handling procedure for liquid
				quality assurance sources for early model PET cameras. Dose calibration
				procedures are the same as in OAR 333-116-0850(6).
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807