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 333-116-0180 - Determination of Dosages of Unsealed Radioactive Material for Medical Use

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee must:
(1)
			 Assay, within 30 minutes before medical use, the activity of each
			 radiopharmaceutical dosage that contains more than 370 kilobecquerels (10 uCi)
			 of an alpha-, beta-, or photon-emitting radionuclide;
(2) For a dosage of an alpha- or
			 beta-emitting radionuclide prepared by the licensee, this determination must be
			 made by direct measurement or by a combination of measurements and
			 calculations.
(3) A licensee must
			 not use a dosage if the dosage differs from the prescribed dosage by more than
			 20 percent, unless authorized in writing by an authorized user.
(4) Retain a record of the assays required by
			 this rule in accordance with OAR 333-100-0057. The record must contain the:
(a) Generic name, trade name or abbreviation
			 of the radiopharmaceutical, its lot number and expiration dates and the
			 radionuclide;
(b) Patient's name
			 and identification number if one has been assigned;
(c) Prescribed dosage and activity of the
			 dosage at the time of assay or a notation that the total activity is less than
			 370 kilobecquerels (10 uCi);
(d)
			 Date and time of the assay;
(e)
			 Date and time of administration; and
(f) Initials of the individual who performed
			 the assay.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0190 - Authorization for Calibration and Reference Source

Current through Register Vol. 63, No. 7, July 1, 2024
Any person authorized by OAR 333-116-0030  for medical use of
				radioactive material may receive, possess and use the following radioactive
				material for check, calibration and reference use:
(1) Sealed sources manufactured and
			 distributed by persons specifically licensed pursuant to OAR 333-102-0290  or
			 equivalent provisions of the U.S. Nuclear Regulatory Commission (NRC) Agreement
			 State or Licensing State and that do not exceed 1.11GBq (30 mCi)
			 each;
(2) Any radioactive material
			 listed in OAR 333-116-0300, 333-116-0320  or 333-116-0360  with a half-life of
			 100 days or less in individual amounts not to exceed 1.11GBq (30 mCi), except
			 Y-90 sources not to exceed 2.8 GBq (75 mCi);
(3) Any radioactive material listed in OAR
			 333-116-0300, 333-116-0320  or 333-116-0360  with a half-life greater than 100
			 days in individual amounts not to exceed 7.4 MBq (200 uCi) each; and
(4) Technetium-99m in amounts as
			 needed.
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 333-116-0200 - Requirements for Possession of Sealed Sources and Brachytherapy Sources

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee in
			 possession of any sealed source or brachytherapy source must follow the
			 radiation safety and handling instructions supplied by the manufacturer or
			 equivalent instructions approved by the Authority, and must maintain the
			 instructions for the duration of source use in a legible form convenient to
			 users.
(2) A licensee in possession
			 of a sealed source must assure that:
(a) The
			 source is tested for leakage before its first use unless the licensee has a
			 certificate from the supplier indicating that the source was tested within six
			 months before transfer to the licensee; and
(b) The source is tested for leakage at
			 intervals not to exceed six months or at intervals approved by the Authority,
			 another Agreement State, a Licensing State or the U.S. Nuclear Regulatory
			 Commission in the Sealed Source and Device Registry (SS&D).
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0220 - Labeling of Vials and Syringes

Current through Register Vol. 63, No. 7, July 1, 2024
Each syringe and vial that contains unsealed byproduct material
				must be labeled to identify the radiopharmaceutical drug. Each syringe shield
				and vial shield must also be labeled unless the label on the syringe or vial is
				visible when shielded. The label must include the radiopharmaceutical name or
				abbreviation, the type of diagnostic study or therapy procedure to be performed
				and the patient's name.
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 333-116-0250 - Surveys for Contamination and Ambient Radiation Dose Rate

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must
			 survey with an appropriate radiation detection survey instrument, at the end of
			 each day of use, all areas where radiopharmaceuticals are routinely prepared
			 for use or administered. Radiation surveys are not required in areas where
			 patients or human research subjects are confined when they cannot be released
			 under OAR 333-116-0260. Radiation surveys are required when patients receive a
			 therapeutic dose or brachytherapy implant and prior to release.
(2) A licensee must survey with an
			 appropriate radiation detection survey instrument at least once each week all
			 areas where radiopharmaceuticals or radioactive wastes are stored.
(3) A licensee must conduct the surveys
			 required by section (1) and (2) of this rule so as to be able to measure dose
			 rates as low as 1 uSv (0.1 mrem) per hour.
(4) A licensee must establish dose rate
			 action levels for the surveys required by sections (1) and (2) of this rule and
			 must require that the individual performing the survey immediately notify the
			 Radiation Safety Officer if a dose rate exceeds an action level.
(5) A licensee must survey for removable
			 contamination each day of use all areas where radiopharmaceuticals are
			 routinely prepared for use or administered and each week where radioactive
			 materials are stored.
(6) A
			 licensee must conduct the surveys required by section (5) of this rule so as to
			 be able to detect contamination on each wipe sample of 33.3 Bq (2000
			 dpm).
(7) A licensee must establish
			 removable contamination action levels for the surveys required by section (5)
			 of this rule and must require that the individual performing the survey
			 immediately notify the Radiation Safety Officer if contamination exceeds action
			 levels.
(8) A licensee must retain
			 a record of each survey required by this rule in accordance with OAR
			 333-100-0057. The record must include the date of the survey, a sketch of each
			 area surveyed, action levels established for each area, the measured dose rate
			 at several points in each area expressed in Sv mrem per hour or the removable
			 contamination in each area expressed in Bq (dpm) per 100 square centimeters,
			 the serial number and the model number of the instrument used to make the
			 survey or analyze the samples and the initials of the individual who performed
			 the survey.
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 333-116-0255 - Surveys Of Patients And Human Research Subjects Treated With A Remote Afterloader Unit

Current through Register Vol. 63, No. 7, July 1, 2024
(1) 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 the source(s) has been removed from the patient or human research
			 subject and returned to the safe shielded position.
(2) A licensee shall retain a record of these
			 surveys in accordance with OAR 333-100-0057.
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 333-116-0260 - Release of Patients Containing Therapeutic Quantities of Byproduct material or Permanent Implants

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 The licensee may authorize the release from its control of any individual who
			 has been administered unsealed byproduct material or implants containing
			 byproduct material if the total effective dose equivalent to any other
			 individual from exposure to the released individual is not likely to exceed
			 five millisieverts (0.5 rem).
Note: The current revision of NUREG-1556, Vol. 9, "Consolidated
				Guidance About Materials Licenses: Program-Specific Guidance About Medical
				Licenses'' describes methods for calculating doses to other individuals and
				contains tables of activities not likely to cause doses exceeding 5 mSv (0.5
				rem).
(2) The licensee must
			 provide the released individual, or the individual's parent or guardian, with
			 instructions, including written instructions, on actions recommended to
			 maintain radiation exposures to other individuals as low as is reasonably
			 achievable if the total effective dose equivalent to any other individual is
			 likely to exceed one millisievert (0.1 rem). If the dose to a breast-feeding
			 infant or child could exceed one millisievert (0.1 rem) assuming there were no
			 interruption of breast-feeding, the instructions must also include:
(a) Guidance on the interruption or
			 discontinuation of breast-feeding; and
(b) Information on the potential
			 consequences, if any, of failure to follow the guidance.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0280 - Storage of Volatiles and Gases

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must store volatile
			 radiopharmaceuticals and radioactive gases in the shipper's radiation shield
			 and container.
(2) A licensee must
			 store and use a multidose container in a properly functioning fume
			 hood.
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 333-116-0290 - Decay-In-Storage

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee may
			 hold radioactive material with a physical half-life of less than 120 days for
			 decay-in-storage before disposal in ordinary trash and is exempt from the
			 requirements of OAR 333-120-0500  of these rules if the licensee:
(a) Holds radioactive material for decay a
			 minimum of 10 half-lives;
(b)
			 Monitors radioactive material at the container surface before disposal as
			 ordinary trash and determines that its radioactivity cannot be distinguished
			 from the background radiation level with an appropriate radiation detection
			 survey instrument for the radiation being monitored, set on its most sensitive
			 scale and with no interposed shielding;
(c) Removes or obliterates all radiation
			 labels, except radiation labels on materials that are within containers and
			 that will be managed as biomedical waste after they have been released from the
			 licensee; and
(d) Separates and
			 monitors each generator column individually with all radiation shielding
			 removed to ensure that its contents have decayed to background radiation level
			 before disposal.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0300 - Use of Unsealed Radioactive Material for Uptake, Dilution or Excretion Studies for Which a Written Directive Is Not Required

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee may use any unsealed
			 radioactive material for a diagnostic use involving measurements of uptake,
			 dilution or excretion that:
(a) The Food and
			 Drug Administration (FDA) has accepted a "Notice of Claimed Investigational
			 Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA);
			 and
(b) Is obtained from a
			 manufacturer or preparer licensed under OAR 333-102-0285  or equivalent Nuclear
			 Regulatory Commission or Agreement State requirements; or
(c) Is prepared and compounded by an
			 authorized nuclear pharmacist, a physician who is an authorized user, or an
			 individual under the supervision of either as specified in OAR 333-116-0100,
			 333-116-0670  and 333-116-0670(3)(B); or
(d) Is prepared by the licensee for use in
			 research in accordance with a Radioactive Drug Research Committee-approved
			 application or an Investigational New Drug (IND) protocol accepted by
			 FDA.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0310 - Possession of Survey Instrument

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee authorized to use radioactive material for uptake,
				dilution and excretion studies must have in its possession a portable radiation
				detection survey instrument capable of detecting dose rates over the range one
				Sv (0.1 mrem) per hour to one mSv (100 mrem) per hour. The instrument must be
				operable and calibrated in accordance with OAR 333-116-0170.
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 333-116-0320 - Use of Radiopharmaceuticals, Generators and Reagents Kits for Imaging and Localization Studies for Which a Written Directive Is Not Required

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee may
			 use any radioactive material in a diagnostic radiopharmaceutical, except
			 aerosol or gaseous form, or any generator or reagent kit for preparation and
			 diagnostic use of a radiopharmaceutical containing radioactive material for:
(a) Which the Food and Drug Administration
			 has accepted a "Notice of Claimed Investigational Exemption for a New Drug"
			 (IND) or approved a "New Drug Application" (NDA); or
(b) Which is prepared and compounded by an
			 authorized nuclear pharmacist, a physician who is an authorized user, or an
			 individual under the supervision of either as specified in OAR 333-116-0100,
			 333-116-0670  or 333-116-0680; or
(c) Obtained from a manufacturer or preparer
			 licensed under divisions 333-102 and 333-116 or equivalent Nuclear Regulatory
			 Commission or Agreement State requirements.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0330 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentration

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must
			 not administer to humans a radiopharmaceutical containing more than 0.15 kBq
			 (0.15 uCi) of molybdenum-99 per MBq (mCi) of technetium-99m; or
(2) More than 0.02 kilobecquerel 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).
(3) A licensee that
			 uses molybdenum-99/technetium-99 generators for preparing technetium-99m
			 radiopharmaceuticals must measure the molybdenum-99 concentration in each
			 eluate from a generator to demonstrate compliance with section (1) of this
			 rule.
(4) 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 section (1) of this rule.
(5) A licensee who must measure molybdenum
			 concentration or strontium-82 and strontium-85 must retain a record of each
			 measurement in accordance with OAR 333-100-0057. The record must include, for
			 each elution or extraction of technetium-99m, the measured activity of the
			 technetium expressed in MBq (mCi), the measured activity of the molybdenum
			 expressed in kBq (uCi), the ratio of the measures expressed as kBq (uCi) of
			 molybdenum per MBq (mCi) of technetium, the date of the test and the initials
			 of the individual who performed the test.
(6) A licensee must report immediately to the
			 Authority in accordance with OAR 333-116-1011  each occurrence of molybdenum-99
			 concentration exceeding the limits specified in section (1) of this
			 rule.
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 333-116-0340 - Control of Aerosols and Gases

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee who administers radioactive
			 aerosols or gases must do so with a system that will keep airborne
			 concentrations within the limits prescribed by OAR 333-120-0130  and
			 333-120-0180.
(2) The system must
			 either be directly vented to the atmosphere through an air exhaust or provide
			 for collection and decay or disposal of the aerosol or gas in a shielded
			 container.
(3) A licensee must only
			 administer radioactive gases in rooms that are at negative pressure compared to
			 surrounding rooms.
(4) Before
			 receiving, using or storing a radioactive gas, the licensee must calculate the
			 amount of time needed after a release to reduce the concentration in the area
			 of use to the occupational limit listed in  10 CFR Part 20  Appendix B to 20.1001
			 to 20.2401. The calculation must be based on the highest activity of gas
			 handled in a single container and the measured available air exhaust
			 rate.
(5) A licensee must post the
			 time calculated in accordance with section (4) of this rule at the area of use
			 and require that, in case of a gas spill, individuals evacuate the room until
			 the posted time has elapsed.
(6) A
			 licensee must check the operation of collection systems before each use and
			 measure the ventilation rates in areas of use at intervals not to exceed six
			 months. Records of these checks and measurements must be maintained for five
			 years or until inspected by the Authority.
(7) A copy of the calculations required in
			 section (4) of this rule must be recorded and retained for the duration of the
			 license.
Publications: Publications referenced are available from the
				  agency.
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 333-116-0350 - Possession of Survey Instruments

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee authorized to use radioactive material for imaging
				and localization studies must have in its possession a portable, radiation
				detection survey instrument capable of detecting dose rates over the range of
				one Sv (0.1 mrem) per hour to one mSv (100 mrem) per hour and a portable
				radiation measurement survey instrument capable of measuring dose rates over
				the range ten Sv (1 mrem) per hour to ten millisieverts (1000 mrem) per hour.
				The instruments must be operable and calibrated in accordance with OAR
				333-116-0170.
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 333-116-0360 - Use of Unsealed Radioactive Materials or Radiopharmaceuticals for Which a Written Directive is Required

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee may use any unsealed radioactive material identified
				in OAR 333-116-0680(2)(b)(F)  prepared for medical use for which a written
				directive is required that is obtained from:
(1) A manufacturer or preparer licensed under
			 OAR 333-102-0285, U.S. Nuclear Regulatory Commission, or equivalent Agreement
			 State requirements; or
(2) A PET
			 radiopharmaceutical producer licensed under OAR 333-102-0190(11)  U.S. Nuclear
			 Regulatory Commission or equivalent Agreement State requirements; or
(3) Excluding production of PET
			 radionuclides, prepared by:
(a) An authorized
			 nuclear pharmacist;
(b) A physician
			 who is an authorized user on a license from the Authority, other Agreement
			 State, or the U.S. Nuclear Regulatory Commission and meets the specified
			 requirements in OAR 333-116-0670  or 333-116-0680; or
(c) An individual under the supervision, as
			 specified in OAR 333-116-0100, of the authorized nuclear pharmacist in
			 subsection (3)(a) of this rule or the physician who is an authorized user in
			 subsection (3)(b) of this rule; or
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0370 - Imaging and Localization: Safety Instruction

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must provide oral and written
			 radiation safety instruction for all personnel caring for patients or human
			 research subjects undergoing radiopharmaceutical therapy who cannot be released
			 under OAR 333-116-0260. Refresher training must be provided at intervals not to
			 exceed one year.
(2) To satisfy
			 section (1) of this rule, the instruction must describe the licensee's
			 procedures for:
(a) Patient or human research
			 subject control;
(b) Visitor
			 control; including
(A) Routine visitation to
			 hospitalized individuals in accordance with OAR 333-120-0180(1)(a);
			 and
(B) Visitation authorized in
			 accordance with OAR 333-120-0180(3).
(c) Contamination control;
(d) Waste control; and
(e) Notification of the Radiation Safety
			 Officer or authorized user in case of the patient's death or medical
			 emergency.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0390 - Possession of Survey Instruments

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee authorized to use radioactive material for
				radiopharmaceutical therapy must have in its possession a portable radiation
				detection survey instrument capable of detecting dose rates over the range 1
				uSv (0.1 mrem) per hour to 1 mSv (100 mRem) per hour and a portable radiation
				measurement survey instrument capable of measuring dose rates over the range 10
				uSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The instruments must be
				operable and calibrated in accordance with OAR 333-116-0170.
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 333-116-0400 - Use of Sealed Sources for Diagnosis

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must use only sealed sources
			 that are not in medical devices for diagnostic medical uses if the sealed
			 sources are approved in the Sealed Source and Device Registry for diagnostic
			 medicine. The sealed sources may be used for diagnostic medical 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.
(2) A licensee must only use medical devices
			 containing sealed sources for diagnostic medical uses if both the sealed
			 sources and medical devices are approved in the Sealed Source and Device
			 Registry for diagnostic medical uses. The diagnostic medical devices may be
			 used for diagnostic medical 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.
(3) Sealed sources and
			 devices for diagnostic medical uses may be used in research in accordance with
			 an active Investigational Device Exemption (IDE) application accepted by the
			 U.S. Food and Drug Administration provided the requirements of OAR
			 333-116-0140(6)  are met.
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 333-116-0410 - Availability of Survey Instrument

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee authorized to use radioactive material as a sealed
				source for diagnostic purposes must have available for use a portable radiation
				detection survey instrument capable of detecting dose rates over the range one
				uSv (0.1 mrem) per hour to 100 mrem (one mSv) per hour and a portable radiation
				measurement survey instrument capable of measuring dose rates over the range
				ten uSv (1 mrem) per hour to ten mSv (1000 mrem) per hour. The instrument must
				be operable and calibrated in accordance with OAR
				333-116-0170.
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 333-116-0420 - Use of Sources for Manual Brachytherapy

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee must use only brachytherapy sources for therapeutic
				medical uses:
(1) As 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 Food and Drug Administration and are
			 manufactured, labeled, packaged and distributed under a specific license issued
			 by the U.S. Nuclear Regulatory Commission or an Agreement State provided that
			 the requirements of OAR 333-116-0140  are met.
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 333-116-0425 - Surveys After Source Implant and Removal

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Immediately after implanting sources in a
			 patient or a human research subject, the licensee must make a survey to locate
			 and account for all sources that have not been implanted.
(2) Immediately after removing the last
			 temporary implant source from a patient or a human research subject, the
			 licensee must make a survey of the room and the patient or the human research
			 subject with an appropriate radiation detection survey instrument to confirm
			 that all sources have been removed.
(3) A licensee must retain a record of the
			 surveys required by sections (1) and (2) of this rule in accordance with OAR
			 333-100-0057.
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 333-116-0430 - Safety Instructions

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 licensee must provide oral and written radiation safety instruction to all
			 personnel caring for a patient receiving implant therapy. Refresher training
			 must be provided at intervals not to exceed one year.
(2) To satisfy section (1) of this rule, the
			 instruction must describe:
(a) Size and
			 appearance of the brachytherapy sources;
(b) Safe handling and shielding instructions
			 in case of a dislodged source;
(c)
			 Procedures for patient control;
(d)
			 Procedures for visitor control including both:
(A) Routine visitation to hospitalized
			 individuals in accordance with OAR 333-120-0180(1)(a); and
(B) Visitation authorized in accordance with
			 OAR 333-120-0180(3); and
(e) Procedures for notification of the
			 Radiation Safety Officer or authorized user if the patient dies or has a
			 medical emergency.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0440 - Safety Precaution

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 licensee must, for each patient or human research subject receiving implant
			 therapy:
(a) Not place the patient or human
			 research subject in the same room with a patient or human research subject who
			 is not receiving radiation therapy;
(b) Post the patient's or human research
			 subject's door with a "Caution: Radioactive Materials" sign and note on the
			 door or in the patient's chart where and how long visitors may stay in the
			 patient's room;
(c) Authorize
			 visits by individuals under age 18 only on a case-by-case basis with the
			 approval of the authorized user after consultation with the Radiation Safety
			 Officer;
(d) Promptly after
			 implanting the sources, survey the dose rates in contiguous restricted and
			 unrestricted areas with a radiation measurement survey instrument to
			 demonstrate compliance with OAR 333-120-0180  of these rules. Retain a record of
			 each survey in accordance with OAR 333-100-0057. Each record must include the
			 time and date of the survey, a sketch of the area or list of points surveyed,
			 the measured dose rate at several points expressed in microsieverts (mrem) per
			 hour, the instrument used to make the survey and the initials of the individual
			 who made the survey; and
(e)
			 Instruct the patient or human research subject and, where appropriate, the
			 patient's or human research subject's family, orally and in writing concerning
			 radiation safety precautions that will help to keep the radiation dose to
			 household members and the public as low as reasonably achievable before
			 releasing the patient if the patient was administered a permanent
			 implant.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0445 - Calibration Measurements of Brachytherapy Sources

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Before the first medical use of a
			 brachytherapy source on or after July 1, 2006, a licensee must have:
(a) Determined the source output or activity
			 using a dosimetry system that meets the requirements of OAR
			 333-116-0560(1);
(b) Determined
			 source positioning accuracy within applicators; and
(c) Used published protocols currently
			 accepted by nationally recognized bodies to meet the requirements of section
			 (1) of this rule.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0447 - Strontium-90 Sources for Ophthalmic Treatments

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Licensees who use strontium-90 for
			 ophthalmic treatments must ensure that certain activities as specified in
			 section (2) of this rule are performed by either:
(a) An authorized medical physicist;
			 or
(b) An individual who:
(A) Is identified as an ophthalmic physicist
			 on:
(i) A specific medical use license issued
			 by the U.S. Nuclear Regulatory Commission or an Agreement State;
(ii) A permit issued by a U.S. Nuclear
			 Regulatory Commission or Agreement State broad scope medical use
			 licensee;
(iii) A medical use
			 permit issued by a U.S. Nuclear Regulatory Commission master material licensee;
			 or
(iv) A permit issued by a U.S.
			 Nuclear Regulatory Commission master material licensee broad scope medical use
			 permittee; and
(B) Holds
			 a master's or doctor's degree in physics, medical physics, other physical
			 sciences, engineering, or applied mathematics from an accredited college or
			 university; and
(C) Has
			 successfully completed one year of full-time training in medical physics and an
			 additional year of full-time work experience under the supervision of a medical
			 physicist; and
(D) Has documented
			 training in:
(i) The creation, modification,
			 and completion of written directives;
(ii) Procedures for administrations requiring
			 a written directive; and
(iii)
			 Performing the calibration measurements of brachytherapy sources as detailed in
			 OAR 333-116-0445.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0450 - Brachytherapy Sources Inventory

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 licensee must maintain accountability at all times for all brachytherapy
			 sources in storage or use.
(2) As
			 soon as possible after removing sources from a patient or human research
			 subject, the licensee must return brachytherapy sources to a secure storage
			 area.
(3) A licensee must retain
			 the records required in sections (1) and (2) of this rule in accordance with
			 OAR 333-100-0057.
(a) For temporary implants,
			 the record must include:
(A) The number and
			 activity of sources removed from storage, the time and date they were removed
			 from storage, the name of the individual who removed them from storage, and the
			 location of use; and
(B) The number
			 and activity of sources returned to storage, the time and date they were
			 returned to storage, and the name of the individual who returned them to
			 storage.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0460 - Release of Patients Treated with Temporary Implant

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Immediately after removing the last
			 temporary implant source from a patient or human research subject, the licensee
			 must make a radiation survey of the patient or human research subject with an
			 appropriate radiation detection survey instrument to confirm that all sources
			 have been removed. The licensee must not release from confinement for medical
			 care a patient or human research subject treated by temporary implant until all
			 sources have been removed.
(2) A
			 licensee must retain a record of patient surveys which demonstrate compliance
			 with section (1) of this rule in accordance with OAR 333-100-0057. Each record
			 must include the date of the survey, the name of the patient, the dose rate
			 from the patient expressed as Sv (mrem) per hour and measured within one meter
			 from the patient and the initials of the individual who made the
			 survey.
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 333-116-0470 - Possession of Survey Instruments

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee authorized to use radioactive material for implant
				therapy must have in its possession a portable radiation detection survey
				instrument capable of detecting dose rates over the range 1 uSv (0.1 mrem) per
				hour to 1 mSv (100 mRem)per hour and a portable radiation measurement survey
				instrument capable of measuring dose rates over the range 10 uSv (1 mrem) per
				hour to 10 mSv (1000 mrem) per hour. The instruments must be operable and
				calibrated in accordance with OAR 333-116-0170.
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 333-116-0475 - Therapy Related Computer Systems

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The licensee shall perform acceptance
			 testing on the treatment planning system of therapy-related computer systems in
			 accordance with published protocols accepted by nationally recognized bodies.
			 At a minimum, the acceptance testing must include, as applicable, verification
			 of:
(a) The source-specific input parameters
			 required by the dose calculation algorithm;
(b) The accuracy of dose, dwell time, and
			 treatment time calculations at representative points;
(c) The accuracy of isodose plots and graphic
			 displays; and
(d) The accuracy of
			 the software used to determine sealed source positions from radiographic
			 images.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0480 - Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must only use sealed sources:
(a) Approved and as provided for in the
			 Sealed Source and Device Registry in photon emitting remote afterloader units,
			 teletherapy units, or gamma stereotactic radiosurgery units for therapeutic
			 medical uses; or
(b) In research
			 involving photon-emitting remote afterloader units, teletherapy units, or gamma
			 stereotactic radiosurgery units in accordance with an active Investigational
			 Device Exemption (IDE) application accepted by the U.S. Food and Drug
			 Administration provided the requirements of OAR 333-116-0140  are
			 met.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0485 - Other Medical Uses of Byproduct Material or Radiation from Byproduct Material

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee shall use byproduct or a radiation source not
				specifically addressed in OAR 333-116-0300  through 333-116-0480  in accordance
				with the manufacturer's radiation safety and operating
				instructions.
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 333-116-0490 - Installation, Maintenance, Adjustment and Repair

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Only a person specifically licensed by
			 the Nuclear Regulatory Commission or an Agreement State must install, maintain,
			 adjust, or repair a remote afterloader unit, teletherapy unit, or gamma
			 stereotactic radiosurgery unit that involves work on the source(s) shielding,
			 the source(s) driving unit, or other electronic or mechanical component that
			 could expose the source(s), reduce the shielding around the source(s), or
			 compromise the radiation safety of the unit or the source(s).
(2) Except for low dose-rate remote
			 afterloader units, only a person specifically licensed by the Nuclear
			 Regulatory Commission or an Agreement State must install, replace, relocate, or
			 remove a sealed source or source contained in other remote afterloader units,
			 teletherapy units, or gamma stereotactic radiosurgery units.
(3) For a low dose-rate remote afterloader
			 unit, only a person specifically licensed by the Nuclear Regulatory Commission
			 or an Agreement State or an authorized medical physicist must install, replace,
			 relocate, or remove a sealed source(s) contained in the unit.
(4) A licensee must retain a record of the
			 installation, maintenance, adjustment, and repair of remote afterloader units,
			 teletherapy units, and gamma stereotactic radiosurgery units in accordance with
			 OAR 333-100-0057. For each installation, maintenance, adjustment and repair,
			 the record must include the date, description of the service, and name(s) of
			 the individual(s) who performed the work.
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 333-116-0495 - Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must:
(a) Secure the unit, the console, the console
			 keys, and the treatment room when not in use or unattended;
(b) 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 the source(s);
(c) Prevent dual operation of more than one
			 radiation producing device in a treatment room if applicable; and
(d) Develop, implement, and maintain written
			 procedures for responding to an abnormal situation when the operator is unable
			 to place the source(s) 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 must 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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0500 - Amendment

Current through Register Vol. 63, No. 7, July 1, 2024
In addition to the requirements specified in OAR 333-116-0040,
				a licensee must apply for and must receive a license amendment before:
(1) Making any change in the treatment room
			 shielding;
(2) Making any change in
			 the location of the teletherapy unit within the treatment room;
(3) Using the teletherapy unit in a manner
			 that could result in increased radiation levels in areas outside the
			 teletherapy treatment room;
(4)
			 Relocating the teletherapy unit; or
(5) Allowing an individual not listed on the
			 licensee's license to perform the duties of the teletherapy
			 physicist.
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 333-116-0525 - Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must control access to the
			 treatment room by a door at each entrance.
(2) A licensee must equip each entrance to
			 the treatment room with an electrical interlock system that will:
(a) Prevent the operator from initiating the
			 treatment cycle unless each treatment room entrance door is closed;
(b) Cause the source(s) to be shielded when
			 an entrance door is opened; and
(c)
			 Prevent the source(s) 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.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0530 - Possession of Survey Instrument

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee authorized to use radioactive material in a
				teletherapy therapy unit must have in its possession either both a portable
				radiation detection survey instrument capable of detecting dose rates over the
				range one Sv (0.1 mrem) per hour to 100 mrem (one mSv) per hour and a portable
				radiation measurement survey instrument capable of measuring dose rates over
				the range ten Sv (1 mrem) per hour to ten mSv (1000 mrem) per hour. The
				instruments must be operable and calibrated in accordance with OAR
				333-116-0170.
Statutory/Other Authority: ORS
				  453.635
Statutes/Other Implemented: ORS
				  453.605 -
				  453.807