reglab/statecodes huggingface dataset:
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0205 - Operating and Emergency Procedures

Current through Register Vol. 63, No. 7, July 1, 2024
The licensee's or registrant's operating and emergency
				procedures must include instructions in at least the following:
(1) Handling and use of sources of radiation
			 to be employed so that:
(a) No individual is
			 likely to be exposed to radiation doses in excess of the standards established
			 in division 120 of these rules; and
(b) Use of sealed sources in wells without
			 surface casing for protecting fresh water aquifers, if appropriate.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0210 - Requirements for Personnel Safety: Personnel Monitoring

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The licensee must not permit an
			 individual to act as a logging supervisor or logging assistant unless that
			 person wears a personnel dosimeter at all times during the handling of licensed
			 radioactive materials. Each personnel dosimeter must be assigned to and worn by
			 only one individual. Film badges must be replaced at least monthly and other
			 personnel dosimeters replaced at least quarterly. After replacement, each
			 personnel dosimeter must be promptly processed.
(2) The licensee must provide bioassay
			 services to individuals using licensed materials in subsurface tracer studies
			 if required by the license.
(3)
			 Personnel monitoring records must be maintained in accordance with OAR
			 333-100-0057  and for inspection until the Authority authorizes
			 disposition.
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 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0301 - Security

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A logging
			 supervisor must be physically present at a temporary jobsite whenever licensed
			 materials are being handled or are not stored and locked in a vehicle or
			 storage place. The logging supervisor may leave the jobsite in order to obtain
			 assistance if a source becomes lodged in a well.
(2) During well logging, except when
			 radiation sources are below ground or in shipping or storage containers, the
			 logging supervisor or other individual designated by the logging supervisor
			 must maintain direct surveillance of the operation to prevent unauthorized
			 entry into a restricted area, as defined in
			 333-100-0005.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0305 - Handling Tools

Current through Register Vol. 63, No. 7, July 1, 2024
The licensee must provide and require the use of tools that
				will assure remote handling of sealed sources other than low activity
				calibration sources.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0310 - Subsurface Tracer Studies

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Protective gloves and other appropriate protective clothing and equipment must
			 be used by all personnel handling radioactive tracer material. Precautions must
			 be taken to avoid ingestion or inhalation of radioactive materials.
(2) No licensee shall cause the injection of
			 radioactive material into potable aquifers without prior written authorization
			 from the Authority.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0315 - Particle Accelerators

Current through Register Vol. 63, No. 7, July 1, 2024
No licensee or registrant shall permit above-ground testing of
				particle accelerators, designed for use in well-logging, which results in the
				production of radiation, except in areas or facilities so controlled or
				shielded that the requirements of OAR
				333-120-0100 and 333-105-0030 as applicable, are met.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0325 - Energy Compensation Source

Current through Register Vol. 63, No. 7, July 1, 2024
The licensee may use an Energy Compensation Source (ECS) which
				is contained within a logging tool, or other tool components, only if the ECS
				contains quantities of licensed material not exceeding 3.7 MBq (100
				microcuries).
(1) For well logging
			 applications with a surface casing for protecting fresh water aquifers, use of
			 the ECS is only subject to the requirements of
			 333-113-0120,
			 333-113-0125  and
			 333-113-0130.
(2) For well logging applications without a
			 surface casing for protecting fresh water aquifers, use of the ECS is only
			 subject to the requirements of
			 333-113-0010,
			 333-113-0120,
			 333-113-0125,
			 333-113-0130,
			 333-113-0150  and
			 333-113-0501.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0335 - Tritium Neutron Generator Target Source

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Use of a tritium neutron generator target
			 source, containing quantities not exceeding 1,110 GBq (30 curies) and in a well
			 with a surface casing to protect fresh water aquifers, is subject to the
			 requirements of this division except
			 333-113-0010,
			 333-113-0135  and
			 333-113-0501.
(2) Use of a tritium neutron generator target
			 source, containing quantities exceeding 1,110 GBq (30 curies) or in a well
			 without a surface casing to protect fresh water aquifers, is subject to the
			 requirements of this division except
			 333-113-0135.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0401 - Radiation Surveys

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Radiation
			 surveys must be made and recorded for each area where radioactive materials are
			 used and stored.
(2) Radiation
			 surveys must be made and recorded before transport for the radiation levels in
			 all occupied positions and on the exterior of each vehicle used to transport
			 radioactive material. Such surveys must include each source of radiation or
			 combination of sources to be transported in the vehicle.
(3) If the sealed source assembly is removed
			 from the logging tool before departing the jobsites, the logging tool detector
			 must be energized, or a survey meter used, to assure that the logging tool is
			 free of contamination.
(4)
			 Radiation surveys must be made and recorded at the jobsite or well-head for
			 each tracer operation, except those using hydrogen-3, carbon-14 and sulfur-35.
			 These surveys must include measurements of radiation levels before and after
			 the operation.
(5) If the licensee
			 has reason to believe that, as a result of any operation involving a sealed
			 source, the encapsulation of the sealed source could be damaged by the
			 operation, the licensee must conduct a radiation survey, including a
			 contamination survey, during and after the operation.
(6) The licensee must make a radiation survey
			 at the temporary jobsite before and after each subsurface tracer study to
			 confirm the absence of contamination.
(7) Records required pursuant to sections (1)
			 through (6) of this rule must include the dates, the identification of
			 individual(s) making the survey, the identification of survey instruments(s)
			 used and an exact description of the location of the survey. Records of these
			 surveys must be maintained in accordance with
			 333-100-0057.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0403 - Radioactive Contamination Control

Current through Register Vol. 63, No. 7, July 1, 2024
(1) If the licensee detects evidence that a
			 sealed source has ruptured or licensed materials have caused contamination, the
			 licensee must initiate immediately the emergency procedures required by
			 333-113-0205.
(2) If contamination results from the use of
			 licensed material in well logging, the licensee must decontaminate all work
			 areas, equipment, and unrestricted areas.
(3) During efforts to recover a sealed source
			 lodged in the well, the licensee must continuously monitor, with an appropriate
			 radiation detection instrument or a logging tool with a radiation detector, the
			 circulating fluids from the well, if any, to check for contamination resulting
			 from damage to the sealed source.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0405 - Documents and Records Required at Field Stations

Current through Register Vol. 63, No. 7, July 1, 2024
Each licensee or registrant must maintain, for inspection by
				the Authority, the following documents and records for the specific devices and
				sources used at the field station:
(1)
			 Appropriate license, certificate of registration or equivalent
			 document(s);
(2) Operating and
			 emergency procedures;
(3)
			 Applicable rules;
(4) Records of
			 the latest survey instrument calibrations pursuant to OAR
			 333-113-0115;
(5) Records of the latest leak test results
			 pursuant to OAR
			 333-113-0120;
(6) Records of quarterly inventories required
			 pursuant to OAR
			 333-113-0125;
(7) Utilization records required pursuant to
			 OAR
			 333-113-0130;
(8) Records of inspection and maintenance
			 required pursuant to OAR
			 333-113-0145;
(9) Survey records required pursuant to OAR
			 333-113-0401;
			 and
(10) Training records required
			 pursuant to OAR
			 333-113-0201.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0410 - Documents and Records Required at Temporary Jobsites

Current through Register Vol. 63, No. 7, July 1, 2024
Each licensee or registrant conducting operations at a
				temporary jobsite must have the following documents and records available at
				that site for inspection by the Authority:
(1) Operating and emergency
			 procedures;
(2) Survey records
			 required pursuant to OAR
			 333-113-0401  for the period of operation at the site;
(3) Evidence of current calibration for the
			 radiation survey instruments in use at the site;
(4) When operating in the state under
			 reciprocity, a copy of the appropriate license, certificate of registration or
			 equivalent document(s);
(5)
			 Shipping papers for the transportation of radioactive material;
(6) Copy of the license;
(7) Current leak test; and
(8) Validation certificate.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.807
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 113 - RADIATION SAFETY REQUIREMENTS FOR WIRELINE SERVICE OPERATIONS AND SUB-SURFACE TRACER STUDIES › Section 333-113-0501 - Notification of Incidents, Abandonment and Lost Sources

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Notification of incidents and sources
			 lost in other than well logging operations must be made in accordance with
			 appropriate provisions of division 120 of these rules.
(2) Whenever a sealed source or device
			 containing radioactive material is lodged downhole the licensee must:
(a) Monitor at the surface for the presence
			 of radioactive contamination with a radiation survey instrument or logging tool
			 during logging tool recovery operations;
(b) If the environment, any equipment, or
			 personnel are contaminated with licensed material, they must be decontaminated
			 before release from the site or release for unrestricted use; and
(c) Notify the Authority immediately by
			 telephone and subsequently, within 30 days, by confirmatory letter if the
			 licensee knows or has reason to believe that a sealed source has been ruptured.
			 This letter must identify the well or other location, describe the magnitude
			 and extent of the escape of radioactive material, assess the consequences of
			 the rupture and explain efforts planned or being taken to mitigate these
			 consequences.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 114 - TRAINING FOR EMERGENCY RESPONSE TO RADIOACTIVE MATERIAL INCIDENTS › Section 333-114-0001 - General

Current through Register Vol. 63, No. 7, July 1, 2024
The purpose of these rules is to insure that the response to a
				radioactive material accident be both swift and appropriate to minimize damage
				to any person, property, domestic animals, wildlife or the
				environment.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.755
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 114 - TRAINING FOR EMERGENCY RESPONSE TO RADIOACTIVE MATERIAL INCIDENTS › Section 333-114-0005 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
For the purposes of ORS 469.611 and these rules:
(1) "Certified Training" means radiological
			 safety training in which performance has been demonstrated through the
			 satisfactory completion of an authorized exam.
(2) "Authorized Exam" means an exam, either
			 written or oral; or a performance demonstration that has been authorized by the
			 Authority as adequate to demonstrate the competency of a particular skill
			 level. Whenever possible authorized exams will be developed consistent with the
			 programs and policies with the Oregon Department of Energy, Oregon Department
			 of Environmental Quality, State Fire Accreditation Board, and the Board on
			 Police Standards and Training.
(3)
			 "Skill Level" means:
(a) "Radiological Monitor
			 (RM)" means person who has demonstrated competency through the satisfactory
			 completion of an authorized (RM) exam and therefore is qualified to be a member
			 of a radiological response team. An RM must be recertified every four
			 years;
(b) "Regional Radiological
			 Technical Assistant (RRTA)" means a person who has demonstrated competency
			 through the satisfactory completion of an authorized RRTA exam. An RRTA is also
			 qualified to instruct employees of emergency services agencies in the proper
			 response to transportation accident involving radioactive materials. An RRTA
			 must be recertified every two years;
(c) "Radiological Officer (RO)" means a
			 person who has demonstrated competency through the satisfactory completion of
			 an authorized RO exam and therefore is qualified to advise a community before
			 during and after a nuclear attack and/or incident. A RO must be recertified
			 every three years;
(d)
			 "Radiological Monitor Instructor (RMI)" means a person who has demonstrated
			 competency through the satisfactory completion of an authorized RMI exam and
			 therefore is qualified to be an instructor of "Radiological Monitoring". An RMI
			 must be recertified every three years.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 114 - TRAINING FOR EMERGENCY RESPONSE TO RADIOACTIVE MATERIAL INCIDENTS › Section 333-114-0010 - Training

Current through Register Vol. 63, No. 7, July 1, 2024
In order to receive certification in radiological safety
				training from the Oregon State Public Health Division a person must
				satisfactorily complete the authorized exam administered by an authorized
				Public Health Division representative. A county will receive certification of
				training after it has qualified two Regional Radiological Technical Assistants,
				and completed a radioactive/hazardous materials emergency response exercise as
				defined in these rules. An "emergency services agency", as defined in ORS
				401.025, will receive certification of training after it has qualified one
				Radiological Monitor per duty shift.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.755
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 114 - TRAINING FOR EMERGENCY RESPONSE TO RADIOACTIVE MATERIAL INCIDENTS › Section 333-114-0015 - Radioactive/Hazardous Materials Emergency Response Exercise

Current through Register Vol. 63, No. 7, July 1, 2024
This is defined as a practice response to an accident involving
				radioactive or other hazardous materials. The exercise should involve all
				organizations that would normally be present in a real incident, including but
				not limited to: Firefighting, law enforcement, prehospital and hospital
				emergency medical care, highway maintenance and state technical support
				agencies.
Stat. Auth.: ORS 453.635
Stats. Implemented: ORS 453.605 -
				  453.755
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0010 - Purpose and Scope

Current through Register Vol. 63, No. 7, July 1, 2024
This division contains the requirements and provisions for the
				production, preparation, compounding and use of radionuclides in the healing
				arts and for issuance of licenses authorizing the medical use of this material
				in Oregon. These requirements and provisions provide for the radiation safety
				of workers, the general public, patients, and human research subjects. The
				requirements and provisions of this division are in addition to, and not in
				substitution for, others in these rules. The requirements and provisions of
				these rules apply to applicants and licensees subject to this division unless
				specifically exempted.
Stat. Auth.: ORS 453.635
Stats. 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 333-116-0020 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
As used in this division, the following definitions
				apply:
(1) "Address of use" means the
			 building or buildings identified on the license as the location(s) where
			 radioactive material may be received, used, or stored.
(2) "Area of use" means location(s) at the
			 address of use set aside for the purpose of receiving, using or storing
			 radioactive material.
(3)
			 "Associate Radiation Safety Officer" means an individual who:
(a) Meets the requirements in OAR
			 333-116-0640  and 333-116-0760; and
(b) Is currently identified as an Associate
			 Radiation Safety Officer for the types of use of byproduct materials for which
			 the individual has been assigned duties and tasks by the Radiation Safety
			 Officer on:
(A) A specific medical use license
			 issued by the Authority, U.S. Nuclear Regulatory Commission, or an Agreement
			 State; or
(B) A medical use permit
			 issued by the U.S. Nuclear Regulatory Commission master material
			 licensee.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0025 - FDA, Other Federal, and State Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
Nothing in this part relieves the licensee from complying with
				applicable FDA, other Federal, and State requirements governing
				radiopharmaceutical drugs or devices.
Stat. Auth.: ORS 453.635
Stats. 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 333-116-0027 - Implementation

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must
			 implement the provisions in division 333-116 no later June 15, 2006.
(2) When a requirement in division 333-116
			 differs from the requirement in an existing license condition, the more
			 restrictive requirement must govern until there is a license amendment or
			 license renewal.
(3) Any existing
			 license condition, not affected by a requirement in division 333-116, remains
			 in effect until the license is amended or renewed.
(4) If a license condition exempted a
			 licensee from a provision of division 333-116 on June 15, 2006, it will
			 continue to exempt a licensee from the corresponding provision in division
			 333-116.
(5) If a license condition
			 cites provisions in division 333-116 that will be deleted on June 15, 2006,
			 then the license condition remains in effect until the license is amended or
			 renewed to modify or remove the condition.
(6) Licensees must continue to comply with
			 any license condition that requires it to implement procedures required by OAR
			 333-116-0525,
			 333-116-0580,
			 333-116-0583,
			 and
			 333-116-0587  until there is a license amendment or renewal that modifies the license
			 condition.
Stat. Auth.: ORS 453.635
Stats. 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 333-116-0030 - License Required

Current through Register Vol. 63, No. 7, July 1, 2024
(1) No person
			 shall manufacture, produce, acquire, receive, possess, use or transfer
			 radioactive material for medical use except in accordance with a specific or
			 general license issued pursuant to this division or as otherwise provided in
			 this division.
(2) Unless
			 prohibited by license condition, a specific license is not needed for an
			 individual to:
(a) Receive, possess, use or
			 transfer radioactive material in accordance with the rules in this division
			 under the supervision of an authorized user as provided in OAR
			 333-116-0100;
			 or
(b) Prepare unsealed byproduct
			 material for medical use in accordance with the rules in this division under
			 the supervision of an authorized nuclear pharmacist or authorized user as
			 provided in OAR
			 333-116-0100.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0035 - Application for License, Amendment, or Renewal

Current through Register Vol. 63, No. 7, July 1, 2024
(1) An application must be signed by the
			 management of the facility.
(2) An
			 application for a license for medical use of radioactive material as described
			 in OAR
			 333-116-0300,
			 333-116-0320,
			 333-116-0360,
			 333-116-0400,
			 333-116-0420  and
			 333-116-0480  and medical use of byproduct material as described in OAR
			 333-116-0485  must be made by filing a "Radioactive Materials License Application: Medical."
			 A request for a license amendment or renewal may be submitted in letter
			 format.
(3) Licensing of remote
			 afterloaders as described in OAR
			 333-116-0480  requires a separate "Radioactive Materials License Application: The Medical
			 License application must be completed and submitted to the Authority. A request
			 for a license amendment or renewal may be submitted in letter format.
(4) An application for a license for medical
			 use of radioactive material as described in OAR
			 333-116-0800,
			 Licensing and Registration of Positron Emission Tomography (PET) Facilities,
			 must be made by filing a "Radioactive Materials License Application: Medical."
(a) In addition to the information required
			 in the "Radioactive Materials License Application: Medical," the application
			 must also include information regarding any radiation safety aspects of the
			 medical use of the radioactive material that is not addressed in this division,
			 as well as any specific information necessary for:
(A) Radiation safety precautions and
			 instructions;
(B) Training and
			 experience of proposed users;
(C)
			 Methodology for measurement of dosages or doses to be administered to patients
			 or human research subjects; and
(D)
			 Calibration, maintenance, and repair of equipment necessary for radiation
			 safety.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0040 - License Amendments

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee must apply for and must receive a license
				amendment:
(1) Before receiving or
			 using radioactive material for a method or type of medical use not permitted by
			 the license issued under this division;
(2) Before permitting anyone to work as an
			 authorized user, authorized nuclear pharmacist, ophthalmic physicist, or
			 authorized medical physicist under the license except:
(a) For an authorized user; an individual who
			 meets the requirements in OAR 333-116-0760, 333-116-0660, 333-116-0670,
			 333-116-0680, 333-116-0683, 333-116-0687, 333-116-0690, 333-116-0710  and
			 333-116-0720.
(b) For an authorized
			 nuclear pharmacist; an individual who meets the requirements in OAR
			 333-116-0910  and 333-116-0760.
(c)
			 For an authorized medical physicist; an individual who meets the requirements
			 in OAR 333-116-0905  and 333-116-0760.
(d) An individual identified as an authorized
			 user, authorized nuclear pharmacist, ophthalmic physicist or an authorized
			 medical physicist on a Nuclear Regulatory Commission or Agreement State license
			 that authorizes the use of radioactive material in medical use or in the
			 practice of nuclear pharmacy.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0045 - Provisions for Research Involving Human Subjects

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee may conduct research involving
			 human research subjects only if it uses the byproduct materials specified in,
			 and for the uses authorized by its license.
(2) If the research is conducted, funded,
			 supported, or regulated by a federal agency that has implemented the Federal
			 Policy for the Protection of Human Subjects (Federal Policy), the licensee
			 shall, before conducting research:
(a) Obtain
			 review and approval of the research from an Institutional Review Board, as
			 defined and described in the Federal Policy; and
(b) Obtain "informed consent," as defined and
			 described in the Federal Policy, from the human research subject.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0050 - Notifications

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee
			 shall provide the Authority, no later than 30 days after the date that the
			 licensee permits an individual to work under the provisions of OAR 333-116-0040  as an authorized user, authorized medical physicist, ophthalmic physicist, or
			 authorized nuclear pharmacist:
(a) A copy of
			 the board certification and, as appropriate, verification of completion of:
(A) Training for the authorized medical
			 physicist under OAR 333-116-0905;
(B) Any additional case experience required
			 in OAR 333-116-0680  for an authorized user under OAR 333-116-0360; or
(C) Device specific training in OAR
			 333-116-0720  for the authorized user under OAR 333-116-0480; or
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0055 - Exemptions Regarding Type A Specific Licenses of Broad Scope

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee possessing a Type A specific license of broad scope
				for medical use is exempt from:
(1)
			 The provisions of OAR 333-116-0040(2);
(2) The provisions of OAR 333-116-0040(7)
 
			 regarding additions to or changes in areas of use only at the addresses
			 specified in the license;
(3) The
			 provisions of OAR 333-116-0050(1);
(4) The provisions of OAR 333-116-0050(2)(a)
 
			 for an authorized user, ophthalmic physicist or authorized nuclear pharmacist,
			 and
(5) The provisions of OAR
			 333-116-0140(1).
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 333-116-0057 - License Issuance

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The
			 Authority must issue a license for the medical use of radioactive material if:
(a) The applicant has filed a "Radioactive
			 Materials License Application: Medical" in accordance with the instructions in
			 OAR
			 333-116-0035;
(b) The applicant has paid any applicable fee
			 as provided in division 103 of these rules;
(c) The Authority finds the applicant
			 equipped and committed to observe the safety standards established by the
			 Authority in these rules for the protection of the public health and safety;
			 and
(d) The applicant meets the
			 requirements of division 102 of these rules.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0059 - Specific Exemptions

Current through Register Vol. 63, No. 7, July 1, 2024
The Authority may, upon application of any interested person or
				upon its own initiative, grant such exemptions from the regulations in this
				division as it determines are authorized by law and will not endanger life or
				property or the common defense and security and are otherwise in the public
				interest.
Stat. Auth.: ORS 453.635
Stats. 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 333-116-0090 - Authority and Responsibilities for the Radiation Protection Program

Current through Register Vol. 63, No. 7, July 1, 2024
(1) In addition to
			 the radiation protection program requirements of OAR 333-120-0020, a licensee's
			 management must approve in writing:
(a)
			 Requests for a license application, renewal, or amendment before submittal to
			 the Authority;
(b) Any individual
			 before allowing that individual to work as an authorized user, authorized
			 nuclear pharmacist, or authorized medical physicist; and
(c) Radiation protection program changes that
			 do not require a license amendment and are permitted under OAR
			 333-116-0123.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0100 - Supervision

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee who
			 permits the receipt, possession, use or transfer of radioactive material by an
			 individual under the supervision of an authorized user as allowed by OAR
			 333-116-0030  must:
(a) In addition to the requirements in
			 OAR
			 333-111-0010,
			 instruct the supervised individual in the licensee's written radiation
			 protection procedures, written directive procedures, the licensee's written
			 quality management program, the Oregon Rules for the Control of Radiation and
			 the license conditions appropriate to that individual's use of radioactive
			 material; and
(b) Require the
			 supervised individual to follow the instructions of the supervising authorized
			 user for medical uses of radioactive material, written radiation protection
			 procedures, written directive procedures, regulations of division 333-116, and
			 license conditions with respect to the medical use of radioactive
			 material.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0105 - Written Directives

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 written directive must be prepared, dated and signed by an authorized user
			 prior to administration of I-131 sodium iodide greater than 1.11 Megabecquerels
			 (MBq) (30 microcuries (uCi)), or any therapeutic dosage of a
			 radiopharmaceutical, or any therapeutic dose of radiation from radioactive
			 material.
(a) If, because of the emergent
			 nature of the patient's condition, a delay in order to provide a written
			 directive would jeopardize the patient's health, an oral directive is
			 acceptable.
(b) The information
			 contained in the oral directive must be documented as soon as possible in
			 writing in the patient's record.
(c) A written directive must be prepared
			 within 48 hours of the oral directive.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0107 - Procedures for Administrations Requiring a Written Directive

Current through Register Vol. 63, No. 7, July 1, 2024
(1) For any
			 administration requiring a written directive, the licensee must develop,
			 implement, and maintain written procedures to provide high confidence that:
(a) The patient's or human research subject's
			 identity is verified before each administration; and
(b) Each administration is in accordance with
			 the written directive.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0110 - Visiting Authorized User

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 licensee may permit any visiting authorized user to use licensed material for
			 medical use under the terms of the licensee's license for 60 days each year if:
(a) The visiting authorized user has the
			 prior written permission of the licensee's management and, if the use occurs on
			 behalf of an institution, the institution's Radiation Safety
			 Committee;
(b) The licensee has a
			 copy of the Authority license or a license issued by the U.S. Nuclear
			 Regulatory Commission, an Agreement State or a Licensing State, that identifies
			 the visiting authorized user by name as an authorized user for medical use;
			 and
(c) Only those procedures for
			 which the visiting authorized user is specifically authorized by the Authority
			 license are performed by that individual.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0120 - Mobile Nuclear Medicine Service Administrative Requirements

Current through Register Vol. 63, No. 7, July 1, 2024
(1) The Authority
			 will only license mobile nuclear medicine services in accordance with OAR
			 333-116-0300,
			 333-116-0320,
			 and
			 333-116-0400  of this division and OAR
			 333-102-0130.
(2) Mobile nuclear medicine service licensees
			 must:
(a) Obtain a letter signed by the
			 management of each client for which services are rendered that authorizes use
			 of licensed radioactive material at the client's address of use. This letter
			 must clearly delineate the authority and responsibility of both the client and
			 the mobile medical service. If the client is licensed, the letter must document
			 procedures for notification, receipt, storage and documentation of transfer of
			 radioactive material delivered to the client's address for use by the mobile
			 medical service. The mobile nuclear medicine service licensee must retain the
			 letter for three years after the last provision of service.
(b) Check instruments used to measure the
			 activity of unsealed byproduct material for proper function before use at each
			 client's address or on each day of use, whichever is more frequent. At a
			 minimum, the check for proper function must include a constancy
			 check;
(c) Check survey instruments
			 for proper operation with a dedicated check source before use at each client's
			 address; and
(d) Survey all areas
			 of use to ensure compliance with the requirements in division 333-120 before
			 leaving a client's address.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0123 - Radiation Safety Program Changes

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee may revise its radiation
			 protection program without Authority approval if:
(a) The revision does not require a license
			 amendment under OAR
			 333-116-0040;
(b) The revision is in compliance with the
			 regulations and the license;
(c)
			 The revision has been reviewed and approved by the Radiation Safety Officer,
			 licensee management and, if applicable, the Radiation Safety Committee;
			 and
(d) The affected individuals
			 are instructed on the revised program before the changes are
			 implemented.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0125 - Quality Management Program

Current through Register Vol. 63, No. 7, July 1, 2024
(1)
			 Each applicant or licensee under this division, as applicable, must establish
			 and maintain a written quality management program to provide high confidence
			 that radioactive material or radiation from radioactive material will be
			 administered as directed by the authorized user. The quality management program
			 must include written policies and procedures to meet the following specific
			 objectives:
(a) That, prior to
			 administration, a written directive (see NOTE below) is prepared for:
(A) Any teletherapy radiation dose;
(B) Any gamma stereotactic radiosurgery
			 radiation dose;
(C) Any
			 brachytherapy radiation dose;
(D)
			 Any administration of quantities greater than 1.11 megabecquerels (30 uCi) of
			 either sodium iodide I-125 or I-131; or
(E) Any therapeutic administration of a
			 radiopharmaceutical, other than sodium iodide I-125 or I-131;
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0130 - Repealed

Current through Register Vol. 63, No. 7, July 1, 2024
Stat. Auth.: ORS
				  453.635
Stats. 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 333-116-0140 - Suppliers

Current through Register Vol. 63, No. 7, July 1, 2024
A licensee may use for medical use only:
(1) Radioactive material manufactured,
			 produced, labeled, prepared, compounded, packaged and distributed in accordance
			 with a license issued pursuant to these rules or the equivalent rules of
			 another Agreement State, a Licensing State or the U.S. Nuclear Regulatory
			 Commission.
(2) Reagent kits,
			 radiopharmaceuticals, or radiobiologics that have been manufactured, labeled,
			 packaged and distributed in accordance with an approval issued by the U.S.
			 Department of Health and Human Services, Food and Drug
			 Administration.
(3)
			 Radiopharmaceuticals compounded from a prescription in accordance with the
			 regulations of the state Board of Pharmacy.
(4) Teletherapy and brachytherapy sources
			 manufactured and distributed in accordance with a license issued pursuant to
			 these regulations, or the equivalent regulations of another Agreement State, a
			 Licensing State, or the U.S. Nuclear Regulatory Commission.
(5) Sealed sources or devices
			 non-commercially transferred from a  10 CFR, Part 35  licensee or Agreement State
			 medical licensee.
(6) Sealed
			 sources or devices manufactured, labeled, packaged, and distributed in
			 accordance with a license issued under chapter 333, division 102 or equivalent
			 requirements of the U.S. Nuclear Regulatory Commission or an Agreement State.
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 333-116-0150 - Quality Control of Imaging Equipment

Current through Register Vol. 63, No. 7, July 1, 2024
(1) Each licensee must establish written
			 quality control procedures for all diagnostic equipment used to obtain images
			 from radionuclide studies. As a minimum the quality control procedures and
			 frequencies must include quality control procedures recommended by equipment
			 manufacturers or procedures which have been approved by the Authority. The
			 licensee must conduct quality control procedures in accordance with written
			 procedures.
(2) Copies of
			 procedures and records generated from implementing these procedures must be
			 maintained 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 333-116-0160 - Possession, Use, Calibration and Check of Dose Calibrators

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A medical use
			 licensee authorized to administer either radiopharmaceuticals or unsealed
			 radioactive materials must possess a dose calibrator and use it to measure the
			 amount of activity of radionuclides prior to administration to each patient or
			 human research subject. The licensee must also develop, implement and maintain
			 written procedures for proper calibration and operation of the dose
			 calibrator.
(2) At a minimum, a
			 licensee must:
(a) Check each dose calibrator
			 for constancy and proper operation with a dedicated check source at the
			 beginning of each day of use. To satisfy the requirement of this rule, the
			 check must be done on a frequently used setting with a sealed source of not
			 less than 1.85 megabecquerels (50 uCi) of any photon-emitting radionuclide with
			 a half-life greater than 90 days. The results of this test must be within +ten
			 percent of the sources stated activity. Sources used for the daily constancy
			 test must be determined by the manufacturer to be within +five percent of the
			 stated activity and traceable to the National Institute of Standards and
			 Technology or other standards recognized as being equivalent by the National
			 Institute of Standards and Technology.
(b) Test each dose calibrator for accuracy
			 upon installation and at intervals not to exceed 12 months thereafter by
			 assaying at least two sealed sources containing different photon-emitting
			 radionuclides 1.85 megabecquerels (50 uCi) each, at least one of which has a
			 principal photon energy between 100 keV and 500 keV. All sources used to
			 satisfy the accuracy test must be determined by the manufacturer to be within
			 +five percent of the stated activity and traceable to the National Institute of
			 Standards and Technology or other standards recognized as being equivalent by
			 the National Institute of Standards and Technology;
(c) Test each dose calibrator for linearity
			 upon installation and at intervals not to exceed three months thereafter over
			 the range of use between 1.1 megabecquerels (30 microcuries) and the highest
			 dosage that will be administered; and
(d) Test each dose calibrator for geometry
			 dependence upon installation over the range of volumes and volume
			 configurations for which it will be used. The licensee must keep a record of
			 this test for the duration of the use of the dose calibrator.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0165 - Possession, Use Calibration, and Check of Instruments to Measure Dosages of Alpha- or Beta-emitting Radionuclides

Current through Register Vol. 63, No. 7, July 1, 2024
(1) For other than unit dosages, a licensee
			 must possess and use instrumentation to measure the radioactivity of alpha- or
			 beta-emitting radionuclides. A licensee must measure, by direct measurement or
			 by combination of measurements and calculations, the amount of radioactivity in
			 dosages of alpha- or beta-emitting radionuclides prior to administration to
			 each patient or human research subject.
(2) A licensee must develop, implement, and
			 maintain written procedures for use of the instrumentation. At a minimum, a
			 licensee must:
(a) Perform tests before
			 initial use, and following repair, on each instrument for accuracy, linearity,
			 and geometry dependence, unless it is not appropriate for the use of the
			 instrument; and make adjustments when necessary;
(b) Perform accuracy annually;
(c) Perform linearity tests annually over the
			 range of medical use; and
(d) Check
			 each instrument for constancy and proper operation at the beginning of each day
			 of use.
Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 116 - USE OF RADIONUCLIDES IN THE HEALING ARTS › Section 333-116-0170 - Calibration and Check of Survey Instrument

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A licensee must ensure that the survey
			 instruments used to show compliance with OAR chapter 333, divisions 116 and 120
			 have been calibrated before first use, annually and following repair.
(2) To satisfy the requirements of section
			 (1) of this rule the licensee must:
(a)
			 Calibrate all required scale readings up to 10 millisieverts (1000 mrem) per
			 hour with a radiation source;
(b)
			 For each scale that must be calibrated, calibrate two readings separated by at
			 least 50 percent of scale reading; and
(c) Conspicuously note on the instrument the
			 date of calibration.