justicedao/ipfs_state_laws huggingface dataset:
333-106-0010 Administrative Controls (1) Registrants shall be responsible for directing the operation of the X-ray system(s) under their administrative control. The registrant or the registrant's agent shall assure that the requirements of this rule are met in the operation of the X-ray system(s). (2) An X-ray system and/or the operation of the X-ray system which does not meet the provisions of these rules shall not be operated for diagnostic or therapeutic purposes. (3) For X-ray equipment manufactured after July 31, 1974, the registrant shall assure that the equipment will remain in compliance with the Code of Federal Regulations, Title 21. Statutory/Other Authority: ORS 453.605 - 453.755 Statutes/Other Implemented: ORS 453.605 - 453.755 History: PH 14-2008, f. & cert. ef. 9-15-08 HD 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0015 General Requirements: Technique Chart A useable up-to-date chart shall be provided in the vicinity of, or correctly programmed into the diagnostic X-ray system's control panel which specifies, for all examinations performed with that system, the following information: (1)(a) Patient's anatomical size in centimeters versus technique factors to be utilized. (b) For veterinary X-rays, the patient’s anatomical size in centimeters or weight in pounds versus technique factors to be used. (2) Film-screen combination to be used. (3) Type and focal distance of the grid to be used, if any. (4) Source to image receptor distance to be used. (5) Units utilizing phototimers shall have a chart indicating cell choice, optimum kVp and density setting as well as other applicable requirements of this rule. (6) Units utilizing automatic techniques that are incorporated in the X-ray machine are considered to meet the requirements of sections (1), (2), (3) and (4) of this rule. (7) In cases where machine use is restricted to intraoral radiography, or one operator and less than three techniques, the registrant is exempt from the requirements of this rule. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, amend filed 10/09/2020, effective 10/09/2020 PH 28-2019, amend filed 12/19/2019, effective 12/19/2019 PH 24-2014, f. & cert. ef. 8-15-14 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0020 General Requirements: Written Rules and Procedures For safe operation of the registrants X-ray system the following apply when required in writing by the Authority: (1) Written safety procedures: (a) Shall be mandatory for hospitals and radiologists; (b) Shall include any equipment limitations or restrictions; (c) Shall include any restrictions of the operating technique required for the safe operation of the X-ray system. (2) Written procedures shall be available for review at any time to all individuals operating X-ray equipment. (3) The operator shall be able to demonstrate familiarity with these procedures. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.752 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0025 General Requirements: Protection of Patients and Personnel (1) Except for patients who cannot be moved out of the unprotected area, only the staff and ancillary personnel required for the medical procedure or training shall be in the unprotected area during the radiographic exposure. (2) Other than the patient being examined, all individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by 0.5 millimeter (mm) lead equivalent. (3) Staff and ancillary personnel shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 mm lead equivalent. (4) Patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 mm lead equivalent or shall be so positioned that the nearest portion of the body is at least two meters from both the tube head and the nearest edge of the image receptor. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0040 General Requirements: Patient Holding and Restraint (1) When a patient or film must be provided with auxiliary support during a radiation exposure: (a) Mechanical holding devices shall be provided and used when the technique permits. The safety rules, required by OAR 333-106-0020, shall list individual projections where holding devices cannot be used. (b) Written safety procedures, as required by OAR 333-106-0020, shall indicate the requirements for selecting a holder and the procedure the holder shall follow. (c) The human holder shall be protected, as required by OAR 333-106-0025. (2) No individual shall be used routinely to hold film or patients. (3) Occupationally exposed personnel are prohibited from holding human patients during radiographic examination. (4) The Authority may require a separate record to be maintained which would include the name of the human holder, date of the examination, number of exposures and technique factor used for the exposure(s). (5) In those cases where the patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest exposed to the useful beam shall be protected by not less than 0.5 mm lead equivalent material. (6) Holding of patients shall be permitted only when it is otherwise impossible to obtain the necessary radiograph. (7) Individuals stressing joints shall be exempt from section (3) of this rule. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 14-2008, f. & cert. ef. 9-15-08 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0050 General Requirements: Personnel Monitoring All individuals who are associated with the operation of an X-ray system are subject to the requirements of OAR 333-120-0100 and 333-120-0210. In addition: (1) When protective clothing or devices are worn on portions of the body and a personnel monitoring device(s) is required, at least one such monitoring device shall be utilized as follows: (a) When an apron is worn, the monitoring device shall be worn at the collar outside of the apron; (b) The dose to the whole body based on the maximum dose attributed to the most critical organ (which are the gonads, the blood-forming organs, head and trunk or lens of the eye), shall be recorded in the reports required by OAR 333-120-0650(3). If more than one device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body. (2) Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited. Statutory/Other Authority: ORS 453.605 - 453.755 Statutes/Other Implemented: ORS 453.605 - 453.755 History: PH 14-2008, f. & cert. ef. 9-15-08 HD 24-1994, f. & cert. ef. 9-6-94 HD 15-1994, f. & cert. ef. 5-6-94 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0060 General Requirements: Radiation Use and Safety Instructor Qualifications The training required in OAR 333-106-0055(1) must be taught by an Authority approved instructor. Approval will be based upon the following criteria. (1) A medical use and safety instructor is an individual who is currently: (a) Licensed as a Radiologic Technologist and approved as an education provider by the Oregon Board of Medical Imaging; or (b) A dental radiation use and safety instructor is an individual who is currently licensed by the Oregon Board of Dentistry as a dentist, hygienist, or has been approved by the Oregon Board of Dentistry as a radiation use and safety instructor. (2) A veterinarian radiation use and safety instructor is an individual who is currently: (a) Licensed by the Oregon Veterinary Medical Examining board as a Veterinarian, or a Veterinary Technician; or (b) Is currently licensed as a Radiologic Technologist by the Oregon Board of Medical Imaging, and has completed training specific to veterinarian radiography, including training in animal restraint, and has a minimum of two years of experience in taking veterinary radiographs. (3) On a case by case basis, if an evaluation by the Authority reveals the individual has alternative qualifications that are substantially equivalent to the qualifications listed in subsections (1)(a), (1)(b), (2)(a) or (2)(b) of this rule or is an individual who is qualified under OAR 333-106-0005(80) as a qualified expert, or OAR 333-101-0230 as a Hospital Radiology Inspector. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 172-2022, amend filed 08/11/2022, effective 08/20/2022 PH 32-2014, f. 12-22-14, cert. ef. 1-1-15
333-106-0105 General Requirements: Information and Maintenance Record and Associated Information (1) The registrant shall maintain the following information for each X-ray and automatic film processing system for inspection by the Authority: (a) Model, serial numbers and manufacturer's user manuals for all X-ray systems and automatic film processors; (b) Tube rating charts and cooling curves; (c) Records of surveys, calibrations maintenance, and modification performed on the X-ray system(s) with names of persons who perform such services; (d) A scale drawing of the room in which a stationary X-ray system is located with such drawing indicating the current use of areas adjacent to the room and an estimate of the extent of occupancy by individuals in such areas. In addition, the drawing shall include: (A) The result of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or (B) The type and thickness of materials, or lead equivalency, of each protective barrier. (e) A copy of all correspondence with this Authority regarding that X-ray system; (f) Provisions in section (1) of this rule shall pertain to X-ray systems placed in service after the effective date of these rules. (2) X-ray Log. Each facility shall maintain an X-ray log containing the patient's name, the type of examinations, and the dates the examinations were performed and the name of the X-ray operator. The X-ray log must have a cover page containing the printed names of all X-ray operators and a sample of their signed initials. The following facilities are exempt from these requirements: (a) Dental facilities that maintain patient records showing the type and date of the examination and the operator's name; (b) Industrial facilities doing industrial X-ray only; (c) Veterinary facilities; (d) Hospitals or clinics who employ only fully licensed X-ray operators; (e) Doctors' offices or clinics with only 1 X-ray operator, or 1 X-ray exam; (f) Academic, when not X-raying humans. (3) Intraoral radiography is exempt from the requirements set forth in paragraphs (1)(d)(A) and (B) of this rule. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, amend filed 10/09/2020, effective 10/09/2020 PH 14-2008, f. & cert. ef. 9-15-08 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 15-1994, f. & cert. ef. 5-6-94 HD 1-1991, f. & cert. ef. 1-8-91
333-106-0110 General Requirements: Plan Review When required by the Authority, and: (1) Prior to construction, the floor plans and equipment arrangement of all new installations, or modifications of existing installations, utilizing X-rays for diagnostic or therapeutic purposes must be submitted to the Authority for review and approval. The required information is as set out in division 120. (2) The Authority may require the applicant to utilize the services of a qualified expert to determine the shielding requirements prior to the plan review and approval. (3) The approval of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in division 120. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 12-2006, f. & cert. ef. 6-16-06 HD 15-1994, f. & cert. ef. 5-6-94 HD 1-1991, f. & cert. ef. 1-8-91
333-106-0120 General Requirements: Information on Radiation Shielding for Plan Reviews — Optional In order to provide an evaluation or technical advice on shielding requirements for a radiation installation, the following information must be submitted: (1) The plans should show, as a minimum, the following: (a) The normal location of the X-ray system’s radiation port; the port’s travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors; the location of the operator’s booth; and the location of the X-ray control panel; (b) The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned; (c) The dimensions of the room(s) concerned; (d) The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present; (e) The make and model of the X-ray equipment and the maximum technique factors; (f) The type of examination(s) or treatment(s) which will be performed with the equipment. (2) Information on the anticipated workload of the X-ray system(s). (3) If the services of a qualified expert have been utilized to determine the shielding requirements, a report, including all basic assumptions used, shall be submitted with the plans. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.775 History: HD 1-1991, f. & cert. ef. 1-8-91
333-106-0130 General Requirements: Design Requirements for an Operator’s Booth (1) Space Requirements when required by OAR 333-106-0110 of these rules: (a) The operator shall be allotted not less than 7.5 square feet (0.697 m2) of unobstructed floor space in the booth; (b) The operator's booth may be any geometric configuration with no dimension of less than 2 feet (0.61 m); (c) The space shall be allotted excluding any encumbrance by the X-ray control panel, such as overhang, cables, or other similar encroachments; (d) The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall cassette not reach the operator's station in the booth. (2) Structural Requirements: (a) The booth walls shall be permanently fixed barriers of at least seven feet (2.13 m) high; (b) When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed; (c) Shielding shall be provided to meet the requirements of division 120 of these rules. (3) X-ray Exposure Control Placement: The X-ray exposure control for the system shall be fixed within the booth and: (a) Shall be at least 40 inches (1.02 m) from any open edge of the booth wall which is nearest to the examining table; (b) Shall allow the operator to use the majority of the available viewing windows. (4) Viewing System Requirements: (a) Each booth shall have at least one viewing device which will: (A) Be so placed that the operator can view the patient during any exposure; and (B) The device shall be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door which allows access to the room cannot be seen from the booth, then that door must have an interlock controlling the exposure which will prevent the exposure if the door is not closed. (b) When the viewing system is a window, the following requirements also apply: (A) The viewing area shall be at least one square foot (0.0929 m2); (B) The design of the booth shall be such that the operator's expected position when viewing the patient and operating the X-ray system is at least 18 inches (0.457 m) from the edge of the booth; (C) The material constituting the window shall have the same lead equivalence as that required in the booth's wall in which it is mounted. (c) When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of subsection (4)(a) of this rule; (d) When the viewing system is by electronic means: (A) The camera shall be so located as to accomplish the general requirements of subsection (4)(a) of this rule; (B) There shall be an alternate viewing system as a backup for the primary system. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 12-2006, f. & cert. ef. 6-16-06 HD 15-1994, f. & cert. ef. 5-6-94 HD 1-1991, f. & cert. ef. 1-8-91
333-106-0215 Fluoroscopic X-ray Systems Requirements: Fluoroscopic Barrier Transmitted Radiation Rate Limits (1) The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed two mR (0.516 uC/kg) per hour at 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of entrance exposure rate. (2) Measuring Compliance of Barrier Transmission: (a) The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm; (b) If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop; (c) If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm; (d) Movable grids and compression devices shall be removed from the useful beam during the measurement; and (e) The attenuation block shall be positioned in the useful beam 10 centimeters from the point of measurement of entrance exposure rate and between this point and the input surface of the fluoroscopic imaging assembly. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0220 Fluoroscopic X-ray Systems Requirements: Fluoroscopic Indication of Potential and Current During fluoroscopy and cinefluorography X-ray tube potential and current shall be continuously indicated. Deviation of X-ray tube potential and current from the indicated values shall not exceed the maximum deviation stated by the manufacturer. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.625, 453.635 & 453.695 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0225 Fluoroscopic X-ray Systems Requirements: Fluoroscopic Source-to-Skin Distance The source-to-skin distance shall not be less than: (1) 38 cm on stationary fluoroscopes manufactured on or after August 1, 1974; (2) 35.5 cm on stationary fluoroscopes manufactured prior to August 1, 1974; (3) 30 cm on all mobile fluoroscopes; and (4) 20 cm for image intensified fluoroscopes used for specific surgical application. The written safety procedures must provide precautionary measures to be adhered to during the use of this device. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0230 Fluoroscopic X-ray Systems Requirements: Fluoroscopic Timer (1) Means shall be provided to present the cumulative on-time of the fluoroscopic tube. (2) The maximum cumulative time of the timing device shall not exceed five minutes without resetting. (3) A signal audible to the fluoroscopist, or the appropriate operator, shall indicate the completion of any preset cumulative on-time; or if no audible signal is provided, the exposure shall terminate. Statutory/Other Authority: ORS 453.752 - 453.775 Statutes/Other Implemented: ORS 453.752 - 453.775 History: PH 14-2008, f. & cert. ef. 9-15-08 HD 4-1985, f. & ef. 3-20-85
333-106-0235 Fluoroscopic X-ray Systems Requirements: Mobile Fluoroscopes In addition to the other requirements of OAR 333-106-0201 through 333-106-0245 of these rules, mobile fluoroscopes shall provide intensified imaging. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0240 Fluoroscopic X-ray Systems Requirements: Fluoroscopic Control of Scattered Radiation (1) Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation which originates from under the table. The attenuation required shall not be less than 0.25 mm lead equivalent. (2) Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual: (a) Is at least 120 cm from the center of the useful beam; or (b) The radiation has passed through not less than 0.25 mm lead equivalent material including, but not limited to, drapes, Bucky-slot cover, sliding or folding panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in OAR 333-106-0025; (c) Upon application to the Authority, providing adequate justification, exceptions to this section may be made in some special procedures where a sterile field will not permit the use of the normal protective barriers or where the protective barriers would interfere with the procedures. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0245 Fluoroscopic X-ray Systems Requirements: Fluoroscopic Radiation Therapy Simulation Systems Radiation therapy simulation systems shall be exempt from all the requirements of OAR 333-106-0201 through 333-106-0245 provided that: (1) Such systems are designed and used in such a manner that no individual other than the patient is in the X-ray room during periods of time when the system is producing X-rays; and (2) Systems which do not meet the requirements of OAR 333-106-0230 are provided with a means of indicating the cumulative time that an individual patient has been exposed to X-rays. Procedures shall require in such cases that the timer be reset between examinations. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85