justicedao/ipfs_state_laws huggingface dataset:
333-106-0310 Additional Requirements for Radiographic Machines: Source-to-Skin Distance (1) All mobile or portable radiographic systems shall be provided with means to limit the source-to-skin distance to equal to or greater than 30 cm. This is considered to have been met when the collimator or cone provides the required limits. (2) Any device provided to limit the SSD must be durable and securely fastened to the system. 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
333-106-0315 Additional Requirements for Radiographic Machines: Exposure Reproducibility The coefficient of variation of exposure shall not exceed 0.05 when all technique factors are held constant. This requirement shall be deemed to have been met if, when four exposures are made at identical technique factors, the value of the average exposure (E) is greater than or equal to five times the maximum exposure (Emax) minus the minimum exposure (Emin). E >5 (Emax - Emin). Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2013, f. & cert. ef. 1-29-13 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
333-106-0320 Additional Requirements for Radiographic Machines: Radiation from Capacitor Energy Storage Equipment in Standby Status Radiation emitted from the X-ray tube when the exposure switch or timer is not activated shall not exceed a rate of two milliroentgens (0.516 uC/kg) per hour at five centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open. Statutory/Other Authority: ORS 453.605 - 453.755 Statutes/Other Implemented: ORS 453.605 - 453.755 History: PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85
333-106-0345 Purpose and Scope (1) OAR 333-106-0350 through 333-106-0369 establishes requirements governing the use of computed tomography (CT) scanners in the healing arts; and (2) Applies to all registrants who use a CT scanner for the intentional exposure of humans for diagnostic imaging. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14
333-106-0355 CT Equipment Requirements (1) CT equipment requirements shall comply with the Food and Drug Administration’s 21 CFR in the following areas: (a) Information to be provided for users — Part 1020.33(c); (b) Quality Assurance — Part 1020.33(d); (c) Control and indication of conditions of operation — Part 1020.33(f); (d) Tomographic plane indication and alignment — Part 1020.33(g); (e) Beam-on and status indicators — Part 1020.33(h); (f) Scan increment accuracy — Part 1020.33(i); and (g) CT number mean and standard deviation — Part 1020.33(j). (2) CT equipment shall be maintained in compliance with the requirements of section (1) of this rule. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14 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
333-106-0360 Computed Tomography X-ray Systems: Facility Design Requirements (1) A fixed CT scanner room shall be a permanent part of the building or equipment. Portable shields shall not be used for permanent installations. (2) The CT scanner shall be situated in a protected area and is subject to design approval by a qualified expert. National Council on Radiation Protection and measurements (NCRP) Report #147 shall be used as guidance for determining adequate shielding. (3) The control panel for a fixed CT scanner shall be in a protected area. (4) Movable barriers with electrical interlocks shall not be approved in lieu of compliance with section (3) of this rule. (5) The operator of a fixed CT scanner shall be able to see and communicate with the patient from the protective area at the control panel. When an observation window is provided, it shall have a lead equivalence at least equal to that required of the control barrier in which it is installed. (6) Mobile or portable CT scanners used routinely in one location shall be considered a fixed installation and shall comply with the requirements of sections (1) through (5) of this rule. (7) CT scanners mounted in a vehicle or trailer must meet requirements of sections (1) through (5) of this rule. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.775 History: PH 24-2014, f. & cert. ef. 8-15-14 HD 1-1991, f. & cert. ef. 1-8-91
333-106-0361 Computed Tomography X-ray Systems: Radiation Protection Surveys (1) The registrant must ensure that radiation protection surveys are performed at new facilities, at existing facilities not previously surveyed, and anytime the CT scanner is replaced, moved or structural changes are made in the room. (2) In new facilities, a radiation protection survey must be completed prior to the first clinical use following installation. (3) The radiation protection survey must be performed by a qualified CT medical physicist as defined in OAR 333-106-0367 or a qualified expert as defined in OAR 333-100-0005. (4) Surveys must be conducted with an operable radiation survey instrument that has been calibrated according to manufacturer’s specifications, not to exceed 24 months. If manufacturer specifications are not available, then the radiation survey instrument shall be calibrated every 12 months. (5) The qualified CT medical physicist or qualified expert must verify that: (a) Radiation levels in restricted areas are not likely to cause personnel to receive exposures in excess of the limits specified in OAR 333-120-0100(1); and (b) Radiation levels in unrestricted areas do not exceed the limits specified in OAR 333-120-0180 and 333-120-0190. (6) The radiation protection survey record must be documented and indicate all instances where the facility, in the opinion of the qualified medical physicist or qualified expert, is in violation of applicable regulations. The survey record must also include the: (a) Date of the measurements; (b) Reason the survey is required; (c) Manufacturer's name, model number and serial number of the CT scanner; (d) Manufacturer’s name, model number and serial number of the instrument(s) used to measure radiation levels and the date last calibrated; (e) Floor plan of the areas surrounding the exam room that were surveyed; (f) Measured dose rate at several points in each area expressed in mSv/hr or mR/hr; (g) Calculated maximum level of radiation over a period of one week for each restricted and unrestricted area; (h) Signature of the individual responsible for conducting the survey; and (i) The survey must be available for review at the time of inspection. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14
333-106-0362 Computed Tomography X-ray Systems: Operating Procedures and Conditions of Operation (1) Within six months following the effective date of these rules, the CT facility shall establish default scanning protocols in consultation with a qualified CT medical physicist. (2) Default scanning protocols shall be password protected or a written policy shall be in place that prohibits anyone from changing protocols without documented approval from the CT medical director, lead CT technologist or supervising CT radiologist. (a) Each facility shall establish a policy to review all of their default CT protocols at least annually to ensure they are correct and are the intended protocols. (b) Written and signed documentation of this annual review shall be kept and made available for inspection for each CT unit at the facility. (3) The CT operator shall ensure all technique factors and dose indices are appropriate for the protocol being used and the patient being imaged. This may be accomplished by reviewing dose indicator devices if available or dose indices such as the technique factors. (4) The facility shall establish a written policy for retaking CT exams on patients. (5) Staff shall not be required by the licensee or registrant to hold patients during CT examinations. (6) When a patient must be held in position for a CT procedure, mechanical supporting or restraining devices shall be used unless contraindicated. If the patient must be held by an individual, this individual shall wear a protective apron of 0.5 millimeter minimum lead equivalence and be so positioned that no part of his or her body shall be in the path of the primary beam and that his or her body is as far as possible from the edge of the primary beam. (7) Only individuals whose presence is necessary are allowed in a CT scan room during exposure. Each individual, except the patient, shall be protected by at least 0.5 millimeter lead equivalent aprons or a whole body protective barrier. (8) A CT scanner shall not be left unattended without locking the apparatus, room, or building in some manner which must prevent use of the apparatus by unauthorized persons. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14
333-106-0363 Computed Tomography X-ray Systems: Quality Control Program (1) The registrant shall ensure that a CT quality assurance phantom is available for testing the CT system. (2) Instructions on the use of the phantom shall be provided. The instructions shall include a schedule of tests appropriate for the CT system, the allowable variations for the test parameters, and a method to store the test results. (3) Within six months following the effective date of these rules, a CT facility shall establish and implement a quality control program under the direction of a CT medical physicist. (4) Evaluations and tests shall be performed following written procedures and methods. (5) Corrective action shall be taken and documented according to instructions provided by the qualified CT medical physicist if the results of an evaluation or test fall outside the control limits. (6) The qualified CT medical physicist shall determine the frequency of each test. An on-site CT Radiologic Technologist shall be identified to be responsible for the ongoing quality control testing. (7) The ongoing quality control evaluation must include, at a minimum, the following: (a) Water CT number accuracy check and standard deviation (noise); (b) Artifact evaluation; (c) Visual checklist; and (d) Printer quality control (if used for primary interpretation). Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14
333-106-0366 Computed Tomography X-ray Systems: Dose Limits The CTDIvol for the following CT examinations on standard phantoms shall not exceed the dose limits listed below: (1) Adult head, 80 mGy; (2) Adult abdomen, 30 mGy; (3) Pediatric abdomen (five years of age or 40 pounds, 20 mGy; and (4) Pediatric head, 40 mGy. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14
333-106-0367 Computed Tomography X-ray Systems: Records and Report Retention A facility with a CT scanner shall maintain records and reports on file and shall make the records and reports available for review by the Authority as follows: (1) Records documenting the qualifications of all personnel who worked at the facility as an operator or CT medical physicist. (2) Records of personnel no longer employed by the facility shall be kept on file until the next inspection following the employee’s termination has been completed and the Agency has determined that the facility is in compliance with the CT personnel requirements. (3) A report of a CT medical event required under OAR 333-106-0368 shall be maintained on file for at least seven years. (4) Initial and annual CT medical physicist performance evaluation reports required under OAR 333-106-0364 shall be maintained on file for at least five years. (5) Records of the results from the ongoing quality control evaluation required under OAR 333-106-0363 shall be maintained on file for at least three years. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14
333-106-0369 Computed Tomography X-ray Systems: Report and Notification of a CT Medical Event (1) A CT facility shall notify the Authority within 48 hours of any CT medical event in which a patient who has undergone a CT study has incurred a deterministic radiation injury, such as epilation or erythema. (2) The registrant shall submit a written report to the Authority within 30 days after the CT medical event is discovered. (3) The written report shall include all of the following: (a) The registrant’s name, address, facility registration number, and machine registration tag number as they appear on the registration certificate; (b) The name of the individual who determined a CT medical event occurred; (c) The dates of occurrence and discovery of the CT medical event; (d) A narrative description of the CT medical event, including an estimated dose to the patient, if possible, and body part involved; (e) The cause of the CT medical event; (f) The effect on the individual who received the exposure; (g) A narrative detailing corrective action taken or planned to prevent a recurrence; (h) Certification that the registrant notified the individual or the individual’s responsible relative or guardian and, if not, why not; and (i) The name and signature of the person preparing the report. (4) The report shall not contain the name of the individual who is the subject of the CT medical event or any other information that could lead to identification of the individual. (5) The registrant shall consult with the referring physician prior to notifying the individual that they were involved in a CT medical event. (a) The registrant shall ensure that the individual was notified of the CT medical event no later than one week after the discovery unless unforeseen circumstances exist. (b) The registrant shall not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the CT medical event. (c) If verbal notification is necessary, the registrant shall inform the individual or legal guardian that a written description of the CT medical event can be obtained from the registrant. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 24-2014, f. & cert. ef. 8-15-14
333-106-0370 Computed Tomography X-ray Systems: Operator Requirements (1) Computed Tomography (CT) X-ray systems shall be operated by individuals who are authorized to operate CT in accordance with the statutes and rules of the Oregon Board of Medical Imaging. (2) A CBCT scanner shall be operated by a dentist, hygienist, dental assistant or an individual that meets the requirements in section (1) of this rule after completing a machine specific manufacturer operator training program. (3) A mini-CT machine shall be operated by an ear, nose and throat physician or individual who meets the requirements of section (1) of this rule for otolaryngology imaging after completing a machine specific manufacturer operator training program. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 12-2017, amend filed 10/25/2017, effective 10/25/2017 PH 4-2013, f. & cert. ef. 1-29-13 PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 14-2008, f. & cert. ef. 9-15-08 PH 12-2006, f. & cert. ef. 6-16-06 PH 5-2005, f. & cert. ef. 4-11-05 HD 1-1991, f. & cert. ef. 1-8-91
333-106-0601 Veterinary X-ray Systems: Veterinary Medicine Radiographic Installations Additional Requirements (1) Equipment: (a) The protective tube housing shall be of the diagnostic type; (b) Collimating devices shall be provided and used for collimating the useful beam to the area of clinical interest; (c) All X-ray equipment sold after October 1991 must be equipped with a variable adjustable collimator and beam-defining light that meets all of the requirements of OAR 333-106-0301(1), (2) and (3); (d) The total filtration permanently in the useful beam shall not be less than 0.5 mm Al equivalent for machines operating up to 50 kVp, 1.5 mm Al equivalent for machines operating between 50 and 70 kVp, and 2.5 mm Al equivalent for machines operating above 70 kVp; (e) A device shall be provided to terminate the exposure after a preset time or exposure; (f) A dead-man type of exposure switch shall be provided, together with an electrical cord of sufficient length, so that the operator can stand out of the useful beam and at least 12 feet (3.66 m) from the animal during all X-ray exposures. (2) Structural Shielding: All wall, ceiling and floor areas shall be equivalent to or provided with applicable protective barriers to assure compliance with division 120. (3) Operating Procedures: (a) All individuals shall stand well away from the useful beam and the animal during radiographic exposures; (b) No individual shall be in the X-ray room while exposures are being made unless such individual's assistance is required; (c) When an animal must be held in position during radiography, mechanical supporting or restraining devices shall be available and used as appropriate. (d) If the animal must be held by an individual, the individual shall: (A) Be protected with appropriate shielding devices such as protective gloves, aprons, and thyroid collars; (B) Have no part of an individual’s body be struck by the useful beam of the X-ray; and (C) Ensure that the individual holding the animal is appropriately monitored with the monitoring device being affixed to the outside of their apron, from collar to chest. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 81-2021, amend filed 11/19/2021, effective 11/23/2021 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 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
333-106-0735 Mammography Requirements: Breast Density Notification (1) As used in this rule: (a) "Breast Density" refers to the relative amount of different tissues present in the breast. A dense breast has less fat than glandular and connective tissue. Mammogram films of breasts with higher density are harder to read and interpret than those of less dense breasts. (Source: National Cancer Institute). (b) "Facility" has the meaning given that term in 42 U.S.C. 263b and includes but is not limited to a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician, or other facility that conducts breast cancer screening or diagnosis through mammography activities. "Facility" does not include a facility of the Department of Veterans Affairs. (c) "Mammography activities" means the operation of equipment to produce a mammogram, the processing of the film, the initial interpretation of the mammogram and the viewing conditions for that interpretation. (2) In all cases where a mammogram shows a patient has extreme or heterogeneous breast density, the facility shall incorporate the following notification within the lay summary mammography report provided to the patient: DENSE BREAST TISSUE NOTIFICATION Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. This information about the results of your mammogram is given to you to raise your awareness and to promote discussion with your health care provider. Together, you can decide if you may benefit from further screening. A report of your results was sent to your health care provider. (3) The Dense Breast Tissue Notification statement and guidelines shall be included in the facility’s policy on how they communicate mammography results to the patient and their health care providers. Statutory/Other Authority: ORS 413.042 & 431.823 Statutes/Other Implemented: ORS 431.823 History: PH 32-2014, f. 12-22-14, cert. ef. 1-1-15 PH 14-2013, f. 12-26-13, cert. ef. 1-1-14
333-106-0750 Mammography Requirements: Mammography Personnel Qualifications (1) Operator qualifications. In order to use any mammography X-ray machine the operator of the mammography X-ray unit must have the following qualifications: (a) Have a current license issued by the Oregon Board of Medical Imaging; and (b) Have prior to the effective date of these rules qualified as a radiologic technologist under the MQSA interim rules or completed 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor. The hours of documented training shall include, but not be limited to: (A) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging patients with breast implants; (B) The performance of 25 examinations under the personal supervision of an individual qualified under this section; and (C) At least eight hours of training in each mammography modality to be used by the technologist in performing mammography exams; and (D) Be currently registered and in good standing with the American Registry of Radiologic Technologist (ARRT); and (E) Be certified in mammography by the ARRT or the equivalent; or (F) Provide documented evidence that an ARRT mammography certification test is scheduled. Technologists meeting the requirements of subsection (1)(a) and paragraphs (1)(b)(A), (B), (C), and (D) of this rule may work under the supervision (supervision means that a fully qualified technologist is on-site and readily available to answer questions or assist) of a technologist, meeting all of the requirements of this rule, for up to one year while waiting to take the certification test. (2) Interpreting Physician qualifications. All physicians interpreting mammograms shall meet MQSA qualifications and hold a current license to practice medicine in the State of Oregon. (3) Medical Physicist qualifications. All Medical Physicists conducting surveys and equipment evaluations of mammography facilities and providing oversight of their quality assurance programs shall; (a) Meet MQSA requirements; and (b) Be currently licensed as a vendor by the Authority. 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 10-2011, f. 9-30-11, cert. ef. 10-1-11 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
333-109-0001 Purpose and Scope (1) This division establishes procedures for the registration and the use of particle accelerators. (2) In addition to the requirements of this division, all registrants are subject to the requirements of divisions 100, 101, 120 and 111 of these rules. Registrants engaged in industrial radiographic operations are also subject to the requirements of divisions 105 and 108 of these rules, and registrants engaged in the healing arts are also subject to the requirements of division 106 of these rules. Registrants whose operations result in the production of radioactive material are also subject to the requirements of division 102 of these rules. 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 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85