justicedao/ipfs_state_laws huggingface dataset:
333-101-0055 Approval Not Implied (1) No person, in any advertisement, shall refer to the fact that their facility is registered with the Authority pursuant to the provisions of OAR 333-101-0005 or 333-101-0020 and no person shall state or imply that any activity under such registration has been approved by the Authority. (2) No person shall refer to any rule, or state or imply rules in any advertisement without citing the exact wording of the rule in its entirety. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 1-1991, f. & cert. ef. 1-8-91
333-101-0060 Assembler and/or Transfer Obligation (1) Any person who sells, leases, transfers, lends, disposes, assembles or installs radiation machines in this state must notify the Authority within 15 days of: (a) The name and address of persons who have received these machines; (b) The manufacturer, model and serial number of each radiation machine transferred; and (c) The date of the transfer of each radiation machine. (2) No person shall make, sell, lease, transfer, lend, assemble or install radiation machines or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used must meet the requirements of these rules. (3) In the case of diagnostic x-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the federal diagnostic X-ray standard (21 CFR 1020.30(d)) must be submitted to the Authority within 15 days following completion of the assembly. Such report must suffice in lieu of any other report by the assembler. [Publications: Publications referenced are available from the agency.] Statutory/Other Authority: ORS 453.605 - ORS 453.807 Statutes/Other Implemented: ORS 453.605 - ORS 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-8-91
333-101-0065 Additional Requirements (1) No person shall use a radiation machine unless that machine is registered with the Oregon Health Authority in accordance with OAR 333-101-0005 or is exempt from the registration under OAR 333-101-0010 or 333-101-0025. (2) No registrant shall use a radiation machine unless a current certificate of validation has been issued for that machine. (3) The registrant must comply with any additional requirements or conditions listed on the then current certificate of validation on which the Authority has deemed appropriate or necessary to minimize danger to public health and safety or property. Statutory/Other Authority: ORS 453.605 - ORS 453.807 Statutes/Other Implemented: ORS 453.605 - ORS 453.807 History: PH 10-2011, f. 9-30-11, cert. ef. 10-1-11 PH 12-2006, f. & cert. ef. 6-16-06 HD 1-1991, f. & cert. ef. 1-81-91, Renumbered from 333-101-0030 HD 4-1985, f. & cert. ef. 3-20-85
333-101-0070 X-ray Machine Registration Fee Proration (1) Not withstanding the registration requirements of division 103 of these rules, the Authority must, at the written request of the X-ray machine owner, adjust the registration expiration date of any X-ray machine to coincide with the registration expiration date of other X-ray machines currently registered to the machine owner. (2) When requested in writing the Authority must prorate the registration fee according to the following: (a) If a machine is registered for 19 to 24 months in a biennium, the registration fee shall be 100 percent; (b) If a machine is registered for 13 to 18 months in a biennium the registration fee shall be 75 percent; (c) If a machine is registered for 7 to 12 months in a biennium the registration fee shall be 50 percent; (d) If a machine is registered for 1 day to 6 months in a biennium the registration fee shall be 25 Statutory/Other Authority: ORS 453.605 - ORS 453.807 Statutes/Other Implemented: ORS 453.605 - ORS 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 HD 3-1996, f. & cert. ef. 8-9-96
333-101-0080 X-ray Machine Registration Denial, Suspension, Revocation and Conditions (1) The Authority may deny the registration or may grant a provisional registration permitting temporary operation pending compliance with Authority standards for any of the following: (a) The X-ray machine does not comply with one or more standards adopted by rule by the Authority; (b) The equipment associated with the operation of the X-ray machine does not comply with one or more standards adopted by rule by the Authority; (c) The physical surroundings associated with the operation of the X-ray machine does not comply with one or more standards adopted by rule by the Authority. (2) The Authority may deny, condition, suspend or revoke a X-ray machine registration if the Authority believes that the X-ray machine or the physical surroundings or the equipment used in conjunction with the operation of the X-ray machine presents a danger to the health or safety of the operator or the public. Statutory/Other Authority: ORS 453.761 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, amend filed 10/09/2020, effective 10/09/2020 HD 3-1996, f. & cert. ef. 8-9-96
333-101-0090 Investigation and Civil Penalty (1) If after an investigation by an Authority-employed X-ray machine inspector, the Authority has reason to believe that an act prohibited by OAR chapter 333, division 101 has been committed, the Authority may impose a civil penalty not to exceed $5,000. The Authority reserves the right to pursue other remedies against alleged violators and may take any other disciplinary action at its discretion that it finds proper. (2) In establishing the amount of the penalty for each violation, the Authority must consider, but not be limited to, the following factors: (a) The gravity and magnitude of the violation; (b) The person's, as defined in OAR 333-100-0005, previous record of complying or failing to comply with division 101; (c) The person/company's history in taking all feasible steps or in following all procedures necessary or appropriate to correct the violation; and (d) Such other considerations as the Authority may consider appropriate. (3) Civil penalties must be imposed in the manner provided by ORS 183.413 to 183.470. Statutory/Other Authority: ORS 453.605 - 453.807 & ORS 431A.010 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 72-2020, amend filed 10/09/2020, effective 10/09/2020 PH 12-2006, f. & cert. ef. 6-16-06 HD 3-1996, f. & cert. ef. 8-9-96
333-101-0200 Hospital X-ray Machine Registration (1) Prior to issuance of an X-ray machine registration to a hospital, the X-ray machine must be approved by an X-ray machine inspector employed by the Authority or inspected by an Authority-accredited hospital radiology inspector; and (2) If inspection is performed by an accredited hospital radiology inspector, the test results must be reviewed and approved by the Authority; and (3) All standards adopted by rule of the Authority are met; and (4) A properly completed registration application has been submitted by the X-ray machine owner; and (5) All required fees have been paid. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - ORS 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 HD 3-1996, f. & cert. ef. 8-9-96
333-101-0210 Hospital Radiology Inspector An accredited hospital radiology inspector is an individual who has a combination of education and experience as indicated in OAR 333-101-0220. This individual must have been tested on knowledge of Authority radiation rules governing the X-ray machine inspection program, including but not limited to, safety requirements and inspection procedures. Those individuals with current accreditation are then allowed at a participating hospital’s request, to complete the annual Authority radiation inspection. Statutory/Other Authority: ORS 453.780 - 453.785 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 3-1996, f. & cert. ef. 8-9-96
333-101-0220 Hospital Radiology Inspector Qualifications (1) All applicants for licensure as hospital radiology inspectors must possess at a minimum one of the following combinations of education and experience: (a) One year of experience using X-ray machines and associated auxiliary equipment, and at least one of the following: (A) Certification by the American Board of Radiology or the American Board of Health Physics; (B) A doctoral degree in a physical or biological science; or (C) A doctor of medicine degree or a degree recognized by the Authority as an equally qualified health professional degree. (b) Two years of experience using X-ray machines and associated auxiliary equipment, and a master's degree in a physical or biological science. (c) Four years of experience using X-ray machines and associated auxiliary equipment, and a bachelor's degree in a physical or biological science. (d) Six years of experience using X-ray machines and associated auxiliary equipment, and an associate's degree in a physical or biological science. (2) Experience of an applicant includes, but is not limited to, measuring ionizing radiation, evaluating radiation safety and documenting radiation protection needs in a diagnostic radiology setting. (3) In addition to meeting the education and experience requirements of this section, applicants must be tested on knowledge of Authority rules governing the X-ray machine inspection program, including but not limited to, safety requirements and inspection procedures. (4) Applicants must also complete such additional written or practical testing as the Authority may require. (5) An accreditation must not be issued or renewed to an applicant unless the applicant has paid all required fees. Statutory/Other Authority: ORS 453.605 - 453.807 Statutes/Other Implemented: ORS 453.605 - ORS 453.807 History: PH 12-2006, f. & cert. ef. 6-16-06 HD 3-1996, f. & cert. ef. 8-9-96
333-101-0230 Hospital Radiology Inspector Testing (1) The Authority must offer quarterly examinations for licensure. A schedule of examination dates and times will be available upon request. The Authority reserves the right to alter or adjust examination dates, times and locations as it deems necessary and will notify applicants whenever possible. (2) Testing will be done by the Authority or the Authority's representative and upon passing the test, the Authority will issue a radiology inspector accreditation. (3) Applicants must qualify for examination upon compliance with all applicable provisions of OAR 333-101-0020. Applicants must not be allowed to sit for the examination if documentation is incomplete or incorrect. (4) Documentation must be submitted to the Authority office within seven days of the examination date. No accreditation will be issued without proper documentation. (5) Applicants providing documentation to the Authority must submit the official transcript in a sealed envelope, issued from the school or training organization. The school must attest to the documents authenticity and accuracy. (6) Applicants taking the examination must present photographic identification, such as a driver's license, before sitting for the examination. (7) Each applicant must complete a written examination to test the applicant's knowledge in the following subjects: (a) Licensure and registration requirements and applicable radiation rules including: (A) Registrant's administrative responsibilities; (B) Registrant's X-ray machine operator responsibilities; (C) Registrant's X-ray machine responsibilities; (D) Registrant's responsibilities regarding film, film processing, and all quality control related to the hospital radiology department; and (E) Hospital radiology inspector responsibilities. (b) Authority inspection procedures and practice application; (c) The basic principles of radiation safety; and (d) Inspection equipment and tools. (8) The applicant must pass the examination by a score of at least 75 percent. (9) All examinations must be prescheduled. 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 3-1996, f. & cert. ef. 8-9-96
333-101-0240 Hospital Radiology Inspector Accreditation (1) Accreditation as a radiology inspector shall be valid for two years and shall expire in the second year on the last day of the month of issuance unless renewed. (2) An accreditation may be renewed if the radiology inspector has complied with the continuing education requirements specified in OAR 333-101-0260 and has paid the renewal fee. (3) An accreditation for the current period must be provided by the Authority. 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 3-1996, f. & cert. ef. 8-9-96
333-101-0250 Hospital Radiology Inspector Accreditation Revocation The Authority may condition, suspend, revoke, or refuse to renew accreditation of a radiology inspector for the following reasons: (1) Knowingly falsifying information included on the inspection report form supplied by the Authority. (2) Substantially failing to comply with Authority procedures. (3) Failing to meet Authority accuracy requirements. Statutory/Other Authority: ORS 453.790 Statutes/Other Implemented: ORS 453.605 - 453.807 History: HD 3-1996, f. & cert. ef. 8-9-96
333-101-0260 Hospital Radiology Inspector Continuing Education (1) Each radiology inspector requesting an accreditation renewal must complete 10 clock hours of continuing education every two years from the date of accreditation to qualify for renewal of accreditation. (2) Accreditation will not be renewed without receipt of the required continuing education report, by the Authority. (3) Accredited hospital radiology inspectors failing to obtain 10 clock hours of continuing education every two years, must reapply, complete 5 hours of continuing education for the current year, and successfully pass a written examination. (4) Continuing education includes attendance or participation at a radiology instructional program presented, organized or under the auspices of any organization or association. For example, lectures, post-secondary school, or post-graduate courses, scientific sessions at conventions, or correspondence courses. (5) Subject matter must be related to the law and rules regulating hospital radiology inspectors, and the regulatory concept pertaining to radiation machines and their use in the State of Oregon. (6) Documentation must include the name of the sponsoring institution/association or organization, title of presentation, description of content, name of instructor or presenter, date, clock hours, and a statement of attendance or completion provided by the sponsor. (7) Submission to the Authority of proof of participation in continuing education is the responsibility of the hospital radiology inspector. Such proof must be held by the hospital accredited radiology inspector until submitted to the Authority biennially at the time of renewal. (8) Hours obtained in excess of the 10 required for each two-year period must not be carried forward as credit for the subsequent two-year continuing education requirement. 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 3-1996, f. & cert. ef. 8-9-96
333-101-0270 Hospital Responsibilities Re: X-ray Machines Each hospital that is utilizing the services of an accredited radiology inspector must comply with the following and any other applicable sections of these rules: (1) Contact the Authority, in writing, for information and authorization to allow the hospital to use the services of an accredited radiology inspector: (a) Contact must be made three months prior to the facility's one year inspection due date or before March 1 of each renewal year by the registrant;and (b) Contact with the Authority must be remade and a new authorization given by the Authority for every renewal period. (2) Continually have available the services of an accredited radiology inspector or notify the Authority if they have terminated the services of the accredited radiology inspector. (3) Records of safety inspections must be dept for two years after completion of the last inspection. (4) Have procedures in place and followed which comply with all applicable parts of divisions 100, 101, 106, 109, 111, and 120 of these rules. (5) Have an inspection and safety program in place which complies with all applicable parts of divisions 100, 101, 106, 109, 111 and 120 of these rules. (6) Make records, X-ray machines, and related equipment available for inspection by the Authority during normal working hours. 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 3-1996, f. & cert. ef. 8-9-96
333-101-0280 Authority Responsibilities Regarding the Radiology Inspection The Authority responsibilities must include the following as well as other applicable sections of these rules: (1) Do annual audits of hospital programs to monitor accredited radiology inspector results and to monitor changes in the performance of registered X-ray machines during the registration period. (2) Evaluate registrant test results provided by the accredited radiology inspectors. (3) Grant or deny X-ray machine registrations, accreditation of hospital radiology inspectors and issue documents of registration and accreditation. (4) Deny, condition, suspend, or revoke an X-ray machine registration or radiology inspector accreditation. (5) Grant a provisional registration permitting temporary operation pending compliance with Authority standards. (6) Investigate any alleged prohibited act and resolve complaints against accredited radiology inspectors and their employers. (7) Impose civil penalties. (8) Develop programs to evaluate hazards associated with the use of X-ray machines. (9) Develop testing, training and continued education standards for accreditation of radiology inspectors. (10) Promulgate standards and make regulations relating to the registration of X-ray machines, accreditation of radiology inspectors, X-ray machine operation, physical surroundings and equipment related to the operation of the X-ray machines, operator training, and approved X-ray machine operating practices. (11) Test applicants for radiology inspector accreditation. (12) Collect and disseminate information relating to X-ray machine users. (13) Provide technical assistance and safety information to X-ray machine users. 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 3-1996, f. & cert. ef. 8-9-96
333-101-0290 Accredited Hospital Radiology Inspector Responsibilities The accredited radiology inspector's responsibilities must include the following and compliance with any other applicable sections of these rules: (1) Be currently accredited by the Authority as an accredited hospital radiology inspector. (2) Each accredited hospital radiology inspector conducting a registration inspection on a hospital X-ray machine must collect information and do tests in the manner required by the Authority. (3) Each accredited hospital radiology inspector must make calculations in the manner prescribed by the Authority and must enter the results and such other information as the Authority may require, on a form provided by the Authority. (4) Each accredited hospital radiology inspector must make all inspection records and results available for audit or investigation by Authority inspectors. (5) Accredited hospital radiology inspectors must not misrepresent in any way, a device identifying an X-ray machine registration. (6) Accredited hospital radiology inspectors must not alter, obscure, deface, or remove a device identifying registration of an X-ray machine. (7) Accredited hospital radiology inspectors must possess equipment appropriate and capable of doing the testing, monitoring, etc., required by applicable Authority standards. (8) Assure all X-ray output and scatter radiation monitoring equipment have been calibrated within the past 12 months with X-rays in the same energy range as the diagnostic equipment being evaluated. Such calibration must be traceable to the National Institute of Standards and Technology (NIST). 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 3-1996, f. & cert. ef. 8-9-96
333-102-0010 Exemptions — Radioactive Material Other than Source Material: Exempt Concentrations (1) Except as provided in sections (3) or (4) of this rule, any person is exempt from this division to the extent that such person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations not in excess of those listed in 10 CFR Part 30.70. (2) This section shall not be deemed to authorize the import of byproduct material or products containing byproduct material. (3) A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license outlined in OAR 333-102-0005 to the extent that transfers of radioactive material contained in a product or material in concentrations not in excess of those specified in 10 CFR Part 30.70 and introduced into the product or material by a licensee holding a specific license issued by an Agreement State, or the Nuclear Regulatory Commission, expressly authorizing such introduction. This exemption does not apply to the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being. (4) No person may introduce byproduct material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under section (1) of this rule or equivalent regulations of the U.S. Nuclear Regulatory Commission, any Agreement State, or Licensing State except in accordance with a specific license issued pursuant to OAR 333-102-0245 or the general license granted by OAR 333-102-0340. NOTE: 10 CFR Part 30.70 Schedule A is available from the Public Health Division, Radiation Protection Services. Statutory/Other Authority: ORS 453.635 & 453.665 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 4-2010, f. & cert. ef. 2-16-10 PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 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 1-1995, f. & cert. ef. 4-26-95 HD 1-1991, f. & cert. ef. 1-8-91 HD 4-1985, f. & ef. 3-20-85