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The Oregon Administrative Rules contain OARs filed through June 15, 2014
 
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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION

 

DIVISION 101

REGISTRATION OF RADIATION MACHINES,
GENERAL LICENSE RADIOACTIVE MATERIALS, LICENSING OF RADIATION SERVICES,
AND ACCREDITATION OF HOSPITAL RADIOLOGY INSPECTORS

333-101-0001

Purpose and Scope

(1) This Division provides for the registration of radiation machines, general license radioactive materials, and for the licensing of persons providing radia-tion machine, radioactive material, or tanning installation, consultation, servicing, and/or services, and hospital radiology inspectors performing hospital X-ray machine inspections, unless such activities are subject to other Divisions of these Rules.

(2) In addition to the requirements of this Division, all licensees, registrants, and accredited individuals are subject to the applicable provisions of other portions of these rules.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; HD 3-1996, f. & cert. ef. 8-9-96; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04

333-101-0003

Definitions

(1) "Facility" means the location, building, vehicle, or complex under one administrative control, at which one or more devices or sources of radiation (X-ray, radioactive materials, or non-ionizing radiation) are installed.

(2) "Health Physics Consultant" means a person, business, facility, or institution providing health physics knowledge and skills for a fee. A health physics consultant may not use or possess radioactive material without specific license authorization pursuant to OAR 333-102-0200.

(3) "Inoperable" means disabling equipment such that ionizing radiation cannot be produced. This is accomplished by removing the X-ray tube, removal of the control unit, removal of the power supply or physical removal of the power cord on a free standing unit.

(4) "Storage" means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable.

(5) "Vendor" means a person, business, facility, or institution providing a product or service for a fee. Radiation vendors include machine salespersons, repair and technical personnel, or marketing representatives who sell, demonstrate, or market x-ray machines or tanning beds and provide advice, consultation, service, or technical information to registrants.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.685 & 453.761
Hist.: PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04

333-101-0005

Application for Registration of Radiation Machines

No X-ray machine may be operated on or after July 1, 1996 unless the machine has a valid X-ray machine registration. Each person having a radiation machine must:

(1) Apply, in writing, for registration of such machines with the Authority prior to the operation of a radiation machine. All operable radiation machines must be registered and the appropriate fee, which is listed in division 103 of these rules, must be paid. Hospitals wishing to register any radiation machine must meet the additional requirements of OAR 333-101-0200. To avoid radiation machine registration and fees, the X-ray tube must be removed or the machine must be disassembled. Application for registration must be completed on forms furnished by the Authority and must contain the following information or such other information as may be required:

(a) Name of the owner or person having administrative control and responsibility for use. "Person" is defined in OAR 333-100-0005 to include "organization";

(b) Address and telephone number where the machine is located and used except that a central headquarters address may be given for a mobile machine used at various temporary field locations;

(c) A description of the type, model and control panel serial number of the radiation machine (state I.D. number if issued) and its rated capacity in peak kilovolts and maximum milliamperes;

(d) A description of the use (dental, medical, industrial, veterinary, research, etc.) of the machine;

(e) Date of application and signature of registrant;

(f) The individual and the signature of the individual designated under section (3) of this rule;

(g) If the facility is mobile, the geographic areas within the state to be covered; and

(h) Name of the radiation machine supplier, installer and service agent.

(2) The registrant must notify the Authority within 30 days of any change which increases the radiation output or rating of the radiation machine or of any other change which renders the information required in section (1) of this rule no longer accurate.

(3) When required by the Authority, the registrant must designate an individual who will be responsible for radiation protection for the machine. Such individual must:

(a) Be qualified by training and experience concerning all hazards and precautions involved in operating the machine for which he or she is responsible;

(b) Recommend a detailed program of radiation safety for effective compliance with the applicable requirements of these rules;

(c) Give instructions concerning hazards and safety practices to individuals who may be occupationally exposed to radiation from the machine; and

(d) Make surveys and carry out other procedures as required by these rules.

(4) When, in the opinion of the Authority, the individual designated to be responsible for radiation safety does not have qualifications sufficient to insure safe use of the machine for which he or she is responsible, the Authority may order the registrant to designate another individual who meets the requirements of this division.

(5) Each registrant must prohibit any person from furnishing radiation machine servicing or services as described in OAR 333-101-0020(4) to his radiation machine facility until such person provides evidence that he has been licensed with the Authority as a provider of services in accordance with 333-101-0020.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0007

Application for General License Registration for Radioactive Materials Gauges, In Vitro Testing, Source Material, Reference and Calibration Sources, and Reciprocal Recognition of Specific Radioactive Materials License

Except for specific licensees granted a general license under OAR 333-102-0340 for reciprocal use of specific license radioactive material, each person, pursuant to 333-102-0103, 333-102-0115(1), 333-102-0125, or 333-102-0130, having general license radioactive material must:

(1) Apply for registration of such materials with the Authority within thirty (30) days of possession of such device, in vitro radioactive material used for testing, or source material. Application for registration must be completed on forms furnished by the Authority and must include the name of the general license supplier, installer, and service agent.

(2) The general license registrant must notify the Authority within thirty (30) days of any change in information required in section (1) of this rule.

(3) Each general license registrant must prohibit any person from furnishing servicing or services to any general license device until such person provides evidence that the servicing agent has been registered with the Authority as a provider of services in accordance with OAR 333-101-0020.

(4) Each general license granted pursuant to OAR 333-102-0340 must provide the specific information required pursuant to that rule.

Stat. Auth.: ORS 453.605 - ORS 453.807

Stats. Implemented: ORS 453.605 - ORS 453.807

Hist.: HD 1-1995, f. & cert. ef. 4-26-95; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0010

Exemptions

(1) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this division, providing dose equivalent rate averaged over an area of 10 square centimeters does not exceed 5 microSv (0.5 millirem) per hour at five centimeters from any accessible surface of such equipment. The production, testing or factory servicing of such equipment is not exempt.

(2) Radiation machines while in transit or inoperable are exempt from the requirements of this division. For the purposes of registration and fees, the Authority considers an X-ray unit to be inoperable only if the machine's X-ray tube (insert) has been removed or the machine disassembled. With the X-ray tube in place, and the machine assembled, the unit is considered to be operable. If a machine is "in storage," it must be registered and charged a registration fee. However, an "inoperable" machine need not be registered or assessed a fee.

(3) Domestic television receivers are exempt from the requirements of this division.

(4) Electron microscopes are exempt from the requirements of this division, provided that the dose equivalent rate, averaged over an area of 10 square centimeters, does not exceed 5 microSv (0.5 millirem) per hour at five centimeters from any accessible surface of the equipment.

NOTE: Electron microscope: A type of microscope which uses electrons to produce magnified images and may therefore produce ionizing radiation incidental to its use.

(5) Electron beam welding machines and electron beam furnaces are exempt from the requirements of this division, provided that the dose equivalent rate, averaged over an area of 10 square centimeters, does not exceed 5 microSv (0.5 millirem) per hour at five centimeters from any accessible surface of the equipment.

(6) Persons licensed under OAR 333-102-0200 or equivalent specific licenses rules under an Agreement State or the U.S. Nuclear Regulatory Commission are exempt from this requirement.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0015

Transfer or Disposal of Radiation Producing Machines or Equipment

Whenever radiation producing machines or equipment, including general license devices containing radioactive material, are transferred or disposed of, the Authority must be notified in writing by the registrant within 30 days of the date of such transfer or disposal, and include the name and address of the person to whom it was transferred or its final disposition.

NOTE: General License radioactive materials can only be transferred pursuant to requirements in OAR 333-102.

Stat. Auth.: ORS 453.605 - 453.755
Stats. Implemented: ORS 453.605 - 453.755
Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 1-1995, f. & cert. ef. 4-26-95; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0020

Application for License of Sales, Services, Consultation, and Servicing For Radiation Machines

(1) Each person who is engaged in the business of selling, leasing, transferring, lending, installing or offering to install radiation machines or tanning beds, or is engaged in the business of furnishing or offering to furnish radiation machines, X-ray automatic film processor, X-ray processing chemicals, radioactive material (unless such activities are authorized under a specific license), or tanning servicing or services in this state, must apply for license of such services with the Authority within 30 days following the effective date of this rule or thereafter prior to furnishing or offering to furnish any such services.

(2) Application for a license must be completed on forms furnished by the Authority and must contain the following information or such other information as may be required:

(a) Name, address and telephone number of the following:

(A) The individual or the company to be licensed; and

(B) The owner(s)of the company.

(b) The services that will be provided;

(c) The area of the state and other states to be covered;

(d) A list of the individuals qualified to provide these services; and

(e) The date of application and signature of the individual responsible for the company, beneath a statement of the items specified in OAR 333-101-0020(3).

(3) Each person applying for license under this division must specify:

(a) That they have read and understand the requirements of these rules;

(b) The services for which they are applying for license;

(c) The training and experience that qualify them or their technical staff to discharge the services for which they are applying for license;

(A) Training for radiation machine vendors must include, but must not be limited to, a minimum of one day of training in radiation use and safety.

(B) The training specified in OAR 333-101-0020(3)(c)(A) must be taught by an Authority approved instructor. Approval will be based upon the following criteria;

(i) Current Radiologic Technologist license with the Oregon Board of Radiologic Technology and a minimum of two years of work experience in Radiologic Technology; and

(ii) Experience in the use of radiation measurement instruments; or

(iii) "Qualified Expert" as defined in OAR 333-100-0005; or

(iv) "Health Physics Consultant" as defined in OAR 333-101-0003.

(C) Subjects to be covered must include but not be limited to:

(i) Nature of x-rays;

(ii) Radiation units;

(iii) Biological effects of x-ray radiation;

(iv) Principals of radiation protection;

(v) Radiation survey instruments;

(vi) Personnel monitoring equipment; and

(vii) Applicable federal and state radiation regulations.

(d) The type of measurement instruments to be used, frequency of calibration, source of calibration; and

(e) The type of personnel dosimeters supplied, frequency of reading and replacement or exchange schedule.

(4) All radiation machine vendors who install or repair radiation machines must have measurement instruments that will assure compliance with all x-ray machine, or tanning bed installation requirements according to all applicable federal standards, as well as instruments to properly check items such as collimation, HVL, kVp, mA, time, and radiation output, or assure these tests are made by a qualified expert as needed, and that the information is included in the installation report.

(5) For the purpose of OAR 333-101-0020, services may include but must not be limited to:

(a) Sales or leasing of radiation machines, installation and/or servicing of radiation machines and associated radiation machine components;

(b) Calibration of radiation machines;

(c) Calibration and use of radiation measurement instruments or devices;

(d) Radiation protection or health physics consultations or surveys;

(e) Personnel dosimetry services (not otherwise licensed under these rules);

(f) Installation and/ or servicing of automatic x-ray film processors; and

(g) Providing x-ray film processing chemicals.

(6) No individual shall perform services that are not specifically stated for that individual on the notice of licensure (certificate of validation or acknowledgment of validation) issued by the Authority.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 5-2005, f. & cert. ef. 4-11-05; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0023

Application for License of Sales, Consulting Services, and Servicing for Radioactive Materials Devices under General License

(1) Each person who is engaged in the business of selling, installing, surveying, consulting, training, or servicing radioactive material in general license measuring, gauging, or controlling devices, or selling In Vitro testing kits, or source material, or is engaged in the business of furnishing or offering to furnish radioactive material consulting services in this state, must apply for license of such services with the Authority within 30 days following the effective date of this rule or thereafter prior to furnishing or offering to furnish any such services.

(2) Application for a license must be completed on forms furnished by the Authority.

(3) Each person applying for license under this division must specify:

(a) That they have read and understand the requirements of these rules;

(b) The services for which they are applying for license; and

(c) The training and experience that qualify them or their technical staff to discharge the services for which they are applying for license.

(4) All vendors must have measurement instruments that will assure compliance with all applicable standards, as well as instruments to properly check items such as collimation, time, and radiation output, or assure these tests are made by a qualified expert, and that the information is included in the installation report.

(5) For the purpose of OAR 333-101-0020, services may include but must not be limited to:

(a) Installation and/or servicing of radiation machines and associated radiation machine components;

(b) Calibration of general license radioactive material used for measuring, gauging, or controlling;

(c) Radiation protection or health physics consultations or surveys; and

(d) Personnel dosimetry services (not otherwise licensed under these rules).

(6) No individual shall perform services that are not specifically stated for that individual on the license application (certificate of validation or acknowledgement of validation) issued by the Authority.

(7) Persons licensed under OAR 333-102-0200 (specific radioactive materials license) are exempt from these requirements.

Stat. Auth.: ORS 453.605 - ORS 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 1-1995, f. & cert. ef. 4-26-95; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0025

Out-of-State Radiation Machines

(1) Whenever any radiation machine is to be brought into the state for any temporary use (a period not in excess of 30 days), the person proposing to bring such machine into the state must give written notice to the Authority (at least two working days) before such machine is to be used in the state. The notice must include:

(a) The type of radiation machine;

(b) The nature, duration and scope of use;

(c) The exact locations where the radiation machine is to be used; and

(d) The States in which this machine is registered.

(2) If for a specific case, the two working-day period would impose an undue hardship on the person, upon application to the Authority, permission to proceed sooner may be granted.

(3) The person referred to in section (1) of this rule must:

(a) Comply with all applicable rules of the Authority;

(b) Supply the Authority with such other information as the Authority may reasonably request; and

(c) Not operate within the state on a temporary basis in excess of 180 calendar days per year.

(4) Notwithstanding sections (1), (2), and (3) of this rule, registered general licenses for out-of-state radioactive material under specific license may be brought into the state for use at temporary jobsites only under the provisions of OAR 333-102-0340.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 1-1995, f. & cert. ef. 4-26-95; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0035

Issuance of Notice of Registration for X-ray Machines

(1) Upon a determination that an applicant meets the requirements of the rules, the Authority must issue a registration and/or a validation certificate.

(2) The Authority may incorporate in the notice of registration at the time of issuance or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use and transfer of radiation machines as it deems appropriate or necessary.

(3) Prior to issuance of an X-ray machine registration to a hospital, the X-ray machine will be approved by an X-ray machine inspector employed by the Authority, or inspected by an accredited radiology inspector.

(4) Prior to issuance of an X-ray machine registration to a facility other than a hospital, the X-ray machine must be approved by an X-ray machine inspector employed by the Authority.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 1-1991, f. & cert. ef. 1-8-91; HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0040

Expiration of Notice of Registration

(1) Except as provided by OAR 333-101-0045(2) each notice of registration shall expire at the end of the specified day in the month and year stated therein.

(2) An X-ray machine registration shall terminate if the X-ray machine is relocated for use in a physical surrounding other than the physical surrounding it occupied when originally registered.

Stat. Auth.: ORS 453.761
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 1-1991, f. & cert. ef. 1-8-91; HD 3-1996, f. & cert. ef. 8-9-96

333-101-0045

Renewal of Notice of Registration

(1) Application for renewal of registration must be filed in accordance with OAR 333-101-0005 or 333-101-0020.

(2) In any case in which a registrant has filed an application in proper form for renewal, not less than 30 days prior to the expiration of his existing notice of registration, such existing notice of registration shall not expire until the application status has been determined by the Authority.

Stat. Auth.: ORS 453.605 - ORS 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0050

Report of Changes

The registrant must notify the Authority in writing before making any change which would render the information contained in the application for registration and/or the notice of registration no longer accurate.

Stat. Auth.: ORS 453.605 - ORS 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 1-1991, f. & cert. ef. 1-8-91; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: 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.]

Stat. Auth.: ORS 453.605 - ORS 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 1-1991, f. & cert. ef. 1-8-91; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.605 - ORS 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-81-91; Renumbered from 333-101-0030; PH 12-2006, f. & cert. ef. 6-16-06; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

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

Stat. Auth.: ORS 453.605 - ORS 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

333-101-0080

X-ray Machine Registration Denial

(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.

Stat. Auth.: ORS 453.761
Stats. Implemented: ORS 453.605 - 453.807
Hist.: 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 division 101 of these rules 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 of these rules;

(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 183.090.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - ORS 453.807
Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - ORS 453.807

Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.780 - 453.785
Stats. Implemented: ORS 453.605 - 453.807
Hist.: 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.

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - ORS 453.807

Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807.

Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.790
Stats. Implemented: ORS 453.605 - 453.807
Hist.: 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.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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.

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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).

Stat. Auth.: ORS 453.605 - 453.807
Stats. Implemented: ORS 453.605 - 453.807
Hist.: HD 3-1996, f. & cert. ef. 8-9-96; PH 12-2006, f. & cert. ef. 6-16-06

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