6 CCR 1007-1
PART 2: REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES
2.1 Purpose and Scope.
2.1.1 Authority
Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25-1- 108, 25-1.5-101(1)(l), and 25-11-104, CRS.
2.1.2 Basis and Purpose.
A statement of basis and purpose of these regulations is incorporated as part of these regulations; a copy may be obtained from the Department.
2.1.3 Scope.
This part provides for the registration of facilities, for the certification of radiation machines, for the registration of persons providing radiation machine installation, servicing, and/or services, for the registration of qualified inspectors, and for approval of mammographers and operators.
2.1.4 Applicability.
In addition to the requirements of this part, all registrants are subject to the applicable provisions of Parts 1, 4, 5, 6, 7, 8, 9, 10 and 20 of these regulations.
2.2 Definitions.
As used in this part:
“Air kerma” means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the gray (Gy). For x-rays with energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 rad = 114 roentgen (R) of exposure.
“ARRT” means the American Registry of Radiologic Technologists. “ARRT(R)” , see “radiologic technologist” .
“ASRT” means American Society of Radiologic Technologists. “Assembler” means any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or the owner’s employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services. “Calibration” means to adjust and/or determine: (1) the response or reading of an instrument relative to a series of conventionally true values; or (2) the strength of a radiation source relative to a standard or conventionally true value. This does not include the adjustments made to an x- ray system done as part of its installation or repair.
“Certification Evaluation” (CE) means the evaluation of a radiation machine and/or facility by the Department, or by a qualified inspector, for the purpose of evaluating the performance of the radiation machine system and/or facility against these regulations. “Direct supervision” means the supervisor must be present in the facility and immediately available to furnish assistance and direction to the supervisee throughout the performance of a procedure. The supervisor is not required to be present in the room when the procedure is performed. Direct supervision during the performance of a mammography examination or certification evaluation of the facility's equipment and quality assurance program means that the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the certification evaluation. “Equipment/machine performance adjustments” means the adjustment/repair of one or more functions of an x-ray machine that are required to bring the machine into compliance with these regulations and the manufacturer's specifications. These adjustments do not include the setting(s) of operator-selectable functions, such as time, mA, kVp, etc. for individual exposures. “Facility” means the location, under the same administrative control within one building, or vehicle, or under one roof, at which one or more radiation machines are installed, operated and/or stored.
“FDA” means the United States Food and Drug Administration. “Intercomparison” means the direct comparison, in accord with 2.4.3.3, of two instruments designed to measure the same physical quantity.
“Kerma” means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.
“Limited-scope operator” means an individual who has taken and passed a required test and has approval by the Department pursuant to 2.6.1 to operate x-ray systems and to conduct radiographic examinations of the chest, extremities, skull and spine. “LSO” means limited-scope x-ray machine operator, abbreviated by the ASRT as LXMO, limited x-ray machine operator.
“Mammographer” means a radiologic technologist who has specialized training in performing mammography examinations and has a current registration in mammography with the ARRT. “Medical physicist” means an individual who is approved by the MQSA program to conduct surveys of mammography facilities and machines and to provide oversight of the facility quality assurance program.
“MQSA” means Mammography Quality Standards Act.
“NIST” means National Institute of Standards and Technology. “Provisional mammographer” means an individual radiologic technologist who is currently in or has completed a structured training program in mammography, has a current registration with the ARRT, and is currently approved by the Department.
“Qualified inspector” means an individual who is approved and designated by the Department to perform inspections and evaluate radiation machines, facilities and operators and meets the criteria in Appendix 2B.
“Qualified trainer” means an individual whose training and experience adequately prepares the individual to carry out specified training assignments.
(1) An interpreting physician, radiologic technologist or medical physicist who is approved under MQSA program requirements is considered a qualified trainer for the respective competency.
(2) A physician, radiologic technologist, or operator who is approved pursuant to 2.6.1 is considered a qualified trainer for the respective competency.
(3) Other examples of an individual who might be considered by the Department to be a qualified trainer for the purpose of providing training to meet the requirements of this part include, but are not limited to, an trainer in a post-high-school training institution or a manufacturer's representative.
“Qualified mammographer” means a mammographer who has successfully maintained continuing education and experience requirements and is approved by the Department. “Radiologic technologist” means an individual who is currently registered in radiologic technology with the American Registry of Radiologic Technologists, i.e. ARRT(R). “Storage” means that a radiation machine is in a condition of not being used for an extended period of time and has been made inoperable.
“X-ray system” means an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and necessary supporting structures. Additional components that function with the system are considered integral parts of the system. EXEMPTIONS FROM THE REGULATORY REQUIREMENTS
2.3 Exemptions.
2.3.1 Electronic equipment that produces radiation incidental to operation for other purposes is exempt from the registration and notification requirements of this part, provided that the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 5 microsievert (0.5 millirem) per hour at 5 centimeters from any accessible surface of such equipment. Electronic equipment that fails to meet the dose equivalent rate limit specified in 2.3.1 shall be registered with the Department and inspected in accordance with 2.5.1. The production, testing, or factory servicing of such equipment shall not be exempt.
2.3.2 Radiation machines while in transit or storage incident thereto are exempt from the requirements of this part.
2.3.3 Domestic television receivers, computer monitors, and similar devices are exempt from the requirement of this part.
2.3.4 Radiation machines that are in storage are exempt provided that the electrical circuitry is inactivated, dismantled, and made physically inoperable so that the radiation machine is not capable of producing radiation.
2.3.5 Electron microscopes are exempt from this part provided that they have been initially surveyed to show compliance with 2.3.1.
2.3.6 The legal owner of electronic equipment which meets the requirements of 2.3.1 but which is not specifically exempted under 2.3.2, 2.3.3 and 2.3.4, shall maintain for the lifetime of the equipment radiation measurement results or certification from the manufacturer or a qualified inspector indicating that the equipment complies with the exposure rates specified in 2.3.1.
2.3.7 Electron microscopes and electron microprobes manufactured after September 30, 1999, are exempt from this part provided that the instrument is not capable of exceeding an operating voltage of 50,000 electron volts. Instruments capable of operating at voltages in excess of 50,000 electron volts shall be registered with the Department and inspected in accordance with 2.5.1.
REGISTRATION
2.4 Application for Registration.
2.4.1 Application for Registration of Radiation Machine Facilities.
Each person possessing or in the process of coming into the possession of a radiation machine facility shall:
2.4.1.1 Be registered with the Department;
2.4.1.2 Apply for registration of such facility with the Department prior to the operation of a radiation machine facility;
2.4.1.3 Complete an application for registration on forms furnished by the Department and include all the information required by the form and any accompanying instructions; and 2.4.1.4 Designate on the application form the individual(s) to be responsible for radiation safety of the radiation machine(s) and radiation protection for the facility.
2.4.2 Application for Registration of Servicing and Services.
2.4.2.1 Each person who is engaged in the business of installing or offering to install radiation machines and their related components, or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State, shall be registered with the Department prior to furnishing or offering to furnish any such services.
2.4.2.2 Application for registration shall be completed on forms furnished by the Department and shall contain all information required by the Department as indicated on the forms and accompanying instructions.
(1) Each registration shall be for a period of two (2) years.
(2) Application fee(s) pursuant to Appendix 2A must accompany the application when it is filed. The Department shall not review or otherwise process applications for which no remittance is received. These applications may be returned to the applicant.
(3) The Department shall audit proficiency of each qualified service company engineer.
2.4.2.3 In any case in which a service company, not less than thirty (30) days prior to the expiration of an existing authorization to perform servicing/services, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing authorization shall not expire until final action by the Department.
2.4.2.4 Each person applying for registration under this part shall specify:
(1) That each individual who is applying has read and understands the requirements of these regulations; including the Federal Performance Standard (21 CFR Chapter I, Subchapter J, April 1, 2004); and (2) The services for which registration is being requested (see 2.4.2.1); and (3) The training and experience that qualify the person to provide the services for which registration is being requested; and (4) The type of measurement instruments that will be used to determine compliance with these regulations, including:
(a) The frequency of calibration; and (b) The provider of calibration services; and (5) A written commitment by each service company to meet the instrument calibration requirements specified in 2.4.3.3.
(6) The type of personnel monitoring supplied, frequency of reading, and replacement or exchange schedule as appropriate. (See 4.17 and 4.18)
2.4.2.5 For purposes of this part, services may include but shall not be limited to:
(1) Installation of radiation machines and associated radiation machine components; and (2) Servicing of radiation machines and associated radiation machine components; and (3) Performance adjustments to radiation machines, radiation measurement instruments, and devices; and (4) Radiation protection, health physics consultations or surveys performed by a qualified expert.
2.4.2.6 No person shall perform on radiation machine system or facility any service that is not specifically stated for that person on the Notice of Registration issued by the Department.
2.4.2.7 Assemblers and services and servicing personnel shall provide to the registrant, as required by the Federal Performance Standard (21 CFR Chapter I, Subchapter J, April 1, 2004) and these regulations, instruction manuals, manufacturer specifications and other information notices which are applicable to the newly installed x-ray machine systems or components.
2.4.2.8 A “Notice of Registrant's Rights” Department Form R-65 shall be furnished to the registrant prior to beginning the service or evaluation, whenever a business relationship exists between the qualified inspector and services and servicing provider. This includes when a qualified inspector is also authorized to perform services and servicing, when a qualified inspector is also a qualified expert, and when a qualified inspector, a qualified expert and/or a services and servicing provider is a member of the same corporation, partnership or other formal business relationship.
2.4.2.9 Audits.
(1) The Department shall audit the servicing and services of each registrant and the proficiency of each service company engineer.
(2) Service companies who fail to adequately comply with the provisions of these regulations shall be subject to 2.4.8.
2.4.3 Application for Registration of Qualified Inspectors.
A qualified inspector shall meet the criteria established in Appendix 2B.
2.4.3.1 Non-Department individuals requesting Department approval to perform certification evaluations of radiation machines and facilities shall submit to the Department an application for authorization to perform such evaluations. The application shall be submitted on Department Form R-53, “Application for Registration of a Qualified Inspector,” together with the required fee prescribed in Appendix 2A.
2.4.3.2 Authorization to perform certification evaluations in accordance with the requirements of these regulations shall be for a period of two (2) years. The Department shall provide written notification of the authorization to the qualified inspector.
(1) The Department may withdraw, limit or qualify its approval of individuals to perform certification evaluations upon determining that such action is necessary in order to prevent undue hazard to public health and safety.
(2) In any case in which a qualified inspector, not less than thirty (30) days prior to the expiration of the qualified inspector’s authorization to perform certification evaluations, has filed an application in proper form for renewal or for a new registration authorizing the same activities, such existing authorization shall not expire until final action by the Department.
(3) No qualified inspector shall perform certification evaluations on radiation machine systems or facilities that are not specifically stated for that qualified inspector on the Notice of Registration issued by the Department.
(4) Audits.
The Department shall audit the evaluation findings and inspection procedures of qualified inspectors. A qualified inspector who fails to adequately evaluate radiation machine systems and facilities, or who fails to provide complete and accurate certification reports, or who fails to comply with the provisions of these regulations, shall be subject to the withdrawal of Departmental approval.
2.4.3.3 Instrumentation.
Measurements shall be made with instruments that are sufficiently sensitive to determine compliance with these regulations.
(1) The instruments must be maintained and used in good working order.
(2) Not withstanding the requirement of 4.17.2, such equipment shall be calibrated every two (2) years, or in accordance with the manufacturer's recommendations, whichever is more frequent, or after any repair that could affect the calibration.
(3) Calibrations shall be NIST-traceable where such traceability is feasible.
(4) In lieu of calibration, instrument accuracy may, with Department approval, be determined by intercomparison with a suitable and appropriately calibrated instrument.
(5) Each intercomparison protocol shall be submitted to the Department for review and approval.
(a) The comparison shall be between an instrument that has a current calibration traceable to the National Institute of Standards and Technology (NIST) and an instrument for which a calibration factor is to be determined.
(b) The comparison shall be made using the actual physical quantity to be routinely measured (radiation energy/quality, visible light spectrum, etc.) and shall be compared in the same physical geometry.
(c) Intercomparisons shall be NIST-traceable.
2.4.3.4 Instrumentation for Mammography.
Instruments used for the certification evaluation report to measure the air kerma or air kerma rate of mammography machines shall be calibrated at least once every two (2) years and each time the instrument is repaired. The instrument calibration shall be NIST- traceable and shall be calibrated with an accuracy of + or - six (6) percent (95 percent confidence level) in the mammography energy range.
2.4.4 Approval of Mammographers and Provisional Mammographers.
2.4.4.1 Mammographers as defined in 2.4 are approved by the Department to perform mammography examinations. In addition, mammographers shall meet the requirements of 21 CFR Part 900, Section 900.12(a)(2), April 1, 2004.
2.4.4.2 Radiologic technologists in training who are not registered in mammography by the American Registry of Radiologic Technologists (ARRT) shall apply to the Department for approval as a provisional mammographer.
(1) A provisional mammographer certificate shall be issued for one year as part of a structured training program in mammography. During the one year structured training program, the provisional mammographer shall at all times be under the direct supervision of a qualified mammographer who shall be present on the premises and available for prompt consultation. The provisional certificate for training under this section, 2.4.4.2(1), may not be renewed.
(2) The structured training program shall include, at a minimum, 40 contact hours of documented training specific to mammography under the direct supervision of a qualified mammographer. The hours of documented training shall include, but not necessarily be limited to:
(a) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging of patients with breast implants;
(b) The performance of a minimum of 25 examinations under the direct supervision of a qualified mammographer; and (c) At least eight (8) hours of training in each mammography modality to be used by the technologist in performing mammography examinations.
(3) A fully trained and experienced technologist may apply for a six (6) months operator's provisional certificate subsequent to such training as described in 2.4.4.1 while waiting for the mammography certification test to be given by the ARRT and for the test results to be released. The six (6) month provisional certificate may be renewed only once.
(4) A student radiologic technologist, enrolled in an ARRT-recognized two-(2)-year program, shall be exempt from the requirement of 2.4.4.1, so long as the student remains under the direct supervision of a qualified mammographer during the two-(2)-year program.
2.4.4.3 Application for registration for a provisional certificate shall be completed on forms furnished by the Department and shall contain all the information required by the form and any accompanying instructions.
(1) The application shall be submitted to the Department together with the applicable fee specified in Appendix 2A.
(2) The provisional certificate shall be displayed in the room/area where patient examinations are performed.
2.4.5 Registration by the Department.
This section applies to facility registrants, qualified inspectors, and servicing and services.
2.4.5.1 Upon a determination that an applicant meets the requirements of the regulations, the Department shall issue a Notice of Registration.
2.4.5.2 The Department 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 activities as the Department deems appropriate or necessary.
2.4.6 Report of Changes.
The registrant shall notify the Department in writing within thirty (30) days of making any change which would render inaccurate the information contained in the application for registration and/or, as appropriate, the Notice of Registration.
2.4.7 Approval Not Implied.
No person, in any advertisement, shall refer to the fact that the facility is registered with the Department pursuant to the provisions of 2.4.1, 2.4.2, and 2.4.3, and no person shall state or imply that any activity under such registration has been approved by the Department. REVOCATION OF REGISTRATIONS
2.4.8 Modification and Revocation of Registration.
The terms and conditions of all registrations/certificates shall be subject to amendment, revision, or modification or the registration/certificate may be suspended or revoked by reason of amendments to the Act, or by reason of rules, regulations, and orders issued by the Department. CERTIFICATION EVALUATIONS
2.5 Certification Evaluations.
2.5.1 Frequency of Certification Evaluations.
Each radiation machine registrant shall have its radiation machine(s) and facility evaluated by a Department-approved qualified inspector in accordance with the frequency established in 2.5.1.1 through 2.5.1.2. Such evaluations shall be capable of determining if the machine is safe for the intended uses and in compliance with the specifications of the State Board of Health and the equipment manufacturer. However, these evaluations are in addition to and not intended to replace the recommended equipment service procedures or facility quality assurance programs for purposes of manufacturer(s) equipment repair or quality assurance.
2.5.1.1 Frequency of Inspection by Type
Type Frequency General Purpose Every year Stationary and Mobile Radiographic, Fluoroscopic and Chiropractic Mobile Industrial Every year Radiography, Excluding Airport Inspection, Analytical and Cabinet X-ray Systems Computed Tomography Every year Veterinary, Podiatric, and Every 3 years Dental Out-of-State Radiation Within 1 year prior to Machines (see 2.8, entering State Reciprocity)
Fixed Industrial, i.e., Every 2 years Fixed Radiography Airport Inspection, Every 2 years Analytical and Cabinet X-ray Systems Machines Specifically Every 3 years Designed for and Limited to Bone Densitometry All Other (for example, Every year, unless cone beam systems of otherwise authorized by types specified by the the Department Department)
(1) Podiatry and dental radiation machine facilities that operate radiographic x-ray machine(s) or tomographic or computed tomographic systems that have variable kilovoltage peak (kVp), and variable milliamperage (mA), and variable collimation, shall have these systems evaluated on an annual (every year) frequency.
(2) Podiatry machines that operate at less than or equal to 30 mA shall be evaluated every three years.
(3) Each certification evaluation subsequent to the initial certification evaluation shall be completed in the same month as the previous certification evaluation.
(4) Not withstanding the requirements of 2.5.1.1(3), the registrant may have a certification evaluation of a machine in a month prior to the month in which it is due, which shall become the new month in which the certification is due.
(5) A certification evaluation conducted after the month in which it was due shall not alter or change the month in which subsequent certification evaluations are due.
(6) Each computed tomography inspection shall be by a qualified inspector who is also a qualified expert.
(7) For types of systems specified by the Department pursuant to 2.5.1.1, “All Other” , each initial and subsequent certification evaluation shall be by a qualified inspector who is also a qualified expert, unless otherwise authorized by the Department.
2.5.1.2 New Installations.
All new installations of radiation machine systems or replacement components which affect or could potentially affect a change in the radiation output shall be evaluated within three (3) months of installation except that new installations of mammography systems shall be evaluated by a qualified inspector authorized in mammography prior to being used to perform human examinations.
2.5.1.3 State Inspections.
Any radiation machine and/or facility not inspected in accordance with 2.5.1.1 through 2.5.1.2, or otherwise determined to be out of compliance with these regulations, shall be subject to a Department enforcement inspection and subject to the fees specified in Appendix 2A.
2.5.2 Procedures for Certification Evaluations.
2.5.2.1 Inspection Procedures.
(1) For evaluation of radiation machines and facilities, each qualified inspector shall use procedures, which are adequate for determining compliance with the regulations.
(2) Each qualified inspector shall perform radiation machine system and facility evaluations within the category or categories authorized by the Department.
2.5.2.2 Reporting and Labeling Procedures.
(1) Each qualified inspector shall certify and be responsible to provide accurate and complete Certification Evaluation Reports to the registrant/facility and to the Department on Department Form R-59-1, “X-Ray Facility Certification Evaluation Report,” in accordance with the instructions contained in that form.
(a) A clear and legible report may be substituted for the Department Form R-59- 1, provided that it is in the same format and provides all of the information required by Department Form R-59-1.
(b) Violations of the regulations not specifically related to the performance of the x-ray machine(s) shall be reported to the Department using Department Form R-59-2, “X-Ray Facility Noncompliance Certification Evaluation Report.”
(2) A qualified inspector shall provide to the registrant and Department a copy of the Certification Evaluation Report. The Report shall indicate compliance or specific violations with these regulations. Recommendations for corrective actions should be provided to the registrant (if applicable) to assist in achieving full compliance and/or improving the quality of the imaging process, and improving radiation safety.
(3) When it is determined that the requirements of these regulations or manufacturer's required specifications are met, the qualified inspector shall affix a certification label issued by the Department in a location clearly visible to the machine operator and/or patient.
(4) If the radiation machine fails to meet the requirements specified by these regulations or manufacturer's required specifications, the qualified inspector shall notify the registrant/owner immediately and shall notify the Department within three (3) business days after identifying that the facility is in noncompliance.
(5) If the radiation machine fails to meet the requirements specified by these regulations or required manufacturer specifications and is determined to be unsafe for human use, as described in Appendix 2C, the qualified inspector shall:
(a) Affix to such radiation machine system an “Unsafe for Human Use” label issued by the Department indicating such machine is not authorized for human use. The label shall be affixed in a location clearly visible to the patient.
(b) Notify the registrant/owner immediately and shall notify the Department within three (3) business days after identifying that the facility is in noncompliance.
(6) Concealing, defacing or altering of Department issued labels is prohibited.
(7) Labels shall only be affixed by a qualified inspector on the basis of the certification evaluation.
2.5.2.3 Department Actions.
(1) The Department shall notify the registrant regarding inaction on any item of violation. The Department shall specify a date by which compliance must be achieved.
(2) The Department shall confirm and, if appropriate, verify by inspection, a registrant’s corrective actions to assure compliance of these regulations.
(3) The Department shall charge an inspection fee for the inspection of a radiation machine system or facility if the registrant fails the requirements stated in 2.5.1, or if any item of violation has not been corrected in accordance with the compliance schedule established in 2.5.2.3.1. The Department inspection and fee schedule payment shall be in accordance with Appendix 2A.
2.6 Facility Registrant Responsibilities.
2.6.1 The registrant shall be responsible to ensure that the requirements of these regulations are being complied with for the operation of the radiation machine facility.
2.6.1.1 In any facility regulated by or requiring registration under these regulations, the registrant shall allow only individuals who are adequately trained in radiation safety and the safe and effective use of the machine to operate any radiation machine.
2.6.1.2 At least annually, the registrant shall make a written evaluation of the qualifications of all persons permitted to operate any or all radiation machines at the facility. Records of such evaluations shall be maintained by the facility and produced for examination upon request during any inspection conducted under the requirements of these regulations.
2.6.1.3 Any physician, licensed by the appropriate licensing board, may operate radiation machines as part of the physician’s medical practice and shall be exempt from the provisions of 2.6.1.1 regarding adequate training.
2.6.1.4 A student, enrolled in an ARRT-recognized two-year program, shall be exempt from the requirement 2.6.1 for the duration of the two-year program, so long as the student works under the direct supervision of a qualified radiologic technologist and has documentation from the program that the student has completed education and experience equal to that specified in the adequate training appendices of this part as appropriate for the assigned use of x-ray systems or any radiation machine.
2.6.1.5 Department approval of training as adequate pursuant to 2.6.1.6, 2.6.1.7, 2.6.1.8 and / or 2.6.1.9 shall pertain only to the areas of training and experience specifically named in the Department approval.
(1) Limited-scope x-ray machine operator approval is limited to imaging procedures for x- ray examination of the skull, chest, spine, upper extremities and lower extremities. A limited-scope x-ray machine operator shall not perform radiologic procedures involving the administration or utilization of contrast media, fluoroscopic equipment, mammography, computed tomography, or radiation therapy procedures.
(2) The application for training review and approval or for an examination administered by the Department shall be completed on forms furnished by the Department and shall contain all the information required by the form and any accompanying instructions. The application fee(s) specified in Appendix 2A shall accompany the application.
(3) The Department may, upon application or upon its own initiative, accept as being adequate:
(a) Documented combinations of radiation safety training and experience;
(b) Equivalent approval by another state or agency;
(c) For an individual in practice for a minimum of three of the immediately preceding past five years prior to July 1, 2005, a signed written attestation by the operator and supervisor(s) that the applicable requirements have been met sufficiently to qualify the individual by virtue of prior training and experience.
2.6.1.6 For radiographic x-ray systems used on living humans, “adequately trained” shall mean that the individual has met the requirements of Appendix 2D by:
(1) Being an ARRT-registered radiologic technologist, or having at least equivalent training, certification and/or registration; or (2) Having been approved as a limited-scope x-ray machine operator by passing the Department-required examination.
2.6.1.7 For computed tomography systems used on living humans, “adequately trained” shall mean that the individual has met the requirements of Appendix 2E by:
(1) Being an ARRT-registered radiologic technologist who is also either ARRT- registered in computed tomography or has met the requirements of Section 2E.2.2 in Appendix 2E; or (2) Being certified in computed tomography by a specialty board recognized by the Department, including or in combination with training accepted by the Department.
2.6.1.8 For bone densitometry equipment used in examination of living humans, “adequately trained” shall mean that the individual has met the requirements of Appendix 2F by:
(1) Being an ARRT-registered radiologic technologist or equivalent for bone densitometry; or (2) Being certified in bone densitometry by a specialty board recognized by the Department, including or in combination with training accepted by the Department; or (3) Having been approved as a bone densitometry equipment operator by passing the Department-required examination.
2.6.1.9 For fluoroscopy equipment used in examination of living humans, “adequately trained” shall mean that the individual is an ARRT-registered radiologic technologist, or has at least equivalent certification and/or registration or licensure, including or in combination with training for fluoroscopy accepted by the Department.
2.6.2 If a radiation machine or facility fails to meet the requirements of these regulations or required manufacturer specifications the facility registrant shall:
2.6.2.1 If a radiation machine has been determined to be unsafe for human use
(1) Not use the radiation machine thereafter for human use until subsequent certification by a Department-approved qualified inspector; and (2) Notify the Department of the appropriate corrective action plan within fifteen (15) calendar days of the inspection.
2.6.2.2 Correct any items of violation within the time specified by the Department.
2.6.2.3 Provide documentation to the qualified inspector upon correction of any radiation machine items of violation to confirm that indicated violations and repairs have been completed to bring the radiation machine system and/or facility into compliance. Copies of service reports may be acceptable evidence of completed corrective actions.
2.6.2.4 Provide documentation to the Department upon correction of any facility items of violation to confirm that indicated violations have been addressed to bring the facility into compliance.
2.6.2.5 The facility registrant shall pay the required fee of $50 for each certification label issued to the registrant by the qualified inspector.
2.6.3 Record Retention.
2.6.3.1 The registrant shall maintain for a period of three years (six years for a facility or machine inspected only every three years) copies of personnel qualifications, facility and machine certification evaluations, notice of violations, complaints, investigations, and service records for the x-ray machines and processors for review by the Department.
2.6.3.2 The registrant shall maintain for the duration of the registration, records of shielding evaluations performed for the facility; and until a machine is retired from service, the operator's and service manual provided by the manufacturer, if available.
(1) If the operator's manual is not obtainable from the manufacturer, one must be developed and maintained by the registrant. This shall contain written operating procedures to be followed, including:
(a) A description, including purpose and function, of each control panel knob, button, and meter;
(b) Techniques for collimation and centering of the beam to the image receptor;
(c) The function of all locks and detents; and (d) Emergency shutdown instructions.
The registrant shall permit radiation machine servicing or services as described in 2.4.2.4 only by a person that provides evidence of current registration with the Department as a provider of services in accordance with these regulations.
2.7 Assembler and/or Transfer Obligation.
2.7.1 Any person who sells, leases, transfers, lends, disposes, assembles, trades out or installs radiation machines, or components, which affect radiation output in this State shall notify the Department in writing within fifteen (15) days of installation with the following information:
2.7.1.1 The full name and address of each person who has received the radiation machines or components and the specific location within the facility; and 2.7.1.2 Specific information of the x-ray system or sub-system, including the manufacturer, model, and serial number of each radiation machine or component transferred; and 2.7.1.3 The date of transfer, assembly, or installation of each radiation machine or component; and 2.7.1.4 An affirmation that all instruction manuals and other information as required by the Federal Performance Standard (21 CFR 1020.30(d), April 1, 2004) and a copy of these regulations applicable to the newly installed x-ray machine system or components have been delivered to the registrant.
2.7.2 A report of assembly of a diagnostic x-ray system (Form FDA 2579 or equivalent) submitted in compliance with requirements of the Federal Performance Standard (21 CFR 1020.30(d), April 1, 2004) shall be submitted to the Department within fifteen (15) days following completion of the assembly. Such report shall suffice in lieu of any reports required in 2.7.1.
2.7.3 The assembly is considered completed and operational when the unit is ready for its intended use.
2.7.4 No person shall make, sell, lease, transfer, lend, assemble, or install radiation machines, components or the supplies used in connection with such machines unless such supplies and equipment when property placed in operation and used shall meet the manufacturer's specifications and the requirements of these regulations. RECIPROCITY
2.8 Out-of-State Radiation Machines.
2.8.1 Subject to these regulations, any person who desires to bring radiation machines into this state for temporary use is hereby granted authorization to conduct activities using these machines for a period not to exceed 180 days in any calendar year, provided that:
2.8.1.1 The out-of-state registration, and/or other documents authorizing the use of radiation machines issued by the agency having jurisdiction where the out-of-state registrant maintains an office for directing the registered activity and at which radiation safety records are normally maintained, does not limit the activity authorized by such document to specified installations or locations; and 2.8.1.2 The person proposing to bring such machines into Colorado shall give written notice to the Department at least three (3) working days before such machine is to be used in the state. The notice shall be made using the Department's “X-ray Reciprocity Request” Form R-200 and shall include all information required by that form.
(1) As part of this notice, the person requesting reciprocity shall certify that (1) a copy of all applicable parts of these regulations shall be available at each use location in Colorado; (2) each machine has been evaluated and determined to be in compliance with these, or equivalent, regulations; and (3) that the operation of each radiation machine shall be in accordance with the applicable requirements of these regulations.
(2) In the case of requests to perform a healing arts screening program within this state, the information required in Part 6, Appendix 6C, must be included with the reciprocity request.
(3) In the case of requests to perform mammography screenings within this state, a copy of the person's mammography certificate issued by the FDA (21 CFR 900.11(a), April 1, 2004) must be included with the reciprocity request.
(4) The person requesting reciprocity shall also supply such other information as the Department may request.
2.8.1.3 The out-of-state registrant complies with all applicable regulations of the Department; and 2.8.1.4 The out-of-state registrant shall at all times during work at any work location within Colorado have available the pertinent documentation as required by these regulations, including:
(1) Pertinent registration documentation;
(2) Written authorization from the Department for in-state activities;
(3) Applicable sections of these regulations;
(4) Documentation that each radiation machine has been evaluated in accordance with these regulations, or other state regulations which are equivalent and that the machines comply with the manufacturer's recommended specifications. Evaluations shall have been performed within one year prior to entry into the State as required in 2.5; and (5) In the case of mammography related functions, a copy of the mammography certificate, quality control records, personnel records, and the most recent medical physicist survey.
2.8.2 Based upon an application that includes documentation of why it is not possible or is an undue hardship to provide three (3) days notice, the Department may grant permission to proceed sooner. The Department may also waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities pursuant to 2.8.1.
2.8.3 While in the State of Colorado, all radiation machines may be required to be inspected and/or certified by a qualified inspector who is registered with this Department.
2.8.4 The out-of-state registrant shall notify the Department within one hour after arrival at the actual work location within Colorado and shall notify the Department within one hour after any change of work location within Colorado.
2.8.5 If multiple individuals work concurrently at more than one work location under an approval granted pursuant to this 2.8.1, each day worked per location shall be counted separately toward the limit of 180 days per calendar year.
2.8.6 The Department may revoke, limit, or qualify its approval for the use of radiation machines in Colorado upon determining that the approval was based on false or misleading information submitted to the Department or that such action is necessary in order to prevent undue hazard to public health and safety or property.
2.8.7 Each person operating a radiation machine within Colorado under reciprocity in areas of exclusive federal jurisdiction shall comply with the applicable federal requirements. PART 2, APPENDIX 2A: SCHEDULE OF FEES FOR RADIATION MACHINE SERVICES SCHEDULE OF FEES FOR RADIATION MACHINE SERVICES 4 Category of Radiation Type of fee Maximum Fee Maximum Frequency Machine Services 5 . $129 Per Hour 1. Hourly Rate 6 Certification 7 Each Enforcement Action 2. Enforcement Action $1,157 3. Qualified Inspector or Registration 9 Every 2 Years $160 Servicing and Services 4. Provisional Certification $50 Each Review Mammography 5. Adequate Training Acceptance $50 Each Review 4 Fees listed in Appendix 2A “Schedule of Fees for Radiation Machine Services” are maximum amounts that may be billed for these categories. In no event will the fee exceed that shown in this schedule. 5 Hourly rate. All services rendered by the Department will be based on actual cost and the hourly fee for services will be adjusted every six months from the effective date of these regulations, and an updated version of the fee schedule shall be available upon request. The adjustment will be based on the Denver Consumer Price Index for all urban consumers. Every two (2) years from the effective date of these regulations, the Department will review the fees and the Department's costs. If the adjusted fees and costs for any categories differ by more than ten (10) percent, the Department will propose a revised fee to the State Board of Health for those categories. For each hourly-rate service rendered by the Department, records will be maintained of time spent, by at least fifteen (15) minute intervals, using reasonable accounting procedures. A statement will be sent to the registrant indicating the actual costs incurred.
6 Any registrant that fails the requirements of 2.5.1, or does not correct any violation in accordance with the compliance schedule established in 2.5.2.3, shall be subject to a Department enforcement action at the current hourly rate and/or maximum fee. The Department shall charge enforcement fees, which may include inspection fees for the inspection of radiation machines and facilities that have been determined, by either a qualified inspector or by the Department, to be in noncompliance with these regulations and with the certification frequency. These fees do not include penalties imposed under Part 13. 7 This represents the maximum fee that may be incurred for the Department enforcement actions of each radiation machine and/or facility determined to be in violation with these regulations by either a qualified inspector or by the Department. 8 Qualified inspector registration fee is an individual fee. Servicing and services registration fee is a company fee. 9 The annual fee is $80 and is payable every two (2) years in the amount of $160. This fee is non-refundable in the event that the application is not approved by the Department.
PART 2, APPENDIX 2B: MINIMUM QUALIFICATIONS FOR QUALIFIED INSPECTOR TIER 1 MINIMUM QUALIFICATIONS FOR QUALIFIED INSPECTOR TIER 1 10, 11 Tier 1 includes individuals who are considered by the Department to be fully qualified by virtue of both education and experience.
Tier 2 is a preparatory program for individuals who do not meet the minimum experience requirements for qualified inspector status.
Tier 1 10, 11 The established minimum education and experience criteria for individuals are listed for Tier 1 qualified inspector status. The following are representative but not all inclusive lists of the qualifications of individuals who may have sufficient experience and or training to be given the status of qualified inspector.
10 Tier 1 inspectors are required to meet more stringent qualifications and assume the primary responsibility for all inspections. Tier 2 inspectors are defined as less qualified individuals who are required to work under the direction of Tier 1 inspector(s). This system provides for a mechanism whereby individuals could gain the experience to qualify as Tier 1 inspectors. 11 Receiving approval in one category does not automatically permit inspectors to perform inspections in other categories.
1. Education and Experience a. General Requirements:
GENERAL REQUIREMENTS FOR QUALIFIED INSPECTOR EDUCATION AND EXPERIENCE Education / Experience Certification Board-certified in Not Applicable Diagnostic Radiologic Physics or Radiologic Physics by the American Board of Radiology; or board-certified in Diagnostic Imaging Physics by the American Board of Medical Physics; or Other board certifications 6 months by the American Board of Radiology or comprehensive certification by the American Board of Health Physics; or Doctorate or Masters; or 1 year B.A./B.S.; or 2 years Associate Degree; or 3 years Registered Radiologic 4 years Technologist (Radiography)
b. Educational/Experience Requirements:
(1) The formal education shall be in a related discipline, such as medical physics, health physics, physics, biophysics, biomedical engineering, or equivalent.
(2) For each category of radiation machine for which approval is requested, the experience shall include but not be limited to: measuring ionizing radiation; evaluating radiation machines and components; film processing; and familiarity with the appropriate requirements stated in these regulations.
c. Specific Qualifications for a Qualified Inspector to Inspect Mammography Facilities: Prior to authorization as a qualified inspector for mammography facilities, an applicant shall:
(1) Be board-certified in diagnostic radiologic physics or radiologic physics by the American Board of Radiology; or board-certified in diagnostic imaging physics by the American Board of Medical Physics; or board-certified in an equivalent specialty area by another certifying body recognized by the American College of Radiology; or (2) Hold a master of science, master of arts, or higher degree in the field of physics, applied physics, radiologic physics, biophysics or health physics; have at least two (2) years of training in medical physics in the area of clinical diagnostic radiologic physics; and have had at least three (3) years of experience in conducting mammography equipment performance evaluations; and (3) Have twenty (20) contact hours of documented specialized training in conducting surveys of mammography facilities; and (4) Have the experience of conducting surveys of at least one mammography facility and a total of at least ten (10) mammography units. No more than one survey of a specific unit within a period of sixty (60) days can be counted towards the total mammography unit survey requirement. This experience must be accomplished under the direct supervision of a currently registered qualified inspector in mammography; and (5) Have documented a minimum of fifteen (15) hours of continuing education in mammography which are no more than thirty-six months old; and (6) Have surveyed at least two (2) mammography facilities and a total of at least six (6) mammography units. This experience shall not be more than twenty-four (24) months old; and (7) If performing a certification evaluation including a new modality of mammography imaging, have a minimum of eight (8) hours of training in the new modality prior to performing such a certification evaluation independently; and (8) If the applicant fails to meet the continuing education requirement, obtain the additional continuing education hours, prior to performing any certification evaluation; and (9) If the applicant fails to meet the continuing experience requirement, complete a sufficient number of certification evaluations under the supervision of a currently registered qualified inspector in mammography or a MQSA approved medical physicist to bring the applicant’s total certification evaluations up to the required two (2) facilities and six (6) units in the previous twenty-four (24) months.
2. Proficiency testing for all applicants The Department shall audit proficiency of each qualified inspector. In addition, each applicant shall demonstrate to the Department a satisfactory knowledge of the applicable provisions of the State of Colorado Rules and Regulations Pertaining to Radiation Control .
3. Calibration Records Applicable measuring instruments and devices shall be sufficiently sensitive and calibrated in accordance with 2.4.3.3 to determine compliance with the applicable provisions of the State of Colorado Rules and Regulations Pertaining to Radiation Control . Current calibration records shall be submitted upon initial application and each subsequent renewal application. These records shall be readily available for the Department's review upon reasonable request. Tier 2 An individual who meets the educational but not the experience qualifications listed for a Tier 1 inspector can apply for Department approval to perform evaluations under the tutelage and supervision of a Tier 1 inspector. Before an individual can apply for Tier 2 status, the individual must have worked directly with a Tier 1 inspector for three (3) months. The Tier 1 sponsor shall provide the Department adequate documentation that these requirements are met.
Each individual in this category must submit an application to the Department prior to performing any certification evaluations. The application shall include the name and signature of each Tier 1 individual with whom the applicant will be working.
Each submitted Certification Evaluation Report shall be signed by the Tier 2 inspector and the Tier 1 sponsor. The final responsibility for the content of the report belongs to the Tier 1 inspector who sponsors the Tier 2 inspector.
PART 2, APPENDIX 2C: CRITERIA FOR CLASSIFYING A MACHINE UNSAFE FOR ROUTINE HUMAN USE CRITERIA FOR CLASSIFYING A MACHINE UNSAFE FOR ROUTINE HUMAN USE The operating condition of an x-ray machine and related equipment may be such that the continued operation of that machine endangers the public health and safety. An x-ray machine shall be considered unsafe for human use if:
1. The x-ray machine system has a malfunctioning component or components that could result in an inadvertent exposure to members of the public, the operator, or the patient. Examples include but are not limited to: a timer which fails to terminate the exposure, an exposure switch when activated once produces multiple exposures, a system which produces x-rays without activation of the exposure switch.
2. The x-ray machine is not equipped with a means of determining when x-rays are in production.
3. The x-ray machine is equipped with variable technique factors and the selectors and/or indicators of these technique factors do not permit the operator to determine the factors in use or if the indicated versus the technique factor(s) are in error by fifty (50) percent or more, except for exposure times selected less than 50 millisecond.
4. The collimation of the x-ray beam of a fluoroscopic/spot film system is such that either the length or width of the x-ray field in the plane of the image receptor differs (in excess) from the corresponding image receptor dimensions by more than 25 percent of the source to image distance (SID).
5. The half-value layer of aluminum (or equivalent) filtration in the useful beam is more than fifty (50) percent below the values specified in 6.4.5.1.
6. In addition to the above items a fluoroscopic x-ray system will be considered unsafe if:
a. No operational image intensifier is provided.
b. Except for radiation oncology simulators, the primary protective barrier does not intercept 100 percent of the x-ray beam of a fluoroscopic x-ray system.
c. Except for radiation oncology simulators, the fluoroscopic x-ray system is capable of producing x-rays when the primary protective barrier is not in position to intercept the beam.
d. The fluoroscopic x-ray system has a tabletop entrance exposure rate equal to or greater than 25 R/min at the point where the useful beam enters the patient, except:
(1) During the recording of fluoroscopic images, or (2) When an optional high-level control is activated.
Note that this is normal fluoroscopic mode, and the FDA's regulations (21 CFR 1020.32(e)(2)(II), April 1, 2004) allow up to 20 R/min when recording or using high- level control.
7. An electro-mechanical defect exists which endangers human life when a radiograph is made or fluoroscopy is performed.
PART 2, APPENDIX 2D: X-RAY SYSTEM OPERATOR ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE, INCLUDING LIMITED-SCOPE X-RAY MACHINE OPERATOR (LSO)
X-RAY SYSTEM OPERATOR ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE, INCLUDING LIMITED-SCOPE X-RAY MACHINE OPERATOR (LSO)
The registrant shall require each x-ray system operator to be an individual at least 18 years of age who: 2D1 Is certified or registered by:
2D1.1 The American Registry of Radiologic Technologists; or 2D1.2 A specialty board that has been recognized by the Department, including or in combination with documentation accepted by the Department of the training required by 2D4A through 2D4F; or 2D2 Is accepted in accordance with 2.6.1.5(3) by the Department as having met, prior to July 1, 2005, the requirements of Rule 700 of the Colorado Board Of Medical Examiners; or 2D3 Is accepted by the Department as having:
2D3.1 Been enrolled, prior to July 1, 2005, in a limited-scope x-ray machine operator radiologic technology program that is accredited by a national accrediting institution recognized by the U.S. Department of Education;
2D3.2 Completed that program prior to July 1, 2007; and 2D3.3 Passed the LSO test with a score of 75% or higher on each portion of the test; or 2D4 Is accepted by the Department as a limited-scope x-ray machine operator, having satisfactorily completed:
[Elements of the following are from the 20015 Content Specifications For The Examination For The Limited Scope Of Practice In Radiology and used with ARRT permission.] 2D4.1 At least 80 hours of didactic training providing the minimum hours of instruction in the specific subjects listed in 2D4A through 2D4F:
RADIATION SAFETY (passing score on written test of 75% or higher on the radiation safety module)
2D4A Basic X-Ray Physics—20 hours 1. Structure of matter and the atom 2. General description of production of x rays 3. X-ray emission, quantity and quality 4. Function of filtration and effects it has on x-ray beam collimation 5. Types of function of beam limiting devices 6. Design, features and functions of x-ray tubes 7. Circuitry of the x-ray machine 2D4B Radiobiology—3 hours 1. Effects of ionizing radiation to the human body 2. Molecular and cellular radiobiology 3. Factors that cause somatic and genetic damage 2D4C Radiation Protection—6 hours 1. ALARA 2. Shielding materials 3. Radiation quantity and units of measurement 4. Basic interactions of x-rays with matter 5. Primary and secondary scatter 6. Importance of time, distance, shielding 7. Maximum permissible doses: occupational and public 8. Patient protection RADIOGRAPHIC PROCEDURES (passing score on written test of 75% or higher on radiographic procedures module 2D4D Principles of Exposure—15 hours 1. Factors that control and influence radiographic quality 2. Properties of x-rays 3. Size distortion 4. Shape distortion 5. kVp, mAs, time 6. AEC and manual 7. Grids 8. Collimation 9. Intensifying screens 10. X-ray films and holders 11. Artifacts 12. Inverse square law 2D4E Procedures and Processing—4 hours 1. Film storage and handling 2. Manual, automatic processing film processing and troubleshooting 3. Computed Radiography (CR)
4. Digital Radiography (DR)
5. PACs 6. Quality assurance / quality control 2D4F Anatomy and Positioning—32 hours 1. Chest—4 hours 2. Extremity—12 hours 3. Spine—8 hours 4. Skull—8 hours; and 2D4.2 At least 480 hours of clinical training during which time the individual may perform x-ray examinations only under personal (in attendance during the procedure) supervision of a qualified trainer, including:
2D4.2.1 At least 320 hours experiential training at a clinic; and 2D4.2.2 No more than 160 hours of laboratory training (exclusive of the didactic hours required by 2D4A through 2D4F); and 2D4.3 Performance of the following imaging procedures ( at least 80 examinations in total, with record of each examination kept on file):
2D4.3.1 Ribs—4 examinations 2D4.3.2 Hand—4 examinations 2D4.3.3 Wrist—4 examinations 2D4.3.4 Forearm—4 examinations 2D4.3.5 Elbow—4 examinations 2D4.3.6 Humerus—4 examinations 2D4.3.7 Shoulder—4 examinations 2D4.3.8 Clavicle—4 examinations 2D4.3.9 Femur—4 examinations 2D4.3.10 Tibia - Fibula—4 examinations 2D4.3.11 Ankle—4 examinations 2D4.3.12 Foot—4 examinations 2D4.3.13 Sinuses—4 examinations 2D4.3.14 Skull—4 examinations 2D4.3.15 Facial Bones—4 examinations 2D4.3.16 C-Spine—4 examinations 2D4.3.17 Thoracic Spine—4 examinations 2D4.3.18 Lumbar Spine—4 examinations 2D4.3.19 Chest—4 examinations 2D4.3.20 Hip / Pelvis—4 examinations 2D5 Has maintained a minimum of twenty-four (24) hours of continuing education every two years in the areas of radiology, radiation safety, radiography and similar fields. This education shall: 2D5.1 Conform to guidelines equivalent to the July 1, 2004 ARRT Continuing Education Requirements For Renewal Of Registration ; and 2D5.2 Be documented by certificate(s) or other attestation(s) of satisfactory completion. PART 2, APPENDIX 2E: COMPUTED TOMOGRAPHY (CT) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE COMPUTED TOMOGRAPHY (CT) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The registrant shall require each computed tomography operator to be an individual at least 18 years of age who:
2E1 Is certified:
2E1.1 As ARRT(R) and also certified in computed tomography by ARRT; or 2E1.2 As ARRT(N) or ARRT(T); or 2E1.3 As CNMT by the Nuclear Medicine Technologist Certification Board; or 2E1.4 By a specialty board that has been recognized by the Department, including or in combination with documentation accepted by the Department for the training required by 2E2A through 2E2L; or 2E2 Is ARRT(R) and also has satisfactorily completed:
[Elements of the following are from the July 2004 Content Specifications For The Examination In Computed Tomography and used with ARRT permission.] 2E2.1 At least 60 hours of didactic training providing the minimum hours of instruction in the specific subjects listed in 2E2A through 2E2L:
2E2A IV Procedures—2 hours 1. Venipuncture
2. Injection techniques
1. Types
2. Administration route and dose calculations
3. Special considerations
4. Adverse reactions
1. Technical factors affecting patient dose 2. Radiation protection 3. CT Dose Index (CTDI) / Multiple Scan Average Dose (MSAD) 4. Pediatric dose reduction 2E2D Type of Study (24 hours; 1 hour for each topic—2E2E, 2E2F, 2E2G and 2E2H—for each type of study)
1. Head 2. Neck 3. Chest 4. Abdomen 5. Pelvis 6. Musculo-skeletal 2E2E Sectional Anatomy (for each type of study)
1. Sagittal plane 2. Transverse plane (axial)
3. Coronal plane 4. Off-axis (oblique)
5. Landmarks 6. Pathology recognition 2E2F Contrast Media (for each type of study)
1. Types of agents 2. Indications 3. Contraindications 4. Dose calculation 5. Administration route 6. Scan/prep delay 2E2G Scanning Procedures (for each type of study)
1. Positioning 2. Scout 3. Acquisition methods (e.g., spiral, non spiral, dynamic, multi-row detector) 4. Parameter selection (e.g., slice thickness, mA, time, algorithm, pitch) 5. Protocol modification for pathology or trauma 2E2H Special Procedures (for each type of study)
1. 3-D studies 2. Biopsies 3. Radiation therapy planning 4. Drainage and aspiration 5. Post-myelography 6. CT arthrography and angiography 7. Cardiac gating 2E2I Systems Operation and Components—4 hours 1. Tube 2. Detector (single row and multi row)
3. Collimation 4. Computer and array processor 5. Equipment maintenance 2E2J Image Processing & Display—10 hours 1. Image reconstruction
2. Image display
3. Post-processing
4. Data management
1. Spatial resolution 2. Contrast resolution 3. Noise 4. Quality assurance procedures 2E2L Artifact Recognition and Reduction—4 hours 1. Beam hardening 2. Partial volume averaging 3. Motion 4. Metallic 5. Edge gradient 6. Patient positioning 7. Equipment-induced
2E2.2.2 A signed statement by the individual(s) who provided supervision and evaluation shall be kept on file to document dates and locations of clinical training; and 2E2.3 Documented performance of the following imaging procedures ( at least 60 examinations in total, with record of each examination kept on file): 2E2.3.1 Head—10 examinations 2E2.3.2 Neck—10 examinations 2E2.3.3 Chest—10 examinations 2E2.3.4 Abdomen—10 examinations 2E2.3.5 Pelvis—10 examinations 2E2.3.6 Musculo-skeletal—10 examinations PART 2, APPENDIX 2F: BONE DENSITOMETRY (BD) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE BONE DENSITOMETRY (BD) ADEQUATE RADIATION SAFETY TRAINING AND EXPERIENCE The registrant shall require each bone densitometry equipment operator (BDEO) to be an individual at least 18 years of age who:
2F1 Is certified or registered by:
2F1.1 ARRT(R), ARRT(M), ARRT(N), ARRT(T), or CNMT; or 2F1.2 The International Society for Clinical Densitometry (ISCD), combined with or including the didactic radiation safety training in 2F2A, 2F2B and 2F2C; or 2F1.3 A specialty board that has been recognized by the Department, in combination with documentation accepted by the Department for the training required by 2F2A through 2F2I; or 2F2 Is accepted by the Department as having satisfactorily completed: [Elements of the following are from the 2002 Content Specifications for the Bone Densitometry Equipment Operators Examination and used with ARRT permission.] 2F2.1 At least 30 hours of didactic training recognized by the Department that provided the minimum hours of instruction (as part of, or in addition to, specialty certificate and equipment operation training) in the specific subjects listed in 2F2A through 2F2I; RADIATION SAFETY:
2F2A Basic X-Ray Physics—2 hours 1. Structure of matter and the atom 2. General description of production of x rays 3. X-ray emission, quantity and quality 4. Function of filtration and effects it has on x-ray beam collimation 5. Types of function of beam limiting devices 6. Design, features and functions of x-ray tubes 7. Circuitry of the x-ray machine 2F2B Radiobiology—2 hours 1. Effects of ionizing radiation to the human body 2. Molecular and cellular radiobiology 3. Factors that cause somatic and genetic damage 2F2C Radiation Protection—5 hours 1. ALARA 2. Shielding materials 3. Radiation quantity and units of measurement 4. Basic interactions of x-ray with matter 5. Primary and secondary scatter 6. Importance of time, distance, shielding 7. Maximum permissible dose: occupational and public 8. Patient protection
1. Osteoporosis
2. Bone physiology
3. BMD testing methods (anatomical sites scanned, key advantages and disadvantages)
4. Measuring BMD
1. Computer console
2. X-ray energy production
3. Types of DXA systems
4. Quality control
5. Determining quality in BMD
1. Anatomy
2. Scan acquisition
3. Scan analysis: BMD, T score, Z score 4. Common problems
1. Anatomy
2. Scan acquisition
3. Scan analysis
4. Common problems
5. Follow-up scans
1. Anatomy
2. Scan acquisition
3. Scan analysis
4. Common problems
5. Follow-up scans
1. Anatomy
2. Scan acquisition
3. Scan analysis
4. Common problems
5. Follow-up scans
2F2.2.1 “Direct supervision” means the supervisor must be present in the facility and immediately available to furnish assistance and direction throughout the performance of a procedure. The supervisor is not required to be present in the room when the procedure is performed.
2F2.2.2 A signed statement by the individual(s) who provided supervision and evaluation shall be kept on file to document dates and locations of clinical training; and 2F2.3 Performance of the following imaging procedures (at least 30 examinations in total, with record of each examination kept on file):
2F2.3.1 DXA scanning of the forearm—10 examinations 2F2.3.2 DXA scanning of the lumbar spine—10 examinations 2F2.3.3 DXA scanning of the proximal femur—10 examinations 2F3 Has maintained a minimum of eighteen (18) hours continuing education every three years, documented by certificate(s) or other attestation(s) of satisfactory completion.