Part II. Registration of Radiation Machine Facilities and Services
12VAC5-481-260. Purpose and scope.
A. This part provides for the registration of ionizing radiation machine facilities.
B. In addition to the requirements of this part, all registrants are subject to the applicable provisions of Part 1 (12VAC5-481-10 et seq.), Part IV (12VAC5-481-600 et seq.) and Part X (12VAC5-481-2250 et seq.) of this chapter. In addition, some registrants are subject to provisions of the regulations for Part V (12VAC5-481-1170 et seq.), Part VI (12VAC5-481-1580 et seq.), Part VIII (12VAC5-481-2090 et seq.) and Part IX (12VAC5-481-2140 et seq.) of this chapter.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-270. Exemptions.
A. Electronic equipment that produces radiation incidental to its operation 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 μSv (0.5 mrem) per hour at five centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.
B. Radiation machines while in transit or storage incident thereto are exempt from the requirements of this part.
C. Domestic television receivers are exempt from the requirements of this part.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.
12VAC5-481-280. Shielding plan review.
A. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines shall be available to the agency for review. The required information is found in 12VAC5-481-280 E.
B. The agency may require the applicant to utilize the services of a private inspector to determine the shielding requirements prior to the plan review.
C. The review of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in 12VAC5-481-640 and 12VAC5-481-680 through 12VAC5-481-730.
D. After installation of a radiation machine, the registrant shall maintain for inspection by the agency:
1. The maximum rated technique factors of each machine;
2. A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:
a. The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or
b. The type and thickness of materials, or lead equivalency, of each protective barrier.
E. In order for the private inspector to provide an evaluation, technical advice, and approval on shielding requirements for a radiation installation, the following information shall be required.
1. The plans showing, as a minimum, the following:
a. The normal location of the system's radiation port; the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors or other openings; the location of the operator's booth; and the location of the control panel;
b. The structural composition and thickness or lead equivalent of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;
c. The dimensions of the room(s) concerned;
d. The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present;
e. The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.);
f. The type of examination(s) or treatment(s) that will be performed with the equipment.
2. Information on the anticipated workload of the system(s) in Ma-minutes per week.
3. A report showing all basic assumptions used in the development of the shielding specifications.
F. The following requirements shall be used in the design for an operator's booth:
1. Space requirements:
a. The operator shall be allotted not less than 0.70 square meter (7.5 square feet) of unobstructed floor space in the booth;
b. The operator's booth may be any geometric configuration with no dimension of less than 0.6 m (2 feet);
c. The space shall be allotted excluding any encumbrance by the X-ray control panel, such as overhang, cables, or other similar encroachments;
d. The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall-mounted image receptor will not reach the operator's position in the booth.
2. Structural requirements:
a. The booth walls shall be permanently fixed barriers of at least 2 m (7 feet) high;
b. When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed;
c. Shielding shall be provided to meet the requirements of Part IV (12VAC5-481-600 et seq.) of this chapter.
3. Radiation exposure control placement: The radiation exposure control for the system shall be fixed within the booth and:
a. Shall allow the operator to remain in the protected area and not be exposed to direct scatter, leakage or primary beam radiation;
b. Shall allow the operator to use the majority of the available viewing windows.
4. Viewing system requirements:
a. Each booth shall have at least one viewing device that will:
(1) Be so placed that the operator can view the patient during any exposure; and
(2) Be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door that allows access to the room cannot be seen from the booth, then outside that door there shall be an "X-ray on" warning sign that will be lighted anytime the rotor of the X-ray tube is activated. Alternatively, an interlock shall be present such that exposures are prevented unless the door is closed.
b. When the viewing system is a window, the following requirements also apply:
(1) The window shall have a viewing area of at least 0.09 square meter (1 square foot); Regardless of size or shape, at least 0.09 square meter (1 square foot) of the window area must be centered no less than 0.6 meter (2 feet) from the open edge of the booth and no less than 1.5 meter (5.0 feet) from the floor;
(2) The window shall have at least the same lead equivalence as that required in the booth's wall in which it is mounted.
c. When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of subdivision 1 of this subsection.
d. When the viewing system is by electronic means:
(1) The camera shall be so located as to accomplish the general requirements of subdivision 1 of this subsection; and
(2) There shall be an alternate viewing system as a backup for the primary system.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-290. Registration of radiation machine facilities.
Each person having a radiation machine facility shall:
1. Apply for registration of such facility with the agency within 30 days following installation of equipment. Application for registration shall be completed on forms furnished by the agency and shall contain all the information required by the form and accompanying instructions. Registrations filed with the agency prior to September 20, 2006, shall remain in effect until a renewal notice is issued by the agency pursuant to 12VAC5-481-310.
2. Designate on the application form an individual to be responsible for radiation protection.
3. Submit to the agency as part of any application for registration or renewal of registration one copy of each radiation survey or calibration report for which records are required to be maintained pursuant to 12VAC5-481-1591 A 12 c. Records submitted once need not be submitted again for renewal of registration.
4. Have an initial inspection by a private or state inspector no later than 30 days after the registration of the equipment. Subsequent inspections shall be made periodically in accordance with other parts of these regulations or whenever the equipment is moved to a new location. The agency shall furnish a list of private inspectors.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-300. Issuance of registration certificate.
A. Upon a determination that an applicant meets the requirements of this chapter and has paid the appropriate registration fee, the agency shall issue a registration certificate.
B. The agency may incorporate in the registration certificate 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 he deems appropriate or necessary.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-310. Renewal of registration and approval not implied.
A. Application for renewal of registration shall be filed in accordance with 12VAC5-481-290.
B. In any case in which a registrant not less than 30 days prior to the expiration of his existing registration certificate has filed an application in proper form for renewal, such existing registration certificate shall not expire until the application status has been finally determined by the agency.
C. No person, in any advertisement, shall refer to the fact that he or his facility is registered with the agency pursuant to the provisions of 12VAC5-481-290, and no person shall state or imply that any activity under such registration has been approved by the agency.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-320. Expiration of registration certificate.
Except as provided by 12VAC5-481-310 B, each registration certificate shall expire at the end of the specified day in the month and year stated therein or upon notice issued to the registrant by the agency.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-330. Report of changes.
The registrant shall notify the agency in writing before making any change that would render the information contained in the application for registration and/or the notice of registration no longer accurate.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-340. Private inspector qualifications.
Any person desiring designation as a private inspector for diagnostic x-ray, mammographic or therapeutic x-ray and teletherapy machines must be qualified by training and experience to perform inspections or calibrations according to the following criteria and must submit to the agency a statement on the appropriate form certifying his specific qualifications. In order to maintain designation as a private inspector, the individual must maintain satisfactory performance of work performed in that capacity. The agency shall disqualify any individual from this designation if the agency has determined that the individual has demonstrated unsatisfactory performance as a private inspector. The individual may request an informal hearing.
A. Private inspector, diagnostic x-ray (except mammography). The person must have adequate knowledge, training and experience to measure ionizing radiation, evaluate safety techniques, and advise regarding radiation protection needs to assure compliance with Virginia Rules and Regulations for Ionizing Radiation as evidenced by all of the following:
1. Initial qualifications: evidenced by one or more of the following:
a. Certification by one of the following: American Board of Radiology either in diagnostic or radiological physics, American Board of Health Physics in comprehensive practice, or the American Board of Medical Physics in diagnostic imaging physics.
b. Bachelor's degree in one of the physical sciences or engineering and three years of full-time experience in radiation safety including at least one year in diagnostic x-ray safety. Advanced degrees in related areas may be substituted for experience on an equal time basis, except that no substitution shall be allowed for the required one year of experience in diagnostic x-ray safety.
c. Those individuals listed as private inspectors immediately prior to September 20, 2006, shall be considered grandfathered.
2. Continuing qualifications:
a. Continuing education. Private inspectors must participate in continuing education programs relating to diagnostic x-ray, either by teaching or completing at least 15 continuing education units (CMEs) every three years.
b. Continuing experience. The private inspector must have inspected at least 10 diagnostic x-ray machines within the preceding 12 months.
3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the inspections without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications, as follows:
a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.
b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.
B. Private inspector, therapeutic x-ray and teletherapy machines. The person must have adequate knowledge, training, and experience to calibrate a therapeutic x-ray machine or teletherapy machine, perform inspections and to establish procedures for (and review the results of) spot-check measurements as evidenced by all of the following:
1. Initial qualifications: evidenced by one or more of the following:
a. Be certified by the American Board of Radiology in:
(1) Therapeutic radiological physics or therapeutic medical physics;
(2) Roentgen-ray and gamma-ray physics;
(3) X-ray and radium physics;
(4) Radiological physics;
b. Be certified by the American Board of Medical Physics in Radiation Oncology Physics;
c. Be certified by the Canadian College of Medical Physics; or
d. Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a radiation therapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in 12VAC5-481-3400 A, 12VAC5-481-3420 P, 12VAC5-481-3420 Q, 12VAC5-481-3430 T, and 12VAC5-481-3430 U under the supervision of a radiation therapy physicist during the year of work experience.
Notwithstanding the provisions of 12VAC5-481-3390 D, certification pursuant to subdivisions B 1 a, b, or c of this section shall be required on or before July 1, 2007, for all persons currently qualifying as a radiation therapy physicist pursuant to subdivision B 1 d of this section.
2. Continuing qualifications.
a. Private inspectors must participate in continuing education programs relating to therapeutic x-ray and teletherapy machines, either by teaching or completing at least 15 continuing education units (CEUs) every three years.
b. The private inspector must have inspected at least one therapeutic x-ray or teletherapy facilities and at least one therapeutic x-ray or teletherapy machine within the preceding 12 months.
3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform an inspection without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications, as follows:
a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to five continuing education units during the preceding 12 months.
b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of a sufficient number of facilities and machines under the direct supervision of a private inspector who meets the qualifications of this section to bring the number to the required level.
C. Private inspector, mammography. The person must have adequate knowledge, training, and experience to inspect mammography x-ray machines and facilities. All mammography private inspector conducting inspections of mammography facilities and providing oversight of the facility quality assurance program must meet one of the following tracks, either through the initial master's degree of higher route or the alternative initial bachelor's degree route:
1. Initial qualifications:
Master Route:
a. Be certified by the American Board of Radiology (ABR) or the American Board of Medical Physics (ABMP) in:
(1) Diagnostic radiological physics;
(2) Radiological physics; or
(3) Diagnostic imaging physics;
b. A master's degree or higher in a physical science with at least 20 semester hours or equivalent of graduate or undergraduate physics; and
c. Twenty contact hours of mammography facility training; and
d. The experience of conducting inspections of at least one mammography facility and a total of at least 10 mammography units.
Bachelor Route (must have been qualified before April 28, 1999):
a. A bachelor's degree in a physical science with at least 10 semester hours or equivalent of college level physics;
b. Forty contact hours of documented specialized training in conducting inspections of mammography facilities; and
c. The experience of conducting inspections of at least one mammography facility and a total of at least 20 mammography units. The training and experience requirements must be met after fulfilling the degree requirement.
2. Continuing qualifications.
a. At all times after the third anniversary of completion of the initial requirements of this section, the private inspector shall have taught or completed at least 15 continuing education units in mammography during the preceding three years.
b. At all times after the first anniversary of the completion of the initial requirements of this section, the private inspector shall have inspected at least two mammography facilities and six machines in 24 months.
c. Before a private inspector may begin independently performing mammographic examinations using a new modality, that is, a modality other than one for which the physicist received training to qualify under this section, the inspector must receive at least eight hours of training in inspecting units with the new modality.
3. Reestablishing qualifications. Private inspectors who fail to maintain the required continuing qualifications of this section may not perform the mammography inspections without the supervision of a qualified private inspector. Before independently inspecting another facility, private inspectors must reestablish their qualifications as follows:
a. Private inspectors who fail to meet the continuing educational requirements of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous three years.
b. Private inspectors who fail to meet the continuing experience requirement of this section shall complete a satisfactory inspection of three mammography facilities under the direct supervision of a private inspector who meets the qualifications of this section.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-350. Assembler or transfer obligation.
A. Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines or upon significant service or modification thereof of any radiation machine (such as tube inserts, generators, or collimators) in this state shall notify the agency within 15 days of:
1. The name and address of persons who have received these machines;
2. The manufacturer, model, and serial number of each radiation machine transferred; however, in the case of diagnostic x-ray systems that contain certified components, a copy of the assembler's report (Form FDA 2579) prepared in compliance with the requirements of the Food and Drug Administration's Federal Diagnostic X-ray Standard (21 CFR 1020.30(d)) shall be submitted and shall suffice in lieu of any other report by the assembler; and
3. The date of transfer of each radiation machine.
B. 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 shall meet the requirements of these regulations.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 31, Issue 24, eff. August 27, 2015.
12VAC5-481-360. Reciprocal recognition of out-of-state radiation machines.
A. Whenever any radiation machine is to be brought into the state, for any temporary use, the person proposing to bring such machine into the state shall give written notice to the agency at least two working days before such machine is to be used in the state. The notice shall include:
1. The type of radiation machine;
2. The nature, duration, and scope of use;
3. The exact location(s) where the radiation machine is to be used; and
4. States in which this machine is registered.
B. If, for a specific case, the two-working-day period would impose an undue hardship on the person, upon application to the agency, permission to proceed sooner may be granted.
C. The person referred to in subsection A of this section shall:
1. Comply with all applicable regulations of the agency;
2. Supply the agency with such other information as the agency may reasonably request; and
3. Not operate within the state on a temporary basis in excess of 180 calendar days per year.
4. Supply the agency a copy of a medical physicist or private inspector report not less than one year old indicating the equipment is certified by another state.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006.
12VAC5-481-370. Certification of X-ray systems.
A. Every owner or operator of an X-ray machine shall:
1. Have the machine certified by the agency within 60 days of the date of installation and thereafter according to the inspection schedule in Part VI (12VAC5-481-1580 et seq.) of this chapter; and
2. Have the machine inspected whenever the machine is moved to a new location or according to the schedule in Part VI (12VAC5-481-1580 et seq.) of this chapter, whichever occurs first, by a private or state inspector; and
3. Submit to the agency one copy of each inspection or calibration report for which records are required to be maintained pursuant to Part VI (12VAC5-481-1580 et seq.) of this chapter. If the inspection was performed by a state inspector and the inspection was not initiated by the agency pay the appropriate fee as established by the board.
B. Certification may be denied if any noncompliances are not corrected within 45 days from the date of inspection.
C. The agency shall issue a certificate when the data indicates the machine meets the board's standards. A copy of the certificate shall be displayed by the registrant in a conspicuous place in close proximity to the X-ray machine.
D. Certification may be denied if the machine does not meet the standards set forth in these regulations. If the certification is denied, the machine shall not be used for treatment, diagnosis, or evaluation of patients, whether human or animal, until the standards of the board have been met.
E. Final disposition of the machine, including electrical disconnection or storage, will be made within 90 days of agency review.
F. For facilities providing mammography services, the agency may conduct scheduled and random unannounced inspections, to ensure compliance with laws, regulations, or conditions specified by the board.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.