216-RICR-40-20-3
216-RICR-40-20-3. Registration of X-Ray Equipment Facilities and Radiation Physics Services (version Adoption, 01/01/2019 to 01/04/2022)
3.1 Authority
A. This Part is promulgated
pursuant to the authority conferred under R.I. Gen. Laws § 23-1.3 -5 .
B. This Part requires the
registration of X-ray equipment facilities and the registration of
persons providing installation and/or servicing of X-ray equipment to
Agency registrants or radiation physics services to Agency
registrants or licensees. For purposes of this part, particle
accelerator facilities, whether used primarily for X-ray production
or other purposes, shall be considered X-ray equipment facilities.
C. In addition to the
requirements of this Part, all registrants are subject to the
applicable provisions of other Parts of this Subchapter.
D. Any notifications, reports
or correspondence referenced in this Part shall be directed to the
Agency using contact information specified in § 1.4 of this
Subchapter.
3.2 Incorporation by Reference
A. This Part hereby adopts and
incorporates the National Council on Radiation Protection and
Measurements’ (NCRP) Report 144 “Radiation Protection for
Particle Accelerator Facilities” (2003) by reference, not including
any further editions or amendments thereof and only to the extent
that the provisions therein are not inconsistent with this Part.
B. This Part hereby adopts and
incorporates the National Council on Radiation Protection and
Measurements’ (NCRP) Report 145, “Radiation Protection in
Dentistry” (2003) by reference, not including any further editions
or amendments thereof and only to the extent that the provisions
therein are not inconsistent with this Part.
C. This Part hereby adopts and
incorporates the National Council on Radiation Protection and
Measurements’ (NCRP) Report 147, “Structural Shielding Design for
Medical X-ray Imaging Facilities” (2004) by reference, not
including any further editions or amendments thereof and only to the
extent that the provisions therein are not inconsistent with this
Part.
D. This Part hereby adopts and
incorporates the National Council on Radiation Protection and
Measurements’ (NCRP) Report 148, “Radiation Protection in
Veterinary Medicine” (2004) by reference, not including any further
editions or amendments thereof and only to the extent that the
provisions therein are not inconsistent with this Part.
3.3 Prohibitions and Exemptions
A. Prohibitions. All
registrants shall prohibit any person from furnishing X-ray equipment
servicing or radiation physics services as described in § 3.6 of
this Part to their X-ray equipment facility until such person
provides evidence that they are registered with the Agency as a
provider of services in accordance with § 3.6 of this Part.
B. Exemptions
1. Electronic equipment that
produces radiation incidental to its operation for other purposes is
exempt from the registration and certification requirements of this
Part, providing dose equivalent rate averaged over an area of ten
square centimeters (10 cm2) does not exceed 0.5 mrem (5 uSv) per hour
at five (5) cm from any accessible surface of such equipment. The
production, testing, or factory servicing of such equipment shall not
be exempt.
2. X-ray equipment while in
transit or in storage incident to transit are exempt from the
requirements of this Part. This exemption does not apply to the
providers of X-ray equipment for mobile services.
3. Domestic television
receivers and video display terminals are exempt from the
requirements of this Part.
4. Inoperable X-ray equipment
is exempt from the requirements of this Part. For the purposes of
this Part, an inoperable X-ray equipment means X-ray equipment that
cannot be energized when connected to a power supply without repair
or modification.
5. Financial institutions that
take possession of operable X-ray equipment as the result of
foreclosure, bankruptcy, or other default of payment are subject to
the requirements in this Part. X-ray equipment which is operable for
the sole purpose of selling, leasing or transferring shall be
registered in the Storage category.
3.4 Definitions
A. Whenever used in this Part,
the following terms shall be construed as follows:
1. “Act” means R.I. Gen.
Laws Chapter 23-1.3 entitled "Radiation Control".
2. “Agency” means Rhode
Island Radiation Control Agency (RCA), Center for Health Facilities
Regulation - Radiation Control Program, Rhode Island Department of
Health.
3. "Facility" means
the location, building, vehicle, or complex under one administrative
control, at which one or more radiation machines are installed,
located and/or used.
4. “Registration” means
registration with the Agency pursuant to this Subchapter and the Act.
3.5 General Regulatory
Requirements
3.5.1 Shielding Plan Review
A. Except as otherwise
provided in § 3.5.1(C) of this Part, all new X-ray equipment (as
defined by Part 4 of this Subchapter) facilities and modifications of
existing X-ray equipment facilities utilizing ionizing radiation
machines shall require shielding plan review by the Agency.
B. Prior to construction, the
floor plans, shielding specifications, and equipment arrangement
shall be submitted to the Agency for review and approval. The
required information for all ionizing radiation machines, except
therapeutic radiation machines, is denoted in § 3.13 of this Part.
The required information for therapeutic radiation machines is
contained in § 5.13 of this Subchapter.
C. The Agency may require the
applicant to utilize the services of a person registered to provide
General Radiation Physics Services in developing the information
required by § 3.13 of this Part.
D. Shielding plan review by
the Agency is not required for the following type of X-ray equipment
facilities:
1. Any type of X-ray equipment
which provides sufficient self-shielding to reduce the radiation
levels at all external surfaces of the equipment below those levels
required by §§ 1.7.1, 1.7.7 and 1.8.1 of this Subchapter.
2. Any X-ray equipment
facility performing only dental intraoral and/or panoramic procedures
whose estimated workload has been evaluated in accordance with NCRP
Report 145 [“Radiation Protection in Dentistry” (2003)], and it
has been documented that existing structural configuration will
provide sufficient shielding to reduce the radiation levels to those
required by §§ 1.7.1, 1.7.7 and 1.8.1 of this Subchapter.
3.5.2 Submission of
Application
A. Each person who owns or
possesses and administratively controls an X-ray equipment facility,
unless specifically exempted in § 3.3 of this Part, shall apply for
registration of such facility with the Agency prior to the operation
of an X-ray equipment facility. 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,
including a designated e-mail address for receipt of official Agency
correspondence in electronic format. The issuance of a Certificate of
Registration for an X-ray equipment facility shall not preclude the
Agency from subsequently reassigning the registered X-ray equipment
to a more appropriate registration category and/or requiring the
facility to periodically reregister all X-ray equipment at the
facility. The registration category for an X-ray equipment facility
will be determined in accordance with the provisions of § 15.4.6 of
this Subchapter.
B. Designation of Individual
Responsible for Radiation Protection. An individual to be responsible
for radiation protection shall be designated on each application
form. The qualifications of that individual shall be submitted to
the Agency with the application. The Radiation Safety Officer (RSO)
shall meet the applicable requirements of § 3.15 of this Part and
carry out the responsibilities in § 3.16 of this Part.
C. Designation of Facility
Supervisor
1. An individual responsible
for directing the operation of the X-ray equipment facility shall be
designated on each application form.
2. The designation of a
licensed practitioner of the healing arts shall be required on each
healing arts application.
3. The designation of an
individual licensed in accordance with R.I. Gen. Laws Chapter
5-25 to engage in veterinary medicine shall be
required on each veterinary medicine application.
D. Additional Requirements for
Medical Research on Humans. In addition to the requirements of §§
3.5.2(A), (B) and (C) of this Part, the applicant shall submit, as a
minimum, the following information:
1. A detailed description of
the proposed medical research, including a copy of the form that will
be used to obtain informed consent from the human subjects and an
evaluation of the potential radiation exposure to individuals
participating in the medical research; and
2. The following
documentation:
a. Documentation that the
research is conducted, funded, supported, or regulated by a Federal
Agency which has implemented the Federal Policy for the Protection of
Human Subjects; or
b. Documentation of prior
review and approval of the research activities by an "Institutional
Review Board" as required by 45
C.F.R. Part 46 and 21
C.F.R. Part 56 .
E. Additional Requirements for
Mobile Service Operations. In addition to the requirements of §§
3.5.2(A), (B) and (C) of this Part, the applicant shall submit the
following information:
1. The location where the
X-ray equipment, records, etc. will be maintained for inspection.
This shall be a street address, not a post office box number.
2. A sketch or description of
the normal configuration of each radiation machine's use, including
the operator's position and any ancillary personnel's location during
exposures. If a mobile van is used with a fixed unit inside, furnish
the floor plan indicating protective shielding and the operator's
location; and
3. A current copy of the
applicant's operating and safety procedures including radiological
practices for protection of patients, operators, employees, and the
general public.
F. Signature. Each application
shall be signed by the applicant or a person duly authorized to act
on their behalf.
3.5.3 Shielding Evaluation
Required
A. Prior to routine use, but
in no case later than thirty (30) days subsequent to installation of
the radiation producing equipment and/or modification of the existing
facility, the shielding shall be reviewed and evaluated by a person
registered with the Agency to provide General Radiation Physics
Services.
B. A written report of the
shielding evaluation shall be provided to the facility within ten
(10) days of the evaluation. The report shall specifically address
any shielding and/or radiation protection deficiencies that were
discovered during the evaluation and shall include recommendations
for correcting these deficiencies. Any noted deficiencies shall be
adequately addressed by the facility.
C. Facilities shall provide
the Agency with a copy of the shielding evaluation report within ten
(10) days of receipt of said report.
D. An Agency finding that an
X-ray equipment facility meets appropriate radiation protection
standards shall not preclude the requirement of additional
modifications, should a subsequent analysis of operating conditions
and/or a radiation survey indicate that an individual is likely to
receive a dose in excess of the limits prescribed in §§ 1.7.1,
1.7.7 and 1.8.1 of this Subchapter.
E. Retention of Information
Used to Develop Shielding Plan. After installation of radiation
producing equipment, 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.
3. All information required by
§ 3.5.3(E) of this Part shall be retained until disposal is
authorized by the Agency. All required information shall be retained
in an active file from at least the time of generation until the next
Agency inspection. Information generated prior to the last Agency
inspection may be microfilmed or otherwise archived as long as a
complete copy of said information can be retrieved until such time as
the Agency authorizes final disposal.
3.6 Application for Registration
of X-Ray Equipment Servicing and Radiation Physics Services
A. Each person who is engaged
in the business of installing or offering to install X-ray radiation
equipment in this State, or is engaged in the business of furnishing
or offering to furnish X-ray equipment servicing to an Agency
registrant, or is engaged in the business of furnishing or offering
to furnish radiation physics services to an Agency registrant or
licensee shall apply for registration of such installation and/or
servicing or radiation physics services with the Agency prior to
furnishing or offering to furnish any such servicing or services.
B. Application for
Registration shall be completed on forms furnished by the Agency and
shall contain all information required by the Agency as indicated on
the forms and accompanying instructions, including a designated
e-mail address for receipt of official Agency correspondence in
electronic format.
1. An application for
registration to provide X-ray equipment servicing will be accepted
from either a firm or an individual.
2. An application for
registration to provide radiation physics services will only be
accepted from an individual. If a firm employs more than one
individual to provide radiation physics services, each individual
shall be required to obtain a separate registration.
C. Education and Experience
Requirements for Providers of Radiation Physics Services. In addition
to the other requirements contained in this section, applicants for
Radiation Physics Services must include documentation of the
education and experience that qualify the applicant to discharge the
Radiation Physics Services being requested. The minimum acceptable
education and experience requirements are contained in § 3.14 of
this Part. Applicants who do not explicitly meet the requirements
contained in § 3.14 of this Part, but who believe they have a
combination of training and/or practical experience equivalent to
these requirements, may request special consideration of their
situation and/or issuance of a limited Certificate of Registration by
the Agency.
D. For the purpose of this
Part, X-ray equipment servicing and/or radiation physics services may
include but shall not be limited to:
1. Installation and/or
servicing of X-ray equipment, and associated components;
2. Calibration of X-ray
equipment used by Agency registrants or radiation survey instruments
used by Agency registrants or licensees;
3. Radiation protection and/or
radiation physics consultations or surveys, performed for Agency
registrants or licensees;
4. Personnel dosimetry
services.
E. Restrictions on Provision
of Services
1. Persons offering the
services described in § 3.6(D) of this Part shall not provide such
services to any operational X-ray equipment facility or any facility
utilizing radioactive materials in this state until such facility
provides evidence that it has been registered or licensed with the
Agency in accordance with § 3.5 of this Part or Parts 7 or 9 of this
Subchapter. Persons providing the services described in § 3.6(D) of
this Part to a preoperational X-ray facility or facility intending to
utilize radioactive material shall inform the facility of the
registration or licensing requirements of this Subchapter.
2. An individual registered
with the Agency as a provider of services in accordance with § 3.6
of this Part shall only perform services that are specifically
authorized for that individual on the Certificate of Registration
issued by the Agency.
3.7 Certificate of Registration
A. No person who is required
to be registered under this part shall operate an X-ray equipment
facility or radiation physics service without a valid Certificate of
Registration.
B. The Agency may incorporate
in the Certificate of Registration at the time of issuance or
thereafter by appropriate rule, regulation, or order, such additional
requirements and conditions with respect to the registrant's receipt,
possession, use, and transfer of radiation equipment as it deems
appropriate or necessary.
C. A current Certificate of
Registration or legible copy thereof shall be posted conspicuously at
each registered facility.
D. Except as provided by §
3.7(F) of this Part, each Certificate of Registration shall expire at
the end of the specified day in the month and year stated therein.
E. Application for renewal of
registration shall be filed in accordance with §§ 3.5 or 3.6 of
this Part.
F. In any case in which a
registrant not less than thirty (30) days prior to the expiration of
his existing Certificate of Registration has filed an application in
proper form for renewal, and has remitted the renewal fee, such
existing Certificate of Registration shall not expire until the
application status has been finally determined by the Agency.
3.8 Report of Changes
The registrant shall notify
the Agency in writing before making any change which would render the
information contained in the Application for Registration and/or the
Certificate of Registration no longer accurate. In the case of
disposition of an X-ray system, such notification should specify the
recipient of the system. In the case of modifications involving a
structural change, or the addition or relocation of an X-ray system,
the Agency may require the registrant to submit the information
contained in § 3.13 of this Part.
3.9 Approval Not Implied
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 §§ 3.5 or
3.6 of this Part and no person shall state or imply that any activity
under such registration has been approved by the Agency.
3.10 Assembler and/or Transfer
Obligation
A. Any person who sells,
leases, transfers, lends, disposes, assembles, or installs X-ray
equipment in this State shall notify the Agency within fifteen (15)
days of:
1. The name and address of
persons who have received this equipment.
2. The manufacturer, model,
and serial number of each X-ray system transferred; and
3. The date of transfer of
each X-ray system.
4. In the case of diagnostic
X-ray systems which contain certified components, a copy of the
assembler's report prepared in compliance with requirements of the
Federal Diagnostic X-ray Standard ( 21
C.F.R. § 1020.30(d) ) shall be submitted to the
Agency within fifteen (15) days following completion of the assembly.
Such report shall suffice in lieu of any other report by the
assembler.
B. No person shall make, sell,
lease, transfer, lend, assemble, or install X-ray systems or the
supplies used in connection with such system unless such supplies and
equipment when properly placed in operation and used in this State
shall meet the requirements of this Subchapter.
3.11 Waiver of Registration for
Temporary Use
A. Whenever any X-ray system
is to be brought into the State, for any temporary use, the person
proposing to bring such system into the State shall give written
notice to the Agency at least two (2) working days before such
machine is to be used in the State. The notice shall include:
1. The type of X-ray system;
2. The nature, duration, and
scope of use;
3. The exact location(s) where
the X-ray system is to be used; and
4. The state(s) in which the
X-ray system is registered.
5. Upon receipt of such
notification, the Agency shall determine whether a waiver of
registration will be granted.
B. In addition, the
out-of-State person 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 one hundred and eighty (180)
calendar days per year.
3.12 Registration Fees
In accordance with authority
granted to the Agency in R.I. Gen. Laws §
23-1.3-5(i) , registration fees are payable to the Treasurer,
State of Rhode Island by persons applying for registration. A current
schedule of fees is available in Fee Structure for Licensing,
Laboratory and Administrative Services Provided by the Department of
Health (Part 10-05-2
of this Title). Upon approval of the application, the Agency will
notify the applicant of the correct fee which is due. A Certificate
of Registration will not be issued or renewed until the correct fee
has been remitted. Fees which remain unpaid beyond the expiration
date of the current Certificate of Registration may result in
suspension of registration.
3.13 Information on Radiation
Shielding Required for Plan Reviews
A. All X-Ray Equipment
Facilities must submit the following information for plan reviews:
1. Basic facility information
including:
a. Name;
b. RPS registration number and
telephone number of the individual responsible for the shielding
specifications;
c. Name and telephone number
of the facility supervisor; and
d. The street address
[including room number(s)] of the facility.
e. The plan should also
indicate whether this is a new structure or a modification to
existing structure(s). If the facility is currently registered, the
Agency registration number must be provided.
2. All wall, floor, and
ceiling areas struck by the useful beam shall have primary barriers.
3. Secondary barriers, when
required, shall be provided in all wall, floor, and ceiling areas.
4. Shielding in walls of
diagnostic X-ray facilities shall extend to a minimum height of seven
(7) feet above the floor.
B. X-Ray Equipment Facilities
Up To 150 kV
1. In addition to the
requirements listed in § 3.13(A) of this Part, the plans for all
X-ray equipment facilities which produce only photons with a maximum
energy less than or equal to 150 kV shall contain, as a minimum, the
following additional information:
a. Equipment specifications
including the make and model of the X-ray equipment, the maximum
technique factors and the energy waveform (single phase, three phase,
etc.).
b. The maximum design workload
for the facility in terms of milliamp-minutes or milliamp-seconds per
week. The total anticipated number of patients per week or number of
exposures per week, as well as the type of examination(s) or
treatment(s) which will be performed with the equipment, shall also
be provided.
c. A facility
blueprint/drawing indicating:
(1) Scale (0.25 inch = 1 foot
is typical);
(2) Direction of North;
(3) Normal location of the
X-ray system's radiation port(s);
(4) The port's travel and
traverse limits;
(5) General direction(s) of
the useful beam;
(6) Locations of any windows
and doors; and
(7) The location of the X-ray
control panel.
(8) If the control panel is
located inside the X-ray room, the location of the operator's station
shall be noted in the plan and the operator's station at the control
panel shall be in compliance with § 1.7.1 of this Subchapter.
d. In X-ray facilities
designed for medical use, a window (of lead equivalent at least equal
to that required for the adjacent barrier), mirror or other remote
viewing system shall be provided and so placed that the operator can
see the patient during the exposure without having to leave the
protected area.
e. The structural composition
and thickness or lead/concrete equivalent of all walls, doors,
partitions, floor, and ceiling of the room(s) concerned.
f. 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.
g. At least one example
calculation which shows the methodology used to determine the amount
of shielding required for each physical condition [i.e.: primary and
secondary/ leakage barriers, restricted and unrestricted areas, small
angle scatter, entry door(s) and maze] and shielding material in the
facility. If commercial software is used to generate shielding
requirements, also identify the software used and the
version/revision date.
C. X-Ray Equipment Facilities
Over 150 kV
1. In addition to the
requirements listed in § 3.12(A) of this Part, the plans for all
X-ray equipment/accelerator facilities which produce photons with a
maximum energy in excess of 150 kV and/or electrons and/or protons or
other subatomic particles shall also contain the following
information:
a. Equipment specifications
including: manufacturer and model number of the unit; rad (or rem)
per minute at the isocenter; and the energy(s) and type(s) of
radiation produced [ie: photon, electron, neutron]. The source to
isocenter distance must be specified.
b. Maximum design workload for
the facility including total weekly radiation output [expressed in
rad (or rem)/week at 1 meter], total beam-on time per day or week.
c. Facility blueprint/drawing
(including both floor plan and elevation views) indicating:
(1) Position and orientation
of the X-ray/accelerator unit, scale (0.25 inch = 1 foot is typical);
(2) Type(s) and thickness of
shielding material(s);
(3) Direction of North; and
(4) The locations and size of
all penetrations through each shielding barrier (ceiling, walls and
floor), as well as details of the door(s) and maze.
d. The structural composition
and thickness or lead/concrete equivalent of all walls, doors,
partitions, floor, and ceiling of the room(s) concerned.
e. 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.
f. Description of all
assumptions that were used in shielding calculations including, but
not limited to:
(1) Design energy [i.e.: room
may be designed for 6 MV unit although only a 4 MV unit is currently
proposed];
(2) Presence of integral
beam-stop in unit;
(3) Workload, occupancy and
use(s) of adjacent areas;
(4) Fraction of time that
primary beam will intercept each permanent barrier (walls, floor and
ceiling); and
(5) "Allowed"
radiation exposure in both restricted and unrestricted areas.
g. At least one example
calculation which shows the methodology used to determine the amount
of shielding required for each physical condition [i.e.: primary and
secondary/leakage barriers, restricted and unrestricted areas, small
angle scatter, entry door(s) and maze] and shielding material in the
facility. If commercial software is used to generate shielding
requirements, also identify the software used and the
version/revision date.
D. Neutron Shielding
1. In addition to the
requirements listed in §§ 3.12(A) and (C) of this Part, X-ray
equipment/accelerator facilities which are capable of operating above
10 MV shall submit shielding plans which contain, as a minimum, the
following additional information:
a. The structural composition,
thickness, minimum density and location of all neutron shielding
material.
b. Description of all
assumptions that were used in neutron shielding calculations
including, but not limited to, neutron spectra as a function of
energy, neutron fluence rate, absorbed dose and dose equivalent (due
to neutrons) in both restricted and unrestricted areas.
c. At least one example
calculation which shows the methodology used to determine the amount
of neutron shielding required for each physical condition [i.e.:
restricted and unrestricted areas, entry door(s) and maze] and
neutron shielding material utilized in the facility. If commercial
software is used to generate shielding requirements, also identify
the software used and the version/revision date.
d. The method(s) and
instrumentation which will be used to verify the adequacy of all
neutron shielding installed in the facility.
3.14 Education and Experience
Requirements for Radiation Physics Services
A. Radiotherapy Physics
Services. Calibration and surveys of: therapeutic X-ray equipment;
medical accelerators; teletherapy units, remote afterloader
brachytherapy units and/or stereotactic radiosurgery units utilizing
sealed radioactive sources.
1. Documentation of training
sufficient to qualify as:
a. An Authorized Medical
Physicist pursuant to § 9.5.11 of this Subchapter in the modality(s)
for which registration is being requested; or
b. A Qualified Medical
Physicist pursuant to § 5.3.4 of this Subchapter.
B. Diagnostic X-ray Physics
Services. Calibration and surveys of diagnostic X-ray equipment.
1. Certification by the
American Board of Radiology in:
a. Radiological physics;
b. Roentgen-ray and gamma-ray
physics; or
c. X-ray and radium physics;
or
d. Diagnostic radiological
physics; or
e. Diagnostic medical physics;
or
2. Certification by the
American Board of Medical Physics in Diagnostic Imaging Physics; or
3. Hold a master's or doctor's
degree in radiological physics and submit documentation of
appropriate experience in the area(s) for which registration is being
requested. This experience must have been obtained under the
supervision of an individual qualified to provide Diagnostic X-ray
Physics Services; or
4. Hold a master's or doctor's
degree in health physics or other related radiation discipline and
submit documentation of at least one (1) year of appropriate full
time experience in the area(s) for which registration is being
requested. This experience must have been obtained under the
supervision of an individual qualified to provide Diagnostic X-ray
Physics Services; or
5. Hold a master's or doctor's
degree in a physical science and submit documentation of at least two
(2) years of appropriate full time training and experience in the
area(s) for which registration is being requested. This experience
must have been obtained under the supervision of an individual
qualified to provide Diagnostic X-ray Physics Services; or
6. Hold a bachelor's degree in
health physics or other related radiation discipline and submit
documentation of at least two (2) years of appropriate full time
experience in the area(s) for which registration is being requested.
This experience must have been obtained under the supervision of an
individual qualified to provide Diagnostic X-ray Physics Services; or
7. Hold a bachelor's degree in
a physical science and submit documentation of at least three (3)
years of appropriate full time training and experience in the area(s)
for which registration is being requested. This experience must have
been obtained under the supervision of an individual qualified to
provide Diagnostic X-ray Physics Services.
C. General Radiation Physics
Services. All radiation physics services (except calibration of
health physics instrumentation) for Agency registrants and/or
radioactive materials licensees not covered in §§ 3.13(A) and (B)
of this Part.
1. Comprehensive certification
by the American Board of Health Physics; or
2. Certification by the
American Board of Radiology in
a. Radiological Physics or
b. Roentgen-ray and gamma-ray
physics; or
c. X-ray and radium physics;
or
d. Diagnostic radiological
physics; or
e. Medical nuclear physics or
nuclear medical physics; or
3. Certification by the
American Board of Medical Physics in Nuclear Medicine Physics or
Medical Health Physics; or
4. Hold a master's or doctor's
degree in radiological physics or health physics or other related
radiation discipline and submit documentation of appropriate
experience in the area(s) for which registration is being requested.
This experience must have been obtained under the supervision of an
individual qualified to provide General Radiation Physics Services;
or
5. Hold a master's or doctor's
degree in a physical science and submit documentation of at least one
(1) year of appropriate full time training and experience in the
area(s) for which registration is being requested. This experience
must have been obtained under the supervision of an individual
qualified to provide General Radiation Physics Services; or
6. Hold a bachelor's degree in
health physics or other related radiation discipline and submit
documentation of at least one (1) year of appropriate full time
experience in the area(s) for which registration is being requested.
This experience must have been obtained under the supervision of an
individual qualified to provide General Radiation Physics Services;
or
D. Instrument Calibration
Services. Calibration of health physics instrumentation for Agency
registrants and/or radioactive materials licensees.
1. Compliance with the
criteria required to perform any of the services contained in §§
3.13(A), (B) or (C) of this Part; or
2. Hold at least a bachelor's
degree in physics (or a closely related field such as electrical
engineering) and submit documentation of at least six (6) months of
appropriate full time training and experience in the calibration of
health physics instrumentation.
3.15 Radiation Safety Officer
(RSO) Requirements
3.15.1 General Requirements
A. An RSO shall meet the
following general requirements, as well as any applicable
facility-specific requirements of § 3.15.2 of this Part.
1. Knowledge of potential
radiation hazards and emergency precautions;
2. Completed educational
courses related to ionizing radiation safety or a radiation safety
officer course;
3. Experience in the use and
familiarity of the type of equipment used.
3.15.2 Facility Specific
Requirements
A. Specific RSO requirements
by facility are as follows.
1. Healing arts facilities
subject to Part 4 of this Subchapter shall have:
a. A licensed practitioner RSO
with documentation of a current unrestricted Rhode Island license; or
b. A non-practitioner RSO who
meets the following requirements:
(1) An individual who has a
current unrestricted license, issued in accordance with R.I. Gen.
Laws Chapter 5-68.1, as a radiologic technologist, and has at least
two (2) years of supervised use for the type(s) of radiation machines
covered by the registration; or
(2) An individual who has a
current unrestricted license, issued in accordance with R.I. Gen.
Laws Chapter 5-34, as a nurse practitioner, and has at least two (2)
years of supervised use for the type(s) of radiation machines covered
by the registration; or
(3) An individual who has a
current unrestricted license, issued in accordance with R.I. Gen.
Laws Chapter 5-54, as a physician assistant, and has at least two (2)
years of supervised use for the type(s) of radiation machines covered
by the registration; or
(4) An individual who has a
current unrestricted license, issued in accordance with R.I. Gen.
Laws Chapter 5-31.1, as a dental hygienist, and has at least two (2)
years of performing radiologic procedures under a dentist's
instruction and direction; or
(5) An individual who has a
bachelor's (or higher) degree in a natural or physical science,
health physics, radiological science, nuclear medicine, or nuclear
engineering.
2. Healing Arts facilities
subject to Part 5 of this Subchapter shall have an individual who
meets the requirements for either an Authorized User physician or
qualified medical physicist, as specified in Part 5 of this
Subchapter.
3. Academic institutions
and/or research and development facilities shall have an RSO who is a
faculty or staff member with appropriate training in radiation
protection, radiation engineering, or related disciplines. (If
properly qualified, this individual may also serve as the RSO over
the healing arts section of the facility.)
4. Industrial radiography
facilities shall have an RSO who meets the requirements specified in
§ 10.6.2 of this Subchapter.
5. Other industrial facilities
shall have an RSO whose training and experience is sufficient to
identify and control the anticipated radiation hazards.
3.16 Duties and Responsibilities
of The Radiation Safety Officer (RSO)
A. Specific duties and
responsibilities of the Radiation Safety Officer (RSO) include, but
are not limited to, the following:
1. Establishment and oversight
of operating and safety procedures that maintain radiation exposures
as low as reasonably achievable (ALARA), and periodic review to
ensure that the procedures are current and conform with this
Subchapter;
2. Ensure that individual
monitoring devices are properly used by occupationally-exposed
personnel, that records are kept of the monitoring results, and that
timely notifications are made as required by Part 1 of this
Subchapter;
3. Investigate and report to
the Agency each known or suspected case of radiation exposure to an
individual or radiation level detected in excess of limits
established by this Subchapter and each theft or loss of source(s) of
radiation, determining the cause, and taking steps to prevent its
recurrence;
4. Maintain a thorough
knowledge of relevant management policies and administrative
procedures of the registrant and keep management informed on a
periodic basis of the performance of the registrant's radiation
protection program, if applicable;
5. Authority to institute
corrective actions including shut-down of operations when necessary
in emergency situations or unsafe conditions;
6. Maintain records as
required by this Subchapter; and
7. Ensure that personnel are
adequately trained and complying with this Subchapter, the conditions
of the Certificate of Registration, and the operating and safety
procedures of the registrant.