(A) As used in this rule, "facility" means
the state, any political subdivision, person, public or private institution, or
group, or any unit of one of those entities, but does not include the federal
government agencies, and includes the following:
(1) All buildings, equipment, structures and
other stationary items that are located on a single site or on contiguous or
adjacent sites and that are operated by the same person and have common
corporate or business purposes; and
(2) Portions of a building or structure which
are operated by the same person and have common corporate or business
purposes.
(B)
Notwithstanding the definition of "facility," the director may consider sites
that are not contiguous or adjacent as one facility provided that:
(1) The sites are operated by the same
person;
(2) The sites are of the
same facility type as categorized in paragraph (B) of rule
3701:1-38-04
of the Administrative Code;
(3) The
applicant for a registration provides for one individual responsible for
radiation protection and implementing quality assurance procedures and policies
necessary for effective compliance with Chapter 3748. of the Revised Code and
rules adopted thereunder, and if applicable, one quality assurance committee,
as responsible for all sites; and
(4) The director is reasonably satisfied from
the information provided in the application that the applicant will adequately
control the radiation-generating equipment at all sites listed in the
application. Unless the director has information of violations of Chapter 3748.
of the Revised Code or the rules adopted thereunder at one or more sites, he or
she shall presume the applicant will adequately control the
radiation-generating equipment at all sites if the sites are located not more
than five miles apart.
The director shall continue to renew a registration issued
under this paragraph that contains all the sites listed thereon provided the
registrant demonstrates continued compliance with this paragraph, Chapter 3748.
of the Revised Code, and the rules adopted thereunder.
(C) Except as provided in
paragraph (D) of this rule, every facility that proposes to handle
radiation-generating equipment shall apply for a registration at least thirty
days prior to handling the equipment. Registration is required for dental,
medical, therapeutic, and non-medical radiation-generating equipment.
Application for a registration or renewal thereof shall be made on a form
prescribed and provided by the director and shall be accompanied by a
non-refundable registration fee in accordance with section
3748.07 of the Revised Code. The
application shall include the name and qualifications of the individual
designated as responsible and readily available for radiation protection and
implementing quality assurance policy and procedures necessary for assuring
compliance with Chapter 3748. of the Revised Code and rules adopted thereunder.
Registrations shall expire two years from the date of issuance.
Registration certificates are not transferable. If a facility
is sold or otherwise transferred to another person after a certificate of
registration has been issued, the new handler is required to apply and receive
a new registration certificate for the radiation-generating equipment.
(D) Facilities do not need to
register the following types of radiation-generating equipment:
(1) Electronic equipment that produces
ionizing radiation incidental to its operation for other purposes, if the
exposure rate averaged over an area of ten square centimeters does not exceed
one-half milliroentgen per hour at a distance of five centimeters from any
accessible surface of such equipment; or
(2) Radiation-generating equipment that is
already registered under Chapter 3748. of the Revised Code by its
possessor.
(E) An
applicant for a registration shall submit to the director a complete
application for registration on a form provided by the director together with
the required registration fee. The application shall contain all the
information required on the form and accompanying instructions. The applicant
for a registration shall provide to the director within thirty days of receipt
of the request, all additional requested information. If the director does not
receive the requested information within the thirty days, the director may
consider the application abandoned. Any further consideration for a new
registration shall be pursuant to another application accompanied by another
nonrefundable registration fee.
(F)
The director shall grant a new registration or renewal to any applicant who has
submitted a complete application, paid the registration fee, and is in
compliance with applicable rules adopted under Chapter 3748. of the Revised
Code.
(G) Registrations shall be
renewed in accordance with the standard renewal procedure established in
Chapter 4745. of the Revised Code. The registrant shall apply for renewal at
least thirty days prior to the expiration of the registration.
(H) Any handler that assembles, installs, or
disposes of radiation-generating equipment within this state shall notify the
director, in writing, at least quarterly of such actions.
Each report shall contain the name and address of the facility
that received equipment; the manufacturer, model, and serial number of the
x-ray tube or x-ray generator transferred, disposed of, or installed; and the
date of transfer, disposal, or installation of the radiation-generating
equipment.
The state copy of the United States department of health and
human services, food and drug administration "Report of Assembly of a
Diagnostic X-ray System" form, used for reporting diagnostic x-ray systems
which contain certified components, may be used to meet the notification
requirements for this rule.
(I) No handler shall transfer, service, or
install radiation-generating equipment or the components used in connection
with such equipment unless such components and equipment, when properly placed
in operation and used, meet the requirements of this chapter and all applicable
requirements of Chapter 3701:1-66
,
or 3701:1-67
, or
3701:1-68 of the Administrative Code.
(J) The registrant shall notify the director,
in writing, fifteen days prior to making any change which would render the
information contained in the application for registration or registration
certificate no longer accurate.
(K)
Notwithstanding any other requirements of this rule, out-of-state owners of
radiation-generating equipment who:
(1)
Operate the radiation-generating equipment within Ohio are required to:
(a) Possess a valid Ohio
registration;
(b) Provide written
notification three days prior to the dates when the radiation-generating
equipment will be used in Ohio; and
(c) Assure that the operation of the
radiation-generating equipment complies with all applicable rules in Chapters
3701:1-38, 3701:1-66, 3701:1-67,
3701:1-68, and
3701-72 of the Administrative Code.
(2) Solely transport the radiation-generating
equipment to an Ohio facility to be operated by the Ohio facility are not
required to register. The Ohio facility using the radiation-generating
equipment shall:
(a) Possess a valid Ohio
registration;
(b) Provide written
notification three days prior to the dates when the radiation-generating
equipment will be used in Ohio; and
(c) Verify that the operation of the
radiation-generating equipment complies with all applicable rules in Chapters
3701:1-38, 3701:1-66, 3701:1-67,
3701:1-68, and
3701-72 of the Administrative Code.
(L) Any facility found as an unregistered
handler shall be notified by the director that registration is required
pursuant to the requirements of paragraph (C) of this rule. Any such facility
that does not apply for registration within ten business days of receiving a
notice to register shall be inspected by the department. The unregistered
handler shall pay the fee required by section
3748.13 of the Revised Code.
A facility that handles radiation-generating equipment and
engages in activities involving the use of radiation-generating equipment that
does not obtain an Ohio registration as required by this rule is subject to the
fee for the inspection of an unregistered handler specified in section
3748.13 of the Revised
Code.