| (D) The RSO for an application for registration of
an electronic brachytherapy device shall meet the qualifications of
this subsection and shall carry out the responsibilities of subsection
(n) of this section.
(4) Any time after the filing of the original application,
the agency may require additional information to determine if the
certificate of registration should be issued or denied.
(5) An application for a certificate of registration
may include a request for a certificate of registration authorizing
one or more activities or use locations. Applications for certification
of mammography systems, lasers, laser services, laser hair removal
facilities, laser hair removal training programs, and laser hair removal
individuals shall be made separately.
(6) Applications and documents submitted to the agency
may be made available for public inspection except that the agency
may withhold any document or part thereof from public inspection in
accordance with §289.231(aa) of this title.
(7) Each application for a certificate of registration
shall be accompanied by the fee prescribed in §289.204 of this
title. An application for a certificate of registration for an electronic
brachytherapy device shall be accompanied by the fee prescribed in
Figure: 25 TAC §289.204(j), category (3) for other therapeutic
radiation machines.
(8) Each application shall be accompanied by a completed
RC Form 226-1 (Business Information Form) that shall contain the legal
name of the entity or business. Unless exempt in accordance with the
Business and Commerce Code, Chapter 71, the applicant shall:
(A) be authorized to conduct business in the State
of Texas as listed on the Texas Secretary of State (SOS) web site;
and
(B) file an assumed name certificate with the Texas
SOS if using an assumed name in their application, and/or the office
of the county clerk in the county where the business is located.
(f) Application for registration for human use of radiation
machines.
(1) In addition to the requirements of subsection (e)
of this section, each applicant shall comply with the following.
(A) Each person having a radiation machine used in
the healing arts shall apply for registration with the agency within
30 days after beginning use of the radiation machine, except for mobile
services that shall be registered in accordance with subsection (g)
of this section, and healing arts screening that shall be approved
in accordance with subsection (h) of this section.
(B) Each person having an accelerator or therapeutic
radiation machine capable of operating at or above 1 million electron
volts (MeV) shall apply for and receive a certificate of registration
from the agency before using the accelerator for human use. A person
may energize the accelerator for purposes of installation and acceptance
testing before receiving a certificate of registration from the agency.
(C) Each person having a simulator and/or therapeutic
radiation machine capable of operating below 1 MeV for human use shall
apply for registration with the agency within 30 days of energizing
the equipment.
(2) The applicant shall ensure that radiation machines
are operated by individuals qualified by reason of training and experience
to use the radiation machine for the purpose requested in accordance
with this section in such a manner as to minimize danger to occupational
and public health and safety.
(3) An application for healing arts shall be signed
by a licensed practitioner. The signature of the administrator, president,
or chief executive officer will be accepted in lieu of a licensed
practitioner's signature if the facility has more than one licensed
practitioner who may direct the operation of radiation machines. The
application shall also be signed by the RSO.
(4) An application for accelerators or therapeutic
radiation machines, including electronic brachytherapy devices, for
human use shall be signed by a physician licensed by the Texas Medical
Board. The signature of the administrator, president, or chief executive
officer will be accepted in lieu of a physician's signature if the
facility has more than one physician who may direct the operation
of radiation machines. The application shall also be signed by the
RSO.
(5) Each applicant for accelerators or therapeutic
radiation machines, other than electronic brachytherapy devices, shall
submit:
(A) operating and safety procedures as described in §289.229(h)(1)(G)
of this title; and
(B) a description of the proposed facilities.
(6) Each person having an electronic brachytherapy
device shall apply for and receive a certificate of registration from
the agency before using the device for human use. An application for
an electronic brachytherapy device shall include:
(A) a list identifying the radiation safety officer,
all certified physicians (except visiting certified physicians), licensed
medical physicists, and qualified operators, with documentation of
training and education in accordance with §289.229(h)(1)(D) and
(E) of this title;
(B) a current copy of the quality assurance program
in accordance with §289.229(h)(1)(F) of this title;
(C) a copy of the most current record of surveys, calculations,
and quality assurance checks on each device;
(D) a copy of the device manufacturer's United States
Food and Drug Administration certification;
(E) a copy of the operating and safety procedures as
described in §289.229(h)(1)(G) of this title; and
(F) a description of the proposed facilities showing
how the requirements of §289.229(k) of this title are to be met.
The description of the proposed facilities shall also include:
(i) a diagram of the physical facility showing the
location of the electronic brachytherapy treatment rooms;
(ii) an indication whether the facility is a new structure
or a modification to an existing structure; and
(iii) the type and thickness of the portable shielding
if used and a procedure demonstrating the use of the shielding prior
to treatment.
(g) Application for registration of mobile service
operations.
(1) In addition to the requirements of subsections
(e) and (f) of this section or §289.230 of this title, as applicable,
each applicant shall apply for and receive authorization from the
agency before beginning mobile service operations.
(2) The following shall be submitted:
(A) an established main location where the machine(s),
records, etc. will be maintained for inspection. This shall be a street
address, not a post office box number;
(B) 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 machine inside, furnish the floor plan indicating
protective shielding and the operator's position; and
(C) a current copy of the applicant's operating and
safety procedures regarding radiological practices for protection
of patients, operators, employees, and the general public.
(h) Application for registration of healing arts screening.
(1) In addition to the requirements of subsections
(e) and (f) of this section, each applicant shall apply for and receive
authorization for healing arts screening before initiating a screening
program.
(2) Persons requesting approval from the agency for
healing arts screening programs shall submit:
(A) name and address of the applicant;
(B) diseases or conditions for which the x-ray examinations
are to be used in diagnoses;
(C) a detailed description of the x-ray examinations
proposed in the screening program;
(D) a description of the population to be examined
in the screening program, for example, age, sex, physical condition,
and other appropriate information;
(E) for mobile screening operations, location(s) where
radiation machines are maintained;
(F) operating and safety procedures as follows:
(i) for all radiation machines (except bone densitometers)
to include:
(I) an evaluation of the radiation machines to be used
in the screening program;
(II) documentation that the evaluation was performed
by a licensed medical physicist with a specialty in diagnostic medical
physics;
(III) the evaluation shall show that the machines satisfy
all requirements of this chapter;
(ii) for bone densitometers, the manufacturer's evaluation
of the radiation machine(s) to be used in the screening program;
(G) training data to include:
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