| (-2-) evidence of registration with the Texas Physician
Assistant Board and at least two years of supervised experience in
the use of radiation machines in their respective specialty; or
(-3-) evidence of bachelor's or higher degree in radiologic
technology, health physics, or nuclear technology and at least two
years of supervised experience in the use of radiation machines; and
(-b-) additional documentation for a non-practitioner
RSO without radiation machine-related credentials, and the following
documentation must be provided to be qualified:
(-1-) an attestation by a physician or qualified department
director describing the radiation safety experience and performance
of the RSO responsibilities listed in subsection (n) of this section,
as applicable, and attestation must include that the RSO has achieved
a level of radiation safety knowledge sufficient to function independently
as RSO for the medical use for which they are applying; and
(-2-) documentation of an accredited radiation safety
or radiation machine course completion, and the course must be at
least 24 credit hours and include the principles of image processing,
radiation protections, dose optimization and reduction; biological
effects of ionizing radiation; radiology quality control and improvement;
and review of Texas Regulations related to radiation as applicable.
(ii) Academic institutions or research and development
facilities shall have RSOs who are faculty or staff members with a
bachelor's degree or higher in a radiation-related field and at least
two years of supervised experience in the use of radiation machines
and the following documentation is also required:
(I) an attestation by a physician or qualified department
director describing the radiation safety experience and performance
of the RSO responsibilities listed in subsection (n) of this section,
as applicable, and attestation must include that the RSO has achieved
a level of radiation safety knowledge sufficient to function independently
as RSO for the medical use for which they are applying.
(II) documentation that the individual has satisfactorily
completed 40 hours of education related to safe use of radiation machines
from an accredited institution.
(iii) Industrial radiography operations shall have
an RSO who meets the requirements of §289.255(e)(4)(B) of this
title.
(C) The RSO identified on a certificate of registration
issued before September 1, 1993, need not comply with the training
requirements in this subsection.
(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.
(E) The department may determine that a person who
otherwise meets the RSO qualifications specified in this section is
unqualified to be named as the RSO, based on the person's history
with ensuring a facility's compliance with the Act and rules of this
chapter.
(4) Any time after the filing of the original application,
the department 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 shall be made separately.
(6) Applications and documents submitted to the department
may be made available for public inspection except that the department
may withhold any document or part thereof from public inspection per §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.
(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 per 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) website;
and
(B) file an assumed name certificate with the Texas
SOS if using an assumed name in their application.
(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 department
within 30 days after beginning use of the radiation machine, except
for mobile services that shall be registered per subsection (g) of
this section, and healing arts screening that shall be approved per
subsection (h) of this section.
(B) Each person having an accelerator, therapeutic
radiation machine, or electronic brachytherapy device shall apply
for and receive a certificate of registration from the department
before using the accelerator. A person may energize the accelerator
for purposes of installation and acceptance testing before receiving
a certificate of registration from the department.
(2) The applicant shall ensure that radiation machines
are operated by individuals qualified by training and experience to
use the radiation machines for the purpose requested per 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 instead 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 instead 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, therapeutic radiation
machines, and electronic brachytherapy devices, shall submit:
(A) operating and safety procedures as described in §289.229(h)(1)(G)
of this title;
(B) credentials:
(i) units operating above 1 MeV and electronic brachytherapy
devices shall submit credentials for a Board-Certified Radiation Oncologist;
or
(ii) units under 1 MeV shall submit credentials for
a Board-Certified Dermatologist or Board-Certified Radiation Oncologist;
(C) a copy of the most current record of surveys, calculations,
and quality assurance checks on each device; and
(D) a floor plan of the physical facility.
(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
department 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 the 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 department
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;
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