| (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;
(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) documentation for verification of the following
procedures:
(i) a method of recommending a means of selecting a
physician for patients who do not have a physician;
(ii) a description of the procedures to be used in
advising the individuals screened and their physicians of the results
of the screening procedure and any further medical needs indicated;
and
(iii) a description of the procedures for the retention
or disposition of the radiographs and other records about the x-ray
examinations.
(3) Screening standards/procedures shall meet national
standards such as the American College of Radiology or other national
standards.
(i) Application for registration of radiation machines
for non-human use, including use in morgues, forensic medicine or
investigations, and educational facilities.
(1) In addition to the requirements of subsection (e)
of this section, each applicant shall comply with the following.
(A) Each person having an accelerator for non-human
use shall apply for and receive a certificate of registration from
the department before beginning the use of the accelerator. A person
may energize the accelerator for purposes of installation and testing
before receiving a certificate of registration from the department.
(B) Each person having an accelerator for non-human
use shall submit:
(i) operating and safety procedures as described in §289.229(f)(3)(B)
of this title; and
(ii) a description of the applicant's proposed facilities
per §289.229(f)(2) and (f)(3)(A), (D) and (E) of this title.
(2) Each person having a radiation machine for non-human
use, other than those specified in paragraph (1)(A) of this subsection
and those used for industrial radiographic operations as defined in §289.255
of this title, shall apply for registration with the department within
30 days after beginning use of the machine.
(3) Each applicant for use of radiation machines in
industrial radiographic operations shall submit the information required
in §289.255(t)(1) of this title and receive a certificate of
registration from the department before beginning use of the machine(s).
(4) An application for the uses specified in this subsection
shall be signed by the applicant, registrant, or a person duly authorized
to act for and on the applicant's or registrant's behalf. The application
shall also be signed by the RSO.
(j) Application for registration of radiation machine
services.
(1) In addition to the requirements of subsection (e)
of this section, each applicant shall comply with the following.
(A) Each person who intends to provide radiation services
described in subsection (b)(11) of this section shall apply for and
receive a certificate of registration from the department before providing
the service.
(B) An application for radiation services shall be
signed by the applicant or registrant or a person duly authorized
to act for and on the applicant's or registrant's behalf. The application
shall also be signed by the RSO.
(2) The applicant shall document the qualifications
of the specific training and experience that qualifies each individual
to perform the service as follows:
Cont'd... |
