| (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:
(A) for individuals performing assembly, installation,
or repair of radiation machines in subsection (b)(11)(E) of this section,
document the qualifications listed in paragraph (5) of this subsection;
(B) for individuals performing the services specified
in subsection (b)(10) and (11)(C) of this section, obtain a copy of
the individual's license from the Texas Board of Licensure for Professional
Medical Physicists; and
(C) for all other services, document the qualifications
listed in paragraph (5) of this subsection.
(3) No person shall provide services specified in subsection
(b)(10) and (11) of this section that are not specifically authorized
by the department.
(4) No person shall provide radiation machine services
for a person who cannot produce evidence of a completed application
for registration or a valid certificate of registration issued by
the department except for:
(A) services specified in subsection (b)(11)(B), (C)
and (D) of this section; or
(B) the initial installation of the first machine(s)
for a new certificate of registration.
(5) The minimum education and training for persons
performing radiation machine assembly, installation, or repair are
as follows.
(A) All persons performing radiation machine assembly,
installation, or repair shall meet one of the following requirements:
(i) one year of formal training (may be satisfied by
factory school, military technical training school, or other courses
in radiation machine assembly, installation or repair techniques)
or an associate degree in biomedical equipment repair;
(ii) a bachelor's degree in electrical engineering
with specialized training in radiation producing devices; or
(iii) a combination of training and experience totaling
one year to include:
(I) experience or education providing familiarity with
the type(s) of equipment to be serviced, to include radiation safety;
(II) knowledge of protective measures to reduce potentially
hazardous conditions; and
(III) six months of supervised assembly and repair
of the type(s) of equipment to be serviced.
(B) A registrant holding a valid certificate of registration
who has hired individuals to perform services before September 1,
1993, need not comply with the education and training requirements
in this paragraph. Individuals hired on or after September 1, 1993,
shall comply with the education and training requirements in this
paragraph.
(6) Each applicant for providers of equipment shall
also submit:
(A) the address of an established main location where
the radiation machines, records, etc., will be maintained for inspection.
This shall be a street address, not a post office box number; and
(B) a current copy of the applicant's operating and
safety procedures. This is required when the applicant's personnel
are provided to operate the equipment for their client.
(7) A record documenting the qualifications of each
individual that performs the service shall be made and maintained
for inspection by the department per subsection (v) of this section.
(k) Issuance of certificates of registration.
(1) A certificate of registration application will
be approved if the department determines that an application meets
the requirements of the Act and the requirements of this chapter.
The certificate of registration authorizes the proposed activity in
the form and contains the conditions and limitations as the department
deems appropriate or necessary.
(2) The department may incorporate in the certificate
of registration at the time of issuance, or thereafter by amendment,
additional requirements and conditions concerning the registrant's
possession, use, and transfer of radiation machines subject to this
chapter as it deems appropriate or necessary to:
(A) minimize danger to occupational and public health
and safety;
(B) require additional reports and the keeping of additional
records as may be appropriate or necessary; and
(C) prevent loss or theft of radiation machines subject
to this section.
(3) The department may request, and the registrant
shall provide, additional information after the certificate of registration
has been issued to enable the department to determine whether the
certificate of registration should be modified per subsection (s)
of this section.
(l) Terms and conditions of certificates of registration.
Cont'd... |
