| (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.
(1) Each certificate of registration issued per this
section shall be subject to the applicable provisions of the Act,
now or hereafter in effect, and to the applicable rules and orders
of the department.
(2) No certificate of registration issued or granted
under this section shall be transferred, assigned, or in any manner
disposed of, either voluntarily or involuntarily, to any person unless
the department authorizes the transfer in writing.
(3) Each person registered by the department for radiation
machine use per this section shall confine use and possession of the
radiation machine registered to the locations and purposes authorized
in the certificate of registration.
(4) In deciding whether to grant, deny, amend, renew,
revoke, suspend, or restrict a certificate of registration, the department
may consider the technical competence and compliance history of an
applicant or holder of a certificate of registration. After an opportunity
for a hearing, the department shall deny an application for a certificate
of registration, an amendment to a certificate of registration, or
renewal of a certificate of registration if the applicant's compliance
history reveals that at least three department actions have been issued
against the applicant, within the previous 6 years, that assess administrative
or civil penalties against the applicant, or that revoke or suspend
the certificate of registration.
(m) Responsibilities of the registrant.
(1) The registrant is responsible for complying with
this chapter and the conditions of the certificate of registration.
(2) The registrant shall designate an individual qualified
per subsection (e)(3) of this section as the radiation safety officer
and shall ensure the individual continually performs the responsibilities
of the radiation safety officer as identified in subsection (n) of
this section.
(3) Persons using radiation machines per subsection
(f)(1)(B) of this section (concerning radiation accelerator or therapeutic
radiation machines or electronic brachytherapy devices for human use),
subsection (g) of this section (concerning an application for mobile
service operations), subsection (i)(1)(A) of this section (concerning
persons having an accelerator for non-human use), and subsection (i)(3)
of this section (concerning radiation machines in industrial radiographic
operations) shall have a valid certificate of registration issued
by the department before use.
(4) Other than the initial installation of the first
machines(s) for a new certificate of registration, no person shall
use radiation machines unless they have applied for registration within
30 days of beginning use of the machines per subsection (f)(1)(A)
of this section.
(5) No registrant shall engage any person for services
described in subsection (b)(11) of this section until the person provides
to the registrant evidence of registration with the department.
(6) 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) the initial installation of the first machines(s)
for a new certificate of registration; and
(B) the registrant authorized for demonstration and
sale may demonstrate a radiation machine per paragraph (13) of this
subsection.
(7) The registrant shall notify the department of any
changes that would render the information contained in the application
for registration or the certificate of registration inaccurate. The
notification shall be in writing and signed by an authorized representative.
(A) Notification is required within 30 days after the
following changes:
(i) name or mailing address;
(ii) street address where machine will be used;
(iii) additional use location;
(iv) RSO; or
(v) name and registration number of the contracted
provider of equipment, registered per this section.
(B) The registrant shall notify the department within
30 days after changes in the radiation machines that include:
(i) any change in the category(ies) of machine type
or type of use as specified in §289.231(ll) of this title and
as authorized in the certificate of registration; or
Cont'd... |
