| (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
(ii) any increase in the number of machines authorized
by the certificate of registration in any machine type or type of
use category.
(8) The registrant, or the parent company, shall notify
the department in writing, immediately following the filing of a voluntary
or involuntary petition for bankruptcy. This notification shall include:
(A) the bankruptcy court in which the petition for
bankruptcy was filed; and
(B) the case name and number, and date of filing the
petition.
(9) The registrant shall inventory all radiation machines
in the registrant's possession at an interval not to exceed one year.
(A) The inventory shall include:
(i) manufacturer's name;
(ii) model and serial number of the control panel;
and
(iii) location of radiation machine(s) (for example,
room number).
(B) Records of the inventory shall be made and maintained
for inspection by the department per subsection (v) of this section.
(10) The registrant shall maintain records of receipt,
transfer, and disposal of radiation machines.
(A) The records shall include:
(i) manufacturer's name;
(ii) model and serial number from the control panel;
(iii) date of the receipt, transfer, and disposal;
(iv) name and address of person machine(s) received
from, transferred to, or disposed of; and
(v) name of the individual recording the information.
(B) Records of the receipt, transfer, or disposal of
the machine(s) shall be made and maintained for inspection by the
department per subsection (v) of this section.
(11) The persons using loaner radiation machines shall
comply with the following.
(A) For persons having a valid certificate of registration,
loaner radiation machines may be used for up to 30 days. Within the
following 30 days, the registrant shall:
(i) notify the department of a 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
(ii) notify the department of any increase in the number
of machines authorized by the certificate of registration in any machine
type or type of use category; and
(iii) perform an equipment performance evaluation on
the radiation machine(s) per §289.227(o) of this title.
(B) For persons who do not hold a valid certificate
of registration, loaner radiation machines may be used for human use
up to 30 days, by or under the direction of a practitioner, before
applying for a certificate of registration per subsection (e) of this
section. This does not include:
(i) accelerators for human use as described in subsection
(f)(1)(B) of this section;
(ii) mobile services as described in subsection (g)
of this section;
(iii) healing arts screening as described in subsection
(h) of this section;
(iv) accelerators for non-human use as described in
subsection (i)(1)(A) of this section; and
(v) industrial radiography as described in subsection
(i)(3) of this section.
(12) Persons authorized to provide radiation machines
shall comply with the following.
(A) Providers of equipment shall:
(i) ensure that all radiation machines used on humans
for healing arts purposes meet the requirements of §289.227(o)
of this title; and
(ii) provide radiation machines only to facilities
holding a valid certificate of registration.
(B) Providers of equipment shall keep a log of radiation
machines provided in Texas. The record shall list the following current
information:
(i) date machine is provided;
(ii) name of customer; and
(iii) customer's certificate of registration number.
(C) Records of machines provided shall be made and
maintained for inspection by the department per subsection (v) of
this section.
(13) Persons authorized to perform demonstration and
sale of radiation machines in Texas shall comply with the following.
(A) A daily log shall be maintained and shall include:
(i) date of all demonstrations and sales of radiation
machines performed in Texas;
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