| (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 agency authorizes the transfer in writing.
(3) Each person registered by the agency for radiation
machine use in accordance with 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 making a determination whether to grant, deny,
amend, renew, revoke, suspend, or restrict a certificate of registration,
the agency 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 agency 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 agency 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 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
in accordance with 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 in accordance
with subsection (f)(1)(B) of this section (concerning radiation accelerator
or therapeutic radiation machines for human use), subsection (g) of
this section (concerning 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 agency
prior to 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 in accordance with 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 agency.
(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 agency 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 in accordance with paragraph
(13) of this subsection.
(7) The registrant shall notify the agency of any changes
that would render the information contained in the application for
registration and/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 of 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 in accordance with this section.
(B) The registrant shall notify the agency within 30
days of 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 agency 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 1 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 agency in accordance with 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
agency in accordance with 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 agency 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 agency 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) in accordance with §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 in accordance with 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 agency in accordance with 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;
(ii) name and address of customer; and
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