| (A) Each certificate of registration issued in accordance
with this section shall be subject to the applicable provisions of
the Act, now or hereafter in effect, and to the applicable requirements
of this chapter and orders of the agency.
(B) 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.
(C) 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.
(D) In making a determination whether to grant, deny,
amend, 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 or an amendment to 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 six years, that assess administrative or civil
penalties against the applicant, or that revoke or suspend the certificate
of registration.
(5) Responsibilities of the registrant.
(A) The registrant is responsible for complying with
this section and the conditions of the certificate of registration.
(B) The registrant shall designate an individual qualified
in accordance with paragraph (1)(E)(i) of this subsection as the radiation
safety officer and shall ensure the individual continually performs
the duties of the radiation safety officer as identified in paragraph
(1)(E)(v) of this subsection.
(C) Persons using radiation machines in accordance
with subsection (i)(2) of this section, concerning application for
mobile services, shall have a valid certificate of registration issued
by the agency before initiation of the mobile services.
(D) No person shall use a radiation machine unless
the person has applied for registration within 30 days after beginning
use of the radiation machine in accordance with subsection (i)(1)(B)
of this section.
(E) No registrant shall engage any person for services
described in §289.226(b)(11) of this title (relating to Registration
of Radiation Machine Use and Services) until such person provides
to the registrant evidence of registration with the agency.
(F) 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:
(i) the initial installation of the first radiation
machine for a new certificate of registration; and
(ii) the registrant authorized for demonstration and
sale may demonstrate a radiation machine in accordance with paragraph
(5)(D) of this subsection, except as prohibited by subsection (c)
of this section.
(G) The registrant shall notify the agency in writing
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.
(i) Notification is required within 30 days after the
following changes:
(I) legal business name;
(II) mailing address;
(III) street address where radiation machine will be
used;
(IV) additional radiation machine location;
(V) radiation safety officer; or
(VI) name and registration number of the contracted
"provider of equipment," registered in accordance with §289.226
of this title.
(ii) The registrant shall notify the agency within
30 days after changes in the radiation machines that include:
(I) any change in the category of radiation machine
type or type of use as authorized in the certificate of registration
(for example, addition of a computerized tomography radiation machine);
or
(II) any increase in the number of radiation machines
authorized by the certificate of registration in any radiation machine
type or type of use category.
(H) 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:
(i) the bankruptcy court in which the petition for
bankruptcy was filed; and
(ii) the case name and number, and date of filing the
petition.
(I) The registrant shall inventory all radiation machines
in the registrant's possession at an interval not to exceed one year.
(i) The inventory shall include:
(I) manufacturer's name;
(II) model and serial number of the control panel;
and
(III) location of all radiation machines, for example,
room number.
(ii) Records of the inventory shall be made and maintained
in accordance with subsection (k)(2) of this section for inspection
by the agency.
(J) Receipt, transfer, and disposal of radiation machines.
(i) The registrant shall make and maintain records
of receipt, transfer, and disposal of radiation machines. The records
shall include the following:
(I) manufacturer's name and model and serial number
from the control panel;
(II) date of the receipt, transfer, and disposal;
(III) name and address of person the radiation machines
received from, transferred to, or disposed of; and
(IV) name of the individual recording the information.
(ii) Records of receipt, transfer, and disposal of
radiation machines shall be made and maintained in accordance with
subsection (k)(2) of this section for inspection by the agency.
(K) The following criteria applies to loaner radiation
machines.
(i) For persons having a valid certificate of registration,
loaner radiation machines may be used for up to 30 days. If the loaner
radiation machine is used for more than 30 days, the registrant is
required, within the next 30 days, to complete the following:
(I) notify the agency of any change in the category
of radiation machine type or type of use as authorized in the certificate
of registration (for example, addition of a computerized tomography
radiation machine); or
(II) notify the agency of any increase in the number
of radiation machines authorized by the certificate of registration
in any radiation machine type or type of use category; and
(III) perform an EPE on the radiation machines in accordance
with subsection (j)(5)(J) of this section.
(ii) 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 supervision of a dentist licensed by
Texas State Board of Dental Examiners, before applying for a certificate
of registration in accordance with this section.
(6) Termination of certificates of registration. When
a registrant decides to terminate all activities involving radiation
machines authorized under the certificate of registration, the registrant
shall notify the agency immediately and:
(A) request termination of the certificate of registration
in writing. The request shall be signed by the radiation safety officer,
owner, or an individual authorized to act on behalf of the registrant;
(B) submit to the agency a record of the disposition
of the radiation machines and, if transferred, to whom transferred;
and
(C) pay any outstanding fees in accordance with subsection
(h) of this section.
(7) Modification, suspension, and revocation of certificates
of registration.
(A) The terms and conditions of all certificates of
registration shall be subject to revision or modification. A certificate
of registration may be suspended or revoked by reason of amendments
to the Act, by reason of requirements of this chapter or orders issued
by the agency.
(B) Any certificate of registration may be revoked,
suspended, or modified, in whole or in part in accordance with subsection
(l)(3)(C)(iii) of this section.
(C) Each certificate of registration revoked by the
agency ends at the end of the day on the date of the agency's final
determination to revoke the certificate of registration, or on the
revocation date stated in the determination, or as otherwise provided
by the agency order.
Cont'd... |
