| (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;
(ii) name and address of the customer; and
(iii) customer's certificate of registration number
unless the service provided is an initial installation as described
in paragraph (6) of this subsection.
(B) Records of all demonstrations and sales shall be
made and maintained for inspection by the department per subsection
(v) of this section.
(C) Individuals must not be exposed to the useful beam
except for healing arts purposes and unless such exposure has been
specifically and individually ordered by a licensed practitioner of
the healing arts. This provision specifically prohibits deliberate
exposure for the following purposes:
(i) exposure of an individual for training or demonstration;
(ii) QA/QC testing; or
(iii) other non-healing arts purposes.
(D) Demonstration of radiation machines performed by
the service provider shall be on phantoms only.
(E) The registrant authorized for demonstration and
sale of radiation machines is responsible for performing and documenting
all tests required by §289.227 of this title when demonstration
of a radiation machine involves exposure specifically and individually
ordered by a licensed practitioner of the healing arts.
(n) Responsibilities of RSOs.
(1) Duties of the RSO include:
(A) establishing and overseeing operating and safety
procedures that maintain radiation exposures as low as reasonably
achievable (ALARA);
(i) review them at intervals not to exceed 12 months
to ensure that the procedures are current and conform with this chapter;
and
(ii) review and ensure that all actions required in
this chapter are performed at the respective intervals to maintain
compliance;
(B) ensuring that individual monitoring devices are
properly used by occupationally-exposed personnel, records are kept
of the monitoring results, and timely notifications are made as required
by §289.203 of this title;
(C) investigating and reporting to the department each
known or suspected case of radiation exposure to an individual or
radiation level detected in excess of limits established by this chapter;
(D) assuming control and having the authority to institute
corrective actions including the shut-down of operations when necessary
in an emergency or unsafe conditions;
(E) ensuring that corrective actions for violations
issued by the department are implemented to avoid a repeat violation;
and
(F) maintaining records as required by this chapter.
(2) The RSO shall ensure that personnel are adequately
trained and complying with this chapter, the conditions of the certificate
of registration, and the operating and safety procedures of the registrant.
(3) The RSO shall make entries of the records in paragraph
(1) of this subsection at intervals not to exceed 30 days after receipt
of a monitoring report.
(o) Responsibilities of assemblers and installers.
(1) 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 the initial installation of the first machine(s)
for a new certificate of registration.
(2) Persons who assemble or install radiation machines
shall notify the department of the following information within 30
days after assembly or installation:
(A) the name, address, and certificate of registration
number, except in the case of initial machine installation, of persons
who have received the machines;
(B) the type of radiation machine, the manufacturer's
name, model number, and control panel serial number of each radiation
machine; and
(C) the date of transfer or disposal of each radiation
machine.
(3) Persons who assemble, install, or repair radiation
machines, or components of the machines, shall ensure the radiation
machines meet the applicable requirement of this chapter when the
machines are placed in operation.
(4) Persons assembling, installing, and repairing radiation
machines shall keep a daily log to include the following information:
(A) date of service;
Cont'd... |
