| (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 agency in accordance with
subsection (v) of this section.
(C) Demonstration of radiation machines on humans shall
be performed by or under the direction of a practitioner in accordance
with paragraph (11) of this subsection.
(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 all tests
in accordance with §289.227 of this title for radiation machines
used on humans for demonstration purposes.
(n) Responsibilities of RSOs.
(1) Duties of the RSO include, but are not limited
to:
(A) establishing and overseeing operating and safety
procedures that maintain radiation exposures as low as reasonably
achievable (ALARA), and to review them at intervals not to exceed
12 months to ensure that the procedures are current and conform with
this chapter;
(B) ensuring that individual monitoring devices are
properly used by occupationally-exposed personnel, that records are
kept of the monitoring results, and that timely notifications are
made as required by §289.203 of this title;
(C) investigating and reporting to the agency 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 shut-down of operations when necessary
in emergency situations or unsafe conditions; and
(E) 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.
(o) Responsibilities of assemblers and/or 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 agency 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 agency of the following information within 30 days
of 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:
(A) date;
(B) name of customer;
(C) customer's certificate of registration number unless
the installation is an initial installation described in paragraph
(1) of this subsection; and
(D) records of assembling, installing and repairing
of the machines shall be made and maintained for inspection by the
agency in accordance with subsection (v) of this section.
(5) Equipment performance evaluations shall be performed
as follows:
(A) on all medical, chiropractic or podiatric radiation
machines within 30 days after the initial installation, re-installation,
and after repair of a machine component that would affect the radiation
output that includes but is not limited to the timer, tube, power
supply, and thereafter, in accordance with §289.227(o)(1) of
this title; and
(B) on all dental radiation machines and radiation
machines used in veterinary medicine within 30 days after the initial
installation, re-installation, and after repair of a machine component
that would affect the radiation output that includes but is not limited
to the timer, tube, and power supply, and thereafter, in accordance
with §289.232(i)(7) and §289.233(i)(5)(N) of this title.
(6) Radiation exposure rate (air kerma rate) or dose
measurements for fluoroscopy and computed tomography (CT) radiation
machines, as required by §289.227 of this title, shall be performed
by a licensed medical physicist with a specialty in diagnostic medical
physics.
(7) Radiation entrance exposure (air kerma) data required
during EPEs on general radiographic and special purpose radiation
machines, as defined in §289.227(e) of this title, shall be performed
by or under the supervision of a licensed medical physicist with a
specialty in diagnostic medical physics. The physicist shall:
(A) establish written procedures for non-physicists
that document entrance exposure (air kerma) data;
(B) calculate the entrance exposure (air kerma);
(C) verify the entrance exposure (air kerma) meets
compliance with §289.227(j) of this title; and
(D) sign the EPE reports.
(p) Expiration of certificates of registration.
(1) Except as provided by subsection (r) of this section,
each certificate of registration expires at the end of the day, in
the month and year stated in the certificate of registration.
(2) If a registrant does not submit an application
for renewal of the certificate of registration in accordance with
subsection (r) of this section, as applicable, on or before the expiration
date specified in the certificate of registration, the registrant
shall:
(A) terminate use of all radiation machines and/or
terminate radiation machine servicing or radiation services; and
(B) pay any outstanding fees in accordance with §289.204
of this title.
(3) Expiration of the certificate of registration does
not relieve the registrant of the requirements of this chapter.
(q) Termination of certificates of registration.
(1) When a registrant decides to terminate all activities
involving radiation machines or services authorized under the certificate
of registration, the registrant shall immediately:
(A) request termination of the certificate of registration
in writing signed by the RSO, owner, or an individual authorized to
act on behalf of the registrant; and
(B) submit to the agency a record of the disposition
of the radiation machines, if applicable; and if transferred, to whom
they are transferred.
(2) The registrant shall pay any outstanding fees in
accordance with §289.204 of this title.
(r) Renewal of certificates of registration.
(1) An application for renewal of a certificate of
registration shall be filed in accordance with subsection (e) of this
section and applicable paragraphs of subsections (f) - (j) of this
section.
(2) If a registrant files an application for a renewal
in proper form before the existing certificate of registration expires,
such existing certificate of registration shall not expire until the
application status has been determined by the agency.
(s) Modification, suspension, and revocation of certificates
of registration.
(1) 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 rules in this chapter or orders issued by
the agency.
(2) Any certificate of registration may be revoked,
suspended, or modified, in whole or in part, for:
(A) any material false statement in the application
or any statement of fact required under provisions of the Act;
(B) conditions revealed by such application or statement
of fact or any report, record, or inspection, or other means that
would warrant the agency to refuse to grant a certificate of registration
on an original application;
(C) violation of, or failure to observe any of the
terms and conditions of the Act, this chapter, the certificate of
registration, or order of the agency; or
Cont'd... |
