| (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;
(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
department per 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, and power
supply, per §289.227(o)(2) 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 the timer, tube,
and power supply, per §289.232(j)(5)(J)(i) and §289.233(j)(5)(N)(i)(I)
- (III) of this title, as applicable.
(6) Radiation air kerma rate or dose measurements for
fluoroscopy and computed tomography (CT) radiation machines, as required
by §289.227 and §289.233 of this title shall be performed
by a licensed medical physicist with a specialty in diagnostic medical
physics.
(7) Radiation entrance exposure data required during
EPEs on general radiographic and special purpose radiation machines,
as defined in §289.227(e) and §289.233(d) 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 data;
(B) calculate the entrance exposure;
(C) verify the entrance exposure meets compliance with §289.227(j)
of this title;
(D) retest the machine, by measuring entrance exposure,
at the facility's specified technique after repair or adjustment by
a service technician;
(E) submit any test or EPE results to the facility
within 30 days after completion of testing. Documentation shall include:
(i) name of the facility;
(ii) address of facility; if satellite facility, address
of where the radiation machine is located;
(iii) business email address;
(iv) registration number of the facility;
(v) make, model, and serial number from the machine
control panel;
(vi) registration number of physicist and service company
performing EPE;
(vii) mailing/business address of physicist performing
EPE;
(viii) date of the last calibration of testing equipment;
(ix) signature of physicist that performed the EPE;
(F) retain documentation of subparagraph (E) of this
paragraph according to subsection (v) of this section; and
(G) maintain a calibrated dosimetry system available
for use:
(i) The system shall be calibrated by the National
Institute for Standards and Technology (NIST) or by an American Association
of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration
Laboratory (ADCL).
(ii) The calibration shall be performed within the
previous 24 months and after any servicing that may have affected
system calibration.
(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 per 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 terminate
radiation machine servicing or radiation services as applicable; and
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